Edluar

Generic Name: zolpidem (zole PI dem)

Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

What is zolpidem?

Zolpidem is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Zolpidem is used to treat insomnia. The immediate-release forms of zolpidem are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

Your doctor will determine which form of zolpidem is best for you.

Zolpidem may also be used for purposes not listed in this medication guide.

What is the most important information I should know about zolpidem?

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed. Zolpidem may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

What should I discuss with my healthcare provider before taking zolpidem?

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure you can safely take zolpidem, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease;


• 
  

  lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);

  
  


• 
  

  sleep apnea (breathing stops during sleep);

  
  


• 
  

  myasthenia gravis;

  
  


• 
  

  a history of depression, mental illness, or suicidal thoughts; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The sedative effects of zolpidem may be stronger in older adults. Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

How should I take zolpidem?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.

Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.

Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice. Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.

Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days.

Store at room temperature away from moisture and heat. Do not freeze. Keep the Zolpimist bottle upright when not in use.

What happens if I miss a dose?

Since zolpidem is taken only at bedtime, you will not be on a frequent dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking zolpidem?

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem side effects

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself. Stop using zolpidem and call your doctor at once if you have a serious side effects:

• 
  

  chest pain, fast or irregular heartbeat, feeling short of breath;

  
  


• 
  

  trouble breathing or swallowing; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;

  
  


• 
  

  tired feeling, loss of coordination;

  
  


• 
  

  dry mouth, nose or throat irritation;

  
  


• 
  

  nausea, constipation, diarrhea, upset stomach;

  
  


• 
  

  stuffy nose, sore throat; or

  
  


• 
  

  headache, muscle pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect zolpidem?

You may need a lower dose of zolpidem if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.

Tell your doctor about all other medicines you use, especially:

• 
  

  chlorpromazine (Thorazine);

  
  


• 
  

  itraconazole (Sporanox), ketoconazole (Nizoral);

  
  


• 
  

  rifampin (Rifadin, Rimactane, Rifater); or

  
  


• 
  

  antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).

  
  

This list is not complete and other drugs may interact with zolpidem. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Edluar resources

• Edluar Side Effects (in more detail)
• Edluar Use in Pregnancy & Breastfeeding
• Edluar Drug Interactions
• Edluar Support Group
• 5 Reviews for Edluar - Add your own review/rating

• Edluar Prescribing Information (FDA)


• Edluar Advanced Consumer (Micromedex) - Includes Dosage Information


• Edluar MedFacts Consumer Leaflet (Wolters Kluwer)


• Edluar Consumer Overview


• Zolpidem Prescribing Information (FDA)


• Ambien Monograph (AHFS DI)


• Ambien Prescribing Information (FDA)


• Ambien MedFacts Consumer Leaflet (Wolters Kluwer)


• Ambien Consumer Overview


• Ambien CR Prescribing Information (FDA)


• Ambien CR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Intermezzo Consumer Overview


• ZolpiMist Consumer Overview


• Zolpimist Prescribing Information (FDA)


• Zolpimist Oral Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Edluar with other medications

• Insomnia

Where can I get more information?

• Your pharmacist can provide more information about zolpidem.

See also: Edluar side effects (in more detail)

Glicerolo Dynacren

Glicerolo Dynacren may be available in the countries listed below.

Ingredient matches for Glicerolo Dynacren

Glycerol

Glycerol is reported as an ingredient of Glicerolo Dynacren in the following countries:

• Italy

International Drug Name Search

Nicorette White Ice

nicotine polacrilex

Dosage Form: gum, chewing
Drug Facts

Active Ingredient ( in each chewing piece)

Nicotine polacrilex (equal to 2mg nicotine)

Nicotine polacrilex (equal to 4mg nicotine)

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet


• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase blood pressure.


• stomach ulcer or diabetes

Ask a doctor or a pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth, teeth or jaw problems occur


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  

   

  
  

Keep out of reach of children and pets.

