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).