CIPROFLOXACIN- ciprofloxacin tablet, film coated 
Blenheim Pharmacal, Inc.

----------

MEDICATION GUIDE
CIPROFLOXACIN (SIP-roe-FLOX-a-sin) TABLETS, USP

Read the Medication Guide that comes with ciprofloxacin tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ciprofloxacin tablets?
Ciprofloxacin tablets belong to a class of antibiotics called fluoroquinolones. Ciprofloxacin  tablets can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin tablets.

1. Tendon rupture or swelling of the tendon (tendinitis)

2. Worsening of myasthenia gravis (a disease which causes muscle weakness).

Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section “What are the possible side effects of ciprofloxacin tablets?” for more information about side effects.

What are ciprofloxacin tablets?
Ciprofloxacin tablets are fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria.

Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin tablets. Ciprofloxacin tablets should not be used as the first choice of antibiotic medicine in children under 18 years of age.

Ciprofloxacin tablets should not be used in children under 18 years old, except to treat specific serious infections, such as complicated urinary tract infections and to prevent anthrax disease after breathing the anthrax bacteria germ (inhalational exposure).

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including ciprofloxacin tablets, do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking ciprofloxacin tablets.

Who should not take ciprofloxacin tablets?
Do not take ciprofloxacin tablets if you:

What should I tell my healthcare provider before taking ciprofloxacin tablets?
See “What is the most important information I should know about ciprofloxacin tablets?

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ciprofloxacin tablets?

This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to ciprofloxacin  tablets. If this happens, ciprofloxacin tablets and other antibiotic medicines may not work in the future.

If you have been prescribed ciprofloxacintablets after being exposed to anthrax:

What should I avoid while taking ciprofloxacin tablets?

What are the possible side effects of ciprofloxacin tablets?

○ Ciprofloxacin tablets can cause side effects that may be serious or even cause death. See “What is the most important information I should know about ciprofloxacin tablets?

Other serious side effects of ciprofloxacin tablets include:

You may have serious seizure and breathing problems when you take theophylline with ciprofloxacin tablets. These problems may lead to death. Get emergency help right away if you have seizures or trouble breathing.

Seizures have been reported in people who take fluoroquinolone antibiotics including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking ciprofloxacin tablets will change your risk of having a seizure.

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of ciprofloxacin tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

Allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only one dose. Stop taking ciprofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

Skin rash may happen in people taking ciprofloxacin tablets, even after only one dose. Stop taking ciprofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin tablets.

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:

Pseudomembranous colitis can happen with most antibiotics, including ciprofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin tablets. Stop ciprofloxacin tablets and talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

The nerve damage may be permanent.

People who take ciprofloxacin tablets and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with ciprofloxacin tablets. Your antibiotic medicine may need to be changed.

Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin tablets.

The most common side effects of ciprofloxacin tablets include:

These are not all the possible side effects of ciprofloxacin tablets. Tell your healthcare provider about any side effect that bothers you, or that does not go away.

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

How should I store ciprofloxacin tablets?

Keep ciprofloxacin tablets and all medicines out of the reach of children.

General Information about Ciprofloxacin Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin tablets for a condition for which it is not prescribed. Do not give ciprofloxacin tablets 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 ciprofloxacin tablets. If you would like more information about ciprofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin tablets that is written for healthcare professionals. For more information call 1-800-272-5525.

What are the ingredients in ciprofloxacin tablets?

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

Brands listed are the trademarks of their respective owners.

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: November 2014                          

Revised: 12/2015
Blenheim Pharmacal, Inc.