Migränerton®
capsules
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- Manufacturer:
- Dolorgiet, St.Augustin/Bonn, SRN.
- Sole distributor for the Czech Republic:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- Dolorgiet, St.Augustin/Bonn, SRN.
- Composition:
- Paracetamol 500 mg, Metoclopramide hydrochloride monohydride 5 mg in 1 capsule.
- Indication group:
- antimigrainic
The following information is for health professionals only.
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Characteristics:
Migränerton® cps. is a combined medicinal preparation. One of its ingredients is paracetamol which has and analgetic effect. The second component of Migränerton® cps. is metoclopramide which reduces nausea and vomitus, often connected with migrainous attack by affecting the central nervous system and gastrointestinal tract. Metoclopramide also improves absorption of paracetamol.
Indications:
Therapy of acute migrainous attack.
Contraindications:
Hypersensitivity to any component of the preparation. Parkinson’s syndrome. Prolactin dependent tumors. Epilepsy. Pheochromocytoma. Intestine transit disorder. Bleeding into the GIT. Pregnancy in the 1st trimester, in the 2nd and 3rd trimesters of pregnancy only it really necessary. The preparation is not suitable for children below 15 years of age.
Undesirable effects:
In the cause of treatment weakness, dizziness, motoric restlessness, insomnia and depression, allergic exanthema , intestinal peristalsis with painful contractions and diarrhoea can sometimes appear Reversible extrapyramidal dyskinesis, galactorrhoea (increase in prolactine) and haematopoiesis inhibition can sporadically appear.
Interactions:
Migränerton® cps.may alter the absorption of various other drugs (for example, absorption of digoxin is decreased and absorption of alcohol and tetracycline is enhanced). Concomitant administration of drugs causing enzyme induction in the liver (phenobarbital, phenytoin, rifampicin) may lead to hepatic damage. Same applies to the abuse of alcohol. In case of simultaneous administration of neuroleptic agents extrapyramidal disturbances may appear more often. Migränerton® cps. may intensify the effect of sedative drugs and risk of toxicity tricyklic antidepressants and mono-amino oxidase inhibitors.
Caution:
The preparation may unfavourably affect activities requiring attention and rapid decision-making (car driving, work in heights). The prolong large-dose abuse of analgetic agents may lead to renal damage, hepatic insufficiency or to permanent renal damage with the risk of renal failure (analgesic nephropathy).
Dosage:
The usual dose of Migränerton® cps. is 1 - 2 capsules immediately when the first symptoms of headache appear, or when the first prodromes of migrainous attack appear. The dose can be repeated after 4 hours. The highest daily dose is 6 capsules. The total duration of administration should not exceed 3 - 5 days. In hepatic and renal impairment, the drug should be given in reduced doses and at longer intervals between two doses. Capsules Migränerton® cps. are swallowed unchewed with some water.
Package:
20 capsules.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: May 27, 1999.
The preparation is available on medical prescription only.