CLINDAMYCIN

Posology One applicator full intravaginally at bedtime for 7 consecutive days. In patients for whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective. 4). Elderly No clinical studies have been conducted in populations older than 60.

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. * ADRs identified post-marketing. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. Adverse Drug Reactions Table for Clindamycin Vaginal Cream System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1/1000 to <1/100 Rare ≥ 1/10, 000 to <1/1000 Very Rare < 1/10, 000 Frequency not known (cannot be estimated from available data) Infections and infestations Fungal infection, candida infection Bacterial infection Skin candida Immune System Disorders Hypersensitivity Endocrine disorders Hyperthyroidism Nervous System Disorders Headache, dizziness, dysgeusia Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Upper respiratory infection Epistaxis Gastrointestinal Disorders Abdominal pain, constipation, diarrhoea, nausea, vomiting Abdominal distension, breath odour, flatulence Gastrointestinal disorder, Pseudomembranous colitis*, dyspepsia Skin and Subcutaneous Tissue Disorders Pruritus (non- applicable site), rash Erythema, urticaria Rash maculopapular Musculoskeletal and connective tissue disorders Back pain Renal and urinary disorders Urinary tract infection, glycosuria, proteinuria Dysuria Pregnancy, puerperium and perinatal conditions Abnormal labour Reproductive system and breast disorders Vulvovaginal candidiasis Vulvovaginitis, vulvovaginal disorder, menstrual disorder, vulvovaginal pain, metrorrhagia, vaginal discharge Vulvovaginitis trichomonal, vaginal infection, pelvic pain Endometriosis General disorders and administration site conditions Pain, inflammation Investigations Microbiology test abnormal

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.

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. 2). Excipient information This medicine contains propylene glycol, cetostearyl alcohol, benzyl alcohol and polysorbate 60 (see section 2).

g. contact dermatitis). Benzyl alcohol may cause allergic reactions and mild local irritation. Polysorbate 60 may cause hypersensitivity reactions.

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