APPROVED By NabePla Carooq at	Previously assessed against UK PIL dated June 2014 ORMATION FOR THE USER	Variation 7: To update the name of the manufacturer with consequential changes to the label and leaflet. No other changes approved.
(r) DALACIN C 150 mg Hard Capsules (clindamycin 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.

•    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.

The name of your medicine is DALACIN® C 150 mg Hard Capsules, but it will be referred to as Dalacin in this leaflet.

In this leaflet:

1.    What Dalacin is and what it is used for

2.    Before you take Dalacin

3.    How to take Dalacin

4.    Possible side effects

5.    How to store Dalacin

6.    Further information

1.    What Dalacin is and what it is used for

Dalacin contains clindamycin hydrochloride which is an antibiotic used in the treatment of serious bacterial infections.

2.    Before you take Dalacin

Do not take Dalacin

If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this medicine.

Take special care with Dalacin

Tell your doctor if you have any of the following conditions to help him or her decide if Dalacin is suitable for you:

•    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 Dalacin 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.

•    you suffer from asthma, eczema or hayfever.

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

Taking 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).

•    muscle relaxants used for operations.

•    oral contraceptive pills. You should use extra contraception such as condoms whilst taking Dalacin and for seven days after taking Dalacin.

•    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.

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

Taking Dalacin with food and drink

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

Pregnancy

If you are pregnant or think you might be pregnant you should contact your doctor before taking Dalacin.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Tell your doctor if you will be breastfeeding while taking Dalacin as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Dalacin is appropriate for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, 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 on the ability to drive or use machines have been seen with Dalacin.

Important information about some of the ingredients of Dalacin Capsules

Dalacin Capsules contains lactose a type of sugar.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Dalacin

Always take Dalacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take this medicine.

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

Adults and Elderly Patients

The recommended dose of Dalacin is between 150 and 450mg (1 to 3 capsules) every 6 hours, depending on the severity of your infection.

Children

The recommended 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 your child should have.

Long term use of Dalacin

If you have to take Dalacin 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 Dalacin treatment.

If you take more Dalacin Capsules than you should

If you accidentally take too many Dalacin Capsules 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 Dalacin Capsules left or not. Do not take any more capsules until your doctor tells you to.

If you miss a dose of Dalacin

If the forgotten dose is just a few hours late, use 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 missed dose.

If you stop taking Dalacin

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

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

If you have any further questions on how to take this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Dalacin 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 an uncommon 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

Procured from within the EU & repackaged by PL holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough, SL1 4NL.

Dalacin® C 150 mg Hard Capsules, PL 39352/0097

Dalacin® is a registered trademark of Pfizer Ltd. Leaflet date: 09.07.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clindamycin 150 mg Hard Capsules

(clindamycin 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.

•    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.

The name of your medicine is Clindamycin 150 mg Hard Capsules, but it will be referred to as Clindamycin in this leaflet.

In this leaflet:

1.    What Clindamycin is and what it is used for

2.    Before you take Clindamycin

3.    How to take Clindamycin

4.    Possible side effects

5.    How to store Clindamycin

6.    Further information

1.    What Clindamycin is and what it is used for

Clindamycin contains clindamycin hydrochloride which is an antibiotic used in the treatment of serious bacterial infections.

2.    Before you take Clindamycin

Do not take Clindamycin

If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this medicine.

Take special care with Clindamycin

Tell your doctor if you have any of the following conditions to help him or her decide if Clindamycin is suitable for you:

•    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 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.

•    you suffer from asthma, eczema or hayfever. Clindamycin does not get into the brain and is therefore not suitable for treating serious infections in and around the brain. Your doctor may need to give you another antibiotic if you have these infections.

Taking 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).

•    muscle relaxants used for operations.

•    oral contraceptive pills. You should use extra contraception such as condoms whilst taking Clindamycin and for seven days after taking Clindamycin.

•    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.

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

Taking Clindamycin with food and drink

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

Pregnancy

If you are pregnant or think you might be pregnant you should contact your doctor before taking Clindamycin.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Tell your doctor if you will be breastfeeding while taking Clindamycin as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycin is appropriate for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets blood stained 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 on the ability to drive or use machines have been seen with Clindamycin.

Important information about some of the ingredients of Clindamycin Capsules

Clindamycin Capsules contains lactose a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Clindamycin

Always take Clindamycin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take this medicine.

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

Adults and Elderly Patients

The recommended dose of Clindamycin is between 150 and 450mg (1 to 3 capsules) every 6 hours, depending on the severity of your infection.

Children

The recommended 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 your child should have.

Long term use of Clindamycin

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.

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. Always 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 miss a dose of Clindamycin

If the forgotten dose is just a few hours late, use 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 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 how to take this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Clindamycin 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 an uncommon 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: inflammation of the vagina.

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

•    Keep out of the sight and reach of children.

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

•    Do not store above 25°C.

•    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.

If your medicine gets discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

6.    Further information

What Clindamycin Capsules contain

The active substance is clindamycin hydrochloride. Each capsule contains clindamycin hydrochloride equivalent to 150mg of clindamycin.

The other ingredients are lactose monohydrate, maize starch, talc, magnesium stearate, titanium dioxide E171, gelatin & black iron oxide E172.

What Clindamycin Capsules look like and contents of the pack

Clindamycin Capsules are white hard capsules marked with 'Pfizer' logo on the cap & 'CLIN 150' on the body in black ink and contains a white powder. Clindamycin Capsules 150 mg are available in blister packs of 16 or 24 capsules.

Manufactured by: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poce - sur- Cisse, France.

Procured from within the EU & repackaged by PL holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough, SL1 4NL.

PL 39352/0097

Leaflet date: 09.07.2015