 Pieces of  nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions 2mg

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the gum


• if you smoke 25 or more cigarettes a day; use 4mg nicotine gum


• if you smoke less than 25 cigarettes a day; use according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 piece every 1 to 2 hours	1 piece every 2 to 4 hours	1 piece every 4 to 8 hours

• nicotine gum is a medicine and must be used a certain way to get the best results


• chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.


• repeat this process until most of the tingle is gone (about 30 minutes)


• do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece


• to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks


• if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.


• do not use more than 24 pieces a day


• it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

Directions 4 mg

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the gum


• if you smoke less than 25 cigarettes a day; use 2mg nicotine gum


• if you smoke 25 or more cigarettes a day; use according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 piece every 1 to 2 hours	1 piece every 2 to 4 hours	1 piece every 4 to 8 hours

• nicotine gum is a medicine and must be used a certain way to get the best results


• chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.


• repeat this process until most of the tingle is gone (about 30 minutes)


• do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece


• to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks


• if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.


• do not use more than 24 pieces a day


• it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

 

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.


2. Use Enough – Chew at least 9 pieces of Nicorette per day during the first six weeks.


3. Use Long Enough – Use Nicorette for the full 12 weeks.


4. Use with a support program as directed in the enclosed User’s Guide.

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

Free Audio CD upon request. See inside.

To remove the gum, tear off single unit.

Push gum through foil.

Peel off backing, starting at corner with loose edge.

• not for sale to those under 18 years of age


• proof of age required


• not for sale in vending machines or from any source where proof of age cannot be verified.

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

Other information:

• each 2 mg piece contains: calcium 94 mg, sodium 11 mg


• each 4 mg piece contains: calcium 94 mg, sodium 13 mg


• store at 20 - 25oC (68 - 77oF)


• protect from light

Inactive Ingredients White Ice Mint

each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive Ingredients Original

each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive Ingredients Cinnamon Surge

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive Ingredients Fresh Mint

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

Inactive Ingredients Mint

each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Questions and comments?

call toll-free 1-800-419-4766 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

Distributed by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Sweden

NICORETTE is a registered trademark of the GlaxoSmithKline group of companies.

©2009 GlaxoSmithKline

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 2mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint®

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use Nicorette 4mg

40 PIECES, 2mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 4mg stop smoking aid

Gum

WHITENS TEETH

Coated

FOR BOLD FLAVOR

White Ice Mint®

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicorette 2mg

40 PIECES, 4mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 2mg stop smoking aid

Gum

Original 

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use Nicorette 4mg

110 PIECES, 2mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 4mg stop smoking aid

Gum

Original

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicorette 2mg

110 PIECES, 4mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 2mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon SurgeTM

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use Nicorette 4mg

110 PIECES, 2mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 4mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon SurgeTM

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicorette 2mg

110 PIECES, 4mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 2mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use Nicorette 4mg

100 PIECES, 2mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 4mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicorette 2mg

100 PIECES, 4mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 2mg stop smoking aid

Gum

Mint

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use Nicorette 4mg

110 PIECES, 2mg EACH

Principal Display Panel

Nicorette®

nicotine polacrilex gum, 4mg stop smoking aid

Gum

Mint 

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicorette 2mg

110 PIECES, 4mg EACH

NICORETTE  WHITE ICE MINT nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0474 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACESULFAME POTASSIUM   CARNAUBA WAX   HYPROMELLOSE   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   POLYSORBATE 80   SODIUM BICARBONATE   SODIUM CARBONATE   SUCRALOSE   TITANIUM DIOXIDE   XYLITOL

Product Characteristics Color WHITE Score no score Shape SQUARE Size 15mm Flavor MINT (White Ice Mint) Imprint Code N2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0474-01 20 PARTS In 1 BLISTER PACK None 2 0135-0474-07 40 PARTS In 1 BLISTER PACK None 3 0135-0474-02 100 PARTS In 1 BLISTER PACK None 4 0135-0474-05 160 PARTS In 1 BLISTER PACK None 5 0135-0474-03 190 PARTS In 1 BLISTER PACK None 6 0135-0474-04 210 PARTS In 1 BLISTER PACK None 7 0135-0474-06 120 PARTS In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018612	06/29/2009

