Package leaflet: Information for the user

DALACIN C, 75 mg/5 ml, granules for the preparation of syrup
Clindamycinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Dalacin C is and what it is used for
What you need to know before taking Dalacin C
How to take Dalacin C
Possible side effects
How to store Dalacin C
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 primarily as a bacteriostatic agent and also has bactericidal activity depending on the concentration at the site of infection and the susceptibility of microorganisms.
Clindamycin has been shown to be effective in the treatment of the following bacterial infections caused by microorganisms sensitive to clindamycin:

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,
Septicaemia and endocarditis.

In severe cases of illness, treatment with the intravenous formulation of the drug is recommended.
In patients with endocarditis or septicaemia, treatment should be initiated with intravenous administration of clindamycin.

2. Important information before using Dalacin C

When not to use Dalacin C

If the patient is allergic to clindamycin, 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
Special caution is required when using Dalacin C in patients:

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

During prolonged treatment (for more than 3 weeks), regular monitoring of blood morphology and liver and kidney function tests is necessary.
Severe kidney function disorders may occur. Inform your doctor about all concomitantly used medicines and any existing kidney problems. If the patient experiences reduced urine output or fluid retention causing swelling of the feet, ankles or legs, shortness of breath or nausea, immediate contact with a doctor is required.
Prolonged or repeated use of clindamycin may lead to overgrowth of drug-resistant bacteria or yeasts.
Dalacin C should not be used to treat:
viral respiratory tract infections,
meningitis, due to insufficient antibiotic concentration achieved in cerebrospinal fluid.
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 condition characterized by numerous fluid-filled blisters on swollen and reddened skin), the patient should immediately stop using Dalacin C and consult a doctor without delay.
The patient should consult a doctor if diarrhea occurs during treatment or within several weeks after its completion, especially if it is severe and persistent. This may be a symptom of pseudomembranous colitis (in most cases caused by Clostridioides difficile). This condition, a complication of antibiotic therapy, may be life-threatening. Once pseudomembranous colitis is diagnosed, the doctor should immediately discontinue Dalacin C and initiate appropriate treatment (oral metronidazole is administered; in severe cases, vancomycin is used). Medicines that inhibit intestinal peristalsis or have constipating effects should not be used.

Dalacin C and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Microorganisms resistant to lincomycin are also resistant to clindamycin (so-called cross-resistance).
Due to its neuromuscular transmission blocking properties, clindamycin may enhance the effect of muscle relaxants (e.g. ether, tubocurarine, pancuronium bromides). This may lead to unexpected, life-threatening complications during surgical procedures.
If the patient is simultaneously using clindamycin with 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 anticonvulsant), or carbamazepine (used in the treatment of epilepsy and neuropathic pain), monitoring of treatment progress by the treating physician is recommended.
The effectiveness of oral contraceptives used concurrently with clindamycin has been questioned. Therefore, additional contraceptive methods should be used during treatment with this medicine.
Warfarin or similar medicines affecting blood coagulation: the patient may show increased tendency to bleeding. The doctor may decide to perform regular blood tests to monitor blood clotting.

Dalacin C with food and drink
Dalacin C is rapidly and almost completely absorbed from the gastrointestinal tract. Food taken simultaneously 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 about 2 hours.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Clindamycin crosses the human placenta. After multiple doses, antibiotic concentration in amniotic fluid amounts to approximately 30% of the concentration in maternal blood. Clinical studies in pregnant women have shown that systemic (oral or intravenous) administration of clindamycin during the second and third trimesters of pregnancy is not associated with an increased incidence of congenital malformations. Adequate clinical data in women during the first trimester of pregnancy are lacking.
The doctor may prescribe Dalacin C during pregnancy only if clearly needed.
Clindamycin passes into human milk.
Severe adverse effects in a breastfed infant cannot be excluded. Therefore, the doctor will decide whether the patient may take clindamycin and breastfeed simultaneously.

Driving and using machines
There is no data available regarding the effect of Dalacin C on the ability to drive or operate machinery.

Dalacin C granules for oral solution contain sucrose
5 ml of syrup contains approximately 1.9 g of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, this should be reported to the doctor before using Dalacin C.

