Zindaclin 1% gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zindaclin® 1% Gel
Clindamycin phosphate
Read the entire 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 and you should not give it to other people. It may harm them, even if their symptoms are the same as yours.
??If you consider any of the side effects to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
In this leaflet:
- What Zindaclin is and what it is used for
- Before you use 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 contains the active substance minocycline, which belongs to a group of medicines called tetracycline antibiotics. ZINDACLIN is used to treat acne. Minocycline works by killing the bacteria which cause acne and by reducing inflammation.
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Zindaclin is used to treat mild to moderate acne (spots). Zindaclin contains an antibiotic, clindamycin, which reduces the number of bacteria and prevents skin pores from becoming blocked, thereby stopping new spots from forming. Zindaclin also helps reduce redness in existing spots.
Once you start using Zindaclin, it will take some time before you notice an improvement in your acne.
What is acne?
Acne is a very common skin condition, especially during adolescence, although it is not limited to this stage of life. During puberty, skin glands produce excess sebum in response to normal levels of sex hormones in the body, which can lead to clogged pores and the formation of pimples. When this occurs, the pores become colonized by bacteria. Chemicals produced by these bacteria penetrate deeper layers of the skin, causing redness and the formation of 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 its components (see section 6).
??If you are allergic (hypersensitive) to lincomycin, another type of antibiotic.
An allergic reaction may include rash, skin redness, itching, swelling, or difficulty breathing.
Zindaclin must not be used in children under 12 years of age.
Take special care with Zindaclin:
??If you suffer from an inflammatory bowel disease (such as colitis or Crohn's disease), consult your doctor before using Zindaclin. If you develop diarrhea after using Zindaclin, you must stop treatment immediately and inform your doctor without delay.
??If you are taking other antibiotics, consult your doctor before using Zindaclin.
Use of other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Interactions may occur with other antibiotics such as erythromycin, metronidazole, and aminoglycosides.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking or using any medicine.
Inform your doctor if you are pregnant, think you might be pregnant, or are trying to become pregnant before using Zindaclin.
Clindamycin may pass into breast milk, even when administered only on the skin; therefore, you must not breastfeed while using Zindaclin.
Important information about some of the components of Zindaclin
This medicine contains:
- 200 mg of alcohol (ethanol) per gram, equivalent to 20% w/w. It may cause a burning sensation on eroded skin.
- 400 mg of propylene glycol per gram, equivalent to 40% w/w. Propylene glycol may cause skin irritation.
3. HOW TO USE ZINDACLIN:
Zindaclin must not be ingested. For topical use only.
Follow the instructions for Zindaclin provided by your doctor. If in doubt, consult your doctor or pharmacist.
??Apply Zindaclin once daily. Wash the skin as usual, rinse thoroughly, and gently pat dry. Apply a small amount of gel as a thin layer over the entire area commonly affected by spots.
??It is important to replace the cap after using Zindaclin.
??Do not apply Zindaclin to areas where spots do not usually appear.
??Do not use Zindaclin with the intention of preventing acne, as it does not work in this way.
??Do not apply Zindaclin to each spot individually.
??Do not apply a thick layer of Zindaclin to any particular area, as this will not make spots disappear more quickly.
??Do not cover Zindaclin with dressings (e.g., bandages or patches), as they may increase the risk of irritation.
Take care to avoid applying Zindaclin to the eyes, or inside the nose and mouth. If the gel is accidentally applied to these areas, rinse immediately with plenty of water.
The effectiveness of acne treatment may take several months. You may not see results for several weeks. After this, you should notice gradual but definite improvement, although maximum effectiveness may take several months. Your doctor will schedule a follow-up appointment 6 to 8 weeks after starting 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 instructs.
Do not pick or squeeze spots, as this may worsen acne and may even lead to scarring.
If you use more Zindaclin than you should
Do not worry; wash the treated skin 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, and continue using it as directed by your doctor. Do not use a double amount to make up for a missed dose.
If you have any further questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Zindaclin can have adverse effects, although not everyone experiences them.
Common (affects less than 1 in 10 but more than 1 in 100 people)
- Dry skin
- Skin redness
- Sensation of warmth on the skin
- Irritation around the eyes
- Worsening of acne
- Itching of the skin
Uncommon (affects less than 1 in 100 but more than 1 in 1,000 people)
- Skin pain
- Scaly rash
You can help relieve these adverse effects by applying a non-greasy moisturizing cream to the affected area.
Oral or injectable administration of clindamycin (the active substance in Zindaclin) has caused cases of intestinal inflammation, resulting in diarrhoea with blood and mucus. This reaction is extremely rare when clindamycin is applied to the skin. However, if you develop diarrhoea with blood and mucus, you must stop using Zindaclin immediately and contact your doctor without delay.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, consult your doctor or pharmacist.
5. Storage of ZINDACLIN
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use Zindaclin after the expiry date stated on the tube and carton after the abbreviation Exp. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of ZINDACLIN
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.
Appearance of the product and contents of the container
Zindaclin is a translucent white gel.
Zindaclin is supplied in laminated tubes containing 15, 30, and 60 g of gel, sealed with a closure and a screw cap.
Marketing Authorization Holder
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Carretera de Cazoña-Adarzo, s/n.
39011 Santander
Spain
Manufacturer
Dr August Wolf GMBH & Co. Arzneimittel
Sudbrackstrasse 56, 33611 Bielefeld, Germany
This leaflet was approved in December 2020.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/