ZENATANE- isotretinoin capsule, gelatin coated 
Dr. Reddy's Laboratories Limited

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MEDICATION GUIDE

ZENATANETM (ZEN – a – tān)
(isotretinoin capsules)

Read the Medication Guide that comes with Zenatane™ before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. 

What is the most important information I should know about Zenatane™?

1.  Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Zenatane™. Female patients must not get pregnant:

If you get pregnant while taking Zenatane™, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

2. Serious mental health problems. Zenatane™ may cause:

Stop Zenatane™ and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

After stopping Zenatane™, you may also need follow-up mental health care if you had any of these symptoms.

What is Zenatane™?

Zenatane™ is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Zenatane™ can cause serious side effects (see “What is the most important information I should know about Zenatane™?”). Zenatane™ can only be:

What is severe nodular acne?

Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.

Who should not take Zenatane™?

What should I tell my doctor before taking Zenatane™?

Tell your doctor if you or a family member has any of the following health conditions:

Tell your doctor if you are pregnant or breast-feeding. Zenatane must not be used by women who are pregnant or breast feeding. 

Tell your doctor about all of the medicines you take including prescription and non­prescription medicines, vitamins and herbal supplements. Zenatane™ and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

These medicines should not be used with Zenatane™ unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

How should I take Zenatane™?

You will not be prescribed Zenatane™ if you cannot agree to or follow all the instructions of the iPLEDGE program.

What should I avoid while taking Zenatane™?

What are the possible side effects of Zenatane™?

Stop Zenatane™ and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Zenatane™ may stop long bone growth in teenagers who are still growing.

These are not all of the possible side effects with Zenatane™. Your doctor or pharmacist can give you more detailed information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Dr. Reddys at 1-866-733-3952.

How should I store Zenatane™?

General Information about Zenatane™Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Zenatane™ for a condition for which it was not prescribed. Do not give Zenatane™ to other people, even if they have the same symptoms that you have. It may harm them.                                                                                                                                                                                                                                                                                              This Medication Guide summarizes the most important information about Zenatane™. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zenatane™ that is written for healthcare professionals.

You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients in Zenatane™?

Active Ingredient: isotretinoin

Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain gelatin, glycerin, methylparaben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red  (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333)  containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-27794 containing iron oxide black, N-butyl alcohol, propylene glycol, industrial methylene spirit and shellac.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dilantin is a registered trademark of Warner-Lambert Company LLC.

To reorder additional Medication Guides contact Dr. Reddy’s Customer Service at 1-866-733-3952.

Rx Only

Manufactured by:

Cipla Limited

Kurkumbh Village

Pune – 413 802 INDIA

Manufactured for:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA 

Issued: 0213

Zenatane is a trademark of Dr. Reddy's Laboratories, Inc. and/or its affiliates.

Revised: 02/2013
 
Dr. Reddy's Laboratories Limited