Clindamycin Actavis
Package leaflet: Information for the patient
Clindamycin Actavis 150 mg hard capsules
Clindamycin Actavis 300 mg hard capsules
clindamycin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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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.
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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 Actavis is and what it is used for
2. What you need to know before you take Clindamycin Actavis
3. How to take Clindamycin Actavis
4. Possible side effects
5. How to store Clindamycin Actavis
6. Contents of the pack and other information
1. What Clindamycin Actavis is and what it is used for
Clindamycin Actavis contains the active substance clindamycin and belongs to a group of medicines called antibiotics.
Clindamycin Actavis is used to treat the following infections in adults and children:
- Stomach infections
- Serious infections caused by anaerobic bacteria
- Skin and soft tissue infections
- Tonsillitis
- Dental infections
2. What you need to know before you take Clindamycin Actavis
Do not take Clindamycin Actavis:
if you are allergic to clindamycin, lincomycin or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Clindamycin Actavis.
Tell your doctor if you suffer from problems with your kidneys or liver. Your doctor may need to monitor the amount of clindamycin in your blood and change the dose.
If you have to take Clindamycin Actavis for a long time, your doctor may arrange regular liver, kidney and blood tests.
If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin Actavis 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.
Other medicines and Clindamycin Actavis
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:
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erythromycin, an antibiotic used to treat infections.
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muscle relaxants used for operations.
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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 Actavis 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 beforetaking this medicine.
Breast-feeding
The active substance in this medicine may pass into breast milk. You should not take Clindamycin Actavis whilst breast-feeding.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Clindamycin Actavis.
Clindamycin Actavis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Clindamycin Actavis.
3. How to take Clindamycin Actavis
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 Actavis capsules should always be swallowed whole with a full glass of water whilst in an upright position (i.e. sitting or standing).
Use in adults
The recommended dose is 150 mg to 300 mg taken 3 or 4 times daily.
The dose depends on the severity of your infection.
Children
The recommended dose in children is 15 mg per kg daily, in 3 divided doses.
Children weighing 30 – 45 kg can be given 150 mg, 3 times daily
The maximum dose in children is 20 mg per kg daily, in 4 divided doses.
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 Actavis than you should
If you accidentally take too many Clindamycin Actavis 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 Actavis capsules left or not. Do not take any more capsules until your doctor tells you to.
If you forget to take Clindamycin Actavis
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 Actavis
If you stop taking the medicine too soon your infection may come back again or get worse.
Do not stop taking Clindamycin Actavis 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, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you develop:
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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.
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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).
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blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips.
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yellowing of the skin and whites of the eyes (jaundice).
Other possible side effects may include:
Common (may affect up to 1 in 10 people):
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stomach pain, diarrhoea
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poor liver function
Uncommon (may affect up to 1 in 100 people):
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feeling sick, being sick
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reddening of the skin, itchy skin rash (hives)
Frequncy not known, but may also occur:
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vaginal infection
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reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system
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impaired sense of taste
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throat ulcers, sore throat
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itching
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clindamycin Actavis
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.
6. Contents of the pack and other information
What Clindamycin Actavis contains
- The active substance is clindamycin
- The other ingredients are:
Capsule contents: anhydrous lactose, corn starch, talc, magnesium stearate
Capsule shell: titanium dioxide (E171), gelatin, water, sodium lauril sulfate
Printing ink: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide
What Clindamycin Actavis looks like and contents of the pack
Clindamycin Actavis 150 mg are white hard capsules marked with ‘A714’ on the cap in black ink.
Clindamycin Actavis 300 mg are white hard capsules marked with ‘A718’ on the cap in black ink.
Pack sizes
Blisters: 12, 15, 16, 20, 24, 30, 32, 40, 100 and 104 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
<[To be completed nationally]>
Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in
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