DALACIN 75 mg /5 Ml Granulate

Contents of the leaflet

1. Package Leaflet: Information for the User
2. DALACIN C, 75 mg/ 5 ml, Granules for Oral Solution
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What Dalacin C is and what it is used for
4. Important information before taking Dalacin C
   1. When not to take Dalacin C
   2. Warnings and precautions
   3. Dalacin C with other medicines
   4. Dalacin C with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Dalacin C contains sucrose
5. How to take Dalacin C
   1. Use in patients with liver function disorders
   2. Use in patients with kidney function disorders
   3. Use in patients undergoing hemodialysis
   4. Use of a higher than recommended dose of Dalacin C
   5. Missing a dose of Dalacin C
   6. Stopping treatment with Dalacin C
6. Possible side effects
   1. Reporting side effects
7. How to store Dalacin C
8. Contents of the pack and other information
   1. What Dalacin C contains
   2. What Dalacin C looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about this medicine, please contact the marketing authorization holder:
   6. Other sources of information

Package Leaflet: Information for the User

DALACIN C, 75 mg/ 5 ml, Granules for Oral Solution

Clindamycin

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

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

Contents of the Package Leaflet

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

Dalacin C is an antibiotic. The active substance, clindamycin, acts mainly 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 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 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

Special care should be taken when using Dalacin C in patients:

• allergic to penicillin,
• with liver function disorders,
• with disorders of nerve and 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), 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 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 feet, ankles, or hands, shortness of breath, or nausea, you should contact your doctor immediately.

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 blisters on the skin), 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 seek medical attention immediately.

If you experience diarrhea during or after treatment, especially severe and persistent, you should contact your doctor. It may be a sign of pseudomembranous colitis (in most cases caused by Clostridioides difficile). This disease, being a complication of antibiotic therapy, can be life-threatening. As soon as the diagnosis of pseudomembranous colitis is established, the doctor should recommend discontinuing Dalacin C and starting appropriate treatment (oral metronidazole is given, and in severe cases, vancomycin).

Dalacin C with other medicines

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

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

Due to its properties of inhibiting neuromuscular transmission, clindamycin may enhance the effect of muscle relaxants (e.g., ether, tubocurarine, halogenated pankuronium). 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 your 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Clindamycin crosses the placenta in humans. After multiple doses, the concentration of the antibiotic in the amniotic fluid was about 30% of the concentration found in the mother's blood. In clinical studies in pregnant women, the overall (oral or intravenous) administration of clindamycin in the second and third trimester of pregnancy was not associated with an increased incidence of congenital anomalies.

There are no adequate clinical data in women in the first trimester of pregnancy.

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

Clindamycin passes into human 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 sucrose

5 ml of the syrup contains about 1.9 g of sucrose. If you have previously been diagnosed with intolerance to some sugars, you should tell your doctor before taking Dalacin C.

3. How to take Dalacin C

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

Children and adolescents

The dose of clindamycin will be determined by your doctor based on your body weight, regardless of your weight.

The most common dosage in children is 5 ml of syrup (i.e., 75 mg of clindamycin) four times a day.

Depending on the location and severity of the infection, children from over 4 weeks to 14 years of age are given 8 to 25 mg of clindamycin per kilogram of body weight per day, divided into 3 or 4 equal doses.

In children with a body weight of 10 kg or less, the minimum recommended dose is: 2.5 ml of syrup (i.e., 37.5 mg of clindamycin) three times a day.

Adults and adolescents over 14 years of age

Adults usually take doses of 10 to 30 ml of syrup (i.e., 600 mg to 1800 mg of clindamycin) every 6 to 8 hours.

If higher doses are necessary, e.g., for adults and adolescents over 14 years of age, Dalacin C with a higher active substance content is available (150 mg or 300 mg capsules).

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-hemolytic streptococci, the medicine should be taken for at least 10 days.

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, your 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 prolong the intervals between doses.

Use in patients with kidney function disorders

In patients with kidney failure, there is a slight prolongation of the half-life of clindamycin, which does not require a dose reduction. Also, in patients with severe kidney failure, it is not necessary to reduce the dose when Dalacin C is administered every 8 hours. However, in patients with severe failure or anuria, your 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 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 dialysis or after dialysis.

Method of administration

The medicine is administered orally, using the measuring spoon provided with the packaging.

Method of preparing the syrup

To dissolve the granules, 60 ml of water should be used. It is not recommended to use tap water, but demineralized or distilled water.

The medicine should be dissolved as follows: add most of the prepared water and shake vigorously. Add the remaining water and shake until a uniform solution is obtained.

After dissolving the granules, 5 ml of the prepared syrup contains 75 mg of clindamycin.

Use of a higher than recommended dose of Dalacin C

In case of accidental ingestion of too high a dose of Dalacin C, you should immediately contact your doctor or pharmacist. The doctor will take appropriate action, 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 symptoms of overdose have been observed. There is no antidote that can be used in case of overdose of Dalacin C. Hemodialysis and peritoneal dialysis are not effective.

Missing a dose of Dalacin C

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

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

Stopping treatment with Dalacin C

If you have any further questions about the use of this medicine, ask 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 (pseudomembranous 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 peeling of the skin (toxic epidermal necrolysis)*.
• widespread red skin rash with small blisters containing pus (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 red skin areas with small blisters (small blisters filled with white-yellowish fluid) (acute generalized exanthematous pustulosis, AGEP)*.
• rash, which appears as blisters and looks like small dots (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)*, decrease in the number of white blood cells (leukopenia)*, decrease in the number of platelets (thrombocytopenia)*.
• fluid retention causing swelling of the feet, ankles, or hands, shortness of breath, or nausea.
• cardiac arrest.

Other possible side effects may include:

Common(may affect up to 1 in 10 people)

• blood clots (thrombophlebitis)
• 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)

• low blood pressure
• vomiting
• abdominal pain
• nausea
• taste disorders
• hives
• pain or abscess at the injection site.

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

• itching.

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

• inflammation of the mucous membrane of the esophagus*, open sores or changes in the mucous membrane of the esophagus*.
• vaginal infection*.
• red rash with blisters (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.

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, you should tell your doctor or pharmacist. You can also report side effects 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.

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 Dalacin C

Store in a temperature below 25°C. Protect from light and moisture.

After 2 weeks from preparation of the syrup, any unused portion of the medicine should be discarded.

Medicines should be kept out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that 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. 5 ml of the syrup contains 75 mg of clindamycin, in the form of clindamycin palmitate hydrochloride.
• The other ingredients are: ethyl 4-hydroxybenzoate (E 214), simethicone, sucrose, Poloxamer 188 (Pluronic F68), flavor composition "Felcofix Cherry Blend No. 770".

What Dalacin C looks like and contents of the pack

White powder with a cherry flavor.

Packaging: orange glass bottle (class III) with a child-resistant polypropylene cap with a cellulose wad with a barrier layer of paper, aluminum foil, PE/PET, or with an aluminum foil coating with PE/PET, in a cardboard box.

The cardboard box contains a polystyrene measuring spoon.

The bottle contains 32 g of granules for preparation of 80 ml of syrup, which corresponds to 1.2 g of clindamycin.

Marketing authorization holder

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

Manufacturer

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium.

Pfizer Service Company BV, Hoge Wei 10, 1930 Zaventem, Belgium.

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

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

Date of last revision of the leaflet:02/2025.

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: http://urpl.gov.pl.