3. How to use Dalacin C

This medicine should always be used exactly as directed by your doctor. In case of doubt, consult your
doctor, pharmacist, or nurse.
Children and adolescents
The dose of clindamycin will be determined by the doctor based on the patient's total body weight,
regardless of overweight.
The most common dosage in children: 5 ml of syrup (i.e. 75 mg clindamycin) four times daily.
Depending on the site and severity of infection, children aged over 4 weeks to 14 years are given
orally 8 to 25 mg of clindamycin per kg body weight per day, divided into 3 or 4 equal doses.
In children with body weight of 10 kg or less, the minimum recommended dose is: 2.5 ml of syrup (i.e. 37.5 mg
clindamycin) three times daily.
Adults and adolescents over 14 years of age
In adults, the usual dose is 10 to 30 ml of syrup (i.e. 600 mg to 1800 mg
clindamycin) administered every 6 to 8 hours.
If higher doses are required, e.g. for adults and adolescents over 14 years of age, Dalacin C products with higher content of active substance are available (capsules 150 mg or 300 mg).
Additionally, Dalacin C is also available in the form of 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.
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 Dalacin C is administered every
8 hours. However, in patients with advanced hepatic failure, the doctor should monitor
plasma concentrations of clindamycin. Depending on the results of these tests, dose reduction or
prolongation of dosing intervals may be necessary.
Use in patients with renal impairment
In patients with renal impairment, there is a slight prolongation of the half-life of clindamycin, which
does not necessitate dose reduction. Also in patients with severe renal impairment, dose reduction is not necessary when Dalacin C is administered every 8 hours. However, in patients
with severe renal failure or anuria, the doctor should monitor plasma concentrations of clindamycin.
Depending on the results of these tests, dose reduction or prolongation of dosing intervals
to 8 or even 12 hours may be necessary.
Use in patients undergoing haemodialysis
Clindamycin is not removed from the body during haemodialysis. Therefore, there is no need to
administer an additional dose of the medicine before or after dialysis.
Method of administration
The medicine is administered orally only, using the measuring spoon provided in the package.
Method of preparing the syrup
To dissolve the granules, use 60 ml of water. It is not recommended to use tap water; instead, use demineralized or distilled water.
The medicine should be dissolved as follows: add the majority of the prepared water and shake vigorously.
Add the remaining water and shake until a homogeneous 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 an excessive dose of Dalacin C, seek immediate medical advice from a
doctor or pharmacist. The doctor will take appropriate measures, e.g. gastric lavage.
Overdose of Dalacin C 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 that can be
used after overdose with Dalacin C. Haemodialysis and peritoneal dialysis are ineffective.
Missed dose of Dalacin C
Do not take a double dose to make up for a missed dose.
If a dose is missed, take the medicine as soon as possible, unless the time for the next dose is approaching.
Discontinuation of Dalacin C
In case of any further doubts regarding 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.
You should contact a doctor immediately if the patient experiences:

severe, persistent or bloody diarrhoea (which may be associated with abdominal pain or fever). This is an adverse reaction that may occur during or after antibiotic treatment and may be a sign of a serious intestinal inflammation (pseudomembranous colitis)*.
symptoms of a severe allergic reaction, such as sudden wheezing, difficulty breathing, dizziness, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially if affecting 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, particularly around the mouth, nose, eyes and genital organs ( Stevens-Johnson syndrome )* and a more severe form causing extensive peeling of the skin ( toxic epidermal necrolysis )*
widespread red rash with small blisters containing pus (exfoliative or bullous dermatitis )*
fever, swollen lymph nodes or skin rash, which may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms*, DRESS) (drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms), which may be severe and life-threatening. DRESS symptoms usually begin within a few weeks of exposure to clindamycin*
rare skin eruptions characterised by sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid) (acute generalised exanthematous pustulosis [AGEP])*
skin rash presenting as blisters and resembling small spots (central dark spots surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme
yellowing of the skin and whites of the eyes (jaundice)*
significant decrease in blood cells, which may cause bruising or bleeding, or weaken the immune system (agranulocytosis)*, decreased white blood cell count (leukopenia)*, decreased platelet count (thrombocytopenia)*
fluid retention causing swelling of the legs, ankles or feet, breathlessness or nausea.
cardiac arrest

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

blood clots (phlebitis)
diarrhoea
increased white blood cell count in blood (eosinophilia)
abnormal liver function test results
rash characterised by flat, red areas on the skin covered with small bumps

Uncommon (may affect up to 1 in 100 people)

low blood pressure
vomiting
abdominal pain
nausea
taste disturbances
urticaria
pain, 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)

oesophagitis*, open sores or changes in the oesophageal mucosa*
vaginal infection*
erythematous pustular rash (vesicular rash)*
irritation at the site of administration*

* Adverse reactions observed after the medicine was placed on the market.
Adverse reactions observed only during use of the injectable form of the medicine.
Adverse reactions observed only during use of the oral form of the medicine.
Rare cases of adverse reactions observed after too rapid intravenous administration of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store Dalacin C

Store below 25°C. Protect from light and moisture.
After 2 weeks from preparation of the syrup, any unused portion of the medicine must be discarded.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dalacin C contains

The active substance is clindamycin. 5 ml of syrup contains 75 mg clindamycin as clindamycin hydrochloride palmitate.
The other ingredients are: ethyl parahydroxybenzoate (E 214), simethicone, sucrose, Poloxamer 188 (Pluronic F68), aromatic composition "Felcofix Cherry Blend No. 770".

What Dalacin C looks like and contents of the pack
White powder with a cherry flavour.
Pack: amber glass bottle (type III) with a child-resistant polypropylene cap, with a cellulose wadding liner with a barrier layer of paper, aluminium foil, PE/PET or with a seal of aluminium foil coated with PE/PET, in a cardboard box.
The cardboard box contains a polystyrene dosing spoon.
The bottle contains 32 g granules for the preparation of 80 ml syrup, equivalent to 1.2 g clindamycin.
Marketing Authorisation 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 further information about this medicinal product, contact the
Marketing Authorisation Holder's representative:
Pfizer Polska Sp. z o.o.; tel. 22 335 61 00
Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl