Klimicin

Package Leaflet: Information for the Patient

Klimicin, 300 mg, Hard Capsules

Clindamycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any 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 their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Klimicin and what is it used for

Klimicin contains the active substance clindamycin, an antibiotic belonging to the lincosamide group, used to treat infections. It works by inhibiting the growth of and destroying bacteria that can cause infections.
Klimicin in the form of capsules is used to treat the following severe infections caused by bacteria sensitive to clindamycin:
respiratory tract infections caused by Streptococcus pneumoniaeand other streptococci, Staphylococcus aureus, and anaerobic bacteria;
skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobic bacteria;
bone and joint infections caused by Staphylococcus aureus;
septicaemia caused by Staphylococcus aureus;
intra-abdominal infections caused by anaerobic bacteria;
female genital tract infections caused by anaerobic bacteria.
If the disease is severe, the doctor will use the medicine in the form of an intravenous infusion.
In patients with septicaemia, the doctor will start treatment with intravenous administration of clindamycin.

2. Important information before taking Klimicin

When not to take Klimicin:

if you are allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6);
If you have ever experienced symptoms such as rash, swelling of the face, neck, or body, or difficulty breathing after taking clindamycin, this may indicate an allergy.

Warnings and precautions

Before starting to take Klimicin or during treatment, discuss this with your doctor or pharmacist if:
you have had allergic reactions in the past, especially severe ones. If an allergic reaction or severe skin reaction occurs, tell your doctor immediately, as such reactions have been reported with clindamycin;
you are allergic to penicillin;
Klimicin is used for a long time and you have diarrhoea or changes in the mucous membranes of the mouth and/or vagina, which may indicate superinfection with microorganisms resistant to this medicine;
you have been diagnosed with stomach and intestinal disease (coeliac disease, diverticulitis, Crohn's disease, ulcerative colitis) or AIDS;
you experience diarrhoea during or after treatment (tell your doctor); almost any antibiotic can cause pseudomembranous colitis and diarrhoea caused by Clostridium difficile, ranging from mild diarrhoea to life-threatening colitis; do not take medicines that inhibit intestinal motility (peristalsis) in this case;
you have been diagnosed with meningitis, as clindamycin penetrates poorly into the cerebrospinal fluid;
you have severe kidney or liver dysfunction; your doctor will adjust the dose of the medicine and recommend blood tests to monitor kidney and liver function;
you have been diagnosed with a disease that affects nerve and muscle conduction (e.g. myasthenia gravis, Parkinson's disease).
Acute kidney dysfunction may occur. Tell your doctor about all medicines you are taking and any kidney problems. If you experience decreased urine output or fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea, contact your doctor immediately.
Consult your doctor if any of the above warnings apply to you now or have applied in the past.

Klimicin and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Before planned surgery, electroconvulsive therapy, or in cases where seizures may occur, alwaysinform your doctor that you are taking Klimicin.
Additionally, if you are taking any of the following medicines, tell your doctor:
macrolide antibiotics (e.g. erythromycin) or chloramphenicol;
medicines that inhibit intestinal motility (peristalsis);
gentamicin (an antibacterial medicine);
primaquine (a medicine used to treat malaria);
trovafloxacin (an antibacterial medicine);
levofloxacin (an antibacterial medicine);
warfarin and similar medicines used to thin the blood. Taking them with clindamycin may increase the risk of bleeding. Your doctor may consider it necessary to perform regular blood tests to monitor blood clotting.

Klimicin with food and drink

The medicine can be taken with or without food. Food may delay the absorption of clindamycin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Klimicin can be used in pregnant women only if the doctor considers it necessary.
Breastfeeding
Clindamycin passes into breast milk, so do not breastfeed while taking Klimicin.

Driving and using machines

Klimicin has no or negligible influence on the ability to drive and use machines.

Klimicin contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Klimicin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adult dosage

The recommended daily dose for moderate infections is 150 mg every 6 hours.
For severe infections, the recommended daily dose is 300-450 mg every 6 hours.
The maximum daily dose is 2700 mg.

Elderly patients

No dose adjustment is necessary in elderly patients.

Dosage in children over 10 kg body weight

The recommended daily dose is 8-25 mg/kg body weight, divided into 3 or 4 doses.
The maximum daily dose is 40 mg/kg body weight.
In infections caused by beta-haemolytic streptococci, the medicine should be taken for at least 10 days to minimize the risk of late complications, such as rheumatic fever and glomerulonephritis.

