Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clindamycin phosphate
Waymade Healthcare Plc
G01AA10
Clindamycin phosphate
20mg/1gram
Vaginal cream
Vaginal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07020200
PACKAGE LEAFLET: INFORMATION FOR THE USER DALACIN ® CREAM 2% (clindamycin phosphate) This medicine is available as the above name but will be referred as Dalacin Cream throughout the following leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. IN THIS LEAFLET: 1. What Dalacin Cream is and what it is used for 2. Before you use Dalacin Cream 3. How to use Dalacin Cream 4. Possible side effects 5. How to store Dalacin Cream 6. Further Information 1. WHAT DALACIN CREAM IS AND WHAT IT IS USED FOR Dalacin Cream is a vaginal cream. It contains clindamycin phosphate which is an antibiotic. It is used in the treatment of bacterial vaginosis (a bacterial infection of the vagina). 2. BEFORE YOU USE DALACIN CREAM DO NOT USE DALACIN CREAM If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this cream. Do not use if you suffer with a history of inflammatory bowel disease or antibiotic-associated colitis. TAKE SPECIAL CARE WITH DALACIN CREAM Before taking this medicine make sure that your doctor knows if you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Dalacin Cream TELL YOUR DOCTOR IMMEDIATELY since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (_pseudomembranous _ _colitis_) which can occur following treatment with antibiotics. Dalacin cream is not recommended for use in children. As with all vaginal infections, sexual intercourse during treatment with Dalacin Cream is not recommended. Dalacin Cre Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin Cream 2%. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. Excipients of known effect: Cetostearyl alcohol, propylene glycol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal Cream White, semi-solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antibiotic for the treatment of bacterial vaginosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. Paediatric population: Safety and efficacy in paediatric patients have not been established (see section 4.4). Elderly: No clinical studies have been conducted in populations older than 60. 4.3 CONTRAINDICATIONS Dalacin Cream is contra-indicated in patients previously found to be hypersensitive to preparations containing clindamycin or to any of the excipients listed in section 6.1. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Dalacin Cream should not be used in patients who have demonstrated lincomycin sensitivity. Dalacin Cream 2% is also 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 The use of clindamycin may result in the overgrowth of non-susceptible organisms, particularly yeasts. Virtually all antibiotics have been associated with diarrhoea and in some cases pseudomembranous colitis. Therefore, even though only a minimal amount of drug is absorbed, if significant diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. Dalacin Cream contains oil-based components. Read the complete document