Ciprofloxacin 500mg Film-Coated Tablets

Document: leaflet TEVA UK_PL 00289-1435 change

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CIPROFLOXACIN 250 mg FILM-COATED TABLETS CIPROFLOXACIN 500 mg FILM-COATED TABLETS CIPROFLOXACIN 750 mg FILM-COATED TABLETS

PATIENT LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start

taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1. What Ciprofloxacin is and what it is used for

2. Before you take Ciprofloxacin

3. How to take Ciprofloxacin

4. Possible side effects

5. How to store Ciprofloxacin

6. Further information

OWHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR

• Ciprofloxacin belongs to a group of antibiotics called quinolones, which work by killing bacteria that cause some types of infections • Ciprofloxacin is used to treat bacterial infections, including:

• Infections of the bladder and kidneys • Respiratory infections, such as pneumonia • Infections of the genital organs including uncomplicated gonorrhoea (a sexually transmitted disease) and prostatitis (inflammation of the prostate gland)

• Severe gastro-enteritis (inflammation of the small intestine and the stomach)

• Infections of the skin and soft tissues • Bone infections

• Infections that have spread to the blood • Infections in the abdomen • Infections in patients who have poor immunity • Ciprofloxacin may also be used for treating lung infections in children aged five years or older and adolescents suffering from cystic fibrosis (see also the advice under 'Do not take Ciprofloxacin').

^ BEFORE YOU TAKE CIPROFLOXACIN

Do NOT take Ciprofloxacin

• If you are allergic (hypersensitive) to

Ciprofloxacin or any of the other ingredients of Ciprofloxacin or to other antibiotics of the same type (called quinolones)

• If you are pregnant or breast-feeding • If you have a history of pain or swelling of tendons that were thought to be related to the use of a quinolone antibiotic (See also the advice under 'Take special care with Ciprofloxacin')

• If you take tizanidine for spasticity associated with multiple sclerosis or injury of the spinal cord (See also the advice under 'Taking other medicines')

• If the patient is less than 5 years old • If the patients are 5-17 years old (unless you are being treated for cystic fibrosis) (See also the advice under 'What Ciprofloxacin is and what it is used for').

Take special care with Ciprofloxacin

• If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucous, tell your doctor immediately (See also the advice under 'Possible side effects')

• If you experience pain or swelling of tendons while you are taking these tablets, particularly if you are elderly or are taking medicines known as corticosteroids, rest the affected limb, stop taking the tablets, and see your doctor immediately (See also the advice under 'Do not take Ciprofloxacin' and 'Possible side effects')

• If you feel depressed, anxious or confused, have a mental illness and/or feel that you want to physically harm yourself, stop taking your medicine immediately and consult your doctor (See also the advice under 'Possible side effects')

• If your doctor has told that you are at risk of getting a heart rhythm disorder called 'Torsade de pointes' or if you are taking any medicines that can increase the risk of having this rhythm disorder • While you are taking Ciprofloxacin, do not sunbathe or use a UV tanning lamp because there is an increased risk of skin burning • If you have to have a test for tuberculosis while you are taking Ciprofloxacin, make sure the doctor or nurse knows about your medicine. Ciprofloxacin can interfere with the results of laboratory tests for tuberculosis. ¹

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• You must not take ciprofloxacin if you are already taking tizanidine. Also, you must not start taking tizanidine while you are taking ciprofloxacin. (See above).

• Do not take the following products at the same time as Ciprofloxacin tablets as they can reduce the blood levels of ciprofloxacin.

Take Ciprofloxacin 1 or 2 hours before, or at least 4 hours after these products:

• Indigestion medicines such as antacids, sucralfate

• Some types of food supplements (check with your doctor or pharmacist if these may be a problem)

• Medicines containing buffered didanosine (a drug used to treat HIV infection)

• Products containing iron, zinc, magnesium, aluminium or calcium (including multivitamins)

• Care is also needed if you are taking any of the following:

• Theophylline, pentoxifylline, or medicines that contain caffeine

• Certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs). Some of these (e.g. ibuprofen) are medicines that you can buy without a prescription

• Ciclosporin (used after organ transplant and for e.g. arthritis and severe psoriasis)

• Medicines that prevent the blood from clotting normally (anticoagulants), such as warfarin

• Glibenclamide for diabetes

• Probenecid (used in the treatment of chronic gout or gouty arthritis)

• Metoclopramide (a medicine used to prevent the feeling of sickness (nausea)

• Mexiletine (a medicine used to treat heart rhythm disturbances)

• Phenytoin for epilepsy

• A medicine called ropinirole for Parkinson's disease

• Methotrexate (used to treat certain tumours, psoriasis and rheumatoid arthritis)

• Clozapine an anti-psychotic (to treat conditions such as schizophrenia)

• Tacrine for Alzheimer's disease

• Tizanidine (medicine for spasticity associated with multiple sclerosis or injury or diseases of the spinal cord, See also the advice under 'Do not take Ciprofloxacin')

• Before being given a general anaesthetic, make sure to tell your doctor or dentist that you are taking Ciprofloxacin.

