Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METOCLOPRAMIDE HYDROCHLORIDE
SUNWARD PHARMACEUTICAL SDN. BHD.
METOCLOPRAMIDE HYDROCHLORIDE
100 Tablets; 1000 Tablets; 500 Tablets; 1000 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
SW METOCLOPRAMIDE TABLET Metoclopramide hydrochloride (10mg) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What SW Metoclopramide Tablet is used for 2. How SW Metoclopramide Tablet works 3. Before you use SW Metoclopramide Tablet 4. How to use SW Metoclopramide Tablet 5. While you are using it 6. Side effects 7. Storage and disposal of SW Metoclopramide Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT SW METOCLOPRAMIDE TABLET IS USED FOR For adults, SW Metoclopramide tablet is used for; treatment of nausea and vomiting, including acute migraine. prevention nausea and vomiting induced by radiation and chemotherapy. In children age 1 to 18 years old, SW Metoclopramide Tablet is used as second option to prevent nausea and vomiting induced from chemotheraphy. HOW SW METOCLOPRAMIDE TABLET WORKS The active ingredient in this medicine is Metoclopramide hydrochloride. It blocks the triggers in the brain which cause nausea and vomiting. BEFORE YOU USE SW METOCLOPRAMIDE TABLET _- When you must not use it _ Do not take this medicine if you: are allergic to Metoclopramide hydrochloride or any other ingredients of this medicine (listed in Product Description) have gastrointestinal tract bleeding, obstruction or perforation. are confirmed or suspect with pheochromocytoma (rare type of tumor which releases hormones that may cause high blood pressure). have history of uncontrolled body movement induced by metoclopramide or neuroleptic medications. have epilepsy. have parkinson disease or using levodopa or dopamine agonists (medicine to treat parkinson disease). have history of excessive methemoglobin in the blood which could be due to NADH- cytochrome b5 reductase enzyme deficiency. _ _ _ _ _Children _ Should not be used in for children below age one year old. _- Before you start to use it _ Tell your doctor before taking SW Metoclo- pramide Tablet if you have: kidney or liver problem. neurological Прочитайте повний документ
PROPOSED PACKAGE INSERT METOCLOPRAMIDE TABLET / SYRUP PHARMACOLOGY: Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder. Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although comparatively rare. Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention. The onset of pharmacology action of metoclopramide in 30 to 60 minutes following an oral dose; pharmacological effects persist for 1 to 2 hours. Approximately 85% of the radioactivity of an orally administered radioactive dose appears in the urine within 72 hours. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide. INDICATIONS: _ADULT POPULATION_ Metoclopramide is indicated in adults for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV). - Prevention of radiotherapy induced nausea and vomiting (RINV). - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. _PAEDIATRIC POPULATION_ Metoclopramide is indicated in children (aged 1-18 years) for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option. SIDE EFFECTS/ ADVERSE REACTIONS: The most frequent adverse reactions of metoclopramide are restlessness, drowsiness, fatigue and lassitude that occur in approximately 10% of patients. Less frequently, insomia, headache, dizziness, nausea, bowel disturbance or extrapyramidal symptoms may occur. Rarely depre Прочитайте повний документ