Clindanea

Package leaflet: Information for the user

Clindanea, 600 mg, coated tablets
Clindamycinum
Please read carefully the entire leaflet before taking this medicine, as 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 pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Leaflet contents

1. What Clindanea is and what it is 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 Clindanea is and what it is used for

Clindanea is an antibiotic. The active substance, clindamycin, acts primarily as a bacteriostatic agent and also has bactericidal activity depending on the concentration at the site of infection and the sensitivity of microorganisms.
Clindanea is indicated for the treatment of infections caused by microorganisms sensitive to clindamycin, such as:

• bone and joint infections
• otitis media, pharyngitis, and sinusitis
• dental and oral infections
• lower respiratory tract infections
• pelvic and intra-abdominal infections
• female genital tract infections
• skin and soft tissue infections
• erysipelas
• sepsis and endocarditis

In severe disease, treatment with the intravenous form of the medicine is recommended. In patients with endocarditis or sepsis, treatment should be initiated with intravenous administration of clindamycin.

2. Important information before using Clindanea

When not to use Clindanea
Do not use Clindanea if the patient is allergic to clindamycin or lincomycin (patients 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
Exercise particular caution when using Clindanea in patients:

• who are allergic to penicillin;
• with impaired liver function;
• with neuromuscular conduction disorders (e.g. myasthenia gravis, Parkinson's disease);
• with a history of gastrointestinal disorders (e.g. previous colitis).

During prolonged treatment (lasting more than 3 weeks), regular monitoring of blood morphology and liver and kidney function tests is necessary.
Acute kidney function disorders may occur. Inform your doctor about all concomitantly used medicines and any kidney problems. If the patient experiences reduced urine output or fluid retention causing swelling of the legs, ankles or feet, shortness of breath or nausea, contact a doctor immediately.
Long-term and repeated use of clindamycin may lead to infection and overgrowth of resistant bacteria or yeasts.
Clindamycin should not be used in the treatment of acute viral respiratory tract infections.
Clindamycin does not achieve therapeutic concentrations in cerebrospinal fluid; therefore, Clindanea should not be used in the treatment of meningitis.
If the patient develops severe skin reactions such as drug rash with eosinophilia and systemic symptoms (a serious, life-threatening allergic reaction), Stevens-Johnson syndrome (a disease characterized by numerous skin blisters), or acute generalized exanthematous pustulosis (a disease characterized by numerous fluid-filled pustules on swollen and reddened skin), the patient must stop using Clindanea and consult a doctor for appropriate treatment.
The patient should consult a doctor if diarrhea occurs during or within several weeks after treatment, especially if it is severe and persistent. This may be a symptom of pseudomembranous colitis (in most cases caused by Clostridium difficile). This condition, a complication of antibiotic therapy, may be life-threatening. Immediately after diagnosis of pseudomembranous colitis is confirmed, the doctor should recommend discontinuation of Clindanea and initiate appropriate treatment (oral metronidazole is administered, or vancomycin in severe cases). Do not take medications that inhibit intestinal peristalsis or have constipating effects.

Clindanea with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including over-the-counter medicines.
Clindanea should not be used simultaneously with macrolide antibiotics (e.g. erythromycin) due to antagonistic effects of these drugs on bacteria.

• Microorganisms resistant to lincomycin also show resistance to clindamycin (so-called cross-resistance).
• Clindamycin has neuromuscular blocking properties, which may

potentiate the effects of muscle relaxants (e.g. ether, tubocurarine, pancuronium halides).
Therefore, during surgery using such agents, unexpected life-threatening situations may occur.

• If the patient is concurrently using clindamycin with medications such as rifampicin (an antibiotic used in treating several types of bacterial infections), St. John's wort (used as a natural antidepressant and mood enhancer), phenytoin (an anticonvulsant), or carbamazepine (used in treating epilepsy and neuropathic pain), this may result in loss of antibacterial efficacy of clindamycin. Monitoring of treatment progress by the treating physician is recommended.
• The effectiveness of oral hormonal contraceptives during concomitant use with clindamycin is uncertain. Therefore, during clindamycin treatment, an additional effective contraceptive method should be used.
• Warfarin or similar drugs affecting blood coagulation. The patient may have an increased tendency to bleeding. The doctor may decide to perform regular blood tests to monitor blood clotting.

Clindanea with food and drink
Clindanea is rapidly and completely absorbed from the gastrointestinal tract. Food slightly prolongs the absorption period. When administered on an empty stomach, the drug reaches maximum serum concentration after approximately 45–60 minutes; when administered after a meal, after approximately 2 hours.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Teratogenic effects of the drug have not been detected in human studies. The doctor should carefully weigh the benefits against the risks of using clindamycin during pregnancy and breastfeeding.
Clindamycin may pass into human milk. Clindanea should not be taken during breastfeeding.

Driving and operating machinery
There is no data available on the effect of Clindanea on the ability to drive or operate machinery.

