PATIENT INFORMATION LEAFLET

Zindaclin® 1% Gel

Clindamicina, phosphate

Read this leaflet carefully before you start 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.

??If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of the 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. Storage of Zindaclin
6. Further information

Zindaclin is used to treat mild to moderate acne (pimples). Zindaclin contains an antibiotic, clindamycin, which reduces the number of bacteria and prevents pores from becoming clogged and forming new pimples. Zindaclin also helps to reduce the redness of existing pimples.

Once you start using Zindaclin, it may take some time to notice an improvement in your acne.

What is acne?

Acne is a common skin disorder that occurs during adolescence, but it is not limited to this period of life. During adolescence, the skin glands produce excessive oil in response to normal hormone levels in the body, which can cause pore blockage and lead to blackheads. When this occurs, pores are invaded by bacteria. Chemicals produced by these bacteria penetrate the deeper layers of the skin and produce the redness of pimples that fill with pus.

Do not use Zindaclin

??If you are allergic (hypersensitive) to the active ingredient clindamycin phosphate or to any of its components (see section 6).

??If you are allergic (hypersensitive) to lincomycin, another type of antibiotic.

A hypersensitivity reaction may include hives, skin redness, itching, swelling, or difficulty breathing.

Zindaclin should not be used in children under 12 years.

Be extra careful with Zindaclin:

??If you have any inflammatory intestinal disease (such as colitis or Crohn's disease), consult your doctor before using Zindaclin. If you have diarrhea after using Zindaclin, stop using it immediately and inform your doctor right away.

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

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Interactions may occur with other antibiotics such as erythromycin, metronidazole, and ant-glucosides.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking or using any medication.

Inform your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant before using Zindaclin.

Clindamycin may pass into breast milk, even if it is only applied to the skin, so do not breastfeed your baby while using Zindaclin.

Important information about some of the components of Zindaclin

This medication contains:

• 200 mg of alcohol (ethanol) in each gram, which is equivalent to 20% p/p.It may cause a burning sensation on eroded skin.
• 400 mg of propylene glycol in each gram, which is equivalent to 40% p/p. Propylene glycol may cause skin irritation.

Zindaclin should not be ingested. For use on the skin only.

Follow the Zindaclin instructions provided by your doctor. If in doubt, consult your doctor or pharmacist.

You should use Zindaclin once a day. Wash your skin in the usual way, thoroughly clean and dry the skin with light touches. Apply a small amount of gel in the form of a thin layer over the entire area where acne usually occurs.

It is essential to replace the cap after using Zindaclin.

Do not apply Zindaclin to areas where acne does not usually occur.

Do not use Zindaclin with the intention of preventing acne from appearing, as it does not work in this way.

Do not apply Zindaclin to individual pimples.

Do not apply a thick layer of Zindaclin to any particular area, as this will not make the pimples disappear more quickly.

Do not cover Zindaclin with dressings (e.g., bandages and patches), as they may increase the risk of irritation.

Be careful not to apply Zindaclin to the eyes and the inside of the nose and mouth. If you accidentally apply the gel to these areas, wash them immediately with plenty of water.

The effectiveness of the acne treatment may take several months. You may not see results from the treatment for several weeks. After this, you should notice a gradual but definite improvement, although maximum effectiveness may take several months. Your doctor will schedule a follow-up appointment at 6 to 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 period. Use Zindaclin for as long as your doctor indicates.

Do not try to touch or squeeze the pimples, as this can worsen the acne and even cause scarring.

If you use more Zindaclin than you should

Do not worry, wash the treated skin 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 continue using it as your doctor has instructed. Do not use a double dose to make up for the missed dose.

If you have any other questions about using this product, consult your doctor or pharmacist.

Like all medications, Zindaclin may have adverse effects, although not everyone will experience them.

Frequent(Affects less than 1 in 10 but more than 1 in 100)

Dry skin

Redness of the skin

Sensation of heat on the skin

Irritation around the eyes

Worsening of acne

Itching of the skin

Less frequent(Affects less than 1 in 100 but more than 1 in 1000)

Pain of the skin

Scaly rash

You can alleviate these adverse effects by using a non-greasy moisturizing cream on the affected area.

The administration of clindamicina (active ingredient of Zindaclin) via oral or injectable route has produced cases of intestinal inflammation, which have led to diarrhea with blood and mucus. This reaction is extremely rare when clindamicina is applied to the skin. However, if you experience diarrhea with blood and mucus, you must discontinue Zindaclin administration immediately and inform your doctor subsequently.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not described in this prospectus, consult your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Zindaclin after the expiration date appearing on the tube and box after the abbreviation Cad. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of ZINDACLIN

The name of the medication is Zindaclin 1% Gel.

Zindaclin contains the active ingredient 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.

Appearance of the product and contents of the package

Zindaclin is a transparent white gel.

Zindaclin is presented in laminated tubes of 15, 30, and 60 g of gel with a closure cap and a screw cap.

Holder of the marketing authorization

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Carretera de Cazoña-Adarzo, s/n.

39011 Santander

Spain

Responsible for manufacturing

Dr August Wolf GMBH & Co. Arzneimittel

Sudbrackstrasse 56, 33611 Bielefeld, Germany

This leaflet was approved in December 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/