DALACIN CREAM Vaginal Cream Ref.[6728] Active ingredients: Clindamycin

Before or after initiation of therapy with clindamycin, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.

The use of clindamycin may result in the overgrowth of non-susceptible organisms, particularly yeasts.

Onset of symptoms suggestive of pseudomembranous colitis may occur during or after antimicrobial treatment (see section 4.8). Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important that this is considered in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Moderate cases may improve following withdrawal of the drug.

Clindamycin treatment must be stopped if pseudomembranous diarrhoea occurs. An adequate antibacterial therapy should be prescribed. Drugs inhibiting peristalsis are contraindicated in this situation.

Caution is advised in patients when prescribing clindamycin to individuals with inflammatory bowel disease such as Crohn’s disease or ulcerative colitis.

As with all vaginal infections, sexual intercourse during treatment with clindamycin vaginal cream is not recommended. Latex condoms and diaphragms may be weakened if exposed to the suppository base used in clindamycin vaginal cream. The use of such products within 72 hours following treatment with clindamycin vaginal cream is not recommended as such use could be associated with diminished contraceptive efficacy or protection against sexually transmitted disease.

The use of other vaginal products (such as tampons and douches) during the treatment with clindamycin vaginal cream is not recommended.

Paediatric population

Safety and efficacy in paediatric patients have not been established (see section 4.2).

Excipient information

Dalacin Cream contains propylene glycol, cetostearyl alcohol and benzyl alcohol (see section 2).

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Benzyl alcohol may cause allergic reactions and mild local irritation.

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 (see section 4.9).

No information is available on the concomitant use of other vaginal medications with clindamycin.

Pregnancy

Use of clindamycin is not recommended during the first trimester, as there are no adequate and well-controlled studies in pregnant women over this period.

In clinical trials, intravaginal use of clindamycin vaginal products in pregnant women during second trimester and systemic use of clindamycin phosphate during the second and third trimester has not been associated with congenital abnormalities.

Clindamycin may be used to treat pregnant women if clearly necessary during the second and third trimester of pregnancy.

Reproduction studies performed in rats and mice using oral and parenteral doses of clindamycin, ranging from 100 to 600 mg/kg/day, have revealed no evidence of harm to the fetus due to clindamycin (see section 5.3). In one mouse strain, cleft palates were observed in species treated fetuses; this response was not produced in other mouse strains or in other species, and is therefore considered to be a strain specific effect. Animal reproduction studies are not always predictive of human response.

In a clinical trial in pregnant women during the second trimester, Dalacin Cream was effective in treating bacterial vaginosis, and no drug-related medical events were reported in the neonates. However, as with any drug used during pregnancy, a careful risk-benefit assessment should take place beforehand.

Breast-feeding

It is not known if clindamycin is excreted in human breast milk following the use of vaginally administered clindamycin vaginal cream. 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. No animal fertility studies have been performed using the vaginal route of administration.

The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.

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 (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The safety of clindamycin vaginal cream was evaluated in both non pregnant patients and patients during their second and third trimesters of pregnancy.

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 and Apple App store.

Not applicable.