Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

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

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

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

•    The full name of this medicine is Clindamycin 150mg, 300mg Hard Capsules but within the leaflet it will be referred to as Clindamycin.

What is in this leaflet J What Clindamycin is and what it is used for

What you need to know before you take Clindamycin How to take Clindamycin 4 Possible side effects ^ How to store Clindamycin Contents of the pack and other information

J What Clindamycin is and what it is used for

Clindamycin Capsules contain clindamycin which is an antibiotic used in the treatment of severe bacterial infections.

What you need to know before you take Clindamycin

Do not take Clindamycin

•    if you are allergic to clindamycin, lincomycin or to any of the ingredients of this medicine (listed in section 6).

•    if you have diarrhoea.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Clindamycin Tell your doctor if:

•    you usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin tell your doctor immediately since it may be necessary to interrupt the treatment.

This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

•    you suffer from problems with your kidneys or liver. If you have serious liver or kidney problems, your doctor may reduce your dose of Clindamycin and monitor the amount of Clindamycin in your blood.

•    you suffer from asthma, eczema or hayfever.

Clindamycin 150mg and 300mg Hard Capsules

Clindamycin hydrochloride

If you have to take Clindamycin for a long time, your doctor may arrange regular liver, kidney and blood tests. Do not miss these check-ups with your doctor.

Long term use can also make you more likely to get other infections that do not respond to Clindamycin treatment.

Clindamycin does not get into the brain and is therefore not suitable for treating serious infections in and around the brain (e.g. meningitis). Your doctor may need to give you another antibiotic if you have these infections.

Other medicines and Clindamycin

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.

Some medicines can affect the way this medicine works, or the medicine itself can reduce the effectiveness of other medicines taken at the same time. These include:

•    Erythromycin, an antibiotic used to treat infections.

•    Muscle relaxants used for operations.

•    Warfarin or similar medicines - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

Clindamycin with food and drink

The capsules may be taken either before of after a meal.

Pregnancy and breast-feeding Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breast-feeding

The active substance in this medicine may pass into breast milk. You should not take Clindamycin whilst breast-feeding.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin.

Clindamycin contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Clindamycin.

3| How to take Clindamycin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Clindamycin should always be swallowed whole and washed down with a full glass of water.

Use in adults

The usual dose of Clindamycin is between 150 and 450mg every six to eight hours, depending on the severity of your infection.

If your doctor has prescribed Clindamycin 600mg Capsules, the usual dose is one capsule every 8 hours.

Children

The usual dose in children is between 3 and 6mg per kg every six hours, depending on the severity of the infection.

Your doctor will work out the number of capsules that you or your child should have, and how often they should be taken.

If your child is unable to swallow capsules, talk to your doctor or pharmacist. Other forms of this medicine may be more suitable.

If you take more Clindamycin than you should

If you accidentally take too many Clindamycin contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Clindamycin left or not. Do not take any more capsules until your doctor tells you to.

If you forget to take Clindamycin

If the forgotten dose is just a few hours late, take it straight away. If it is nearly time for your next dose then miss out the forgotten one.

Do not take a double dose to make up for a missed dose.

If you stop taking Clindamycin

If you stop taking the medicine too soon your infection may come back again or get worse.

Do not stop taking Clindamycin unless your doctor tells you to.

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

4| Possible side effects

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

Tell your doctor immediately if you develop:

•    Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is a side effect which may occur during or after completing treatment with antibiotics and can be a sign of serious bowel inflammation.

•    Signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

•    Blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips.

•    Yellowing of the skin and whites of the eyes (jaundice).

Other possible side effects may include:

•    Effects on your nervous system: impaired sense of taste.

•    Effects on your skin: reddening of the skin, skin rash, itching (hives).

•    Effects on your stomach and intestines:

throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhoea.

•    Effects on your blood system: reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system.

•    Effects on your liver: poor liver function.

•    Effects on your genital area: vaginal infection.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Clindamycin

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Clindamycin Capsules contain

•    The active substance is clindamycin.

Each capsule contains clindamycin hydrochloride equivalent to 150mg, 300mg of the active substance.

•    The other ingredients are:

Capsule contents: anhydrous lactose, corn starch, talc, magnesium stearate.

Capsule shell: titanium dioxide (E171), gelatin, water, sodium lauryl sulfate.

Printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol (El520), strong ammonia solution, black iron oxide (E172), potassium hydroxide, purified water.

What Clindamycin Capsules look like and contents of the pack

Clindamycin 150mg Hard Capsules are white hard capsules marked with 'A714' on the cap in black ink.

Clindamycin 300mg Hard Capsules are white hard capsules marked with 'A718' on the cap in black ink.

Pack sizes

Blisters: 150mg: 24 hard capsules.

300mg: 30 hard capsules.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Balkanpharma-Razgrad AD

68, Aprilsko Vastanie Blvd

Razgrad

7200

Bulgaria

This leaflet was last revised in January 2016.

If you would like a leaflet with larger text, please contact 01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

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