150 mg and 300 mg hard capsules
clindamycin
1. What Clindamycin Actavis is and what it is used for
Clindamycin Actavis contains the active substance clindamycin and is part of a group of medicines called antibiotics.
Clindamycin Actavis is used to treat the following infections in adults and children:
- stomach infections
- serious infection caused by certain types of bacteria (anaerobic bacteria)
- skin and soft tissue infections
- tonsillitis
- dental infections
Clindamycin contained in Clindamycin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Clindamycin Actavis
Do not use Clindamycin Actavis
- if you are allergic to clindamycin, lincomycin (another antibiotic ), or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Clindamycin Actavis.
Tell your doctor if you have kidney or liver problems. Your doctor may need to monitor the amount of clindamycin in your blood and change the dose one.
If you need to use Clindamycin Actavis for a long time, your doctor may want to do regular tests on your liver, kidneys, and blood.
If you develop severe or persistent bloody diarrhea during or after treatment with Clindamycin Actavis, tell your doctor immediately as treatment may need to be stopped. This may be a sign of an intestinal inflammation (pseudomembranous colitis ) that may occur as a result of 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 may affect the way this medicine works, or this medicine may cause a weaker effect of other medicines used at the same time. These medicines are as follows:
- erythromycin, an antibiotic used to treat infections.
- muscle relaxants used in surgery.
- warfarin or similar medicines used to thin the blood. You may be at greater risk of bleeding. Your doctor may need to take regular blood tests to check how well your blood is coagulating.
Clindamycin Actavis with food and drink
The capsules can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
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 using this medicine.
Breast-feeding
The active substance in this medicine may be excreted in human milk. You should not use Clindamycin Actavis while breast-feeding.
Driving and using machines
Clindamycin Actavis has no effect on the ability to drive and use machines.
You are responsible for assessing whether you are in good enough condition to drive motor vehicles or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Clindamycin Actavis contains lactose and sodium
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 this medicine.
Clindamycin Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, ie it is essentially ‘sodium-free’.
3. How to use Clindamycin Actavis
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Clindamycin Actavis capsules should always be swallowed whole with a full glass of water in an upright position (ie sitting or standing).
Adults
The recommended dose is between 150 to 300 mg 3 to 4 times a day.
Dose one depends on the severity of your infection.
Children
The recommended dose for children is 15 mg per kg per day, divided into 3 doses.
Children weighing between 30 and 45 kg can be given 150 mg 3 times a day.
The maximum dose for children is 20 mg per kg per day, divided into 4 doses.
Your doctor will calculate the number of capsules you or your child should take and how often they should be taken.
Talk to your doctor or pharmacist if your child is unable to swallow capsules. Other forms of this medicine may be more appropriate.
If you forget to use Clindamycin Actavis
If it has only been a few hours since you forgot dose one, take it immediately. If it is soon time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Clindamycin Actavis
If you stop using the medicine too soon, your infection may come back or get worse.
Do not stop using Clindamycin Actavis unless your doctor tells you to.
If you have any further questions on the use of this product, 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:
- severe, persistent, or bloody diarrhea (which may be accompanied by abdominal pain or fever). This is a side effect that can occur during or after treatment with antibiotics and can be a sign of severe intestinal inflammation.
- signs of a severe allergic reaction, such as sudden wheezing/wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body).
- blisters and scaling of large areas of skin, fever, cough, general malaise, and swelling of the gums, tongue, or lips.
- yellowing skin and whites of the eyes (jaundice).
Other possible side effects are as follows:
Common (may affect up to 1 in 10 people):
- abdominal pain, diarrhea
- poor liver function
Uncommon (may affect up to 1 in 100 people):
- nausea, vomiting
- reddening of the skin, itchy rash ( hives )
Has been reported (occurs in an unknown number of users):
- vaginal infection
- decreased number of blood cells which may cause bruising or bleeding or weakened immune system
- impaired sense of taste
- sore throat, sore throat
- itching
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Clindamycin Actavis
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
The expiration date is the last day of the specified month.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is clindamycin.
- Other ingredients are: Capsule core: lactose, corn starch, talc, magnesium stearateCapsule film coating: titanium dioxide (E171), gelatin, water, sodium lauryl sulfateInk: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide
What the medicine looks like and the contents of the pack
Clindamycin Actavis 150 mg capsules are white, hard capsules marked with “A714” in black ink on the cap.
Clindamycin Actavis 300 mg capsules are white, hard capsules marked with “A718” in black ink on the cap.
Pack sizes
Blister packs: 12, 15, 16, 20, 24, 30, 32, 40, 100 and 104 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa 2600, Bulgaria
Balkanpharma-Razgrad AD
68, April Vastanie Blvd.,
7200 Razgrad
Bulgaria