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Primperan 10mg 30 tabl

SANOFI AVENTIS BELGIUM
Manufacturer: SANOFI AVENTIS BELGIUM

Reference: 0676296

Indications:

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Primperan 10mg 30 tabl

.

Indications:

Symptomatic treatment of disorders of the gastroduodenal motility, delayed gastric emptying and gastroesophageal reflux oesofageaal.
Symptomatic treatment of nausea and vomiting of different origin.
in Adjuvant injection, in the gastro-enterology, by radiological investigations or to facilitate the placement of probes.

Composition:


Tablets.

Metoclopramidum hydrochloridum 10 mg - Lactosum atomis. - Cellulose. microcristallinum - Amylum maydis - Silic. pyrogen. - Magnesii stearas. - Pro tablet. compression. una.
Drinkable solution.

Metoclopramidum hydrochloridum 5 mg - hydroxyethylcellulose. - Natr. cyclamen. - Natr. sacchar. - Methyl. parahydroxybenzoas - Propyl. parahydroxybenzoas - Acid. Citric. - Aurantii essent. - Extract. Abricot compos. of 42/598 - Aqua purificata q.s. ad 5 ml.
Injectable ampoules.

Metoclopramidum hydrochloridum 10 mg - Natr. chlorid. - Aqua ad iniectabilia q.s. ad 2 ml.
Suppositoria adults.

Metoclopramidum bass. 20 mg - Glyceride. pro suppositories. uno.
Suppositoria children.

Metoclopramidum bass. 10 mg - Glyceride. pro suppositories. uno.

Posology and method of use:


ADULTS.

The recommended dose is 15 to 30 mg / day.
not give more than 0.5 mg / kg / day.
In the young adult (18 to 20 years), the lowest recommended dose.
adjuverende If radiological treatment investigate whether the placement of probes, and chemotherapy, the average dose to be inflated from 20 to 50 mg / day.
In case of extremely severe nausea and vomiting, as after some cytostatics may doses up to 10 mg/kg/24 hours (in 5 administrations) are used, if necessary discontinuous way: they refer only to doses of the injectable form.
Oral administration.

½ à 1 tablet 3 times a day for meals.
The dividable tablet Primperan allows the dose to split.
1 to 2 teaspoons of potable solution 3 times per day before meals .
Parenteral administration.

In acute syndromes 1 IM or IV injection, may be repeated.
Rectal administration.
1 à
2 suppositoria of 20 mg per day.
CHILDREN.

to 0.5 mg / kg / day.
Oral administration.

Only potable via oral solution should be used in children over 10 kg.
Children over 10 kg: ¼ to ½ teaspoon of the drinkable solution 2 times a day.
Children over 20 kg: ½ teaspoon 3 times a day.
Children over 30 kg: 1 teaspoon 3 times a day.
Each dose before meals.
Parenteral administration.
IM
or IV
Children under 6 years: 0.1 mg / kg per dose.
Children above 6 years: 2.5 to 5 mg (0.5 ml to 1 ml) per application.
1 injectable ampoule (2 ml) Primperan contains 5 mg / ml.
Rectal administration.

Children over 10 kg: ½ suppository of 10 mg per day.
Children over 20 kg: ½ suppository of 10 mg 2 times a day.
Children over 30 kg: ½ suppository of 10 mg 3 times a day.
The divisible suppositoria Primperan Children 10 mg dose to allow for the splitting.
This form does not administer to children younger than 1 years.

This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.

Contraindications:


Tablets and suppositoria to 20 mg are contraindicated in children up to 18 years.
Hypersensitivity to metoclopramide or any other component of the drug.
Any clinical situation in which a stimulation of the gastro-intestinal motor function is undesirable: gastro-intestinal perforation, digestive bleeding, occlusion or subocclusie.
Pheochromocytoma (metoclopramide may release catecholamines in the tumors, which can lead to a hypertensive crisis, which may be treated with phentolamine).
Antecedents of tardive dyskinesia induced by the neuroleptics or metoclopramide.
Epilepsy.
Parkinson's disease.

