Clindamicin-mip 300

Package Leaflet: Information for the Patient

Clindamycin-MIP 300, 300 mg, Film-Coated Tablets

Clindamycin-MIP 600, 600 mg, Film-Coated Tablets

Clindamycin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Clindamycin-MIP and what is it used for
• 2. Important information before taking Clindamycin-MIP
• 3. How to take Clindamycin-MIP
• 4. Possible side effects
• 5. How to store Clindamycin-MIP
• 6. Contents of the pack and other information

1. What is Clindamycin-MIP and what is it used for

Clindamycin-MIP is in the form of film-coated tablets containing clindamycin hydrochloride. It is an antibiotic - a semi-synthetic derivative of lincomycin, belonging to the group of lincosamides, which do not show similarity to other antibiotics. Depending on the susceptibility of the microorganism and the concentration of the antibiotic, clindamycin may act bacteriostatically or bactericidally. Clindamycin acts on microorganisms such as staphylococci (Staphylococcus aureus, Staphylococcus epidermidis), Streptococcus pneumoniae (in penicillin-resistant pneumococci, partial resistance to clindamycin has been detected), Streptococcus pyogenes group A, Streptococcus viridans, Bacteroides spp., Fusobacterium spp., Actinomycetes spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium, Mycoplasma hominis. The susceptibility of Clostridium spp. bacteria is variable, some species are resistant to clindamycin. Secondary resistance develops rarely. Resistant strains include Enterococcus spp. (E. faecalis, E. faecium), Neisseria spp. (e.g. N. gonorrhoeae, N. meningitidis), Haemophilus spp., Escherichia coli, Klebsiella, Enterobacter, Serratia, Proteus spp., Pseudomonas, Salmonella, Shigella, and Nocardia. There is complete cross-resistance of pathogens to clindamycin and lincomycin, and partial cross-resistance to clindamycin and erythromycin. Indications for use Bacterial infections caused by strains susceptible to clindamycin: bone and joint infections; ear, nose, and throat infections; dental and periodontal infections; lower respiratory tract infections; abdominal cavity infections; pelvic and female genital tract infections; skin and soft tissue infections; scarlet fever. In case of severe infection, it is recommended to use the medication intravenously instead of orally.

2. Important information before taking Clindamycin-MIP

When not to take Clindamycin-MIP

Warnings and precautions

Before starting Clindamycin-MIP, discuss it with your doctor: if there are liver function disorders; if there are disorders of nerve-muscle conduction (e.g. myasthenia gravis and Parkinson's disease); if the patient has previously suffered from stomach and intestinal diseases (e.g. previous colitis). You should consult a doctor, even if the above warnings refer to past situations. During long-term (longer than 3 weeks) use of the medication, periodic monitoring of blood count, liver function, and kidney function is recommended. Acute kidney function disorders may occur. Inform your doctor about all medications being taken and any kidney problems. If the patient's urine output decreases or fluid retention occurs, causing swelling of the legs, ankles, or feet, shortness of breath, or nausea, contact your doctor immediately. Prolonged and repeated use of clindamycin may lead to infection and overgrowth of resistant bacteria or fungi, especially on the skin or mucous membranes. If diarrhea occurs during medication use, especially severe or persistent, the patient should consult a doctor. It may be a symptom of pseudomembranous colitis caused by toxins of overgrown bacteria in the intestine, Clostridium difficile. The doctor will prescribe appropriate treatment - in milder cases, it is enough to stop taking Clindamycin-MIP, in more severe cases, it may be necessary to use an effective antibiotic or chemotherapeutic agent and, if necessary, appropriate symptomatic treatment. Medications that inhibit intestinal peristalsis are contraindicated. In case of anaphylactic shock, discontinue the medication and provide appropriate medical assistance (e.g. adrenergic agents, antihistamines, corticosteroids, or controlled breathing if necessary). Clindamycin can usually be used in patients allergic to penicillin. The occurrence of allergic reactions to clindamycin in individuals allergic to penicillin (so-called cross-allergy) usually does not occur due to structural differences between the two substances. However, anaphylaxis has been observed in some cases during clindamycin treatment in patients with penicillin allergy. A patient allergic to penicillin should inform their doctor before starting clindamycin treatment. Clindamycin should not be used to treat acute viral respiratory infections. Clindamycin does not reach therapeutic concentrations in cerebrospinal fluid, therefore Clindamycin-MIP film-coated tablets should not be used to treat meningitis.

Children

Film-coated tablets are not suitable for use in children under 5-6 years old, who may have difficulty swallowing the medication. When administering clindamycin to children in the form of film-coated tablets, it is often not possible to achieve precise dosing.

Patients with renal and/or hepatic impairment

In patients with moderate or severe liver impairment, the half-life of clindamycin in serum is prolonged. If clindamycin is administered every 8 hours, dose reduction is usually not necessary. In patients with severe liver impairment, it is necessary to monitor the concentration of the medication in the blood serum - depending on the results of these tests, it may be necessary to reduce the dose or extend the interval between individual doses. In patients with renal impairment, the half-life is prolonged. Dose reduction is not necessary in case of mild or moderate impairment, however in patients with severe renal impairment or anuria, it is necessary to monitor the concentration of the medication in the blood serum - depending on the results of these tests, it may be necessary to reduce the dose or extend the interval between individual doses from 8 to 12 hours.

Patients undergoing hemodialysis

Hemodialysis does not remove clindamycin from the blood, therefore additional doses are not necessary before starting dialysis or after dialysis.

