Dalacin C

Package Leaflet: Information for the User

DALACIN C, 300 mg, 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, pharmacist, or nurse.
• 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Dalacin C and what is it used for

Dalacin C is an antibiotic. The active substance, clindamycin, acts primarily bacteriostatically and also bactericidally to a degree dependent on the concentration at the site of infection and the susceptibility of the microorganisms.

It has been shown that clindamycin is effective in the treatment of the following bacterial infections caused by microorganisms susceptible to clindamycin:

• bone and joint infections,
• middle ear, throat, 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 severe cases of the disease, it is recommended to use the medicine intravenously.

In patients with endocarditis or sepsis, it is recommended to start treatment with intravenous administration of clindamycin.

2. Important information before taking Dalacin C

When not to take Dalacin C

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

Warnings and precautions

Particular caution should be exercised when using Dalacin C in patients:

• allergic to penicillin,
• with liver function disorders,
• with disorders of nerve-muscle conduction (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), it is necessary to regularly monitor blood morphology and liver and kidney function indicators.

Acute kidney function disorders may occur. You should inform your doctor about all medicines 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.

Due to the risk of oesophagitis and oesophageal ulceration, it is essential to take Dalacin C exactly as described in section 3.

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

Dalacin C should not be used to treat:

respiratory tract infections caused by viruses,

meningitis, due to the low concentration of the antibiotic achievable in the cerebrospinal fluid.

If you experience severe skin reactions, such as drug rash with eosinophilia and systemic symptoms (a life-threatening allergic reaction), Stevens-Johnson syndrome (a disease characterized by the appearance of numerous skin blisters), or acute generalized exanthematous pustulosis (a disease characterized by the appearance of numerous blisters on swollen and reddened skin), you should stop taking Dalacin C and immediatelyconsult a doctor.

You should consult a doctor if you experience diarrhea during or within a few weeks after treatment. It may be a sign of pseudomembranous colitis (in most cases caused by Clostridioidesdifficile). This disease, being a complication of antibiotic therapy, can be life-threatening. As soon as pseudomembranous colitis is diagnosed, the doctor should recommend discontinuing Dalacin C and initiating appropriate treatment (oral metronidazole is given, and in severe cases - vancomycin). You should not take anti-peristaltic agents or other constipating medications.

Dalacin C with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Microorganisms resistant to lincomycin also show resistance to clindamycin (so-called cross-resistance).

Due to its neuromuscular blocking properties, clindamycin may enhance the effect of muscle relaxants (e.g., ether, tubocurarine, halogenated pancuronium). This may lead to unexpected, life-threatening complications during surgical operations.

If you are taking medicines 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 drug), or carbamazepine (used to treat epilepsy and neuropathic pain), your doctor may recommend monitoring the progress of treatment.

The effectiveness of oral contraceptives used with clindamycin has been questioned. Therefore, during treatment with this medicine, you should use additional contraceptive methods.

Warfarin or similar medicines that affect blood clotting. You may be more prone to bleeding. Your doctor may decide to perform regular blood tests to check its clotting.

Dalacin C with food and drink

Dalacin C is rapidly and almost 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, and when administered after a meal - after about 2 hours.

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.

Your doctor may prescribe Dalacin C during pregnancy only if it is absolutely necessary.

Clindamycin passes into breast milk.

In a breastfed infant, it is not possible to exclude the occurrence of severe side effects.

Therefore, your doctor will decide whether you can take clindamycin and breastfeed at the same time.

Driving and using machines

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

Dalacin C contains lactose

Patients with intolerance to some sugars should contact their doctor before taking Dalacin C.

3. How to take Dalacin C

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

Adults and adolescents over 14 years old

Depending on the location and severity of the infection, in adults and adolescents over 14 years old, clindamycin is used in a dose of 2 to 6 capsules of 300 mg per day (i.e., from 600 mg to 1800 mg per day). The medicine should be administered in 3 or 4 divided doses throughout the day.

If the recommended daily dose does not exceed 900 mg or when clindamycin needs to be used in children under 14 years old, Dalacin C is available with a lower active substance content (75 mg capsules, 150 mg capsules, granules for oral suspension 75 mg/5 ml). If it is not possible to accurately measure the dose of the medicine in mg/kg body weight using capsules, clindamycin should be used in the form of granules for oral suspension.

Capsules containing clindamycin hydrochloride should only be used in children who can swallow the capsule.

Your doctor will determine the dose of clindamycin based on the patient's total body weight, regardless of excess weight.

Dalacin C is also available in the form of a solution for injection and infusion 150 mg/ml.

In the treatment of infections caused by beta-haemolytic streptococci, the medicine should be taken for at least 10 days.

Method of administration

Capsules should be taken whole, with a full glass of water, and at least 30 minutes before lying down to avoid potential oesophageal irritation.

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 Dalacin C is administered every 8 hours. However, in patients with advanced liver failure, the doctor should monitor the clindamycin concentration in the serum. Depending on the results of these tests, it may be necessary to reduce the dose or extend 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 Dalacin C is administered every 8 hours. However, in patients with severe renal failure or anuria, the doctor should monitor the clindamycin concentration in the serum. Depending on the results of these tests, it may be necessary to reduce the dose or extend the intervals between doses to 8 or even 12 hours.

Use in patients undergoing haemodialysis

Clindamycin is not removed from the body during haemodialysis. 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 Dalacin C

In case of accidental ingestion of too much Dalacin C, you should immediately consult a doctor or pharmacist. The doctor will take appropriate actions, e.g., gastric lavage.

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

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

Missed dose of Dalacin C

Do not take a double dose to make up for a missed dose.

If you miss a dose, take the medicine as soon as possible, unless it is almost time for the next dose.

Stopping the use of Dalacin C

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

You should contact your doctor immediatelyif you experience:

• 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*.
• symptoms of a severe allergic reaction, such as sudden wheezing, difficulty breathing, dizziness, swelling of the eyelids or face, lips, throat or tongue, rash or itching (especially if it affects the whole body)*.
• potentially life-threatening skin rashes:
• blisters and peeling of large areas of skin, fever, cough, malaise, and swelling of the gums, tongue, or lips*.
• widespread rash with blisters and peeling of large areas of skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) * and a more severe form, causing widespread skin peeling (toxic epidermal necrolysis) *.
• widespread red skin rash with small pus-filled blisters (exfoliative or pustular dermatitis) *.
• fever, swollen lymph nodes, or skin rash, these may be symptoms of a condition known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), which may be severe and life-threatening. Symptoms of DRESS usually start within a few weeks of exposure to clindamycin*.
• rare skin eruptions characterized by the sudden appearance of areas of red skin with small blisters (small blisters filled with white-yellow fluid) (Acute Generalized Exanthematous Pustulosis (AGEP)) *.
• skin rash, characterized by the appearance of blisters and looks like small spots (central dark spots surrounded by a lighter area, with a dark ring around the edge) called erythema multiforme.
• yellowing of the skin and whites of the eyes (jaundice)*.
• significant decrease in the number of blood cells, which may cause bruising or bleeding, or weakening of the immune system (agranulocytosis)*, decreased white blood cell count (leukopenia)*, decreased platelet count (thrombocytopenia)*.
• fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea.

Other possible side effects may include:

Common(may affect up to 1 in 10 people)

• blood clots (phlebitis)
• diarrhea
• increased white blood cell count (eosinophilia)
• abnormal liver function tests
• rash characterized by a flat, red area on the skin covered with small bumps

Uncommon(may affect up to 1 in 100 people)

• cardiac arrest
• low blood pressure
• vomiting
• abdominal pain
• nausea
• taste disorders
• hives
• pain, abscess at the injection site

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

• itching

Unknown(frequency cannot be estimated from the available data)

• oesophagitis*, open sores or changes in the oesophageal mucosa*.
• vaginal infection and surrounding area*.
• red rash resembling erythema multiforme (pustular rash)*.
• irritation at the injection site*.

* Side effects observed after the medicine was placed on the market.

Side effects observed only during the use of the injectable form of the medicine.

Side effects observed only during the use of the oral form of the medicine.

The occurrence of these side effects is more likely if Dalacin C is used in a lying position and (or) without drinking sufficient water.

Rare cases of side effects observed after too rapid intravenous administration of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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 181C, 02-222 Warsaw, Poland.

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 or its representative.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalacin C

Store below 30°C.

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

Do not use this medicine after the expiry date stated on the packaging after “Expiry Date (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 Dalacin C contains

The active substance of the medicine is clindamycin. Each capsule contains 300 mg of clindamycin in the form of clindamycin hydrochloride.

The other ingredients are: magnesium stearate, corn starch, talc, lactose monohydrate.

Capsule shell: titanium dioxide (E 171), gelatin.

What Dalacin C looks like and contents of the pack

Dalacin C, 300 mg, hard capsules: a two-part, white capsule marked with the inscription “CLIN 300” and “Pfizer”.

Packaging: blisters of PVC/Al foil containing 16 or 20 capsules, in a cardboard box.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

For more information about this medicine, please contact the representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o.; tel. 22 335 61 00.

Date of last revision of the leaflet: 09/2024.

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-dalacinc300 and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: http://www.urpl.gov.pl.