Package leaflet: Information for the user

Clindamycin Hydrochloride 150 mg Capsules, hard

Clindamycin hydrochloride

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 or pharmacist

-    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 or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet

1.    What Clindamycin is and what it is used for

2.    What you need to know before you take Clindamycin

3.    How to take Clindamycin

4.    Possible side effects

5.    How to store Clindamycin

6.    Contents of the pack and other information

1.    What Clindamycin Capsules are and what they are used for

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

2. What you need to know before you take Clindamycin Capsules

Do not take Clindamycin Capsules

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

Warnings and precautions

Talk to your doctor or pharmacist or nurse 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 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 hay fever. 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.

Other medicines and Clindamycin Capsules

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).

•    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.

Clindamycin 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.

Tell your doctor if you will be breast-feeding 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 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 Clindamycin.

Clindamycin Capsules contain lactose monohydrate

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

3. How to take Clindamycin Capsules

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

Use in 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 Capsules

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 forget to take Clindamycin Capsules If the forgotten dose is just a few hours late, use it straightaway. 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 Capsules 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 or 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 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 or 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 this medicine 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.

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

6.    Contents of the pack and other 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, pregelatinised starch, purified talc and magnesium stearate.

Capsule: gelatin, titanium dioxide (E171) and water.

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

What Clindamycin Capsules look like and contents of the pack

Clindamycin Capsules are white hard capsules with a marking of ‘C150’.

Clindamycin Capsules 150mg are available in blister packs of 24 or 100 capsules.

Marketing Authorisation Holder Strandhaven Limited High Road, Seven Kings,

Ilford Essex, IG3 8BS, UK Manufacturer Strandhaven Limited Ilford, Essex.

IG3 8RA.UK

This leaflet was last revised in 12/2015

Leaflet: PIL Clindamycin 150mg Capsules, hard 240x56 0 2 col.indd Color:    Black    Dimemsion.:    240 x 560 mm

Font:    Helvetica Neue    LT 11 pt    Title: 26 pt    Subtitle: 12 pt

Leading:    4,657 mm    (13.2 pt)    Page: 1