Package leaflet: Information for the user

DALACIN C, 150 mg, capsules
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 you personally. 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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, sinusitis,
dental and oral cavity infections,
lower respiratory tract infections,
pelvic and intra-abdominal infections,
female genital tract infections,
skin and soft tissue infections,
gas gangrene,
sepsis and endocarditis.

In severe cases of illness, treatment with the intravenous form of the drug is recommended.
In patients with endocarditis or sepsis, 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 parameters is necessary.
Severe 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.
Due to the risk of oesophagitis and oesophageal ulceration, it is essential that Dalacin C is always taken exactly as described in section 3.
Prolonged or repeated use of clindamycin may lead to overgrowth of drug-resistant bacteria or yeasts.
Dalacin C should not be used to treat:
respiratory tract infections caused by viruses,
meningitis, due to insufficient antibiotic concentration achieved in the cerebrospinal fluid.
If the patient develops severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS) (a severe, 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 Dalacin C and immediately contact a doctor.
The patient should contact a doctor if diarrhoea 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 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). 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 effects of muscle relaxants (e.g. ether, tubocurarine, pancuronium halides). This may lead to unexpected, life-threatening complications during surgical procedures.
If the patient is taking clindamycin simultaneously 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 attending physician is recommended.
The effectiveness of oral contraceptives used concomitantly 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 have an increased tendency to bleed. 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 taken after a meal, after approximately 2 hours.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor may prescribe Dalacin C during pregnancy only if absolutely necessary.
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 at the same time.

Driving and operating machinery
There are no data available on the influence of Dalacin C on the ability to drive vehicles or operate machinery.

Dalacin C contains lactose
Patients with intolerance to certain sugars should consult their doctor before using Dalacin C.

3. How to use Dalacin C

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor, pharmacist, or nurse.
Adults and adolescents over 14 years of age
Depending on the site and severity of infection, adults and adolescents over 14 years of age should
receive clindamycin in a dose of 4 to 12 capsules of 150 mg per day (i.e. 600 mg to 1800 mg per
day).
The medicine should be administered in 3 or 4 divided doses throughout the day.
If higher doses are required, e.g. for adults and adolescents over 14 years of age, Dalacin C with a
higher content of active substance is available (300 mg capsules).
Additionally, Dalacin C is also available as a solution for injection and infusion (150 mg/ml).
Children
Capsules containing clindamycin should only be used in children who are able to swallow a capsule.
In young children who may have difficulty swallowing capsules, clindamycin in the form of granules
for oral syrup preparation is recommended.
The doctor will determine the clindamycin dose based on the patient's total body weight, regardless
of overweight.
Depending on the site and severity of infection, children aged over 4 weeks to 14 years should
receive 8 mg to 25 mg of clindamycin per kilogram of body weight per day.
The medicine should be administered in 3 or 4 equal divided doses throughout the day.
If accurate dosing in mg/kg body weight using capsules is not possible, clindamycin in the form of
granules for oral syrup preparation should be used.
If lower doses are required, Dalacin C with a lower content of active substance is available (75 mg
capsules or granules for oral syrup 75 mg/5 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 swallowed whole with a full glass of water and at least 30 minutes before lying
down, to avoid potential oesophageal irritation.
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
required.
Use in patients with renal impairment
In patients with renal impairment, the half-life of clindamycin is slightly prolonged, but dose
reduction is not required. 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
impairment 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 required.
Use in patients undergoing haemodialysis
Clindamycin is not removed from the body during haemodialysis. Therefore, no additional dose of
Dalacin C is required before or after dialysis.
Use of a higher than recommended dose of Dalacin C
If an overdose of Dalacin C is accidentally taken, seek medical advice immediately 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 for overdose with
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 a dose is missed, take the medicine as soon as possible, unless it is almost time for the next
dose.
Discontinuation of Dalacin C
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 effect that may occur during or after antibiotic treatment and could be a sign of a serious intestinal inflammation*.
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:
- blistering and peeling of large areas of skin, fever, cough, malaise and swelling of 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 skin peeling (toxic epidermal necrolysis) *
- widespread red rash with small blisters containing pus (acute generalized exanthematous pustulosis, AGEP) *
- fever, swollen lymph nodes or skin rash, which may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms), which can 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 with blisters and appearing as 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 reduction in blood cell counts, which may lead to bruising or bleeding, or weakened immune system (agranulocytosis)*, reduced white blood cell count (leukopenia)*, reduced platelet count (thrombocytopenia)*
fluid retention causing swelling of legs, ankles or feet, breathlessness or nausea.

Other possible adverse effects may include:
Common (may occur in up to 1 in 10 people)

blood clots (phlebitis)
diarrhoea
increased number of white blood cells in blood (eosinophilia)
abnormal liver function test results
rash characterised by a flat, red area on the skin covered with small bumps

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

cardiac arrest
low blood pressure
vomiting
abdominal pain
nausea
taste disturbances
urticaria
pain, abscess at the injection site

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

itching

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

oesophageal mucosal inflammation*, open sores or lesions in the oesophageal mucosa*
vaginal and surrounding area infection*
cutaneous vasculitis*
erythema multiforme-like rash (vesicular rash)*
skin reaction characterised by symmetrical, clearly defined redness of skin folds, particularly buttocks, groin and armpits*
irritation at the site of administration*

* Adverse effects observed after marketing authorisation.
Adverse effects observed only during use of the injectable form of the medicine.
Adverse effects observed only during use of the oral form of the medicine.
The occurrence of these adverse effects is more likely if Dalacin C is taken while lying down and (or) without sufficient water.
Rare cases of adverse effects observed after too rapid intravenous administration of the medicine.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects can also be reported to the Marketing Authorisation Holder or its representative.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Dalacin C

Store below 30°C.
Keep the medicine in a place inaccessible and out of sight 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 wastewater 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. Each capsule contains 150 mg of clindamycin
in the form of clindamycin hydrochloride.
Other ingredients: magnesium stearate, corn starch, talc, lactose monohydrate.
Capsule composition: body and cap: titanium dioxide (E 171), gelatin.

What Dalacin C looks like and contents of the pack
Dalacin C 150 mg hard capsules are two-part, white capsules marked with the imprint “CLIN 150”
and “Pfizer”.
Pack: PVC/Al blisters containing 16, 20 or 100 capsules, packed in a cardboard carton.

Marketing Authorisation Holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

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

For further information on this medicinal product, please contact the
Marketing Authorisation Holder’s representative:
Pfizer Polska Sp. z o.o.; tel. 22 335 61 00

Detailed and up-to-date information on this product is available by scanning the QR code
located on the outer packaging using a mobile device. The same information is also accessible via the URL: https://pfi.sr/ulotka-dalacinc150 and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.