Taking Ciprofloxacin with food and drink

Swallow the tablets with plenty of fluid (such as water, but not milk).

Do not chew the tablets.

Do not eat or drink dairy products (such as milk or yoghurt) at the time of taking the tablets. Take Ciprofloxacin tablets either 1-2 hours before or at least 4 hours after eating or drinking dairy products. Dairy products can reduce the effect of ciprofloxacin.

You can take the tablets before, with, or after a meal.

Pregnancy and breast-feeding

Do not take Ciprofloxacin if you are pregnant, think you may be pregnant, or if you are breast-feeding. There is a risk that Ciprofloxacin may harm the growth of babies before and after birth.

Driving and using machines

Ciprofloxacin may make you feel less alert, which may affect your ability to drive or operate machinery. This is more likely to occur at the start of treatment, if the dose is increased, or if you drink alcohol. Therefore, make sure you know how you react to Ciprofloxacin. Don't drive if you feel less alert.

HOW TO TAKE CIPROFLOXACIN

Always take Ciprofloxacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose you are prescribed will depend on the type and severity of your infection.

The usual dose range is 100 mg to 750 mg twice daily.

If you are elderly or have kidney problems, your doctor may give you a single daily dose or a lower dose. Also, special dosing instructions are needed if you are having dialysis to treat kidney problems. In these cases, it is very important to follow your doctor's instructions carefully.

Your doctor will tell you how long your treatment with Ciprofloxacin will last.

If you take more Ciprofloxacin than you should

If you have taken more Ciprofloxacin than you should, consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that the doctor will know what you have taken.

The main effects of overdose are: dizziness, shaking, headache, convulsions, hallucinations, confusion, gastric and intestinal discomfort, and blood in urine.

Codes to be added at Biogal

If you forget to take Ciprofloxacin

If you forget to take Ciprofloxacin at the right time, take it as soon as you remember and take the next tablet as normal. Do not, however, take a double dose to make up for a forgotten tablet.

If you stop taking Ciprofloxacin

It is important that you keep taking Ciprofloxacin until the prescribed course is finished. Do not stop taking the tablets just because you feel better. If you stop too soon, the infection may start up again. If you still feel unwell at the end of your prescribed course of treatment, tell your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Ciprofloxacin can cause side effects, although not everybody gets them.

If any of the following effects happen, you may have had a serious allergic reaction. Stop taking Ciprofloxacin and tell your doctor immediately or go to the casualty department at your nearest hospital. These are very serious side effects, you may need urgent medical attention.

• Skin rash, itching, peeling, blistering or crusting

• Severe or painful redness or sores on your skin or mucous membrane (e.g.) mouth

• Swelling of the face or neck

• Breathing problems

• Raised body temperature (fever)

• Yellow discoloration of the skin or eyes

• Skin rash occurs in less than one patient in every 10 patients treated, itching, peeling, blistering or crusting and swelling of the face or neck occur in less than one patient in every 100 patients treated; all other effects occur in less than one patient in every 1,000 persons treated.

Also tell your doctor immediately and stop taking Ciprofloxacin if you notice:

• Pain or swelling in the tendons or joints. In less than 1 in 10,000 patients treated this may lead to tendon rupture especially of the large tendon at the back of the ankle

• Severe or persistent diarrhoea with bleeding or mucous. Severe and persistent diarrhoea can occur during the treatment or a few days after the treatment. This effect occurs in less than one in every 1,000 patients treated

• A feeling that you want to physically harm yourself. This only occurs in less than 1 in 10,000 patients.

Other possible side effects of Ciprofloxacin are:

Common (affecting fewer than one person in 10 but more than one person in every 100) patients treated:

• Nausea (feeling sick), mild diarrhoea or loose stools.