Special precautions:


If vomiting occurs where the dose is vomited, it is necessary for the interval of intake to respect it before administering metoclopramide again.
Since metoclopramide catecholamines exempt, the product should be used with caution in patients with essential hypertension.
Because of its properties, metoclopramide is some pharmacodynamic properties of dopamine and dopaminergic agonists decrease.
patients with hepatic or severe renal impairment the recommended dose to reduce .
Caution is advised in patients with respiratory insufficiency.
The administration of metoclopramide is not recommended for Parkinson patients, or patients with epilepsy because the benzamides the epileptogenic threshold.
It is not recommended to Primperan are in association with sympathiccomimetica nor less than 15 days after termination of treatment with MAOI or tricyclic antidepressants.
hyperprolactinemia induced by administration of Primperan, the projection of existing cancer of the breast gland worse, without a clear link is known.
Administration of Primperan must be done with caution in such situations.
Because of the possible occurrence of extrapyramidal symptoms, it is advisable not to exceed the recommended doses, especially in children and young adults (it is important to the administered dose to adjust to the weight of the child, there were a number of extrapyramidal symptoms reported when using supra-therapeutic doses) or in people who already showed dyskinesias in previous use of metoclopramide or a neuroleptic, an individual sensitivity is possible.
As for neuroleptics, neuroleptic malignant syndrome may occur, characterized by hyperthermia, extrapyramidal symptoms, instability of the autonomous nervous system and a rise in CPK. Extra attention should be paid in the event of the occurrence of any of these symptoms or koorst. Treatment with Primperan should be discontinued when the suspicion of a malignant neuroleptic syndrome.
Pregnancy.

Although metoclopramide is not teratogenic in animals and proved the clinical use so far has not proved the contrary, the drug during pregnancy with caution be administered.
Lactation.

Metoclopramide passes into breast milk and therefore the administration is not recommended during lactation.

Side effects:


One can observe the following adverse effects: Neurological effects
.
Temporary
sleepiness.
Extrapyramidal symptoms may occur even after taking a single dose, especially children, women and young adults, or if the recommended doses are exceeded: acute dystonias and dyskinesias, parkinsonian syndrome, akathisia.
These adverse reactions disappear completely after the discontinuation of treatment.
Symptomatic treatment may be necessary: benzodiazepines and / or anticholinergic antiparkinsonian agents in both the child and the adult, as dexetimide or biperiden (the latter especially in children).
Digestive effects .

Diarrhea, abdominal cramps.
Other:
asthenia.
previously rare or exceptional.
endocrine effects .

Increased secretion of prolactin, possibly leading to amenorrhea and / or galactorrhea, gynecomastia ..
Cardiovascular adverse effects.

Hypotension (especially with The injectable form).
Tachycardia.
Neurological effects.

vertigineuze Vertigo and feelings: this effect was reported with administration of metoclopramide in high doses, as used in the context anti-cancer chemotherapy.
Depressive inclinations.
Neuroleptic malignant syndrome (see section 'special care').
other.

Allergic reactions (skin rash), including anaphylaxis (angioedema).
Tardive dyskinesia in long-term treatment especially in the elderly.
methaemoglobinaemia.

driving and use machines:


When driving vehicles or operating machinery should be highlighted on the risk of somnolence.

Overdose:


Moderate disturbances of consciousness or an extrapyramidal syndrome can be observed.
Treatment is only symptomatic: myorelaxantia, benzodiazepines and / or anticholinergic anti-Parkinson as dexetimide or biperiden (this latter especially in children).

Interactions:


Association levodopa-metoclopramide is contraindicated (reciprocal antogonisme).
Depre Soren of the central nervous system (morphine derivatives, hypnotics, anxiolytics, some sedative H1-antihistamines, some antidepressants: MAOI, especially tricyclic antidepressants, clonidine and related molecules): the sedative effects of the sensors of the central nervous system depressants and metoclopramide are strengthened.
Primperan the absorption of digoxin in the stomach reduction. The plasma levels of digoxin should be monitored closely.
The absorption of certain drugs in the small intestine can be increased (eg paracetamol).
The effect of metoclopramide on the gastro-intestinal motility by anticholinergic agents is geantagoniseerd and morphine derivatives .
Metoclopramide increases the bioavailability of ciclosporin. The monitoring of plasma levels of cyclosporine is required.
The combination of metoclopramide and a neuroleptic should be avoided.
A few isolated cases of interaction of carbamazepine with metoclopramide and hydroxyzine have been reported.
Concomitant intake of alcohol should be avoided because the sedative effect of alcohol may increase metoclopramide.

 

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