Dalacin C

Leaflet attached to the packaging: information for the user

DALACIN C, 150 mg/ml, solution for injection and infusion

Clindamycin

Read the leaflet carefully before using 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 any not listed in this leaflet, please tell 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 using Dalacin C
• 3. How to use 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 mainly bacteriostatically and also bactericidally to a degree dependent on the concentration at the site of infection and the susceptibility of the microorganisms.

Clindamycin has been shown to be 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.

The use of the product in the form of intravenous administration is indicated in severe cases of the disease.

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

2. Important information before using Dalacin C

When not to use Dalacin C

• If the patient is hypersensitive to clindamycin, lincomycin (persons 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),
• In premature infants or newborns.

Warnings and precautions

• Particular caution should be exercised when using Dalacin C in patients:
• allergic to penicillin,
• with liver function disorders,
• with neuromuscular transmission disorders (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 the patient experiences 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), acute generalized exanthematous pustulosis (a disease characterized by the appearance of numerous blisters on swollen and reddened skin), the patient should stop using Dalacin C and consult a doctor.
• The patient should consult a doctor if, during or after treatment, they experience diarrhoea, especially severe and persistent. This may be a symptom 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 pseudomembranous colitis is diagnosed, the doctor should recommend discontinuing Dalacin C and starting appropriate treatment (metronidazole is given orally, and in severe cases - vancomycin). You should not take anti-peristaltic agents or other constipating agents.

Dalacin C and 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 pankuronium). This may lead to unexpected, life-threatening complications during surgical operations.
• If the patient is 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), it is recommended to monitor the progress of treatment under the supervision of the attending physician.

• The effectiveness of oral contraceptives used simultaneously with clindamycin has been questioned. Therefore, during the use of this medicine, additional contraceptive methods should be used.
• Warfarin or similar medicines that affect blood clotting. The patient may be more prone to bleeding. The doctor may decide to perform regular blood tests to check its clotting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Clindamycin crosses the placenta in humans. After multiple dose administration, 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 abnormalities.

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

Dalacin C contains benzyl alcohol (see section 2 "Dalacin C contains benzyl alcohol and sodium").

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

Clindamycin passes into human breast milk.

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

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

Dalacin C contains benzyl alcohol (see section 2 "Dalacin C contains benzyl alcohol and sodium").

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 benzyl alcohol and sodium

Dalacin C, solution for injection and infusion, contains 18 mg, 36 mg, 54 mg of benzyl alcohol in each 2 ml, 4 ml, and 6 ml of solution, respectively, which corresponds to 9 mg/1 ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Its administration to newborns and small children is associated with the risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). Do not use medicines containing benzyl alcohol in newborns (up to 4 weeks of life) or administer such medicines to small children (under 3 years of age) for more than a week without a doctor's recommendation. Patients with liver or kidney disease, or pregnant or breastfeeding women, should consult their doctor before taking this medicine, as a large amount of benzyl alcohol may accumulate in the body and cause side effects, such as an increase in blood acid levels (so-called metabolic acidosis).

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means that the medicine is considered "sodium-free".

3. How to use Dalacin C

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

The dosage is determined by the doctor, depending on the severity of the infection, the patient's condition, and the susceptibility of the microorganism causing the infection.

Children over 1 month of age

The dose of clindamycin will be determined by the doctor based on the patient's total body weight, regardless of excess weight.

From 20 mg/kg body weight to 40 mg/kg body weight per day in 3 or 4 equal divided doses.

Adults

In severe infections caused by more susceptible microorganisms, smaller doses of 600 mg to 1200 mg per day, given in 2, 3, or 4 equal divided doses, may be sufficient.

In severe abdominal and pelvic infections in women, and in other very severe or complicated infections, 1200 mg to 2700 mg of clindamycin is usually administered in 2, 3, or 4 equal divided doses.

In severe, life-threatening infections, doses of up to 4800 mg per day are used.

Use in patients over 65 years of age

There is no need to modify the administration and dosage.

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.

Method of administration

Dalacin C, solution for injection and infusion, is administered intramuscularly, immediately after withdrawal from the ampoule, or intravenously, after dilution with a suitable solvent.

Dalacin C, solution for injection and infusion, should not be administered intravenously in a rapid bolus injection, undiluted, but should be administered in an infusion lasting at least 10 to 60 minutes.

The method of preparing solutions and incompatibilities is given at the end of the leaflet in the section intended for medical personnel.

Use of a higher than recommended dose of Dalacin C

In case of accidental ingestion of an excessive dose of Dalacin C, you should immediately consult a 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. Haemodialysis 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 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 diarrhoea (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 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 can be severe and life-threatening. DRESS symptoms 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 a white-yellowish fluid) (acute generalized exanthematous pustulosis, AGEP)*.
• skin rash, characterized by the appearance of blisters and resembling 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)*, slight 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.

Common(may affect up to 1 in 10 people)

• blood clots (thrombophlebitis)
• diarrhoea
• 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, 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 oesophagus*, open sores or changes in the mucous membrane of the oesophagus*, vaginal infection*, red rash resembling 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 any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

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 in a temperature below 25°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 stated.

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. 1 ml of solution contains 150 mg of clindamycin in the form of clindamycin phosphate.
• The other ingredients are: benzyl alcohol (E 1519) (see section 2 "Dalacin C contains benzyl alcohol and sodium"), disodium edetate, sodium hydroxide (see section 2 "Dalacin C contains benzyl alcohol and sodium"), water for injections.

What Dalacin C looks like and contents of the pack

Ampoule made of type I glass, containing: 2 ml, 4 ml, or 6 ml of solution, in a cardboard box.

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

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: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.

Information intended only for healthcare professionals

Method of administration

Dalacin C is administered intramuscularly - immediately after withdrawal from the ampoule or intravenously - after dilution with a suitable solvent.

The following intravenous infusion times are usually used:

It is not recommended to administer single intramuscular injections of more than 600 mg, and in a one-hour intravenous infusion - no more than 1200 mg.

The concentration of clindamycin in the infusion solution should not exceed 12 mg/ml, and the infusion rate

• should not exceed 30 mg per minute.

The neck of the ampoule is cut at the narrowing. The colored dot on the neck of the ampoule facilitates proper positioning for opening. The ampoule should be taken in the hand and the colored dot should be positioned towards oneself. The ampoule opens easily after gentle pressure with the thumb on the neck of the ampoule.

Pharmaceutical incompatibilities

The following medicines are physically incompatible with clindamycin phosphate: ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, and magnesium sulphate. The compatibility and stability of mixtures in solutions vary depending on concentrations and other conditions.

Studies have shown that at room temperature for 24 hours, clindamycin phosphate in solutions for injection and infusion, used at usual therapeutic concentrations, containing sodium chloride, glucose, calcium, or potassium, and in solutions containing a complex of B vitamins, does not show physical or biological incompatibilities.

The following antibiotics do not show incompatibilities with clindamycin phosphate: cefalotin, kanamycin, gentamicin, penicillin, or carbenicillin.

The solution of Dalacin C can be diluted in the following intravenous infusion solutions:

• 5% glucose solution,
• 0.9% sodium chloride solution,
• Ringer's solution with lactates for infusion (Hartmann's solution).