Ciprofloxacin 750mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 20532-0013 change

a> o

CD s CD

Oi Q)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 100mg, 250mg, 500mg and 750mg film-coated Tablets

(ciprofloxacin hydrochloride)

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.

In this leaflet:

1. What Ciprofloxacin Tablets are and what are they used for

2. Before you take Ciprofloxacin Tablets

3. How to take Ciprofloxacin Tablets

4. Possible side effects

5. How to store Ciprofloxacin Tablets

6. Further information

1. WHAT CIPROFLOXACIN TABLETS ARE AND WHAT ARE THEY USED FOR

Ciprofloxacin belongs to a group of antibiotics called “quinolones”. It is used to treat infections caused by

bacteria sensitive to ciprofloxacin, including:

Adults

• respiratory tract infections

• urinary tract infections, e.g. cystitis (inflammation of the bladder) and pyelonephritis (inflammation of the kidney and its pelvis)

• sexually transmitted diseases (STDs), e.g. gonorrhoea and prostatitis (inflammation of the prostate gland in men)

• severe gastroenteritis (inflammation of the stomach and intestines)

• infections of the skin and soft tissues

• bone or joint infections

• severe systemic infections (affecting the whole body); e.g. septicaemia, peritonitis, infections in immunosuppressed patients.

Children and adolescents (5-17 years)

• acute lung infections in children with cystic fibrosis.

2. BEFORE YOU TAKE CIPROFLOXACIN TABLETS

Do not take Ciprofloxacin Tablets if you:

• or your child are allergic/hypersensitive to quinolones/ciprofloxacin or any of the other ingredients in the product (see Section 6 'What Ciprofloxacin Tablets contain)

• or your child has a history of tendon disorders from taking similar antibiotics

• are pregnant or breast-feeding.

Do not give Ciprofloxacin Tablets to:

• children under the age of 5.

• children between 5 and 17 years of age, unless they have a lung infection and suffer with cystic fibrosis (a hereditary disease of the exocrine glands).

Take special care with Ciprofloxacin Tablets

Speak to your doctor if you:

• have epilepsy or other central nervous system disorders (see also “NSAIDS” in Section below)

• experience severe or persistent diarrhoea during or after taking the medicine

• have kidney problems

• have family history of or actual defects in activity of the enzyme glucose-6-phosphate dehydrogenase

• suffer from sensitivity to sunlight or artificial UV light. Avoid excessive exposure to sunlight or artificial UV light.

Back

TO uo

V 05

1 05 O CD

• are elderly or being treated with corticosteroids; you may be prone to tendonitis (rupturing of tendons)

• have myasthenia gravis (a neuromuscular disorder characterised by muscle weakness).

It is important to drink plenty of fluids and avoid dehydration during treatment.

Heart problems. Caution should be taken when using this kind of medicine, if you were bom with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Taking other medicines).

Taking other medicines

You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

• xanthine derivatives, i.e. theophylline and pentoxifylline

• non-steroidal anti-inflammatory drugs (NSAIDs) such as fenbufen for pain and inflammation as these can induce fits

• ciclosporin (prevents transplant rejection)

• warfarin (prevents blood clots)

• glibenclamide (an antidiabetic agent)

• probenecid (used mainly to treat gout)

• metoclopramide (for digestive disorders, sickness, and certain conditions which occur after surgery)

• mexiletine (for abnormal heart rhythms)

• phenytoin (prevents epilepsy)

• premedications e.g. papaveretum, atropine or hyoscine (given before surgery)

• ropinirole (treats Parkinson's disease)

• sucralfate (for intestinal ulcers or gastritis)

• diazepam (mainly used to reduce anxiety and aid sleep)

• didanosine (an antiviral medicine).

Your doctor may recommend that you do not take any magnesium, aluminum, calcium, iron or zinc containing medicines while taking ciprofloxacin, e.g. antacids (for indigestion and heartburn) or multivitamin/mineral tablets. If you are taking these medicines, they should be taken at least 4 hours before or 2 hours after taking Ciprofloxacin.

Taking Ciprofloxacin Tablets with food and drink

The tablets can be taken at any time, with or without food; however dairy products with a high calcium content (e.g. milk, yoghurt) may delay the absorption of ciprofloxacin. You should therefore avoid eating dairy products for 4 hours before and 2 hours after taking Ciprofloxacin Tablets.

The following should also be avoided while taking ciprofloxacin:

• caffeine (e.g. coffee, tea), as this may produce undesirable effects.

• alcohol, especially if you are driving or operating machinery.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, do not take Ciprofloxacin Tablets as they may harm your baby. Ask your doctor for advice before taking any medicine.

Driving and using machines

This medicine should not make you drowsy. However you should not drive or operate machinery if you feel dizzy, so your concentration is not impaired while taking Ciprofloxacin Tablets.

3. HOW TO TAKE CIPROFLOXACIN TABLETS

For oral use only.

Ciprofloxacin Tablets should be swallowed with plenty of water, with or without food.

Always take the tablets exactly as your doctor has told you. The pharmacist's label should tell you how much to take and how often.

Adults

• Chest and lung infections: 250 - 500mg twice daily, for up to 28 days.

• Cystitis in women: 100 - 250mg twice daily, for 3 days.

• Other infections of the urinary tract (kidneys, bladder etc): 250 - 500 mg twice daily, for 7 to 14 days.

• Prostatitis: 50mg twice daily, for up to 28 days.

