150 mg hard capsules
clindamycin
1. What Clindamycin Orifarm is and what it is used for
Clindamycin Orifarm belongs to a group of medicines called antibiotics. Antibioticsare used to treat infections. Clindamycin capsules are used to kill certain serious bacterial infection s,
Clindamycin contained in Clindamycin Orifarm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Clindamycin Orifarm
Do not use Clindamycin Orifarm
If you are allergic to clindamycin (the active substance in Clindamycin Orifarm capsules), lincomycin (another antibiotic ), or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using clindamycin capsules.
- If you have diarrhea or if you usually get diarrhea while taking antibiotics or if you have previously had problems with your stomach/intestines. If you experience severe, prolonged, or bloody diarrhea during or after using Clindamycin Orifarm, you must inform your doctor immediately, as it may be necessary to discontinue treatment. It may be a sign of intestinal inflammation (pseudomembranous colitis) that may occur up to several weeks after the end of treatment with antibiotics.
- If you suffer from kidney or liver problems
- If you suffer from asthma , eczema or hay fever
Talk to your doctor, pharmacist, or nurse if you have severe skin reactions or allergiesto clindamycin (see section 4).
If you need to use Clindamycin Orifarm for a long time, your doctor may want to do regular tests on your liver, kidneys, and blood.
Prolonged use may increase the risk of getting other infections that do not improve with treatment with Clindamycin Orifarm. Talk to your doctor as soon as possible if this happens.
Other medicines and Clindamycin Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
- Erythromycin, clarithromycin, telithromycin, rifampicin, antibiotics used to treat infections.
- Itraconazole, voriconazole, is used to treat fungal infections.
- Ritonavir, cobicistat, is used to treat HIV.
- St. John’s wort ( Hypericum perforatum ), used for mild depression and mild anxiety.
- Carbamazepine, phenytoin, and phenobarbital are used for epilepsy.
- Dihydroergotamine, ergotamine, is used for migraines.
- Ergometry, used during childbirth to reduce blood loss.
- Midazolam, triazolam, sedatives, hypnotics.
- Amiodarone, quinidine, is used for an irregular heartbeat.
- Cisapride, used in disorders of the gastrointestinal tract.
- Pimozide, used in mental problems.
- Alfuzosin, used for benign prostatic hyperplasia.
- Simvastatin, lovastatin, cholesterol lowering drugs.
- Sildenafil, used for erection problems and for high blood pressure in the lungs.
- Muscle relaxants used in surgery or other hospital procedures.
- Warfarin or similar blood thinners. You may have an increased tendency to bleed. Your doctor may need to take routine blood tests to check how well your blood can coagulate.
Clindamycin Orifarm with food and drink
You can take the capsules with or without food.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
The active substance in this medicine may be excreted in human milk. Talk to your doctor or pharmacist before using Clindamycin Orifarm while breast-feeding.
Driving and using machines
The use of Clindamycin Orifarm has no known effects on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle 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 Orifarm contains lactose
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Clindamycin Orifarm
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Adults and the elderly:
The recommended dose is 150-450 mg (1-3 capsules) every six hours, depending on the severity of the infection.
Clindamycin Orifarm should always be swallowed whole with a full glass of water in an upright position (ie sitting or standing).
Children:
The recommended dose for children is 3-6 mg per kg body weight every six hours, depending on the severity of the infection. Your doctor will calculate how many capsules your child should take.
If your child is unable to swallow capsules, talk to your doctor or pharmacist. Other dosage forms of clindamycin may be more suitable.
If you forget to take Clindamycin Orifarm
If you find that you have forgotten dose one already after a few hours, take dose one immediately. But if it is almost time for the next dose, then you should skip the forgotten dose one. Do not take a double dose to make up for forgotten dose.
If you stop taking Clindamycin Orifarm
If you stop taking the medicine too quickly, your infection may come back or get worse. Do not stop taking Clindamycin Orifarm until your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects:
- severe, persistent, or bloody diarrhea (which may be linked to abdominal pain or fever). This is a common side effect that can occur after treatment with antibioticsand can be a sign of a serious intestinal inflammation (pseudomembranous colitis). (Usual)
- signs of a severe allergic reaction such as sudden wheezing, difficulty breathing, swollen eyelids, face, lips, throat or tongue, rash or itching (especially if it itches all over the body). (Has been reported)
- yellowing of the skin and whites of the eyes (jaundice). (Has been reported)
- Skin rash that may be serious or life-threatening: (Has been reported)
- widespread rash, with blisters and flaking of large areas of skin, especially around the mouth, nose, eyes, or genitals, is called Stevens-Johnson syndromeor toxic epidermal necrolysis
- a rare rash characterized by rapidly developing red skin areas filled with small pustules (small blisters filled with white-yellow fluid) ( Acute generalized exanthematous pustulosis (AGEP)
- skin rash, which can form blisters and look like small targets (central dark dots surrounded by a lighter area with a dark ring around – erythema multiforme)
- widespread red rash with small blisters (bullous exfoliative dermatitis )
- fever, enlarged lymph nodes, or rash, which may be a symptom of a condition called DRESS (drug reaction with eosinophilia and systemic symptoms).
Other possible side effects can affect:
Common (may affect up to 1 in 10 people):
- diarrhea
- abdominal pain
- abnormal liver values
Uncommon (may affect up to 1 in 100 people):
- vomiting
- nausea
- smooth skin rash or reddening of the skin covered with raised rashes
- hives
Has been reported (occurs in an unknown number of users):
- infection in and around the vagina
- inflammation of the colon, due to Clostridium difficile – infection , causing stomach pain, fever or diarrhea
- effects on your blood system: decreased number of blood cells, which may cause bruising or bleeding or weaken the immune system
- altered sense of taste
- inflammation of the esophagus (esophagus), open sores, or injuries of the esophagus (esophagus)
- yellowing of the skin and whites of the eyes (jaundice)
- red or scaly skin (exfoliative dermatitis ), red measles-like rash (morbilliform rash), 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 Orifarm
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. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
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 hydrochloride equivalent to 150 mg clindamycin.
Other ingredients are:
Capsule content: lactose monohydrate, corn starch, talc, magnesium stearate.
Housing: gelatin and titanium dioxide (E171)
Printing ink: Shellac, iron oxide black (E172), propylene glycol.
What the medicine looks like and the contents of the pack
Clindamycin Orifarm capsules are white/white hard capsules marked “CLIN 150” on the capsule body. They are available in blister packs of 24, 30, 32, 40, or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56 048
102 17 Stockholm
info@orifarm.com