Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vancomycin hydrochloride
Xellia Pharmaceuticals ApS
A07AA09
Vancomycin hydrochloride
250mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 00370594000015
Patient information leaflet VANCOMYCIN CAPSULES 125 MG AND 250 MG VANCOMYCIN HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Vancomycin capsules are and what they are used for 2. What you need to know before you take Vancomycin capsules 3. How to take Vancomycin capsules 4. Possible side effects 5. How to store Vancomycin capsules 6. Contents of the pack and other information 1. WHAT VANCOMYCIN CAPSULES ARE AND WHAT THEY ARE USED FOR HOW DOES THE MEDICINE WORK? Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections. WHAT IS THE MEDICINE USED FOR? Vancomycin is used in adults and adolescents from 12 years of age for the treatment of infections of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the _Clostridium difficile_ _ _bacterium. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VANCOMYCIN CAPSULES Do not take Vancomycin capsules if: • You are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6). TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF: • You have kidney problems • You are hard of hearing • You have inflammatory disorders in the intestines • You are elderly. TAKING OTHER MEDICINES Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. PREGNANCY AND BREAST-FEEDING • You should tell your doctor if you are pregnant, planning to Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancomycin Capsules 250mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg vancomycin hydrochloride equivalent to 250,000 IU vancomycin. 3 PHARMACEUTICAL FORM Capsules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vancomycin capsules are indicated in patients 12 years and older for the treatment of Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 12 to less than 18 years old: _ The recommended vancomycin dose is 125 mg every 6 hours for 10 days for the first episode of non-severe CDI. This dose can be increased to500 mg i every 6 hours for 10 days in case of severe or complicated disease. The maximum daily dose should not exceed 2 g. In patients with multiple recurrences, consideration may be given to treat the current episode of CDI with vancomycin, 125 mg four times daily for 10 days followed by either tapering the dose, i.e., gradually decreasing it until 125 mg per day or a pulse regimen, i.e., 125–500 mg/day every 2–3 days for at least 3 weeks. Treatment duration with vancomycin may need to be tailored to the clinical course of individual patients. Whenever possible the antibacterial suspected to have caused CDI should be discontinued. Adequate replacement of fluid and electrolytes should be instituted. Monitoring vancomycin serum concentrations after oral administration in patients with inflammatory intestinal disorders should be performed (see section 4.4). Special populations _Renal impairment _ Due to the very low systemic absorption, dose adjustment is unlikely, unless substantial oral absorption may occur in case of inflammatory intestinal disorders or _Clostridium difficile_-induced pseudomembranous colitis (see section 4.4)._ _ _Paediatric population _ Vancomycin capsules are not appropriate for the treatm Read the complete document