দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pivmecillinam hydrochloride
Milpharm Ltd
J01CA08
Pivmecillinam hydrochloride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010105; GTIN: 8901175025442
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pivmecillinam hydrochloride is and what it is used for 2. What you need to know before you take Pivmecillinam hydrochloride 3. How to take Pivmecillinam hydrochloride 4. Possible side effects 5. How to store Pivmecillinam hydrochloride 6. Contents of the pack and other information Pivmecillinam belongs to a group of medicines called penicillins. It is a type of antibiotic. Pivmecillinam works by killing germs (bacteria) that cause infections. Pivmecillinam hydrochloride is used to treat infections of the bladder (cystitis) in adults. Your doctor may have prescribed a different use or dosage than stated in this information. Always follow your doctors instructions. DO NOT TAKE PIVMECILLINAM HYDROCHLORIDE If you are allergic to pivmecillinam or any of the other ingredients of this medicine (listed in section 6). If you are allergic to other antibiotics. Such antibiotics include penicillin or cephalosporins. If you have narrowing of the food pipe. If you suffer from a condition which may reduce the amount of a substance called carnitine in your body. Such conditions include carnitine transporter defect, methylmalonic aciduria and propionic acidaemia WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Pivmecillinam hydrochloride. The tablets must be taken with at least half a glass of fluid to prevent that the tablets get stuck in your food pipe. Before you take Pivmecillinam hydrochloride tell your doctor: If you hav সম্পূর্ণ নথি পড়ুন
OBJECT 1 PIVMECILLINAM 200MG FILM-COATED TABLETS Summary of Product Characteristics Updated 14-Oct-2015 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Pivmecillinam hydrochloride 200 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 200 mg of pivmecillinam hydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White to off-white, round shaped, biconvex, film coated tablets debossed with 'F' on one side and '48' on the other side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of adults with acute uncomplicated cystitis due to mecillinam sensitive organisms. 4.2 Posology and method of administration POSOLOGY Adults: The usual dose is 200 mg two times daily for 7 days, alternatively 200 mg 3 times daily for 5 days. PAEDIATRIC POPULATION: Pivmecillinam hydrochloride should not be used in children and adolescents below 18 years because the efficacy and safety have not yet been established. DOSAGE IN THE ELDERLY: Renal excretion of mecillinam is delayed in the elderly, but significant accumulation of the drug is not likely at the recommended adult dosage of Pivmecillinam hydrochloride tablets. HEPATIC IMPAIRMENT Dosage adjustment is not necessary. METHOD OF ADMINISTRATION Route of administration is oral. The tablets must be taken with at least half a glass of water, and preferably taken with or immediately after a meal. 4.3 Contraindications Pivmecillinam hydrochloride is contra-indicated in patients with: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Hypersensitivity to penicillins and/or cephalosporins • Any conditions resulting in impaired transit through the oesophagus. Genetic metabolism anomalies known to be leading to severe carnitine deficiency such as carnitine transporter defect, methylmalonic aciduria and propionic acidaemia. 4.4 Special warnings and precautions for use Antibiotic-associated colitis has been reporte সম্পূর্ণ নথি পড়ুন