Clindamicin Milan

Package Leaflet: Information for the User

Clindamycin Mylan, 300 mg, Hard Capsules

Clindamycin

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

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Clindamycin Mylan is and what it is used for
• 2. Before you take Clindamycin Mylan
• 3. How to take Clindamycin Mylan
• 4. Possible side effects
• 5. How to store Clindamycin Mylan
• 6. Contents of the pack and other information

1. What Clindamycin Mylan is and what it is used for

Clindamycin Mylan contains clindamycin, an antibiotic used to treat severe bacterial infections.

2. Before you take Clindamycin Mylan

When not to take Clindamycin Mylan

• If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Clindamycin Mylan, talk to your doctor:

• if you have ever had diarrhea or usually get diarrhea when taking antibiotics, or if you have ever had stomach or intestinal problems;
• if you have kidney or liver disease;
• if you have asthma, eczema or hay fever;
• if you get severe skin reactions or signs of allergy to Clindamycin Mylan, such as sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching.

During treatment
If you get severe or prolonged diarrhea or diarrhea with blood during or after taking Clindamycin Mylan, tell your doctor immediately, as this may be a sign of a serious condition called pseudomembranous colitis that can occur with antibiotic treatment. Do not take anti-diarrheal medicines without consulting your doctor.
Your doctor may regularly check your liver and kidney function and blood tests. Do not miss your doctor's appointments.
Long-term use of Clindamycin Mylan may also increase the risk of developing another infection, for which clindamycin treatment may not be effective.

Clindamycin Mylan with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take, including those obtained without a prescription and the following:

• macrolide and streptogramin antibiotics, such as erythromycin, virginiamycin, pristinamycin;
• muscle relaxants used during surgery;
• warfarin or similar medicines used to thin the blood, as the risk of bleeding may increase. Your doctor may regularly check your blood clotting;
• medicines that induce CYP3A4 or CYP3A5, such as rifampicin, as they may affect the efficacy of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since the active substance of Clindamycin Mylan may pass into breast milk in small amounts, you should tell your doctor if you are breastfeeding during treatment with this medicine. Breastfeeding is possible during treatment with this medicine. However, if your baby gets diarrhea, blood in the stool, oral thrush or skin reactions, you should contact your doctor as soon as possible to reassess the treatment.

Driving and using machines

Clindamycin has not been shown to affect the ability to drive or use machines.

Clindamycin Mylan contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Clindamycin Mylan

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

Adults and the elderly

The recommended dose of Clindamycin Mylan is 150 to 450 mg every 6 hours, depending on the severity of the infection.

If Clindamycin Mylan is not available in the required dose and form, other available medicinal products should be used.

Use in children and adolescents

The recommended dose for children is 3 to 6 mg/kg every 6 hours, depending on the severity of the infection. Your doctor will determine the required number of capsules for your child.

Method of administration

Clindamycin Mylan should be taken with a full glass of water. The capsules can be taken before or after meals. Clindamycin Mylan capsules should not be given to children who cannot swallow the capsule whole.

Long-term use of Clindamycin Mylan

If long-term use of Clindamycin Mylan is necessary, your doctor may regularly check your liver and kidney function and blood tests. Do not miss your doctor's appointments.
Long-term use of this medicine may also increase the risk of developing another infection, for which clindamycin treatment may not be effective.

Overdose of Clindamycin Mylan

If you accidentally take too much of this medicine, contact your doctor or go to the emergency department of your nearest hospital immediately. Always take the labeled packaging with you, even if you have taken all of your medicine. Do not take any more capsules without consulting your doctor.

Missing a dose of Clindamycin Mylan

If it is only a few hours since you were supposed to take the dose, take it as soon as possible. Do not take the missed dose if it is almost time for your next capsule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Clindamycin Mylan

If you stop taking this medicine too soon, your infection may not be fully treated, and the bacteria may become resistant to antibiotics.
Do not stop taking Clindamycin Mylan without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clindamycin Mylan can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the emergency department of your nearest hospital immediately. The following side effects may require medical attention:

Medical attention:

• severe, persistent diarrhea or diarrhea with blood (which may be accompanied by abdominal pain or fever). This is a rare side effect that can occur during or after antibiotic treatment and may be a sign of a serious condition called pseudomembranous colitis;
• symptoms of a severe allergic reaction, such as sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if affecting the whole body);
• blistering and peeling of large areas of skin, fever, cough, feeling unwell, and swelling of the gums, tongue, or lips;
• yellowing of the skin or whites of the eyes (jaundice);
• fluid retention causing swelling of the feet, ankles, or hands, shortness of breath, or nausea
• skin rash that may be life-threatening: widespread rash and blistering, peeling of large areas of skin, especially around the mouth, nose, eyes, or genitals (Stevens-Johnson syndrome) or more severe symptoms such as widespread skin peeling (more than 30% of the body surface) (toxic epidermal necrolysis)

Acute generalized exanthematous pustulosis (AGEP)

• a rare skin reaction characterized by the rapid appearance of many small pus-filled bumps on a red background;
• erythema multiforme - a rash with well-defined, raised, red spots, sometimes with a pale center, which may be accompanied by blistering;
• pustular psoriasis - widespread, red, scaly skin with pus-filled bumps;
• drug reaction with eosinophilia and systemic symptoms (DRESS), which may be life-threatening, characterized by fever, swollen lymph nodes, or a rash, which may be severe.

Other possible side effects include:

Common (may affect up to 1 in 10 people):

• abnormal liver function tests;
• stomach pain and/or diarrhea.

Uncommon (may affect up to 1 in 100 people):

• nausea or vomiting;
• rash, characterized by a flat, red area of skin covered with small bumps, urticaria.

Frequency cannot be estimated from the available data:

• vaginal or vulvar infection;
• Clostridium difficile-associated diarrhea, which may cause stomach pain, fever, or diarrhea;
• taste disturbance;
• blood disorders: reduction in the number of white blood cells, which may cause bruising or bleeding, or weakening of the immune system;
• esophageal inflammation, ulceration, or lesions of the esophageal mucosa;
• redness or peeling of the skin (exfoliative dermatitis), erythema multiforme, 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 to the Department of Drug Safety Monitoring, 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. You can also report side effects to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clindamycin Mylan

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 after EXP. The expiry date refers to the last day of that month.
The batch number is stated on the carton and blister after Lot.
Do not store above 25°C.
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 protect the environment.

6. Contents of the pack and other information

What Clindamycin Mylan contains

The active substance is clindamycin. Each hard capsule contains 300 mg of clindamycin (as clindamycin hydrochloride).
The other ingredients are: colloidal anhydrous silica, lactose monohydrate (see section 2: "Clindamycin Mylan contains lactose"), maize starch, magnesium stearate, indigo carmine (E 132), titanium dioxide (E 171), and gelatin.

What Clindamycin Mylan looks like and contents of the pack

Clindamycin Mylan 300 mg hard capsules are cylindrical, hard gelatin capsules with a blue cap and white body.
Clindamycin Mylan is available in:

• blister packs in a cardboard box, containing 16 or 30 capsules
• unit dose blister packs in a cardboard box, containing 16 x 1 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

Balkanpharma-Razgrad AD
68 Aprilsko Vastanie Blvd.
7200 Razgrad
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France
Clindamycine Viatris 300 mg gélule
Poland
Clindamycin Mylan
United Kingdom
Clindamycin 300 hard capsules
For further information about this medicine, contact the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet:August 2022