Clindamycin mylan

Package leaflet: Information for the user

Clindamycin Mylan, 300 mg, hard capsules
Clindamycinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Clindamycin Mylan is and what it is used for
2. Important information before taking 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 in the treatment of
serious bacterial infections.

2. Important information before using Clindamycin Mylan

When not to use Clindamycin Mylan

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

Warnings and precautions
Before starting treatment with Clindamycin Mylan, discuss with your doctor:

• if the patient has diarrhoea, or usually develops diarrhoea when taking antibiotics, or if the patient has ever had stomach or intestinal problems;
• if the patient has impaired kidney or liver function;
• if the patient has asthma, skin rash, or hay fever;
• if the patient experiences any severe skin reactions or signs of hypersensitivity to Clindamycin Mylan, such as sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching.

During treatment
If during or after treatment with Clindamycin Mylan the patient develops severe or prolonged diarrhoea, or diarrhoea with blood, inform the doctor immediately, as this may be a symptom of inflammation of the large intestine (pseudomembranous colitis) that may occur after antibiotic therapy. Do not take anti-diarrhoeal medicines before consulting a doctor.
The doctor may regularly order control tests to monitor whether kidney and liver functions remain normal during treatment.
Severe kidney function disorders may occur. Inform the doctor about all concomitant medications and any kidney problems. If the patient produces less urine than usual, or experiences fluid retention causing swelling of the legs, ankles or feet, shortness of breath or nausea, contact the doctor immediately.
Since clindamycin does not penetrate into the brain, it is not suitable for the treatment of severe infections of the brain and surrounding structures. In case such infections occur, the doctor may prescribe another antibiotic.

Clindamycin Mylan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines available without a prescription, as well as the following medicinal products:

• antibiotics known as macrolides and streptogramins, e.g. erythromycin, virginiamycin, pristinamycin;
• muscle relaxants used during surgery;
• warfarin or medicines with similar effects used to thin the blood, as this may increase the risk of bleeding. The doctor may order regular tests to monitor blood clotting;
• medicines inducing CYP3A4 or CYP3A5, e.g. rifampicin, as they may affect the effectiveness of this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Since the active substance of Clindamycin Mylan may pass into human milk in small amounts, the patient should inform the doctor if she intends to breastfeed while using this medicine. Breastfeeding is possible during treatment with this medicine. However, if the infant develops diarrhoea, blood in the stool, oral reactions or skin reactions, contact the doctor immediately to reassess the treatment.

Driving and using machines
The influence of clindamycin on the ability to drive and use machines has not been established.

Clindamycin Mylan contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Clindamycin Mylan

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Adults and elderly patients
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 doses or formulations, other medicinal products available on the market should be used.
Use in children and adolescents
The recommended dose for children is 3 to 6 mg per kg of body weight every 6 hours, depending on the severity of the infection. Your doctor will determine the required number of capsules for the child.
Method of administration
Clindamycin Mylan should be taken with a full glass of water. The capsules may be taken before or after meals. Clindamycin Mylan capsules should not be given to children who are unable to swallow the capsule whole.
Long-term use of Clindamycin Mylan
If long-term treatment with Clindamycin Mylan is necessary, your doctor may recommend regular liver and kidney function tests and blood tests. Do not miss scheduled follow-up appointments with your doctor.
Prolonged use of this medicine may also increase the risk of developing another infection that does not respond to clindamycin treatment.
Taking more Clindamycin Mylan than recommended
If you accidentally take too much Clindamycin Mylan, seek immediate medical attention at your doctor's office or the nearest hospital emergency department. Always bring the labeled packaging with you, regardless of how much medicine has been used. Do not take any further capsules without medical advice.
Missing a dose of Clindamycin Mylan
If several hours have passed since the scheduled dose, take the missed dose as soon as possible. Do not take the missed dose if it is almost time for the next scheduled dose. Do not take a double dose to make up for a missed one.
Stopping treatment with Clindamycin Mylan
Premature discontinuation of Clindamycin Mylan may lead to recurrence of the infection or worsening of symptoms.
Do not stop taking Clindamycin Mylan without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient suspects that any of the following adverse reactions may be occurring,
treatment with this medicine should be stopped immediately and the patient should consult a doctor or go to
the emergency department of the nearest hospital. The following adverse reactions may require medical attention:

• severe, persistent diarrhoea or diarrhoea with blood (which may be associated with abdominal pain or fever). This is an uncommon adverse reaction that may occur during or after antibiotic treatment and may be a sign of a serious intestinal inflammation or pseudomembranous colitis;
• symptoms of a severe allergic reaction, such as sudden wheezing; difficulty breathing; swelling of the eyelids, face or lips; rash or itching (particularly affecting the entire body);
• formation of blisters and peeling of large areas of skin, fever, cough, malaise, and swelling of the gums, tongue or lips;
• yellowing of the skin or whites of the eyes (jaundice);
• fluid retention causing swelling of the legs, ankles or feet, breathlessness or nausea;
• potentially life-threatening skin rashes: extensive rash, formation of blisters and peeling of large areas of skin, particularly around the mouth, nose, eyes or genital area (so-called Stevens-Johnson syndrome), or more severe symptoms involving extensive peeling of the skin affecting more than 30% of the body surface (so-called toxic epidermal necrolysis [Lyell's syndrome]);
• acute generalised exanthematous pustulosis (AGEP);
• rare skin eruption characterised by sudden appearance of numerous pustules filled with white/yellow fluid on reddened skin;
• erythema multiforme – a rash consisting of well-demarcated skin lesions (dark spots surrounded by lighter areas with a dark ring-shaped border), which may be accompanied by blister formation;
• bullous dermatitis characterised by extensive, red skin rash with pustules filled with pus;
• so-called drug reaction with eosinophilia and systemic symptoms (DRESS), characterised by fever, lymph node swelling or skin rash, which may be severe and life-threatening.

Other possible adverse reactions may include:
Common (may affect up to 1 in 10 patients):

• abnormal liver function test results;
• stomach and/or abdominal pain, diarrhoea.

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

• nausea or vomiting;
• rash characterised by flat, red skin surface covered with small papules, urticaria.

Frequency cannot be estimated from available data:

• vaginal and vulvovaginal infection;
• colitis caused by Clostridium difficile infection, causing abdominal pain, fever or diarrhoea;
• taste disturbance;
• blood system disorders: decreased number of white blood cells, which may lead to bruising, bleeding or impaired immune function;
• oesophagitis, ulceration or pathological changes in the oesophageal mucosa;
• skin redness or peeling (exfoliative dermatitis), acne-like rash, itching.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month. The batch number is indicated on the carton and
blister pack 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. Such measures help protect the environment.

6. Contents of the packaging and other information

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

What Clindamycin Mylan looks like and contents of the pack
The 300 mg hard capsules are cylindrical gelatin capsules with a blue cap and a 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 capsule

Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised 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 medicinal product, please contact the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400