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 Benzoyl peroxide, Clindamycin phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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:
Common side effects
(less than 1 in 10 people are affected)
Uncommon side effects
(less than 1 in 100 people affected)
Other side effects
Other side effects with frequencies that cannot be estimated from the available data include:
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.
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.
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 09/2022. 1010658 – P1.2
6 Contents of the pack and other information What Clindamycin + Benzoyl Peroxide Gel contains
What this medicine looks like and contents of the pack
GB
130003609/01
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.
Used together in Clindamycin + Benzoyl Peroxide Gel, these medicines work by:
2 What you need to know before you use this medicine Do not use Clindamycin + Benzoyl Peroxide Gel:
Warnings and precautions Talk to your doctor or pharmacist before using this medicine.
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:
Clindamycin + Benzoyl Peroxide Gel may make some acne medicines less effective when used at the same time. This includes:
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 H ow 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.
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.
If you use more Clindamycin + Benzoyl Peroxide Gel than you should
If you accidentally swallow this medicine
If you forget to use this medicine
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
Clindamycin + Benzoyl Peroxide 10mg/g + 30mg Gel comes as gel containing 10mg / 30mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Clindamycin + Benzoyl Peroxide 10mg/g + 30mg Gel is benzoyl peroxide, clindamycin phosphate.
Medicines with the same active substance, strength and form include: Duac Once Daily 10 mg/g + 30 mg/g Gel. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Clindamycin + Benzoyl Peroxide 10mg/g + 30mg 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.
Clindamycin + Benzoyl Peroxide Gel is indicated for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
For cutaneous use only.
Posology
Adults and Adolescents (aged 12 years and above)
Clindamycin + Benzoyl Peroxide Gel should be applied once daily in the evening, to the entire affected area.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted (see section 4.4).
The safety and efficacy of Clindamycin + Benzoyl Peroxide Gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with this medicine should not exceed more than 12 weeks of continuous use.
Paediatric population
The safety and efficacy of Clindamycin + Benzoyl Peroxide Gel has not been established in children under 12 years of age, therefore this medicine is not recommended for use in this population.
Elderly patients
No specific recommendations.
Method of administration
Clindamycin + Benzoyl Peroxide Gel should be applied in a thin film after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied.
Hands should be washed after application.
Clindamycin + Benzoyl Peroxide Gel must not be administered to patients with known hypersensitivity to:
- clindamycin
- lincomycin
- benzoyl peroxide
- any of the excipients in the formulation listed in section 6.1.
Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water.
Clindamycin + Benzoyl Peroxide Gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
This medicine should be used with caution in atopic patients, in whom further skin drying may occur.
During the first weeks of treatment, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non- comedogenic moisturiser, temporarily reduce the frequency of application of Clindamycin + Benzoyl Peroxide Gel or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.
If severe local irritancy (e.g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, Clindamycin + Benzoyl Peroxide Gel should be discontinued.
As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.
If a patient has sunburn, this should be resolved before using this medicine.
If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Clindamycin + Benzoyl Peroxide Gel should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered.
The product may bleach hair or coloured fabrics. Avoid contact with hair, fabrics, furniture or carpeting.
Resistance to clindamycin
Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing anti-microbial resistant Propionibacterium acnes and commensal flora (see section 5.1).
Cross-resistance
Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy (see section 4.5).
No formal drug-drug interaction studies have been performed with Clindamycin + Benzoyl Peroxide Gel.
Concomitant topical antibiotics, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol and/or astringents, should be used with caution as a cumulative irritant effect may occur.
This medicine should not be used in combination with erythromycin- containing products due to possible antagonism to the clindamycin component.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore caution should be exercised with concomitant use.
Concomitant application of Clindamycin + Benzoyl Peroxide Gel with tretinoin, isotretinoin and tazarotene should be avoided since benzoyl peroxide may reduce their efficacy and increase irritation. If combination treatment is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening).
Using topical benzoyl peroxide-containing preparations at the same time as topical sulfonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange).
Pregnancy
There are no adequate data from the use of this medicine in pregnant women. Animal reproductive/developmental studies have not been conducted with Clindamycin + Benzoyl Peroxide Gel or benzoyl peroxide. There are limited data on the use of clindamycin and benzoyl peroxide alone in pregnant women. Data from a limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/new-born child.
Reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin, revealed no evidence of impaired fertility or harm to the foetus due to clindamycin.
The safety of Clindamycin + Benzoyl Peroxide Gel in human pregnancy is not established. Therefore, this medicine should only be prescribed to pregnant women after careful risk/benefit assessment by the physician in charge.
Breastfeeding
Use of Clindamycin + Benzoyl Peroxide Gel has not been studied during breastfeeding. Percutaneous absorption of clindamycin and benzoyl peroxide is low however; it is not known whether clindamycin or benzoyl peroxide is excreted in human milk following the use of this medicine. Oral and parenteral administration of clindamycin has been reported to result in the appearance of clindamycin in breast milk. For this reason, Clindamycin + Benzoyl Peroxide Gel should be used during lactation only if the expected benefit justifies the potential risk to the infant.
To avoid accidental ingestion by the infant if used during lactation, this medicine should not be applied to the breast area.
Fertility
There are no data on the effect of Clindamycin + Benzoyl Peroxide Gel on fertility in humans.
Not relevant
Adverse drug reactions (ADRs) are summarised below for Clindamycin + Benzoyl Peroxide Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin , that occurred either during clinical studies or that were spontaneously reported. Adverse drug reactions are listed by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1,000) and not known (cannot be estimated from the available data).
MedDRA SOC
Very Common
Common
Uncommon
Not known**
Immune system disorders
Allergic reactions including hypersensitivity and anaphylaxis
Nervous system disorders*
Headache4
Paraesthesia1
Gastrointestinal disorders
Colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain
Skin and subcutaneous tissue disorders*
Pruritus, burning sensation, dryness, erythema, peeling (Generally reported as 'slight' in severity.
Frequency relates to data from solicited tolerability assessments during the clinical trial)
Dermatitis, photosensitivity reaction
Erythematous rash, worsening of acne
Urticaria
General disorders and Administration site conditions
Application site pain4
Application site reactions including skin discoloration
1At site of application.
2Based on post-marketing reports with topical clindamycin 10 mg/g + benzoyl peroxide 50 mg/g gel. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency however, systemic reactions are rarely seen.
3Reported from studies conducted with topical clindamycin 10 mg/g + benzoyl peroxide 50 mg/g gel.
4Reported from studies conducted with topical clindamycin 10 mg/g foam.
Local Tolerability
During the pivotal clinical trial with a Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel, patients were assessed for local cutaneous signs and symptoms of erythema, dryness, peeling, itching, and burning/stinging. The percentage of patients that had symptoms present before treatment, during treatment, and present at week 12 are shown in the next two tables:
Percentage of Subjects in the Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel Group (N=327) with Symptoms of Burning/Stinging and Itching (patient assessed)
Before Treatment
(Baseline)
Maximum During Treatment
End of Treatment
(Week 12)
Slight
Mod
Strong
Slight
Mod
Strong
Slight
Mod
Strong
Burning/ Stinging
15%
4%
0
20%
6%
1%
8%
2%
<1%
Itching
28%
6%
1%
29%
9%
1%
17%
2%
0
Percentage of Subjects in the Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel Group (N=327) with Signs of Dryness, Erythema and Peeling (investigator assessed)
Before Treatment
(Baseline)
Maximum During Treatment
End of Treatment
(Week 12)
Slight
Mild
Mod
Severe
Slight
Mild
Mod
Severe
Slight
Mild
Mod
Severe
Dryness
15%
2%
1%
0
24%
7%
2%
0
9%
1%
1%
0
Erythema
19%
11%
5%
0
26%
13%
5%
<1%
19%
4%
2%
0
Peeling
10%
2%
0
0
17%
3%
1%
0
4%
<1%
0
0
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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).
Excessive application of Clindamycin + Benzoyl Peroxide Gel may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.
Excessive application of topically applied clindamycin may result in absorption of sufficient amounts to produce systemic effects.
In the event of accidental ingestion of Clindamycin + Benzoyl Peroxide Gel, gastrointestinal adverse reactions similar to those seen with systemically administered clindamycin may be seen.
Appropriate symptomatic measures should be taken to provide relief from irritation due to excessive application.
Accidental ingestion should be managed clinically or as recommended by the National Poisons Centre, where available.
Ask anything about Clindamycin + Benzoyl Peroxide 10mg/g + 30mg 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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