Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clindamycin phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Zindaclin is used to treat acne (spots). Zindaclin is an antibiotic that reduces the number of bacteria and stops the skin pores becoming blocked and new spots forming. Zindaclin may also help to reduce the redness of the spots you already have. It will take some time once you have started using Zindaclin before you see your acne improving. What is acne? Acne is an extremely common skin condition most common in adolescence, but not restricted to this stage of life. During adolescence, glands in the skin produce extra grease in response to normal amounts of sex hormones in the body, and this can cause blocked pores, resulting in blackheads. When this happens the pores are invaded by bacteria. The chemicals produced by these bacteria go into deeper layers of the skin and produce red spots filled with pus.
e Zindaclin Do not use Zindaclin y If you are allergic (hypersensitive) to the active substance clindamycin phosphate or any of the other ingredients (See Section 6). y If you are allergic (hypersensitive) to lincomycin another type of antibiotic. Zindaclin should not be used by children under the age of 12 years. Take special care with Zindaclin y Before you use Zindaclin consult your doctor if you suffer from a condition known as inflammatory bowel disease or you have had diarrhoea when you have taken antibiotics. If you do get diarrhoea, when using Zindaclin, you must stop using it straight away and tell your doctor immediately. Other medicines and Zindaclin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you use more Zindaclin than you should You do not need to worry, just wash your treated skin with plenty of water. Contact your doctor or your local hospital if you are worried. If you forget to use Zindaclin Use it as soon as you remember and then continue to use as your doctor has told you. Do not apply a double dose to make up for a forgotten application. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, Zindaclin can cause
Zindaclin Zindaclin must not be taken by mouth. It is for use on the skin only. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. y You should use Zindaclin once a day. Wash as normal, rinse well and pat your skin dry. Apply a small amount of gel in a thin layer to the whole of the area where you usually get the spots. y It is important to replace the cap after you have used Zindaclin. Do not y apply Zindaclin to areas where you do not usually get spots. y use Zindaclin in an attempt to stop you getting acne, it does not work that way. y just dab Zindaclin onto individual spots. y apply a thick layer of Zindaclin in any particular area as this will not get rid of the spots any quicker. Take care to avoid your eyes, inside your nose or mouth when applying Zindaclin. If you accidentally put gel on these areas, wash them straight away with plenty of water. Successful treatment of acne can take several months. You may not see any effect of treatment for several weeks. After that you should note a gradual but definite improvement but maximum benefit may take several months. You may need to use more than one tube of Zindaclin during each course of treatment. Use Zindaclin for as long as your doctor tells you. Try not to pick or squeeze spots as this can make your acne worse and even lead to scarring.
What Zindaclin contains The name of your medicine is Zindaclin 1% Gel. Zindaclin gel contains the active ingredient clindamycin phosphate. Each tube of gel contains 1.2% clindamycin phosphate equivalent to 1% clindamycin. Zindaclin also contains propylene glycol, purified water, ethanol, zinc acetate, hydroxyethylcellulose and sodium hydroxide. What Zindaclin looks like and contents of the pack Zindaclin is a white translucent gel. Zindaclin is available in y 15g or 30g laminate tubes with a seal covering the opening and a screw cap. Marketing Authorisation Holder Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield Hampshire, GU32 3QG, United Kingdom. Manufacturer Dr. August Wolff GmbH & Co KG Arzneimittel Sudbrackstrasse 56 33611, Bielefield Germany. Date of preparation of this leaflet: December 2024 1010647 – P2.1
Artwork for:
Aspire Pharma Limited
Product name:
Zindaclin 1% Gel
Size:
30g
PL/PA no:
PL35533/0294
Type:
Leaflet
Artwork dimensions:
148mm x 540mm
Reason for request:
Change of ownership
Version no:
2.1
Date of revision:
3.12.24
Colours:
As swatches
Font(s):
Helvetica Neue Std
A/W software:
Indesign CC
For submission only
Black
, although not everybody gets them. Common (may affect up to 1 in 10 people) y Dry skin y Redness of the skin y Skin burning y Irritation around eyes y Worsening of acne y Itchy skin. Uncommon (may affect up to 1 in 100 people) y Painful skin y Scaly rash. You can relieve these unwanted effects by using an oil free moisturiser on the affected area. When clindamycin (the active ingredient in Zindaclin) is given by mouth or injection it has been known to cause inflammation of the bowel, leading to diarrhoea with blood and mucus. This reaction is extremely rare when clindamycin is applied on the skin. However, if you get diarrhoea with blood and mucus, stop using Zindaclin and contact your doctor. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Zindaclin Keep out of the sight and reach of children. Zindaclin does not require any special storage conditions. Do not use Zindaclin after the expiry date which is stated on the tube and box after the abbreviation used for expiry date. The expiry date refers to the last day of that month.