Dosage in patients with renal impairment

For patients with severe renal impairment, the doctor will adjust the dose based on serum concentration measurements.
No dose adjustment is necessary in patients undergoing haemodialysis, peritoneal dialysis, or haemofiltration.

Dosage in patients with hepatic impairment

The doctor will adjust the dose based on serum concentration measurements.

Method of administration

Swallow the capsules with a glass of water.

Overdose of Klimicin

If you take more than the recommended dose, contact your doctor immediately.
Your doctor will provide symptomatic treatment. If the overdose was recent, the doctor may perform gastric lavage. You should drink plenty of fluids. The medicine cannot be removed from the body by haemodialysis or peritoneal dialysis.

Missing a dose of Klimicin

Take Klimicin as directed by your doctor. If you forget to take a dose, take it as soon as possible. Then continue to take the medicine as directed by your doctor. Do not take a double dose to make up for the missed dose.

Stopping treatment with Klimicin

It is very important to take the medicine for as long as your doctor has prescribed. Do not stop treatment early, even if you feel better. Stopping treatment too early may cause the infection to recur, and may lead to complications such as kidney inflammation or rheumatic fever.
If you do not feel better after 14 days of treatment, consult your doctor again.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Klimicin can cause side effects, although not everybody gets them.
The most common side effects of clindamycin are allergic reactions and gastrointestinal reactions.

If you experience any of the following reactions, stop taking Klimicin and consult your doctor immediately:

• swelling of the face, lips, mouth, throat, or tongue, which may cause difficulty swallowing or breathing;
• chills;
• dizziness, loss of consciousness;
• blistering and peeling of the skin and mucous membranes.
• severe, prolonged diarrhoea;
• muscle weakness
• erythema multiforme - a rash with well-defined, circular, red patches, which may be accompanied by blistering
• drug rash with eosinophilia and systemic symptoms (DRESS), characterized by fever, swollen lymph nodes, or rash, which can be severe and life-threatening
• acute generalized exanthematous pustulosis (AGEP) - a type of skin eruption characterized by the sudden appearance of numerous small, white or yellowish bumps on red skin. These are very serious side effects. Their occurrence may indicate a severe allergic reaction to Klimicin or another serious side effect associated with taking the medicine. Immediate medical attention may be required in a hospital.

Tell your doctor immediately if you experience:

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

The following side effects may occur with the use of Klimicin, with their frequency of occurrence:
Very common (may affect more than 1 in 10 people): allergic reactions with rash, diarrhoea, oesophagitis, vomiting, abdominal pain, nausea.
Common (may affect up to 1 in 10 people): pseudomembranous colitis, changes in blood cell counts, such as agranulocytosis, leucopenia, neutropenia, thrombocytopenia, eosinophilia, maculopapular rash, urticaria, abnormal liver function tests.
Uncommon (may affect up to 1 in 100 people): taste disturbances, neuromuscular blockade, .
Rare (may affect up to 1 in 1,000 people): fever, erythema multiforme, severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, bullous dermatitis, pruritus, angioedema).
Very rare (may affect up to 1 in 10,000 people): severe, acute allergic reactions, anaphylactic reaction, transient hepatitis, polyarthritis.
Frequency not known (cannot be estimated from the available data): vaginal infection, Clostridium difficilecolitis, anaphylactic shock, pseudoanaphylactic reactions, hypersensitivity, dizziness, somnolence, headache, drug rash with eosinophilia and systemic symptoms (involving the liver, kidneys, lungs, heart), anorexia, bloating, gas, oesophagitis, oral thrush, jaundice, pustular rash appearing suddenly all over the body, angioedema (of the tongue, face, throat).
Long-term treatment may lead to superinfections with resistant microorganisms, most commonly fungi.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Klimicin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Klimicin contains

The active substance is clindamycin. One capsule contains 300 mg of clindamycin in the form of clindamycin hydrochloride.
The other ingredients are: lactose monohydrate, magnesium stearate, talc, maize starch.
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Klimicin looks like and contents of the pack

Klimicin capsules are brown and contain a crystalline, almost white powder.
PVC/PVDC/Aluminium blisters in a cardboard box contain 16 or 100 capsules.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz S.R.L.
Str. Livezeni nr. 7
Târgu Mureş, Romania
For more information about this medicine, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: +48 22 209 70 00
Date of last revision of the leaflet:04/2025
(logo of the marketing authorization holder)