NICORETTE  WHITE ICE MINT nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0475 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACESULFAME POTASSIUM   CARNAUBA WAX   D&C YELLOW NO. 10   ALUMINUM OXIDE   HYPROMELLOSE   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   POLYSORBATE 80   SODIUM CARBONATE   SUCRALOSE   TITANIUM DIOXIDE   XYLITOL

Product Characteristics Color WHITE (cream) Score no score Shape SQUARE Size 15mm Flavor MINT (White Ice Mint) Imprint Code N4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0475-01 20 PARTS In 1 BLISTER PACK None 2 0135-0475-07 40 PARTS In 1 BLISTER PACK None 3 0135-0475-02 100 PARTS In 1 BLISTER PACK None 4 0135-0475-05 160 PARTS In 1 BLISTER PACK None 5 0135-0475-03 190 PARTS In 1 BLISTER PACK None 6 0135-0475-04 210 PARTS In 1 BLISTER PACK None 7 0135-0475-06 120 PARTS In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	06/29/2009

NICORETTE  ORIGINAL nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0157 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   GLYCERIN   SODIUM BICARBONATE   SODIUM CARBONATE   SORBITOL

Product Characteristics Color WHITE (beige) Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0157-09 50 PARTS In 1 BLISTER PACK None 2 0135-0157-07 110 PARTS In 1 BLISTER PACK None 3 0135-0157-10 170 PARTS In 1 BLISTER PACK None 4 0135-0157-11 200 PARTS In 1 BLISTER PACK None 5 0135-0157-12 220 PARTS In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018612	06/29/2009

NICORETTE  ORIGINAL nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0158 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   D&C YELLOW NO. 10   GLYCERIN   SODIUM CARBONATE   SORBITOL

Product Characteristics Color WHITE (beige) Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0158-09 50 PARTS In 1 BLISTER PACK None 2 0135-0158-07 110 PARTS In 1 BLISTER PACK None 3 0135-0158-10 170 PARTS In 1 BLISTER PACK None 4 0135-0158-11 200 PARTS In 1 BLISTER PACK None 5 0135-0158-12 220 PARTS In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	06/29/2009

NICORETTE  CINNAMON SURGE nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0466 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACACIA   ACESULFAME POTASSIUM   CARNAUBA WAX   HYPROMELLOSE   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   POLYSORBATE 80   SODIUM BICARBONATE   SODIUM CARBONATE   SUCRALOSE   TITANIUM DIOXIDE   XYLITOL

Product Characteristics Color WHITE Score no score Shape SQUARE Size 15mm Flavor CINNAMON Imprint Code N2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0466-01 20 PARTS In 1 BLISTER PACK None 2 0135-0466-07 40 PARTS In 1 BLISTER PACK None 3 0135-0466-02 100 PARTS In 1 BLISTER PACK None 4 0135-0466-05 160 PARTS In 1 BLISTER PACK None 5 0135-0466-03 190 PARTS In 1 BLISTER PACK None 6 0135-0466-04 120 PARTS In 1 BLISTER PACK None 7 0135-0466-06 210 PARTS In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018612	06/29/2009

NICORETTE  CINNAMON SURGE nicotine polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0467 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACACIA   ACESULFAME POTASSIUM   CARNAUBA WAX   D&C YELLOW NO. 10   ALUMINUM OXIDE   HYPROMELLOSE   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   POLYSORBATE 80   SODIUM CARBONATE   SUCRALOSE   TITANIUM DIOXIDE   XYLITOL

Product Characteristics Color WHITE (cream) Score no score Shape SQUARE Size 15mm Flavor CINNAMON Imprint Code N4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0467-01 20 PARTS In 1 BLISTER PACK None 2 0135-0467-02 100 PARTS In 1 BLISTER PACK None 3 0135-0467-03 190 PARTS In 1 BLISTER PACK None 4 0135-0467-04 120 PARTS In 1 BLISTER PACK None 5 0135-0467-05 160 PARTS In 1 BLISTER PACK None 6 0135-0467-06 210 PARTS In 1 BLISTER PACK None

Nipent

Pronunciation: PEN-toe-sta-tin
Generic Name: Pentostatin
Brand Name: Nipent

The use of doses higher than specified by the manufacturer of Nipent is not recommended. Severe kidney, liver, lung, and central nervous system problems (toxicities) have occurred in some studies when using higher than recommended doses. Nipent is not recommended for use with fludarabine. The use of pentostatin in combination with fludarabine has caused severe lung problems; in some cases, this has led to death. Ask your doctor or pharmacist for more information.