Clindamycin can pass into breast milk, even if you only use it on your skin, so you should not breast feed while using Zindaclin.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Important information about some of the ingredients of Zindaclin
6. Content of the pack and other information
This medicine contains y About 200mg alcohol (ethanol) in each gram which is equivalent to about 20% w/w. It may cause a burning sensation on damaged skin. y 400mg propylene glycol in each gram. Propylene glycol may cause skin irritation.
Zindaclin 1% Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Zindaclin 1% Gel is clindamycin phosphate.
This leaflet reproduces the patient information leaflet approved for Zindaclin 1% Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
ZINDACLIN is indicated for the treatment of mild to moderate acne vulgaris.
Adults and adolescents
Apply a thin film of ZINDACLIN once daily to the affected area.
Children
ZINDACLIN is not indicated for use in children below the age of 12 years.
Cutaneous use.
ZINDACLIN is contra-indicated in patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that ZINDACLIN should not be used in patients who have demonstrated lincomycin sensitivity.
Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous colitis; however if diarrhoea occurs the product should be discontinued immediately.
Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-associated colitis. Colitis is usually characterised by severe persistent diarrhoea and abdominal cramps. Should antibiotic associated colitis occur appropriate diagnostic and therapeutic measures (such as vancomycin treatment) should be taken immediately.
Responses may not be seen for 4-6 weeks.
Although the risk of systemic absorption following the administration of ZINDACLIN is low, the potential for the development of gastrointestinal adverse effects should be taken into account when considering treatment in patients with a previous history of antibiotic-associated colitis, enteritis, ulcerative colitis or Crohn's disease.
Prolonged use of clindamycin may cause resistance and/or overgrowth of non susceptible bacteria or fungi although this is a rare occurrence.
Cross resistance may occur with other antibiotics such as lincomycin and erythromycin. See Section 4.5.
Contact with the eyes or the mucous membranes of the nose and mouth should be avoided. In the event of accidental contact with the eyes or mucous membranes bathe the affected area with copious amounts of cool water.
No interactions have been reported with topical clindamycin.
For clindamycin applied cutaneously no clinical data on exposed pregnancies are available. Data on a limited number of pregnancies exposed to clindamycin administered by other routes indicate no adverse effects on pregnancy or on the health of the foetus/newborn child. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Orally and parenterally administered clindamycin has been reported to appear in breast milk. It is not known whether clindamycin is excreted in human milk following use of ZINDACLIN. As a general rule, patients should not breastfeed while taking a drug since many drugs are excreted in human milk. Sensitisation and diarrhoea cannot be ruled out in nursed infants.
For use during pregnancy and lactation, benefit and possible risks have to be weighed carefully against each other.
Approximately 10% of patients can be expected to experience an adverse reaction. These reactions are typical of irritant dermatitis. The incidence of these is likely to increase if an excess of gel is used. Should irritation occur, the use of a moisturiser may be of benefit.
The table below shows all adverse reactions reported with ZINDACLIN in clinical trials. They are listed in decreasing order of incidence.
Organ System
Common
(>1/100, <1/10)
Uncommon
(>1/1000, <1/100)
Skin and subcutaneous tissue disorder
Dry skin
Erythema
Skin burning
Irritation around eyes
Acne exacerbation
Pruritis
Painful skin
Scaly rash
Whilst no case of severe diarrhoea or pseudomembranous colitis has been reported in clinical trials with ZINDACLIN, and only a small amount of clindamycin is absorbed percutaneously, pseudomembranous colitis has very rarely been reported with the use of other topical clindamycin products. Therefore a theoretical risk of pseudomembranous colitis with ZINDACLIN exists (please refer to Section 4.4).
Irritant dermatitis may occur when excessive quantities of ZINDACLIN are applied. The use of a suitable moisturiser may be of benefit in these cases. In subsequent applications a thin film of ZINDACLIN should be applied in accordance with the dosage instructions (see section 4.2).
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Zindaclin 1% Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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