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Alna ocas beipackzettel ciprofloxacin

By Apothecary Shop Wholesale Inc. | Last revised: 21 June 2011

How should I take ciprofloxacin tablets?

  • Take ciprofloxacin tablets exactly as prescribed by your healthcare provider.
  • Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or ocas chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • Take ciprofloxacin extended-release tablets one time each day at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you cannot swallow the tablet whole.
  • Ciprofloxacin tablets can be taken with or without food.
  • Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
  • Drink plenty of fluids while taking ciprofloxacin tablets.
  • Do not skip any doses, or stop taking ciprofloxacin tablets even if you begin to feel better, until you finish your prescribed treatment, unless:
  • 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 miss a dose of ciprofloxacin tablets, take it as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
  • If you miss a dose of ciprofloxacin extended-release tablets, take it as soon as you remember. Do not take more than one dose in one day.
  • If you take too much, call your healthcare provider or get medical help immediately.

If you have been prescribed ciprofloxacin tablets after being exposed to anthrax:

  • Ciprofloxacin tablets has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • Take ciprofloxacin tablets exactly as prescribed by your healthcare provider. Do not stop taking ciprofloxacin tablets without talking with your healthcare provider. If you stop taking ciprofloxacin tablets too soon, it may not keep you from getting the anthrax disease.
  • Side effects may happen while you are taking ciprofloxacin tablets. When taking your ciprofloxacin tablets to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping ciprofloxacin tablets too soon are more important than the risks of side effects with ciprofloxacin tablets.
  • If you are pregnant, or plan to become pregnant while taking ciprofloxacin tablets, you and your healthcare provider should decide whether the benefits of taking ciprofloxacin tablets for anthrax are more important than the risks.

What should I avoid while taking ciprofloxacin tablets?

  • Ciprofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin tablets affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking ciprofloxacin tablets, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

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 aboutciprofloxacin tablets?”

Other serious side effects of ciprofloxacin tablets include:

  • Central Nervous System Effects: 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:

o feel dizzy

o seizures

o hear voices, see things, or sense things that are not there (hallucinations)

o feel restless

o tremors

o feel anxious or nervous

o confusion

o depression

  • Serious allergic reactions: Allergic reactions 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:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
    • yellowing of the skin or eyes. Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin tablets (a liver problem).
  • Skin rash: 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.
  • Serious heart rhythm changes (QT prolongation and torsades de pointes): 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:
    • who are elderly
    • with a family history of prolonged QT interval,
    • with low blood potassium (hypokalemia),
    • who take certain medicines to control heart rhythm (antiarrhythmics).
  • Intestine infection (Pseudomembranous colitis): 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.
  • Changes in sensation and possible nerve damage (Peripheral Neuropathy): Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin tablets. 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:
    • pain
    • burning
    • tingling
    • numbness
    • weakness

Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage.

  • Low blood sugar (hypoglycemia): 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.
  • Sensitivity to sunlight (photosensitivity): See “What should I avoid while takingciprofloxacin tablets?”
  • Joint Problems: 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:

  • nausea
  • headache
  • diarrhea
  • vomiting
  • vaginal yeast infection
  • changes in liver function tests
  • pain or discomfort in the abdomen

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?

  • Ciprofloxacin Tablets:

o Store ciprofloxacin tablets below 86°F (30°C).

  • Ciprofloxacin Extended-Release Tablets:

o Store ciprofloxacin extended-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

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.

What are the ingredients in ciprofloxacin tablets?

  • Ciprofloxacin Tablets:

o Active ingredient: ciprofloxacin

o Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, corn starch and titanium dioxide.

  • Ciprofloxacin Extended-Release Tablets:

o Active ingredient: ciprofloxacin

o Inactive ingredients: crospovidone, colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, polyethylene glycol, succinic acid and titanium dioxide

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA

Revised: 0309

Repackaged By: Apothecary Shop Wholesale Inc.
23620 N. 20th Dr. STE 12
Phoenix, AZ 85085

Apothecary Shop
WHOLESALE, INC.

NDC 42852-001-02

CIPROFLOXACIN

20 Tablets, USP

500 mg

Rx Only

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED

PRINCIPAL DISPLAY PANEL -- 20 Tablet Bottle Label

(click image for full-size original)

CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42852-001(NDC:55111-127)
Route of Administration ORAL DEA Schedule
alna ocas beipackzettel ciprofloxacin cellspacing="0">
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ciprofloxacin Hydrochloride (ciprofloxacin) Ciprofloxacin Hydrochloride 500 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Hypromelloses
Magnesium Stearate
Cellulose, Microcrystalline
Polyethylene Glycol 400
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code R;127
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42852-001-02 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075593 07/01/2011
Labeler — Apothecary Shop Wholesale Inc. (963582023)

Revised: 06/2011 Apothecary Shop Wholesale Inc.

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