Nipent is used for:

Treating certain types of cancer.

Nipent is an antineoplastic. How it prevents growth of cancer cells is unknown.

Do NOT use Nipent if:

• you are allergic to any ingredient in Nipent


• you are taking fludarabine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nipent:

Some medical conditions may interact with Nipent. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an infection, chickenpox, kidney problems, or blood problems

Some MEDICINES MAY INTERACT with Nipent. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carmustine, cyclophosphamide, etoposide, fludarabine, or vidarabine because the risk of side effects, including life-threatening lung toxicity, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nipent may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nipent:

Use Nipent as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nipent is administered as an injection at your doctor's office, hospital, or clinic.


• If Nipent accidentally spills on your skin, wash it off immediately with soap and water.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Nipent, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Nipent.

Important safety information:

• Nipent may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Nipent may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• Check with your doctor before having vaccinations while you are using Nipent.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Nipent.


• The use of birth control is recommended while you are using Nipent.


• LAB TESTS, including liver function, kidney function, and complete blood cell count, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nipent with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Nipent has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Nipent. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Nipent during pregnancy. It is unknown if Nipent is excreted in breast milk. Do not breast-feed while taking Nipent.

Possible side effects of Nipent:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fatigue; headache; loss of appetite; muscle pain; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; cough; eye pain or changes in vision; fever; hoarseness; itching; pain, redness, or swelling at the injection site; sore throat; sores on the mouth or lips; unusual bruising or bleeding; unusual tiredness or weakness

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nipent side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nipent:

Nipent is usually handled and stored by a health care provider. If you are using Nipent at home, store Nipent as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Nipent, please talk with your doctor, pharmacist, or other health care provider.


• Nipent is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nipent. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nipent resources

• Nipent Side Effects (in more detail)
• Nipent Use in Pregnancy & Breastfeeding
• Nipent Drug Interactions
• Nipent Support Group
• 0 Reviews for Nipent - Add your own review/rating

• Nipent Prescribing Information (FDA)


• Nipent Advanced Consumer (Micromedex) - Includes Dosage Information


• Nipent Concise Consumer Information (Cerner Multum)


• Nipent Monograph (AHFS DI)


• Pentostatin Prescribing Information (FDA)


• Pentostatin Professional Patient Advice (Wolters Kluwer)

Compare Nipent with other medications

• Hairy Cell Leukemia

Pausogest

Pausogest may be available in the countries listed below.

Ingredient matches for Pausogest

Estradiol

Estradiol is reported as an ingredient of Pausogest in the following countries:

• Czech Republic


• Lithuania

Estradiol hemihydrate (a derivative of Estradiol) is reported as an ingredient of Pausogest in the following countries:

• Hungary


• Slovakia

Norethisterone

Norethisterone is reported as an ingredient of Pausogest in the following countries:

• Czech Republic


• Hungary


• Lithuania

Norethisterone 17ß-acetate (a derivative of Norethisterone) is reported as an ingredient of Pausogest in the following countries:

• Slovakia

International Drug Name Search

Nora-BE

Generic Name: progestin contraceptives (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For Nora-BE

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Nora-BE

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy, or history of or


• Heart or circulation problems or


• Kidney disease, severe or


• Migraine headaches—May cause fluid buildup and make these conditions worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Breast disease (e.g., breast lumps or cysts), history of—May make this condition worse in certain types of diseases that do not react to progestins in a positive way.

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Nora-BE. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Nora-BE

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Nora-BE Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


• hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain or cramping


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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