What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0164.


Clindamycin + Benzoyl Peroxide 10mg/g + 50mg/g Gel

Package leaflet: Information for the patient

Clindamycin + Benzoyl Peroxide 10mg/g + 50mg/g Gel

clindamycin + anhydrous benzoyl peroxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Clindamycin + Benzoyl Peroxide Gel is and what it is used for
2. What you need to know before you use this medicine
3. How to use Clindamycin + Benzoyl Peroxide Gel
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1 What Clindamycin + Benzoyl Peroxide Gel is and what it is used for

Clindamycin + Benzoyl Peroxide Gel contains two medicines: clindamycin and benzoyl peroxide. Clindamycin + Benzoyl Peroxide Gel belongs to a group of medicines known as ‘anti-acne preparations’.

This medicine is used for treating mild to moderate acne on your skin.

  • Clindamycin is an antibiotic which stops the bacteria involved in acne from reproducing.
  • Benzoyl peroxide reduces blackheads and whiteheads. It also kills the bacteria involved in acne.

Used together in Clindamycin + Benzoyl Peroxide Gel, these medicines work by:

  • fighting the bacteria that can cause acne
  • treating existing blackheads, whiteheads, and spots
  • lowering the number of red, inflamed acne spots

This medicine is for use by adults and adolescents aged twelve years or over.

2 What you need to know before you use this medicine

Do not use Clindamycin + Benzoyl Peroxide Gel:

  • if you are allergic to clindamycin, lincomycin, benzoyl peroxide or any of the other ingredients of this medicine (listed in Section 6).

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you start using Clindamycin + Benzoyl Peroxide Gel.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

  • Only use Clindamycin + Benzoyl Peroxide Gel on your skin. Keep it away from areas like your eyes, lips, mouth or inside your nose.
  • Do not use the gel on any irritated areas of your skin. For example, if you have cuts, grazes, sunburn or broken skin.

  • If you accidentally get this medicine in your eyes, mouth, lips, or inside your nose rinse with plenty of water.

  • Do not use too much Clindamycin + Benzoyl Peroxide Gel on sensitive areas of skin.
  • Most patients will experience some skin redness and peeling during the first few weeks of treatment. If your skin becomes irritated, you may need to use an oil-free moisturiser, use this medicine less often, or stop using it for a short period to allow your skin to recover and then re-start treatment.
  • Stop treatment and see your doctor if skin irritation is severe (severe redness, dryness, itching, stinging, or burning) or does not improve.
  • Try not to let Clindamycin + Benzoyl Peroxide Gel come into contact with coloured fabrics, including clothing, towels, bed linen, furniture or carpeting. This medicine can bleach these materials.
  • This medicine may bleach hair.
  • This medicine can make your skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/lamps and minimise the time you spend in the sun. You should use a sunscreen and wear protective clothing while using Clindamycin + Benzoyl Peroxide Gel.

Check with your doctor or pharmacist before using this medicine if:

  • You have ever had any of the following gut problems: ‘regional enteritis’, ‘ulcerative colitis’, or ‘antibiotic-associated colitis’.
  • If you develop stomach cramps or diarrhoea that does not improve or is severe, stop using this medicine and contact your doctor immediately. Antibiotics may cause a condition that results in severe diarrhoea and stomach cramps. Although this is unlikely to happen with antibiotics applied to the skin.
  • If you have recently used other clindamycin or erythromycin-containing medicines, there is an increased chance that Clindamycin + Benzoyl Peroxide Gel will not work as well as it should.

  • Tell your doctor or pharmacist if you have used any other clindamycin or erythromycin-containing medicines recently.

Children

Do not give this medicine to children under twelve years. It is not known if it works or if it is safe for them.

Other medicines and Clindamycin + Benzoyl Peroxide Gel

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Tell your doctor or pharmacist if you are using any of the following:

  • any other acne treatments including antibiotics used on your skin
  • medicated or ‘abrasive’ soaps and cleansers
  • soaps or cosmetics that have a strong drying effect
  • products which contain large amounts of alcohol or ‘astringents’

This is because when used together with Clindamycin + Benzoyl Peroxide Gel, they may irritate your skin over time.

Clindamycin + Benzoyl Peroxide Gel may make some acne medicines less effective when used at the same time. This includes:

  • Some acne medicines that are applied to the skin which contain tretinoin, isotretinoin or tazarotene

  • Tell your doctor or pharmacist if you are also using one of these medicines. You may need to use the two products at different times of the day (e.g. one in the morning and the other in the evening). Using other acne medicines at the same time as Clindamycin + Benzoyl Peroxide Gel can increase the risk of skin irritation.

  • Stop treatment and see your doctor if skin irritation becomes severe (severe redness, dryness, itching, stinging or burning).

  • Clindamycin + Benzoyl Peroxide Gel should not be used at the same time as erythromycin-containing medicines.
  • Applying Clindamycin + Benzoyl Peroxide Gel at the same time as medicines such as dapsone and sulfacetamide can cause a temporary colour-change of skin or facial hair (yellow/orange colour). This will not be permanent.
  • One of the medicines in Clindamycin + Benzoyl Peroxide Gel can affect how certain general anaesthesia medicines work (called “neuromuscular blocking agents”).

