PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Zindaclin  1% Gel

Clindamycin phosphate
Read this entire leaflet carefully before using this medicine

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Zindaclin is and what it is used for
Before using Zindaclin
How to use Zindaclin
Possible side effects
How to store Zindaclin
Further information

1. What Zindaclin is and what it is used for

Zindaclin is used to treat mild to moderate acne (spots). Zindaclin contains an antibiotic (clindamycin) that reduces the number of bacteria, helps prevent the blockage of skin pores, and the formation of new spots. Zindaclin may also help reduce redness in existing spots.
Once you start using Zindaclin, it will take some time before you see an improvement in your acne.

What is acne?
Acne is a very common skin condition, most frequently occurring during adolescence, although it is not limited to this stage of life. During adolescence, glands in the skin produce excess sebum in response to the levels of sex hormones in the body, leading to clogged pores and the development of blackheads. When this occurs, the pores become colonized by bacteria. Chemicals produced by these bacteria penetrate deeper layers of the skin, resulting in red, pus-filled spots.

2. Before using Zindaclin

Do not use Zindaclin

If you are allergic (hypersensitive) to the active substance clindamycin phosphate or to any of the other ingredients contained in the product (see section 6)
If you are allergic (hypersensitive) to lincomycin, another type of antibiotic.

An allergic reaction may include rash, redness, itching, swelling, or breathing difficulties.
Zindaclin must not be used in children under 12 years of age.
Take special care with Zindaclin

Before using Zindaclin, consult your doctor if you suffer from a condition known as inflammatory bowel disease (such as colitis or Crohn's disease) or if you have experienced diarrhoea when taking antibiotics. If you develop diarrhoea while using Zindaclin, stop treatment immediately and consult your doctor.
If you are taking other antibiotics, consult your doctor before using Zindaclin.

Taking other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Interaction may occur with other antibiotics such as erythromycin, metronidazole, and aminoglycosides.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.
Inform your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby before using Zindaclin.
Clindamycin may pass into breast milk, even when used only on the skin; therefore, you should avoid breastfeeding while using Zindaclin.
Important information about some ingredients of Zindaclin
The product contains:

Approximately 20% ethanol. Each gram contains about 0.2 g of alcohol.
Propylene glycol, which may cause skin irritation.

3. How to use Zindaclin

Zindaclin must not be taken by mouth. It is for topical use only.
Always use Zindaclin exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.

Use Zindaclin once daily. Wash as usual, rinse thoroughly and pat the skin dry. Apply a small amount of gel in a thin layer to the entire area where you usually have acne.
It is important to close the tube with the cap after using Zindaclin.

Do not

apply Zindaclin to areas where you do not normally have acne.
use Zindaclin to try to prevent acne, as it does not work in this way.
apply Zindaclin only to individual pimples.
apply a thick layer of Zindaclin, as this will not clear acne more quickly.
cover Zindaclin with dressings (e.g. bandages or plasters), as this may increase the risk of irritation.

Take care to avoid the eyes, inside of the nose or mouth when applying Zindaclin. If the gel is accidentally applied to these areas, rinse immediately with plenty of water.
Several months may be needed to achieve satisfactory acne treatment. You may not see any effect of treatment for several weeks. After this time, you may notice gradual and definite improvement, although maximum benefit may take several months. Your doctor will normally review your treatment after 6 or 8 weeks. Zindaclin should be used for a maximum of 12 weeks. More than one tube of Zindaclin may be required for each treatment course. Use Zindaclin for as long as your doctor has prescribed.

Try not to touch or squeeze pimples, as this may worsen your acne and may also cause scarring.

If you use more Zindaclin than you should
Do not worry; simply wash the treated area thoroughly with plenty of water. Contact your doctor or local hospital if you are concerned.

If you forget to use Zindaclin
Use it as soon as you remember, then continue using it as prescribed by your doctor. Do not use a double amount to make up for a forgotten application.

If you have any questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zindaclin can cause side effects, although not everyone experiences them.

Common (less than 1 in 10 but more than 1 in 100 people):

Dry skin
Skin redness
Skin burning
Irritation around the eyes
Worsening of acne
Itching of the skin

Uncommon (less than 1 in 100 but more than 1 in 1000 people):

Skin pain
Desquamating rash

You may relieve these side effects by applying a non-greasy moisturizer to the affected area.

When clindamycin (the active substance in Zindaclin) is administered orally or by injection, it is known to cause intestinal inflammation, leading to diarrhoea with blood and mucus. This reaction is extremely rare when clindamycin is applied to the skin.

Nevertheless, if you experience diarrhoea with blood and mucus, stop treatment with Zindaclin and contact your doctor immediately.

If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Zindaclin

Keep this medicine out of the reach and sight of children.
Zindaclin does not require any special storage conditions.
Do not use Zindaclin after the expiry date stated on the tube and carton following the abbreviation "Exp". The expiry date refers to the last day of the 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. Other information

What Zindaclin contains
The name of the medicine is Zindaclin 1% Gel.
Zindaclin contains the active substance clindamycin phosphate. Each gram of gel contains 10 mg of clindamycin (1% w/w), equivalent to 11.88 mg of clindamycin phosphate.
Zindaclin also contains propylene glycol, purified water, ethanol, zinc acetate, hydroxyethylcellulose and sodium hydroxide.

Description of the appearance of Zindaclin and the contents of the pack
Zindaclin is a white translucent gel.
Zindaclin is packed in laminated tubes of 15 g, 30 g, 60 g, sealed with a protective film and fitted with a screw cap.

Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano, 160
21042 Caronno Pertusella VA
Italy

Manufacturing, Packaging and Batch Release
Dr August Wolff GmbH & Co. Arzneimittel
Sudbrackstrasse 56, 33611 Bielefeld
Germany

This Patient Information Leaflet was last approved on