Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

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

The use of Dalacin may result in the overgrowth of nonsusceptible 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. It is therefore, 
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 Dalacin Vaginal Ovules to individuals with Inflammatory Bowel Disease such as Crohn’s Disease or Ulcerative Colitis.

As with all vaginal infections, sexual intercourse during treatment with Dalacin Vaginal Ovule is not recommended. Latex condoms and diaphragms may be weakened if exposed to the ovule base used in Dalacin Vaginal Ovules (see section 6.2). The use of such products within 72 hours following treatment with Dalacin Vaginal Ovules 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 Dalacin Vaginal Ovules is not recommended.

Safety and efficacy studies have not been performed with Dalacin Vaginal Ovule in the following populations: pregnant women, lactating women, patients with impaired hepatic function, immunodeficient or colitis.

Paediatric population
Safety and efficacy of Dalacin Vaginal Ovule in paediatric patients has not been established.

Effects on Driving

4.7         Effects on ability to drive and use machines

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