ZINDACLIN 1% Gel

Зміст інструкції

1. Zindaclin  1% Gel
   1. What Zindaclin is and what it is used for
   2. Before using Zindaclin
   3. How to use Zindaclin
   4. Possible side effects
   5. How to store Zindaclin
   6. Other information

Zindaclin  1% Gel

Clindamycin phosphate

Read this leaflet carefully before taking 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Zindaclin is and what it is used for
• 2. Before using Zindaclin
• 3. How to use Zindaclin
• 4. Possible side effects
• 5. How to store Zindaclin
• 6. Further information

1. What Zindaclin is and what it is used for

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

What is acne?
Acne is an extremely common skin condition, mainly in adolescence but
not restricted to this stage of life. During adolescence, the glands in the skin
produce excess fat in response to the amount of sex hormones in the body, and this
causes the blockage of pores, which leads to the formation of blackheads. When this happens the
pores are invaded by bacteria. The chemicals produced by these bacteria penetrate into
the deeper layers of the skin and produce red, pus-filled pimples.

2. Before using Zindaclin

Do not use Zindaclin

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

An allergic reaction may include skin rash, redness, itching, swelling or difficulty
breathing.
Zindaclin should 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

diarrhoea when taking antibiotics. If you experience diarrhoea while using Zindaclin,
stop treatment and consult your doctor immediately.

• If you are taking other antibiotics, consult your doctor before using Zindaclin

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including over-the-counter medicines.
Interaction with other antibiotics such as erythromycin, metronidazole and
aminoglycosides is possible.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant, if you think you may be pregnant or are trying to become
pregnant before using Zindaclin.
Clindamycin can pass into breast milk, even if used only on the skin, so you should
avoid breastfeeding while using Zindaclin.

Important information about some ingredients of Zindaclin
The product contains:

• Approximately 20% ethanol. Each gram contains approximately 0.2 g of alcohol.
• Propylene glycol may cause skin irritation.

3. How to use Zindaclin

Zindaclin must not be taken orally. It is for external use only.
Always use Zindaclin as your doctor has advised. If you have any doubts, ask your
doctor or pharmacist.

• You should use Zindaclin once a day. Wash as usual, rinse well and pat your skin dry. Apply a small amount of gel in a thin layer to the entire area where you usually have pimples.
• It is important to close the tube with the cap after using Zindaclin.

Do not

• apply Zindaclin to areas where you do notusually have pimples.
• use Zindaclin in an attempt to prevent acne, it does not work that way
• apply Zindaclin to individual pimples
• apply a thick layer of Zindaclin as this will not eliminate pimples more quickly
• cover Zindaclin with fabrics (e.g. bandages and plasters) as this may increase the risk of irritation.

Be careful to avoid the eyes, the inside of the nose or mouth when applying
Zindaclin. If you accidentally get the gel in these areas, wash immediately with
plenty of water.
Many months may be needed for satisfactory acne treatment. You may not
see any effect of the treatment for several weeks. After that you may notice a
gradual and permanent improvement, although the maximum benefit may not be obtained until
many months. Your doctor will normally carry out checks after 6 or 8 weeks of
treatment. Zindaclin should be used for a maximum of 12 weeks. You may need
to use more than one tube of Zindaclin during each treatment cycle. Use
Zindaclin for the time your doctor has prescribed.
Try not to touch or squeeze pimples as this can worsen your acne and also
cause scarring.

If you use more Zindaclin than you should
Do not worry, simply wash the treated area 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 and then continue to use it as your doctor has prescribed. Do not
use a double dose to make up for a missed dose.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zindaclin can cause side effects, although not everybody gets them.
Common (less than 1 in 10, but more than 1 in 100 people)
Dry skin
Skin redness
Skin burning
Eye irritation
Worsening of acne
Skin itching
Uncommon (less than 1 in 100, but more than 1 in 1000 people)
Skin pain
Scaling rash
You can relieve these side effects by using a non-greasy moisturizer on 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 diarrhea with blood and mucus. This
reaction is extremely rare when clindamycin is applied to the skin.
In any case, if you have diarrhea with blood and mucus, stop treatment with Zindaclin and
contact your doctor immediately.
If any of these side effects gets worse, or if you notice any side effect not listed in this
leaflet, tell your doctor or pharmacist.

5. How to store Zindaclin

Keep this medicine out of the reach and sight of children.
Zindaclin does not require special storage conditions.
Do not use Zindaclin after the expiry date which is stated on the tube and the carton after
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 translucent white gel.
Zindaclin is packaged in laminated tubes of 15 g, 30 g, 60 g with a protected closure
by a film and screw cap.

MARKETING AUTHORISATION HOLDER
Difa Cooper S.p.A.
Via Milano, 160
21042 Caronno Pertusella VA
Italy

MANUFACTURE, PACKAGING AND BATCH RELEASE
Dr August Wolff GmbH & Co. Arzneimittel
Sudbrackstrasse 56, 33611 Bielefeld
Germany