CLINDAMYCIN 300 MG CAPSULES HARD - patient leaflet, side effects, dosage

BROWN & BURK

Keep this medicine 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 wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 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 theirsigns 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.

6. Contents of the pack and other information

1. What Clindamycin is and what it is used for

What Clindamycin Capsules looks like and contents of the pack

Clindamycin 75 mg capsules, hard are green transparent (body) / green transparent (Cap), size ‚3‘ hard gelatin capsule printed with ‚M‘ on cap and ‚40‘ on body filled with white to off-white granular powder. Approximately 16 mm in length.

Clindamycin 150 mg capsules, hard are green transparent (body) / light blue opaque (Cap), size ‚2‘ hard gelatin capsule printed with ‚M‘ on cap and ‚41‘ on body filled with white to off-white granular powder. Approximately 18 mm in length.

Clindamycin 300 mg capsules, hard are light blue opaque / light blue opaque, size ‚0‘ hard gelatin capsule printed with ‚M‘ on cap and ‚42‘ on body filled with white to off-white granular powder. Approximately 21 mm in length.

Clindamycin 75 mg (150 mg and 300 mg) capsules, hard are available in blister packs of 6,10,12,24, 30 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Limited,

5MarryatClose,

Hounslow West,

TW45DQ,

United Kingdom.

This leaflet was last revised in 06/2018

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2. what you need to know before you take clindamycindo not take clindamycinif you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Clindamycin 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 occurfollowing treatment with antibiotics.
• You sufferfrom problems with your kidneys or liver.
• You sufferfrom asthma, eczema or hayfever.
• You develop any severe skin reactions or hypersensitivity to Clindamycin.

Other medicines and Clindamycin

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

• Muscle relaxants used for operations (neuromuscular­blockers).
• 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.

100 mm

• CYP3A4 orCYP3A5 inducers like rifampicin may impact effectiveness ofthe medicine.

Clindamycin with food, drink and alcohol

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

Pregnancy and breast-feeding

Pregnancy

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

Ask your doctor or pharmacistfor advice before taking any medicine.

Breast-feeding

Tell yourdoctor if you will be breast-feeding while taking Clindamycin may be passed into breast milk. Your doctor will decide if Clindamycin is appropriate for you. If you continue to take Clindamycin, you should stop breast-feeding.

Driving and using machines

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

Clindamycin Capsules contains lactose

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

• 3. Howto take Clindamycin

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

You should swallow the whole capsule with some liquid. It can be taken with or without food, according to your preference. Do not crush the capsules.

Adults and Elderly Patients

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

Use in Children

This medicine is used for children who are able to swallow capsules. The recommended dose in children is between 12 and 25 mg / kg /day of bodyweight, divided into six hourly doses, depending on the severity of the infection. Your doctor will work out the number of capsules that your child should have. If your child is unable to swallow capsules, talkto yourdoctor or pharmacist.

Longterm 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 yourdoctor.

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 than you should

If you have taken too many Clindamycin or if a child has accidently taken 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 yourdoctor tells you to.

If you forget to take Clindamycin

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose.

Do not take a double dose to make up for a forgotten dose. If you are in doubt, always consult your doctor or pharmacist.

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 tel Is 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, this medicine can cause side effects, although not everybody gets them.

Tell yourdoctor immediately if you develop:

• Severe, persistent or bloody diarrhoea (which may be associated with stomach pain orfever). 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 or pseudomembranous colitis.
• Signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, dizziness, swelling of the eyelids or face or lips or throat or tongue, 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 ofthe skin and whites ofthe eyes (jaundice).
• Potentially life threatening skin rashes:

. skin rash, which may blister, and looks like small targets (central dark spots = = surrounded by a paler area, with a dark ring around the edge – erythema multiforme),

. widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis),

. fever, swollen lymph nodes or skin rash, these may be symptoms of a condition known as DRESS (Drug reaction with eosinophilia and systemic symptoms) and can be severe and lifethreatening.

Other possible side effects may include:

Common (may affect up to 1 in 10 people):

• abnormal liverfunction tests (poor liverfunction)
• pain in the stomach / abdomen, diarrhoea.
• feeling sick or being sick
• rash- characterized by a flat red area on the skin that is covered with small bumps, hives,
• infection inside and around the vagina
• inflammation of the large intestine which causes abdominal pain, fever or diarrhoea due to infection by Clostridium difficile,
• effects on your blood system: reduced numbers of blood cells which may cause bruising or bleeding orweaken the immune system,
• changes in the way things taste,
• inflammation of the lining of the oesophagus (gullet), open sores or lesions in the lining of the oesophagus (gullet),
• yellowing ofthe skin and whites ofthe eyes (jaundice),
• red or scaly skin (exfoliative dermatitis), red measles-like rash (rash morbilliform), itching.

Back Side

Size: 240 × 200 mm