  • Tell your doctor or pharmacist if you are going to have surgery.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy, breast-feeding and fertility

There is only limited information about the safety of this medicine in pregnant women.

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 using this medicine.

Your doctor will consider the benefit to you and the risk to your baby of using Clindamycin + Benzoyl Peroxide Gel while you’re pregnant.

It is not known whether the ingredients of Clindamycin + Benzoyl Peroxide Gel can pass into breast milk. One of the medicines in Clindamycin + Benzoyl Peroxide Gel is clindamycin. When clindamycin is taken by mouth or injection, it may pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Clindamycin + Benzoyl Peroxide Gel.

Do not use this medicine on your breast if you are breast-feeding.

3 How to use Clindamycin + Benzoyl Peroxide Gel

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • Use Clindamycin + Benzoyl Peroxide Gel once a day in the evening.
  • It may take 2 to 5 weeks before you see the effect of this medicine.
  • Do not use for more than 12 weeks at one time. Your doctor will tell you how long your treatment will last.

How to apply this medicine

1. Completely remove any make-up.

2. Wash the affected area of skin well. Then rinse with warm water and gently pat dry.

3. Put a thin film of gel on the entire area of affected skin, using your fingertips.

4. Apply to all of the areas of your skin which have acne, not just to the individual spots. If the gel does not rub into your skin easily, you are using too much.

  • For your face only, use an amount of gel from the tube which reaches from the tip of your finger to the first joint (the first crease on your finger). This is a ‘finger tip’.
  • For your face and back, use two and a half ‘finger tips’ in total.

5. If you get a lot of dryness or skin peeling, you can use an oil-free, fragrance free, hypoallergenic moisturiser, use Clindamycin + Benzoyl Peroxide Gel less frequently or stop treatment for a short period, to allow your skin to adjust to the treatment. This medicine may not work properly if it is not applied every day.

6. Wash your hands after using the gel.

7. After it has dried, you can use a non-greasy make-up.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you use more Clindamycin + Benzoyl Peroxide Gel than you should

  • Take care not to apply too much. Applying too much gel or applying it more frequently will not help your spots clear up more quickly, and may cause skin irritation. If this does happen, use the gel less often, or stop using it for a few days and then start again.

If you accidentally swallow this medicine

  • If you do accidentally swallow the gel, seek medical advice. You may get symptoms similar to when you take antibiotics by mouth (an upset stomach).

If you forget to use this medicine

  • Do not use a double dose to make up for forgotten individual doses.
  • Apply the next dose at the usual time.

Don’t stop Clindamycin + Benzoyl Peroxide Gel without advice

Don’t use the gel for more than 12 weeks at one time, without talking to your doctor. Use this medicine for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

It is important to continue to use the gel as prescribed by your doctor. If you stop too soon, your acne may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Clindamycin + Benzoyl Peroxide Gel and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

  • signs of an allergic reaction (such as swelling of your face, eyes, lips or tongue, nettle rash or difficulty breathing, collapse)
  • severe or prolonged diarrhoea, or abdominal cramps
  • severe burning, peeling or itching.

Other possible side effects:

If you notice any of these side effects, try using this medicine less often, or stop using it for one or two days and then start again.

Very common side effects

(at least 1 in 10 people are affected)

At site of application:

  • Redness, peeling, dryness

These side effects are generally mild.

Common side effects

(less than 1 in 10 people are affected)

  • Headache

At site of application:

  • Burning, pain, sensitivity to sunlight

Uncommon side effects

(less than 1 in 100 people affected)

  • Tingling (paraesthesia), worsening acne, red, itchy skin, rash (dermatitis, erythematous rash).

Other side effects

Other side effects with frequencies that cannot be estimated from the available data include:

  • Allergic reactions
  • Inflammation of the intestine, diarrhoea, including bloody diarrhoea, stomach pain

At the site of application:

  • Skin reactions, discoloration of the skin
  • Raised itchy rash (hives)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: 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.

5 How to store this medicine

Keep this medicine out of the sight and reach of children.

Pharmacist: Store in a refrigerator (2°C-8°C). Do not freeze.

Patient: After you have received Clindamycin + Benzoyl Peroxide Gel from the pharmacist, do not store it above 25°C and discard after 2 months.

Do not use this medicine after the expiry date which is stated on the tube and carton (after “Exp:”). The expiry date refers to the last day of that month.

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 protect the environment.

6 Contents of the pack and other information

What Clindamycin + Benzoyl Peroxide Gel contains

  • The active substances are: clindamycin phosphate, equivalent to clindamycin 1% w/w (10mg/g) and hydrous benzoyl peroxide, equivalent to anhydrous benzoyl peroxide 5% w/w (50mg/g).
  • The other ingredients are: carbomer, dimeticone, disodium lauryl sulfosuccinate, disodium edetate, glycerol, silica, colloidal hydrated, poloxamer 182, purified water and sodium hydroxide.

What this medicine looks like and contents of the pack

  • Clindamycin + Benzoyl Peroxide Gel comes in tubes containing 25, 30, 50 and 60 grams.
  • The gel is off-white yellow in colour.
  • Each carton contains one tube of Clindamycin + Benzoyl Peroxide Gel.
  • Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aspire Pharma Limited
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer:

Jadran-Galenski Laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia

This leaflet was last revised in 11/2020.

1010514 - P1.4

GB 130003609/01