Clindanea

Package Leaflet: Information for the User

Clindanea, 600 mg, Film-Coated Tablets

Clindamycin

Read the Package Leaflet Carefully Before Taking This Medication, 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 any not listed in this leaflet, please tell your doctor or pharmacist (see section 4).

Table of Contents of the Leaflet

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

1. What is Clindanea and what is it used for

Clindanea is an antibiotic. The active substance, clindamycin, acts primarily bacteriostatically and also bactericidally, depending on the concentration at the site of infection and the susceptibility of the microorganisms.

Clindanea is indicated for the treatment of infections caused by microorganisms susceptible to clindamycin, such as:

• bone and joint infections
• middle ear, throat, and sinus infections
• dental and oral infections
• lower respiratory tract infections
• infections in the pelvic and abdominal cavity
• female genital tract infections
• skin and soft tissue infections
• scarlet fever
• septicaemia and endocarditis.

In cases of severe disease, intravenous administration of the medicine is recommended. In patients with endocarditis or septicemia, it is recommended to start treatment with intravenous clindamycin.

2. Important information before taking Clindanea

When not to take Clindanea

If you are allergic to clindamycin or lincomycin (people allergic to one of these substances may also be allergic to the other, so-called cross-allergy) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Particular caution is required when taking Clindanea in patients:

• allergic to penicillin;
• with liver function disorders;
• with neuromuscular transmission disorders (e.g., myasthenia, Parkinson's disease);
• with a history of gastrointestinal diseases (e.g., previous colitis).

During long-term use of the medicine (for more than 3 weeks), regular monitoring of blood morphology and liver and kidney function tests is necessary.

Acute kidney function disorders may occur. You should inform your doctor about all medications you are taking and any kidney problems you have. If you experience a decrease in urine output or fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea, you should contact your doctor immediately.

Prolonged and repeated use of clindamycin may lead to infection and overgrowth of resistant bacteria or fungi.

Clindamycin should not be used to treat acute viral respiratory infections.

Clindamycin does not reach therapeutic concentrations in cerebrospinal fluid, so Clindanea should not be used to treat meningitis.

If you experience severe skin reactions, such as drug rash with eosinophilia and systemic symptoms (a life-threatening allergic reaction, see section 2), Stevens-Johnson syndrome (a disease characterized by the appearance of numerous skin blisters), acute generalized exanthematous pustulosis (a disease characterized by the appearance of numerous fluid-filled blisters on swollen and reddened skin), or angioedema, you should stop taking Clindanea and consult a doctor for appropriate treatment.

You should consult a doctor if you experience diarrhea during or after treatment, especially if it is severe and persistent. It may be a sign of pseudomembranous colitis (in most cases caused by Clostridium difficile), a potentially life-threatening complication of antibiotic therapy. As soon as pseudomembranous colitis is diagnosed, the doctor should recommend discontinuing Clindanea and starting appropriate treatment (oral metronidazole or, in severe cases, vancomycin). You should not take anti-peristaltic agents or other constipating medications.

Clindanea and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

Clindanea should not be taken with macrolide antibiotics (e.g., erythromycin) due to their opposing effects on bacteria.

• Microorganisms resistant to lincomycin also show resistance to clindamycin (so-called cross-resistance).
• Clindamycin has neuromuscular blocking properties, which may enhance the effect of muscle relaxants (e.g., ether, tubocurarine, halogenated pankuronium). Therefore, during operations using such agents, unexpected life-threatening situations may occur.

If you are taking clindamycin with other medications, such as rifampicin (an antibiotic used to treat several types of bacterial infections), St. John's Wort (used as a natural antidepressant and mood enhancer), phenytoin (an antiepileptic medication), or carbamazepine (used to treat epilepsy and neuropathic pain), it may reduce the antibacterial effect of clindamycin. It is recommended to monitor treatment progress with your doctor.

• The effectiveness of oral hormonal contraceptives during concurrent use with clindamycin is uncertain. Therefore, during clindamycin treatment, you should use additional effective contraception.
• Warfarin or similar medications that affect blood clotting. You may be more prone to bleeding. Your doctor may decide to perform regular blood tests to check blood clotting.

Clindanea with food and drink

Clindanea is rapidly and completely absorbed from the gastrointestinal tract. Food taken at the same time slightly prolongs the absorption period. After administration on an empty stomach, the medicine reaches its maximum concentration in serum after about 45-60 minutes. When administered after a meal, it reaches its maximum concentration after about 2 hours.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.

In human studies, no teratogenic effects of the medicine have been detected. The doctor should carefully weigh the benefits and risks of using clindamycin during pregnancy and breastfeeding.

Clindamycin may pass into breast milk. You should not take Clindanea while breastfeeding.

Driving and using machines

There is no data on the effect of Clindanea on the ability to drive and use machines.

Clindanea contains lactose

One film-coated tablet contains 10.48 mg of lactose (monohydrate). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Clindanea

Clindanea should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents over 14 years

Depending on the severity and location of the infection, adults and adolescents over 14 years should take 600 mg to 1800 mg of clindamycin per day. The daily dose is divided into 3-4 doses.

Clindanea film-coated tablets should be swallowed with a sufficient amount of liquid (e.g., 1 glass of water).

Children and adolescents

Clindanea 600 mg film-coated tablets are not intended for use in children and adolescents under 14 years due to the lack of possibility of appropriate dosing.

