Stopadol Migraine 20 tablets

Stopadal Migraine 20 tablets

Composition

Active ingredients:

Ergotamine tartrate — 1 mg

Paracetamol — 325 mg

Caffeine anhydrous — 50 mg

Metoclopramide hydrochloride — 5 mg

Description

Stopadal Migraine is a combination medication for the treatment of acute migraine attacks and migraine variants. It contains ergotamine, paracetamol, caffeine, and metoclopramide, which effectively reduce pain, alleviate headaches, and control nausea and vomiting that often accompany migraines. The combination of these components provides a synergistic effect.

Indications for Use

Treatment of acute migraine attacks and migraine variants.

Directions for Use and Doses

For relief of migraine headaches, the usual adult dose is one to two tablets at the first warning of an attack. If symptoms persist, one tablet may be taken every half hour, up to 6 tablets within a 24-hour period. Do not exceed 10 tablets per week.

Contraindications

Known hypersensitivity to any of the product components.

Pregnancy.

Heart diseases (coronary insufficiency).

Peripheral vascular occlusion.

Severe hypertension.

Severe liver or kidney dysfunction.

Glaucoma.

Prostate enlargement.

Pyloric stenosis, gastrointestinal obstruction.

History of neuroleptic or metoclopramide-induced dyskinesia.

Epilepsy.

Pheochromocytoma.

Co-administration with levodopa.

Not to be used in the post-operative period (within 3-4 days after pyloroplasty or gastrointestinal anastomosis).

Not for use in children under 18 years old.

Precautions

-This product is intended only for the treatment of acute migraine attacks, not for prevention.

-Avoid prolonged use or exceeding the recommended doses.

-Due to its vasoconstrictive properties, ergotamine may cause myocardial ischemia or infarction even in healthy individuals without heart disease.

-If symptoms of overdose occur (numbness, tingling in the limbs, nausea, vomiting, chest pain), stop using the product immediately and consult a physician.

-Do not take with other paracetamol-containing products.

-Metoclopramide should only be used for short-term treatment (up to 5 days).

-Special caution should be taken when prescribing with other centrally acting drugs or in the elderly, as they are at increased risk of extrapyramidal reactions.

-Patients should be monitored for possible adverse effects, including extrapyramidal symptoms, drowsiness, confusion, and hallucinations.

-Careful administration is required when combined with other CNS depressants or antipsychotics.

Pregnancy and Lactation

Ergotamine-containing products are contraindicated during pregnancy due to their oxytocic and vasoconstrictive effects on the placenta and umbilical cord. Ergotamine, metoclopramide, and paracetamol are excreted in breast milk and may cause symptoms like vomiting, diarrhea, weak pulse, and unstable blood pressure in infants. Therefore, Stopadal Migraine should not be used during breastfeeding.

Side Effects

When used at the recommended doses, side effects are rare but may include:

Ergotamine: nausea, vomiting, headache, dizziness, allergic reactions (including anaphylactic shock), blood pressure elevation, peripheral vasoconstriction.

Caffeine: nervousness, insomnia, diuresis, usually due to overdose.

Paracetamol: skin rash, allergic reactions.

Metoclopramide: long-term use may result in dyskinesia, including involuntary repetitive body movements, even after discontinuation of the drug.

Storage Conditions

Store in a dry place at a temperature not exceeding 30°C.

Keep out of reach of children.

Packaging

The package contains 2 blisters of 10 tablets and an instruction leaflet.