4.1. Therapeutic indications

Clindamycin is indicated for the treatment of acne vulgaris.

4.2. Posology and method of administration

Apply a thin film of this medicine twice daily to the affected area.

Shake well before use.

4.3. Contraindications

This medicine is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin or to any of the excipients listed in section 6.1.

This medicine is contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.

4.4. Special warnings and precautions for use

Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe diarrhoea and pseudomembranous colitis (see section 4.8). Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhoea and colitis have been reported infrequently with topical clindamycin. Therefore, the physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or colitis. If significant or prolonged diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.

Diarrhoea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-associated colitis. Colitis is usually characterized by persistent, severe diarrhoea and abdominal cramps.

Endoscopic examination may reveal pseudomembranous colitis. Stool culture for C. difficile and/or assay for C. difficile toxin may be helpful to diagnosis.

Vancomycin is effective in the treatment of antibiotic-associated colitis produced by C. difficile. The usual dose is 125 - 500 mg orally every 6 hours for 7 - 10 days. Additional supportive medical care may be necessary.

Mild cases of colitis may respond to discontinuance of clindamycin alone. Colestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro, and cholestyramine has been effective in the treatment of some mild cases of antibiotic-associated colitis. Colestyramine resins have been shown to bind vancomycin; therefore, when both colestyramine and vancomycin are used concurrently, their administration should be separated by at least two hours.

The lotion has an unpleasant taste and caution should be exercised when applying medication around the mouth.

This medicine should be prescribed with caution to atopic individuals.

4.5. Interaction with other medicinal products and other forms of interaction

Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women during the first trimester. A moderate amount of data from clinical trials in pregnant women (between 300-1000 pregnancy outcomes) during the second and third trimesters indicates systemic administration of clindamycin has not been associated with an increased frequency of congenital abnormalities or feto/neonatal toxicity. Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity (see section 5.3). Animal reproduction studies are not always predictive of human response.

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.

Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

Breast-feeding

It is not known whether clindamycin is excreted in human breast milk following use of this medicine. Clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 μg/mL following systemic use.

Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Fertility

Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability.

4.7. Effects on ability to drive and use machines

Clindamycin has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000) and Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Very Common

(≥1/10)

Common

(≥1/100 to <1/10)

Uncommon

(≥ 1/1 000 to <1/100)

Not Known (cannot be estimated from available data)

Infections and Infestations

Folliculitis, Pseudomembranous colitis (see section 4.4)

Eye Disorders

Stinging of the eye, Eye pain

Gastrointestinal Disorders

Gastrointestinal disorder

Abdominal pain

Skin and Subcutaneous Tissue Disorders

Seborrhoea,

Skin irritation,

Urticaria, Dry Skin

Dermatitis contact

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects.

In the event of overdosage, general symptomatic and supportive measures are indicated as required.