Uncommon (affecting fewer than one person in 100 but more than one person in every 1000) patients treated:

• Thrush (a yeast infection)

• Loss of appetite

• Headache, dizziness, inability to sleep (insomnia), restlessness, confusion, a general feeling of weakness or tiredness

• Altered sense of taste

• Vomiting (being sick), indigestion, flatulence (wind), stomach pains

• Joint pain

• Increase in bilirubin (a chemical) in the blood

• Increase in some blood chemicals that normally pass through the kidneys or reflect how the liver is working

• Low numbers of some types of white blood cells, that could cause an increased risk of infections. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or local symptoms such as a sore throat or mouth or urinary problems you should see your doctor immediately, and make sure that you inform her/him about your medicine

• An increase in one type of white blood cell that can sometimes be associated with breathing difficulties.

Very rare (affecting fewer than one person in every 10,000) patients treated:

• Thrush in the gut

• Migraine

• Unsteadiness of gait, abnormal sensation, abnormal muscle tone, twitching, 'grand mal' fits involving the whole body, and increase in the pressure around your brain, anxiety, mental illness

• Taste loss, loss or disturbance of the sense of smell, disturbed vision (seeing double, colour vision disturbances), ringing in the ears (tinnitus), and hearing loss (especially high frequency hearing loss), which returns to normal once treatment with Ciprofloxacin finishes

• Inflammation of the blood vessels which may be associated with a raised skin rash, blisters and crusting

• Heart rhythm disturbances, irregular or rapid heartbeat

• Inflammation of the liver (hepatitis)

• Severe anaemia, decreases in all types of blood cells

• Increase in some blood chemicals that reflect how the pancreas is working.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE CIPROFLOXACIN Keep out of the reach and sight of children.

Expiry date

Do not use Ciprofloxacin after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION What Ciprofloxacin contains

• The active substance is ciprofloxacin hydrochloride

• Each 250 mg film-coated tablet contains 250 mg of ciprofloxacin as hydrochloride

• Each 500 mg film-coated tablet contains 500 mg of ciprofloxacin as hydrochloride

• Each 750 mg film-coated tablet contains 750 mg of ciprofloxacin as hydrochloride

• The other ingredients are microcrystalline cellulose, povidone, croscarmellose sodium, colloidal silica and magnesium stearate. The coating contains hypromellose, macrogol 400 and the colour titanium dioxide (E171).

What Ciprofloxacin looks like and contents of the pack

• 250 mg: White, biconvex, round film-coated tablets, debossed "CIP 250" and breakline on one side and plain on the other. The tablet can be divided into equal halves.

The product is available in pack sizes¹ of 8, 10, 12, 16, 20, 30, 50, 100 and 160 tablets

• 500 mg: White, capsule shaped film-coated tablets, debossed "CIP 500" and breakline on one side and plain on the other. The tablet can be divided into equal halves.

The product is available in pack sizes¹ of 6, 8,

10, 12, 16, 20, 30, 50, 100, 120 and 160 tablets

• 750 mg: White, capsule shaped film-coated tablets, debossed "CIP 750" on one side and plain on the other.

The product is available in pack sizes¹ of 8, 10, 12, 16, 20, 30, 50, 100 and 160 tablets.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tenlec Pharma Ltd, Broadlands, Hailsham BN27 1PQ

Company responsible for Manufacture

TEvA UK Limited, Eastbourne, BN22 9AG

This leaflet was last approved in April 2008

T7WT1

Rare (affecting fewer than one person in every

1,000 patients but not more than one person in

10,000) treated:

• Thrush affecting the mouth or vagina

• Increased sugar in the blood

• Hallucinations, pins and needles or altered sensation, nightmares, depression, uncontrolled shaking, fits, sleepiness, aggravation of the symptoms of myasthenia gravis

• Increased heart rate, fainting, hot flushes, low blood pressure

• Difficulty swallowing, inflammation of the pancreas, which may be associated with severe stomach and/or back pain

• Yellowing of the skin and eyes (jaundice), liver problems leading to liver failure

• Increased risk of sunburn, raised skin rash

• Muscle pain or weakness, joint swelling, pain in the limbs, hands or feet, back pain

• Problems with the kidneys leading to their failure, crystals in the urine

• Pain, chest pain, sweating, drug fever, swelling in the limbs, the blood vessels or face

• Anaemia, changes in blood clotting or decreases in several types of white blood cells that can lead to an increased risk of infection (see above).

TEVA UK LIMITED

Before starting treatment with Ciprofloxacin, tell your doctor:

• If you have previously had "fits" or suffer from epilepsy or you have ever suffered from other conditions related to the brain (e.g. brain damage or stroke)

• if you or any member of your family have a deficiency in the blood enzyme called glucose-6-phosphate dehydrogenate (G6PD)

• if you have a problem with weakness in your muscles called myasthenia gravis • if you have problems with the liver and kidneys. Your doctor may reduce the dose of the tablets if your kidneys are not working properly.