• Gonorrhoea: 250 - 500mg as a single dose.

• Severe gastroenteritis: 500mg twice daily, for 3 to 7 days.

• Skin and soft tissue infections: 500mg twice daily, for 5 to 10 days.

• Bone and joint infections: 500 - 750mg twice daily, for 5 to 10 days.

• Severe systemic infections: 500 - 750mg twice daily.

• In some severe infections, the standard dose may be increased to up to 750mg ciprofloxacin twice a day. Elderly

Elderly patients will receive a dose depending on the severity of the disorder and on their kidney function. This may therefore be lower than the standard doses stated above.

Children and adolescents (5 -17 years)

Ciprofloxacin Tablets are generally unsuitable for this patient group, except in specific cases such as those who have cystic fibrosis. The dose required will be calculated by the doctor depending on the child/adolescenfs body weight. The usual duration of treatment is 10 to 14 days.

This medicine is not recommended for use in children under 5 years of age.

Patients with reduced kidney function

The doctor may reduce your dose by half or monitor the levels of ciprofloxacin in your blood and adjust your dose accordingly. This applies particularly if you are on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD), when the maximum dose would be 500mg once a day. If you have a liver problem in addition to reduced kidney function, the dose will need to be reduced accordingly.

Take your medicine at regular intervals for as long as directed by your doctor, even if you feel better, or the infection may return.

If you take more Ciprofloxacin Tablets than you should

If you or someone else has taken too many Ciprofloxacin Tablets, seek medical advice immediately. Take this leaflet and any remaining tablets with you, if possible.

If you forget to take Ciprofloxacin Tablets

If you miss a dose, take your tablets as soon as you remember and continue as before. Do not take a double dose to make up for the forgotten one.

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

4. POSSIBLE SIDE EFFECTS

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

You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or

swelling of the face, lips, throat or tongue. If this happens to you, stop taking the tablets immediately

and seek medical help.

STOP taking the tablets immediately and seek medical help if any of the following occur:

• severe skin reactions including Stevens-Johnson Syndrome

• tendonitis, particularly of the Achilles tendon. If you experience this, rest the affected limb, discontinue treatment and seek medical advice immediately.

• pulmonary embolism, symptoms of which include chest pain, shortness of breath, palpitations and coughing up blood.

• “pseudomembranous colitis” which causes attacks of diarrhoea, sometimes containing blood and/or mucus), severe headaches or migraines, liver problems (e.g. jaundice - yellowing of the skin and whites of eyes) as well as kidney problems (decreased urinary frequency). These are potentially serious side effects and you will need to seek urgent medical attention.

• paranoia, hallucinations, unclear speech and disorganised or restless behaviour (involving in some cases risk of self-injury).

Common: feeling sick, diarrhoea, vomiting, indigestion, stomach ache, wind, loss of appetite, dizziness,

headache, tiredness, tremor, restlessness and confusion.

Less common: heart palpitations, pain or swelling of the joints, hiccups, nose bleeds and build up of fluid in

the lungs to cause shortness of breath.

Very rare: distortion or absence of sense of smell and impaired taste, difficulty in sleeping, increased sweating, numbness, swelling of the hands and feet, fits, fainting, fast heartbeat, hot flushes, anxiety, nightmares, distress, weakness, depression, muscle pain, uncontrollable movement of the limbs, ringing in the ears or impaired hearing, visual disturbances and skin reactions (e.g. red spots, blood blisters, small raised lumps which may scab, particularly on the legs and sensitivity to light.

Not known frequency: Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)

The following have also been reported:

• blood abnormalities which may result in dizziness, tiredness and making you more prone to minor infections. You should tell your doctor as soon as possible if this happens to you.

• muscle weakness, crystalluria (pain or discomfort when passing water), blood in the urine or increased blood sugar, resulting in feeling thirsty and a need to urinate more often which may need treatment by your doctor.

Long-term and repeated use of ciprofloxacin can lead to infections with bacteria or fungi which do not respond to treatment.

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

5. HOW TO STORE CIPROFLOXACIN TABLETS

Keep out of the reach and sight of children.

Store below 25°C in the original package.

Do not use Ciprofloxacin Tablets after the expiry date stated on the label, or if you notice visible signs of deterioration such as chipped, broken or discoloured tablets.

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

6. FURTHER INFORMATION

What Ciprofloxacin Tablets contain

The active substance is ciprofloxacin, 25mg, 500mg or 750mg per tablet.

The other ingredients are croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate. The tablet film-coat consists of hypromellose, lactose monohydrate, titanium hydroxide (El71), macrogol 4000, sodium citrate and water.

What Ciprofloxacin Tablets look like and contents of the pack

Ciprofloxacin Tablets are white or yellowish, oval, biconvex and film-coated, embossed with 'C250' (250mg), 'C500' (500mg) or 'C750' (750mg) on one side. They are supplied in blister packs of 10 or 100 tablets (the 250mg and 500mg strengths are also available in pack size 20s).

Marketing Authorisation Holder

Aurobindo Pharma Limited Ares Odyssey Business Park West End Road South Ruislip, HA4 6QD United Kingdom

Manufacturer

Actavis hf, Reykjavikurvegur 78,

222 Hafnarfjdrdur, Iceland OR

Actavis Limited,

B16 Bluebel Industrial Estate,

P1506995

Zejyun ZTN 08, Malta

This leaflet was last revised in {02/2013}.