Clindamycin-MIP and other medications

Inform your doctor about all medications being taken or recently taken, as well as any medications planned to be taken. Clindamycin should not be used simultaneously with macrolide antibiotics (e.g. erythromycin) due to antagonistic effects observed in vitro. Microorganisms resistant to lincomycin also show resistance to clindamycin (so-called cross-resistance). Clindamycin has properties that inhibit nerve-muscle conduction, which may enhance the effect of muscle relaxants (e.g. ether, tubocurarine, halogenated pancuronium). Therefore, during operations using such agents, unexpected life-threatening situations may occur. A patient being treated with clindamycin and a medication that reduces blood clotting (warfarin or a similar medication) may show a greater tendency to bleed. The doctor may decide to perform regular blood tests to check its clotting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medication. In human studies, no teratogenic effects of the medication have been detected. However, the benefit and risk ratio of using clindamycin during pregnancy and breastfeeding should be carefully considered. Clindamycin passes into breast milk. In a breastfed newborn, hypersensitivity, diarrhea, and fungal infection may occur.

Driving and operating machinery

Clindamycin-MIP has no influence or insignificant influence on the ability to drive and operate machinery.

3. How to take Clindamycin-MIP

This medication should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist. ChildrenDepending on the severity and location of the infection, in children over 5 years old, 8-25 mg of clindamycin per kilogram of body weight is used. The daily dose is administered in 3 or 4 divided doses. Film-coated tablets are not suitable for use in children under 5-6 years old, who may have difficulty swallowing the medication. When administering clindamycin to children in the form of film-coated tablets, it is often not possible to achieve precise dosing. AdultsDepending on the severity and location of the infection, in adults and adolescents over 14 years old, 600 mg to 1.8 g of clindamycin is used per day. The daily dose is administered in 3 or 4 divided doses. If a dose less than 1.2 g per day is necessary, as well as in children under 14 years old, a medication with a lower active substance content should be used. Method of administrationClindamycin-MIP film-coated tablets should be swallowed without chewing, with a sufficient amount of liquid (e.g. 1 glass of water). The medication can be taken regardless of meals. Clindamycin-MIP should be taken regularly, at the same time every day. The doctor will recommend how long to take Clindamycin-MIP. Do not stop treatment earlier, as its effect may be ineffective.

Taking a higher dose of Clindamycin-MIP than recommended

Symptoms of clindamycin overdose and poisoning are not known. In case of overdose of the medication taken orally (film-coated tablets), gastric lavage is recommended. Clindamycin cannot be removed from the blood by dialysis or peritoneal dialysis. A specific antidote is not known. In case of taking a higher dose of the medication than recommended, consult a doctor or pharmacist immediately.

Missing a dose of Clindamycin-MIP

Usually, missing a single dose of the medication does not cause symptoms. Treatment should be continued without changes. Do not take a double dose to make up for the missed dose. However, remember that Clindamycin-MIP is effective only when taken regularly.

Stopping Clindamycin-MIP treatment

In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Clindamycin-MIP can cause side effects, although not everybody gets them. Inform your doctor immediately if you experience:

• fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea

Uncommon side effects (in 1 to 10 out of 1000 patients):

• abdominal pain, nausea, vomiting, or diarrhea of mild severity. All these symptoms are dose-dependent and disappear during or after treatment. Inflammation of the esophagus, tongue, or oral mucosa may also occur.

Rare side effects (in 1 to 10 out of 10,000 patients):

• urticaria-like rash, itching, and hives;
• thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), eosinophilia (increased eosinophil count), neutropenia (reduced neutrophil count), or granulocytopenia (reduced granulocyte count);
• transient slight increase in serum aminotransferase activity;
• nerve-muscle conduction block.

Very rare side effects (less than 1 in 10,000 patients):

• pseudomembranous colitis;
• edema (Quincke's edema, joint edema), drug fever, polymorphic erythema (e.g. Stevens-Johnson syndrome), Lyell's syndrome, and anaphylactic shock. The above reactions may occur after the first administration of the medication;
• transient hepatitis with cholestatic jaundice;
• pruritus, exfoliative and bullous dermatitis;
• vaginitis;
• polyarthritis;
• changes in taste and smell.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Clindamycin-MIP

Store the medication out of sight and reach of children. Do not use this medication after the expiry date stated on the carton after "Expiry Date". The expiry date refers to the last day of the month. Store at a temperature below 30°C. Do not use this medication if you notice that the tablets have changed color to yellow-brown. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clindamycin-MIP contains

• The active substance of the medication is clindamycin. One Clindamycin MIP 300 film-coated tablet contains 300 mg of clindamycin (Clindamycinum) in the form of 344 mg of clindamycin hydrochloride. One Clindamycin MIP 600 film-coated tablet contains 600 mg of clindamycin (Clindamycinum) in the form of 688 mg of clindamycin hydrochloride.
• Other excipients are: microcrystalline cellulose, mannitol, talc, colloidal silica, magnesium stearate, crospovidone, Eudragit E 12.5%, titanium dioxide (E 171), magnesium stearate, macrogol.

What Clindamycin-MIP looks like and contents of the pack

Clindamycin MIP 300: white, round, biconvex film-coated tablets. Clindamycin MIP 600: white, oblong film-coated tablets with a dividing line. Clindamycin-MIP 300 packaging contains 6, 12, 16, or 30 film-coated tablets. Clindamycin-MIP 600 packaging contains 6, 12, 16, 30, or 32 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MIP Pharma Polska Sp. z o.o. ul. Orzechowa 5 80-175 Gdańsk Tel.: 58 303 93 62 Fax: 58 322 16 13 e-mail: [email protected]

Manufacturer

Chephasaar, Chemisch-pharmazeutische Fabrik GmbH Mühlstrasse 50 D-66386 St. Ingbert Germany

Date of last revision of the leaflet: