Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
METOCLOPRAMIDE HYDROCHLORIDE
RAFA LABORATORIES LTD
A03FA01
TABLETS
METOCLOPRAMIDE HYDROCHLORIDE 10 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
METOCLOPRAMIDE
METOCLOPRAMIDE
Metoclopramide is an antiemetic and stimulates GI motility. Adult population :Pramin is indicated in adults for: - Prevention of postoperative nausea and vomiting (PONV)- Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV)- Prevention of nausea and vomiting caused by radiation therapy- Symptomatic treatment of nausea and vomiting, including nausea and vomiting caused by migraine attack. In migraine attacks, metoclopramide can be used concomitantly with oral analgesics to improve their absorption.- Diabetic gastroparesis Pediatric population:Pramin is indicated in children aged 1 to 18 years for: - Second line-therapy: Treatment of established postoperative nausea and vomiting (PONV)- Second-line therapy: Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV)
2020-10-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only PRAMIN TABLETS ACTIVE INGREDIENT: Each tablet contains: Metoclopramide hydrochloride 10 mg For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your condition. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to prevent nausea and vomiting and to stimulate motility of the digestive system. The medicine is given in specific conditions, as determined by the doctor. THERAPEUTIC GROUP: dopamine receptor antagonists 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for the list of the additional ingredients, see section 6). • You suffer from conditions in which stimulating the digestive system may cause harm, such as: bleeding in the digestive system, obstruction or perforation in the digestive system (e.g., in the intestine or stomach). • You suffer or it is suspected that you suffer from pheochromocytoma (a rare tumor of the adrenal gland). • You suffer or have suffered in the past from involuntary repetitive muscle spasms (tardive dyskinesia), after taking certain medicines (such as neuroleptic medicines or medicines containing metoclopramide). • You suffer from Parkinson's disease or epilepsy. • You are taking levodopa, or other dopaminergic medicine. See also section 'Drug interactions'. • You had gastrointestinal surgery in the last 3-4 days. • You suffer or have suffered in the pas Կարդացեք ամբողջական փաստաթուղթը
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pramin® Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Metoclopramide hydrochloride 10 mg. Excipients with known effects: Each tablet contains about 75 mg lactose and 0.7 mg Ponceau 4r lake. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round, pink scored tablets marked “RAFA”.The tablets may be cut in half using the scored line. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Metoclopramide is an antiemetic and stimulates GI motility. Adult population Pramin® Tablets are indicated in adults for: - Prevention of postoperative nausea and vomiting (PONV) - Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) - Prevention of nausea and vomiting caused by radiation therapy - Symptomatic treatment of nausea and vomiting, including nausea and vomiting caused by migraine attack. In migraine attacks, metoclopramide can be used concomitantly with oral analgesics to improve their absorption. - Diabetic gastroparesis Pediatric population Pramin® Tablets are indicated in children aged 1 to 18 years for: - Second line-therapy: Treatment of established postoperative nausea and vomiting (PONV) - Second-line therapy: Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) 4.2 Posology and method of administration Posology Adult patients For all adult indications except diabetic gastroparesis (see below): - The recommended dose is 10 mg, 1 to 3 times a day. - The maximum recommended daily dose is 30 mg or 0.5 mg/kg bodyweight whichever is lower. 2 - The maximum recommended treatment period is usually 5 days. Pediatric population Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3). Pediatric patients For all pediatric indications: - The recommended dose is 0.1 mg to 0.15 mg/kg bodyweight, 1 to 3 times a day. - The maximum recommended daily dose is 0.5 mg/kg bodyweight. The tablets are not suitable for use Կարդացեք ամբողջական փաստաթուղթը