Clindacne

Package Leaflet: Information for the Patient

CLINDACNE, 10 mg/g, gel

Clindamycin

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Clindacne and what is it used for
• 2. Important information before using Clindacne
• 3. How to use Clindacne
• 4. Possible side effects
• 5. How to store Clindacne
• 6. Package contents and other information

1. What is Clindacne and what is it used for

Clindacne is a gel medicine for application to the skin. The medicine contains clindamycin phosphate, which, when applied to the skin, is converted into clindamycin, a semi-synthetic antibiotic from the group of so-called lincosamides. Clindamycin inhibits the growth of Propionibacterium acnesbacteria, which are one of the causes of common acne.

Indications

Clindacne is intended for local treatment of mild and moderately severe forms of common acne.

2. Important information before using Clindacne

When not to use Clindacne

• if the patient is allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Clindacne, the doctor or pharmacist should be consulted:

• if the patient has a history of or currently has colitis caused by antibiotics, enteritis, ulcerative colitis, or Crohn's disease,
• if the patient has experienced diarrhea after using antibiotics.

The doctor should be informed immediately:

• if the patient experiences diarrhea during or after using the medicine. Persistent diarrhea, usually accompanied by painful abdominal cramps, may be a symptom of pseudomembranous colitis (see section 4). It may be necessary to discontinue the use of the medicine. The doctor will determine the cause and recommend the necessary actions.

Contact with the eyes, nasal mucosa, oral mucosa, and damaged skin should be avoided. If the medicine gets into the eye or in case of accidental contact with the mucous membrane, these areas should be rinsed immediately with a large amount of cold water.

Children and adolescents

The safety of using Clindacne in children under 12 years of age has not been established.

Clindacne and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use.
During the use of Clindacne, other medicines should not be applied to the skin at the same time.
Particularly, the doctor should be informed if the patient is using any of the following medicines:

• erythromycin or lincomycin (antibiotics used to treat bacterial infections)
• warfarin and similar medicines used to thin the blood, as their concurrent use with Clindacne may increase the risk of bleeding. The doctor may order regular blood coagulation tests.

Before surgery, the doctor and anesthesiologist should be informed about the use of Clindacne, as clindamycin may enhance the effect of muscle relaxants.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Clindacne may be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary.
Breastfeeding
Clindacne should not be used during breastfeeding.

Driving and using machines

Clindacne does not affect the ability to drive or use machines.

Clindacne contains methyl parahydroxybenzoate and propylene glycol

Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late reactions).
Due to the presence of propylene glycol, the medicine may cause skin irritation.

3. How to use Clindacne

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted again.
Clindacne is intended for local application to the skin.

Use in adults and adolescents over 12 years of age

A thin layer of the gel should be applied to the affected skin twice a day.
The gel should be applied to clean skin.
After using the medicine, hands should be washed.

Use in children under 12 years of age

The safety of using Clindacne in children under 12 years of age has not been established.

Using more than the recommended dose of Clindacne

Using more than the recommended dose of the medicine may cause systemic side effects of clindamycin (see sections 2 and 4).

Missing a dose of Clindacne

A double dose should not be used to make up for a missed dose.

Stopping the use of Clindacne

In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should stop using Clindacne immediately and contact their doctor:

• diarrhea, especially acute or persistent (sometimes with the presence of mucus and blood in the stool), which may be accompanied by crampy abdominal pain. These may be symptoms of pseudomembranous colitis. This is a very rare side effect (may affect no more than 1 in 10,000 people), caused by the absorption of clindamycin phosphate through the skin into the body and may occur during the use of Clindacne on the skin.

Other side effects that may occur during the use of Clindacne:

Common (may affect no more than 1 in 10 people):

• irritation, itching.

Rare (may affect no more than 1 in 1,000 people):

• dry skin, contact dermatitis, skin oiliness, folliculitis.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Clindacne

Store at a temperature below 25°C.
Do not store in the refrigerator or freeze.
The medicine should be stored out of sight and reach of children.
Shelf life after first opening the package - 12 months.
Do not use this medicine after the expiration date stated on the package. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Clindacne contains

• The active substance of the medicine is clindamycin, in the form of clindamycin phosphate. 1 g of gel contains 10 mg of clindamycin.
• The other ingredients are: carbomer, macrogol, propylene glycol, allantoin, methyl parahydroxybenzoate, sodium hydroxide, purified water.

What Clindacne looks like and what the package contains

Clindacne is a gel.
The available package of the medicine is an aluminum tube containing 15 g or 30 g of gel, placed in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
Ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of the last update of the leaflet: