PRIMPERAN 10 MG 10 TAB

* Antiemetic. Treatment of vomiting and nausea. Prokinetic action. Breakable tablets. * Composition: Each tablet contains: & & Metoclopramide hydrochloride 10.5 mg Equivalent to Metoclopramide hydrochloride anhydrous 10 mg. * Therapeutic indications: & & Symptomatic treatment of nausea and vomiting including delayed nausea and vomiting induced by antimitotic agents. * Dosage and administration: & & – Reserved for adults and children over 20 kg (i.e. about 6 years old) only. & & – Nausea and vomiting: & & Adults: 1/2 to 1 tablet, 3 times daily, before meals, with an interval of 6 hours between intakes. & & In this indication, this dosage is not suitable for children. & & – Delayed nausea and vomiting induced by certain treatments: & & Adults and children weighing more than 20 kg: 0.5 mg / kg, 4 times daily, i.e. 1 tablet per 20 kg of bodyweight per dose. & & – Route of administration: oral route. & & – Frequency and time of administration: Leave an interval of at least 6 hours between doses. * Contraindications: & & – Hypersensitivity to metclopramide or any of the components. & & – If stimulation of gastrointestinal motility is hazardous to the patient: in the event of gastrointestinal & & bleeding, mechanical obstruction or gastrointestinal perforation. & & – In patients having previously presented with tardive dyskinesia induced by neuroleptics or metoclopramide. & & – In patients with known or suspected pheochromocytoma (apart from as a provocative test); & & serious hypertensive events have been reported with dopamine antagonists including certain & & benzamides in this patient category, & & – In combination with dopamine agonists and selegline. & & – Known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase & & deficiency. * Special warning and precautions for use: & & # Special warnings: & & – Only the oral drop form is suitable for infants. & & – Neurological undesirable effects (extrapyramidal syndrome) may develop, particularly in children & & and in young adults. & & – Since neuroleptic malignant syndrome has been reported in exceptional cases, treatment must be & & immediately discontinued in the event of unexplained hyperthermia or hyperthermia associated with & & other symptoms of malignant syndrome (pallor, vegetative disorders, impaired consciousness, & & muscular rigidity). & & – In the event of vomiting, or partial/complete rejection of the dose administered, maintain the stipulated & & dosing interval before readministering the medicinal product. & & – In the event of profuse vomiting, it is essential to guard against dehydration. The patient may be & & rehydrated orally using “sweet-saline” solutions (oral rehydration solutions) given in small quantaties & & at regular intervals. & & – Cases of methemoglobinemia, possibly due to NADH-cytochrome b5 reductase deficiency, have been & & reported. In such an event, treatment must be immediately and definitively discontinued, and appropriate & & measures implemented. & & – Due to the presence of lactose, this medicinal product is contraindicated in the event of congenital & & galactosemia, glucose/galactose malabsorption syndrome or lactose deficiency. & & # Sepcial precuations for use: & & – Use of this medicinal product is not recommended in epileptic patients (increased frequency and intensity & & of fits). & & – In the event of renal or hepatic impairment, it is advisable to reduce the dosage. * Pregnancy and lactation: & & – Metoclopramide should be be used only if needed during pregnancy. & & – Metoclopramide passes into breast milk. In consequence, breast-feeding should be avoided. & & Breast-feeding is not recommended in the event of premature birth or high-dose treatment. * Effects on ability to drive and use machines: & & Drivers and machine operators must be made aware of the risk of drowsiness related to & & use of the medicinal product. * Contraindication in children less than 18 years. * Not to be used without medical supervision. * Store at temperature not exceeding 30 degrees C, in a dry place. * Produced by: sanofi-aventis Egypt s.a.e. Under license of: sanofi-aventis – France. * Barcode: 6223003991128 (same as that for: PRIMPERAN 10 MG 20 TAB).