Use in patients with liver function disorders

In patients with moderate to severe liver function disorders, the half-life of clindamycin is prolonged. It is not necessary to reduce the dose when Clindanea is administered every 8 hours. However, in patients with advanced liver failure, the doctor should monitor the clindamycin concentration in serum. Depending on the results of these tests, it may be necessary to reduce the dose or prolong the intervals between doses.

Use in patients with kidney function disorders

In patients with renal failure, there is a slight prolongation of the half-life of clindamycin, which does not require a dose reduction. Also, in patients with severe renal failure, it is not necessary to reduce the dose when Clindanea is administered every 8 hours. However, in patients with severe renal failure or anuria, the doctor should monitor the clindamycin concentration in serum. Depending on the results of these tests, it may be necessary to reduce the dose or prolong the intervals between doses to 8 or even 12 hours.

Use in patients undergoing hemodialysis

Clindamycin is not removed from the body during hemodialysis. Therefore, it is not necessary to administer an additional dose of the medicine before or after dialysis.

Use of a higher than recommended dose of Clindanea

If you have taken a dose of the medicine higher than recommended, you should immediately contact your doctor or pharmacist. The doctor will take appropriate actions, e.g., gastric lavage.

Overdose of Clindanea may cause severe allergic reactions (serum reactions, angioedema, anaphylactic reactions up to anaphylactic shock).

To date, no symptoms of overdose have been observed. There is no known antidote that can be used after an overdose of Clindanea. Hemodialysis and peritoneal dialysis are not effective.

Missing a dose of Clindanea

You should not take a double dose to make up for a missed dose.

If you miss a dose, you should take it as soon as possible, unless it is close to the time for the next dose.

Stopping treatment with Clindanea

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

You should stop taking Clindanea and immediately inform your doctor if you experience fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea.

Severe side effects:

• kidney damage, including acute kidney failure,
• anaphylactoid reactions (a type of allergic reaction).

Possible severe hypersensitivity reactions, such as:

• rash,
• anaphylactic shock, anaphylactic reactions, anaphylactoid reactions (sudden, life-threatening allergic reactions), which may include symptoms such as: difficulty breathing or wheezing, swelling, rash, itching, fever, chills
• itching,
• hives,
• angioedema (possible swelling of the lips, tongue, throat, or larynx, which may cause difficulty breathing),
• hypotension,
• shortness of breath, as well as:
• severe skin reactions, such as toxic epidermal necrolysis (Lyell's syndrome), bullous pemphigoid (Stevens-Johnson syndrome) (a disease characterized by the appearance of numerous skin blisters), drug rash with eosinophilia and systemic symptoms (DRESS) (a life-threatening allergic reaction, see section 2), acute generalized exanthematous pustulosis (AGEP) (a disease characterized by the appearance of numerous fluid-filled blisters on swollen and reddened skin), angioedema, exfoliative dermatitis, bullous dermatitis, erythema multiforme, pityriasis rosea.
• pseudomembranous colitis (severe, persistent, or bloody diarrhea [which may be associated with abdominal pain or fever]). This is a side effect that may occur during or after antibiotic treatment and may be a sign of severe colitis.

You should stop taking Clindanea and immediately inform your doctor if you experience any of the above side effects.

Other side effects are listed below:

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

• eosinophilia (an increase in the number of eosinophils in the blood - a type of white blood cell)
• diarrhea
• abnormal liver function tests
• papular rash

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

• taste disorders
• abdominal pain, nausea, vomiting

Rare (may affect up to 1 in 1,000 people):

• itching.

Frequency not known (cannot be estimated from the available data):

• -Clostridioides difficile-associated disease (colitis), vaginal infection
• agranulocytosis, leukopenia, neutropenia (reduced number of different types of white blood cells), thrombocytopenia (reduced platelet count)
• esophageal ulceration, esophagitis
• allergy
• jaundice

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. 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 181 C, 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 medicine.

5. How to store Clindanea

Store in a temperature below 30°C.

Keep the medicine out of the sight and reach of children.

Do not use Clindanea after the expiry date stated on the carton after "EXP".

The expiry date refers to the last day of the month.

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 Clindanea contains

The active substance of the medicine is clindamycin (Clindamycinum).

One film-coated tablet contains 600 mg of clindamycin in the form of clindamycin hydrochloride.

The other ingredients of the medicine are:

Core:

Mannitol

Microcrystalline cellulose

Crospovidone type A

Colloidal anhydrous silica

Magnesium stearate

Talc

Coating Opadry OY-L-28900 White with the composition:

Lactose monohydrate

Hypromellose 15cP

Titanium dioxide (E 171)

Macrogol 4000

What Clindanea looks like and contents of the pack

Clindanea is a white, oval, film-coated tablet with a dividing line, divisible on both sides. The tablets can be divided into equal doses.

Available packs: 6, 12, and 30 film-coated tablets. The film-coated tablets are packaged in PVC/PE/PVDC/Aluminum blisters, 6 tablets per blister, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Solinea Sp. z o.o.

Elizówka ul. Szafranowa 6

21-003 Ciecierzyn

Poland

Tel: 81 463-48-82

Fax: 81 463-48-86

Email: biuro@solinea.pl

Manufacturer:

Haupt Pharma Wűlfing GmbH

Bethelner Landstr. 18

31028 Gronau/Leine

Germany

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:

Solinea Sp. z o.o.

Elizówka ul. Szafranowa 6

21-003 Ciecierzyn, Poland

Tel: 81 463-48-82

Fax: 81 463-48-86

Email: biuro@solinea.pl

Date of the last revision of the leaflet:

December 2023