Clindanea contains lactose.
One coated tablet contains 10.48 mg of lactose (monohydrate).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Clindanea

Clindanea must always be taken as prescribed by the physician. In case of doubt, consult a doctor or pharmacist.
Adults and adolescents over 14 years of age
Depending on the severity and location of the infection, adults and adolescents over 14 years of age should receive daily doses of clindamycin ranging from 600 mg to 1800 mg. The daily dose should be divided into 3 to 4 doses.
Clindanea coated tablets should be swallowed with an adequate amount of liquid (e.g. one glass of water).
Children and adolescents
Clindanea 600 mg coated tablets are not intended for use in children and adolescents under 14 years of age due to the inability to appropriately adjust the dosage.
Use in patients with hepatic impairment
In patients with moderate to severe hepatic impairment, the half-life of clindamycin is prolonged. Dose reduction is not necessary when Clindanea is administered every 8 hours. However, in patients with advanced liver failure, the physician should monitor clindamycin plasma concentrations. Depending on the results of these tests, dose reduction or extended dosing intervals may be required.
Use in patients with renal impairment
In patients with renal impairment, there is a slight prolongation of clindamycin half-life, which does not necessitate dose reduction. Also in patients with severe renal impairment, dose reduction is not required when Clindanea is administered every 8 hours. However, in patients with severe renal impairment or anuria, the physician should monitor clindamycin plasma concentrations. Depending on test results, dose reduction or extended dosing intervals to 8 or even 12 hours may be necessary.
Use in patients undergoing hemodialysis
Clindamycin is not removed from the body during hemodialysis. Therefore, there is no need to administer an additional dose before or after dialysis.
Use of doses higher than recommended
If a dose higher than recommended is taken, consult a doctor or pharmacist immediately. The physician will take appropriate measures, e.g. gastric lavage.
Overdose of Clindanea may cause severe allergic reactions (serum sickness-like reactions, angioedema, anaphylactic reactions up to anaphylactic shock).
Symptoms of overdose have not been observed so far. There is no known antidote for overdose with Clindanea. Hemodialysis and peritoneal dialysis are ineffective.
Missed dose of Clindanea
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose.
Discontinuation of Clindanea
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Clindanea may cause adverse reactions, although not everyone experiences them.
The administration of Clindanea must be stopped immediately and the doctor must be informed without delay if the
patient develops fluid retention causing swelling of the legs, ankles or feet, shortness of breath or
nausea.
Serious adverse reactions:

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

Possible serious hypersensitivity reactions, such as:

• rash,
• anaphylactic shock, anaphylactic reactions, anaphylactoid reactions (sudden, life-threatening allergic reactions), symptoms of which may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills,
• itching,
• urticaria,
• angioedema (possible swelling of lips, tongue, throat, larynx making breathing difficult),
• hypotension,
• dyspnea, and also:
• severe skin reactions such as toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme bullosum (Stevens-Johnson syndrome) (a disease characterized by the appearance of numerous skin blisters), drug reaction with eosinophilia and systemic symptoms - DRESS (a severe, life-threatening allergic reaction, see section 2), acute generalized exanthematous pustulosis - AGEP (a disease characterized by the appearance of numerous fluid-filled pustules on swollen and reddened skin), angioedema, exfoliative dermatitis, bullous dermatitis, varicella-like rash, erythema multiforme.
• pseudomembranous colitis (severe, persistent or bloody diarrhea [which may be associated with abdominal pain or fever]). This is an adverse reaction that may occur during or after antibiotic treatment and may indicate a serious intestinal inflammation. The administration of Clindanea must be stopped immediately and the doctor must be informed without delay if the patient experiences any of the above-mentioned adverse reactions.

Other adverse reactions are listed below:
Common (may occur in up to 1 in 10 people):

• eosinophilia (increased number of eosinophils in blood – a type of white blood cells)
• diarrhea
• abnormal liver function tests
• maculopapular rash

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

• taste disturbances
• abdominal pain, nausea, vomiting

Rare (may occur in up to 1 in 1000 people):

• itching.

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

• Clostridioides difficile-associated disease (intestinal disease), vaginal infection
• agranulocytosis, leukopenia, neutropenia (decreased number of various types of white blood cells in blood), thrombocytopenia (decreased number of platelets)
• esophageal ulceration, inflammation of the esophageal mucosa
• hypersensitivity
• jaundice

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clindanea

Store 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 stated 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 packaging and other information

What Clindanea contains
The active substance in Clindanea is clindamycin (Clindamycinum). One coated tablet contains 600 mg of clindamycin in the form of clindamycin hydrochloride.
Other components of the medicine are:
Tablet core:
Mannitol
Microcrystalline cellulose
Cross-linked polyvinylpyrrolidone type A
Anhydrous colloidal silica
Magnesium stearate
Talc
Coating Opadry OY-L-28900 White, composed of:
Lactose monohydrate
Hypromellose 15 cP
Titanium dioxide (E 171)
Macrogol 4000

What Clindanea looks like and contents of the packaging
Clindanea is a white, oval, film-coated tablet with a score line on both sides, allowing the tablet to be divided into equal doses.
Available pack sizes: 6, 12 and 30 film-coated tablets. The film-coated tablets are packed in PVC/PE/PVDC/Aluminium blisters containing 6 tablets per blister, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
Tel: 81 463-48-82
Fax: 81 463-48-86
E-mail: [email protected]

Manufacturer:
Haupt Pharma Wülfin GmbH
Bethelner Landstr. 18
31028 Gronau/Leine
Germany

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn, Poland
Tel: 81 463-48-82
Fax: 81 463-48-86
E-mail: [email protected]

December 2023