Document: leaflet MAH GENERIC_PL 33155-0009 change

• leaflet MAH BRAND_PLPI 15814-1165
• leaflet MAH GENERIC_PL 33155-0009

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clindamycin 150 mg capsules, hard

clindamycin hydrochloride

What is in this leaflet:

1.    What Clindamycin Rivopharm capsules are and what they are used for

2.    What you need to know before you take Clindamycin Rivopharm capsules

3.    How to use Clindamycin Rivopharm capsules

4.    Possible side effects

5.    How to store Clindamycin Rivopharm capsules

6.    Contents of the pack and other information

1.    WHAT CLINDAMYCIN RIVOPHARM CAPSULES ARE AND WHAT THEY ARE USED FOR

Clindamycin Rivopharm 150 mg capsules, hard (called Clindamycin capsules in the rest of this leaflet) belong to a group of medicines called antibiotics. Antibiotics are used to treat infections. Clindamycin capsules are used to kill certain serious bacterial infections.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE CLINDAMYCIN CAPSULES

Do not use Clindamycin capsules:

If you have been told you are allergic (hypersensitive) to clindamycin (the active ingredient in Clindamycin capsules), lincomycin (another antibiotic) or to any of the ingredients of Clindamycin capsules (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Clindamycin capsules

•    If you have diarrhoea or 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 capsules 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.

•    If you suffer from problems with your kidneys or liver.

•    If you suffer from asthma, eczema or hayfever.

•    If you have been told by your doctor that you have an intolerance to some sugars.

Other medicines and Clindamycin capsules

Some medicines can affect the way Clindamycin works, or Clindamycin itself can reduce the effectiveness of other medicines taken at the same time. Make sure your doctor knows if you are taking any medicines listed here:

•    Erythromycin, an antibiotic used to treat infections.

•    Muscle relaxants used for operations or hospital procedures.

•    Oral contraceptive pills. You should use extra contraception such as condoms whilst taking Clindamycin capsules and for seven days after your last dose of Clindamycin capsules.

•    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.

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines including medicines obtained without a prescription.

Clindamycin capsules with food and drink

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

Pregnancy and breast-feeding

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

The effects of Clindamycin capsules on the unborn child are not known.

Tell your doctor if you will be breast feeding while taking Clindamycin capsules as the active substance in this medicine may be passed into breast milk.

Your doctor will decide if Clindamycin capsules are appropriate for you. It is not likely that a nursing infant will take in very much of the active substance from the milk it drinks. However, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.

Driving and using machines

No effects have been reported on the ability to drive or use machines after taking Clindamycin capsules.

Clindamycin capsules contain lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO USE CLINDAMYCIN CAPSULES

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

Adults and the elderly

The usual dose is 150 mg -450 mg (1-3 capsules) every six hours, depending on the severity of your infection.

Use in children

The usual dose in children is between 3 and 6 mg per kg of body weight every six hours, depending on the severity of the infection. Your doctor will work out the number of capsules that your child should have.

Long Term use of Clindamycin capsules

Your doctor will decide if you are taking Clindamycin capsules for a long time and 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 which do not respond to Clindamycin capsules treatment.

If you take more Clindamycin capsules than you should

If you accidentally take too many Clindamycin capsules contact your doctor at once or go to the nearest hospital casualty department.

Take the labelled medicine package with you, whether there are any Clindamycin capsules left or not. Do not take any more capsules until your doctor tells you to.

If you forget to take Clindamycin capsules

If you forget the dose just a few hours late, take it straight away. If it is nearly time for your next dose miss out the forgotten one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Clindamycin capsules

If you stop taking the medicine too soon your infection may come back again or get worse. Do not stop taking Clindamycin capsules unless your doctor tells you to.

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

4.    POSSIBLE SIDE EFFECTS

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

Tell your doctor immediately if you have any of the following side effects:

•    severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after 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

•    Skin: reddening of the skin, skin rash, itching (hives)

•    Stomach and intestines: throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhoea

•    Blood system: reduced numbers of blood cells (shown on blood tests) which may cause bruising or bleeding or weaken the immune system

•    Liver function: shown by blood tests

•    Genital area: inflammation of the vagina

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

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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE CLINDAMYCIN CAPSULES

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

Do not use Clindamycin capsules after the expiry date which is stated on the carton and the blister foil. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from light.

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.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Clindamycin capsules contain

•    The active substance is clindamycin hydrochloride equivalent to 150 mg of the active substance clindamycin.

•    The other ingredients are:

Capsule contents: lactose monohydrate, maize starch, talc, magnesium stearate.

Shell: gelatine and titanium dioxide (E171)

Printing ink: Shellac, iron oxide black (E172), propylene glycol.