CLINDAMYCIN

Posology The recommended dose is one pessary intravaginally at bedtime, for three consecutive days. 6). Older people The use of Clindamycin 100 mg Pessaries has not been studied in patients over 65 years of age. Patients with renal impairment The use of Clindamycin 100 mg Pessaries has not been studied in patients with impaired renal function.

Paediatric population The safety and efficacy of Clindamycin 100 mg Pessaries in children under 16 years of age has not been established. 6). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

The safety of Clindamycin pessaries was evaluated in non-pregnant patients in clinical trials.

Frequencies reported are as follows:

Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100). System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Infections and infestations Fungal infection, candida infection Nervous system disorders Headache Gastrointestinal disorders Abdominal pain, diarrhoea, nausea Vomiting Skin and subcutaneous tissue disorders Pruritus (non-application site) Rash Musculoskeletal and connective tissue disorders Flank pain Renal and urinary disorders Pyelonephritis, dysuria Reproductive system and breast disorders Vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal disorder Vaginal infection, vaginal discharge, menstrual disorder General disorders and administration site conditions Application site pain, pruritus (topical application site), localized oedema, pain, pyrexia Pseudomembranous colitis is a class event for antibacterials.

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 or Apple App Store.

Before or after initiation of therapy with Clindamycin 100 mg Pessaries, 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 100 mg Pessaries 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 contra-indicated in this situation. Caution is advised in patients when prescribing Clindamycin 100 mg Pessaries 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 100 mg Pessaries is not recommended. 2). The use of such products within 72 hours following treatment with Clindamycin 100 mg Pessaries 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 100 mg Pessaries is not recommended. Safety and efficacy studies have not been performed with Clindamycin 100 mg Pessaries in the following populations: pregnant, lactating women, patients with impaired hepatic function, immunodeficiency or colitis.

2).

1. Clindamycin 100 mg Pessaries are also contraindicated in individuals with a history of antibiotic-associated colitis.