Synkapton (Tablets) Instructions for Use

Marketing Authorization Holder

Strallhofer Pharma, GmbH (Austria)

Manufactured By

Roesch & Handel (Austria)

ATC Code

N02CA52 (Ergotamine in combination with other drugs, excluding psycholeptics)

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Ergotamine (Rec.INN WHO Registered)

Dimenhydrinate (Rec.INN WHO Registered)

Dosage Form

Synkapton

Coated tablets, 25 mg+100 mg+1 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Coated tablets of a red-brown color, sugar-coated.

Excipients: lactose monohydrate – 50 mg, microcrystalline cellulose – 37 mg, corn starch – 42.8 mg, povidone – 4.7 mg, talc – 3.8 mg, tartaric acid – 2.5 mg, gelatin – 2 mg, magnesium stearate – 1.2 mg, docusate sodium – 0.00425 mg, sodium benzoate – 0.00075 mg.

Shell composition: sucrose – 76.443 mg, rice starch – 3 mg, acacia gum – 7 mg, talc – 56 mg, titanium dioxide – 14 mg, quinoline yellow dye (E104) – 0.47 mg, ponceau 4R dye (E124) – 0.075 mg, indigo carmine (E132) – 0.012 mg.

10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimigraine activity

Pharmacotherapeutic Group

Antimigraine agent

Pharmacological Action

A combined drug.

Dimenhydrinate suppresses the vomiting center.

Caffeine enhances the absorption of ergotamine in the intestine and increases the tone of extracranial vessels.

Ergotamine increases the tone of extracranial vessels, which are dilated during a migraine attack, and relieves headache.

The therapeutic effect develops after 30 minutes and lasts for 3-6 hours.

Pharmacokinetics

Ergotamine is slowly and incompletely absorbed from the gastrointestinal tract. After oral administration of 2 mg, the plasma concentration is 0.36 ng/ml; simultaneous intake of caffeine increases the plasma concentration to 0.7 ng/ml.

The T_1/2 of ergotamine from plasma is 2 hours. 90% of its metabolites are excreted in the bile.

Caffeine is rapidly absorbed after oral administration, the time to reach C_max is 1 hour, T_1/2 is 3-7 hours. It is excreted in the urine as metabolites.

Dimenhydrinate is well absorbed after oral administration, T_1/2 is 5-8 hours. It is metabolized in the liver and excreted in the urine as metabolites.

Indications

Migraine (relief of an attack).

ICD codes

Dosage Regimen

Orally, with plenty of water. For children over 12 years and adults: at the first signs of migraine – 1 tab. If improvement does not occur, take another 1 tab. after 30 minutes. The drug can be repeated every 30 minutes until the maximum daily dose of 4 tabs is reached. If an individual daily dose has been previously established, it may be prescribed as a single dose at the onset of migraine signs.

Weekly intake should not exceed 10 tabs.

For children from 6 to 12 years: 1/2 tab.

Adverse Reactions

Drowsiness, increased fatigue, constipation, allergic reactions, mydriasis, peripheral vasoconstriction, sensation of cold in the extremities, paresthesia, chest pain.

Contraindications

Hypersensitivity to the active substances; impaired peripheral circulation; obliterating endarteritis; coronary artery diseases; epilepsy; glaucoma; prostatic hypertrophy; bronchial asthma; coronary artery disease; children under 6 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindication — children under 6 years of age.

Special Precautions

The patient should always carry the drug with them, especially in situations that provoke a migraine attack: menstruation, weather fluctuations, eye strain, use of oral contraceptives, consumption of certain foods (coffee, cheese, chocolate). It is important to manage to take the drug in the prodromal phase, and not after a developed migraine attack.

It is used only for relieving a migraine attack, and not for long-term treatment. After a week of using the drug, a break is necessary. If migraine attacks are frequent, the frequency of drug administration must be agreed with the attending physician.

Drug Interactions

Concomitant use with sedatives and hypnotics enhances their effectiveness.

Troleandomycin, macrolides, beta-blockers – increased vasoconstriction.

Synkapton reduces the effectiveness of heparin, phenothiazine.

Dimenhydrinate may mask the ototoxicity of aminoglycosides.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.