HEMICRANEAL TABLETS

Introduction

Package Leaflet: Information for the Patient

Hemicraneal 300 mg/100 mg/1 mg Coated Tablets

Paracetamol/Caffeine/Ergotamine Tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Hemicraneal tablets are and what they are used for
2. What you need to know before you take Hemicraneal tablets
3. How to take Hemicraneal tablets
4. Possible side effects
5. Storing Hemicraneal tablets
6. Contents of the pack and further information.

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1. What Hemicraneal tablets are and what they are used for

Hemicraneal tablets belong to a group of medicines called antimigraine medicines.

Hemicraneal tablets are indicated for migraine attacks, equivalent migrainous conditions, and vasomotor headaches.

2. What you need to know before you take Hemicraneal tablets

Do not take Hemicraneal tablets

• If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine.
• If you have peripheral circulation disorders, vascular disease that decreases blood flow to the arms and legs (vascular occlusive disease); heart disease due to decreased blood flow to the heart (ischemic heart disease); hypertension; generalized infection (sepsis); kidney failure; liver disease.
• If you are taking any other medicine listed in the "Use with other medicines" section without consulting your doctor.
• If you are pregnant or breastfeeding.

Warnings and precautions

During treatment with Hemicraneal tablets, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

• This medicine should only be taken during acute migraine attacks or vascular-type headaches (vasomotor headache) and not as a treatment to prevent their onset.
• You should avoid prolonged use of this medicine or use at doses higher than recommended, as higher doses than recommended may cause contraction of the arteries, which can lead to cerebral or cardiac disorders (vasospasm), and after prolonged treatments, alterations in the membrane that covers the lungs (pleura), the membrane that covers the intestinal loops (peritoneum), or more rarely, the heart valves.
• In case of tingling, numbness, or burning sensation in the skin or coldness of hands and feet, you should stop treatment and consult your doctor.

• You should avoid excessive use of Hemicraneal tablets, as it may worsen and increase the frequency of your headaches.

Use of Hemicraneal in athletes

If you are an athlete, you should know that this medicine contains caffeine, which may result in a positive doping test.

Use of Hemicraneal with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Especially if you are being treated with:

• those medicines that are eliminated by the same route as ergotamine, as it may favor the onset of ergotism, such as: other ergotamine preparations; other medicines for the treatment of migraine, such as sumatriptan, almotriptan, naratriptan; medicines for the treatment of HIV infection, such as amprenavir, nelfinavir, ritonavir, saquinavir, efavirenz; macrolide antibiotics (erythromycin, clarithromycin, and azithromycin); medicines for the treatment of fungal infections, such as ketoconazole, itraconazole, or voriconazole, and sibutramine, which is used for the treatment of obesity.
• beta-blockers (nadolol, oxprenolol, propanolol, timolol) and dopamine.
• Chloramphenicol, as it may increase its toxicity due to paracetamol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Pregnancy and breastfeeding

Hemicraneal tablets should not be used during pregnancy and breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It should be taken into account that some symptoms, such as drowsiness, dizziness, and weakness, caused by the migraine crisis itself, may affect the ability to drive or use machines.

Important information about some of the ingredients of Hemicraneal tablets

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Hemicraneal tablets

Follow exactly the administration instructions of Hemicraneal tablets indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Posology

The recommended dose of Hemicraneal tablets in adult patients is 2 tablets at the onset of the first symptoms of the crisis; if it does not subside, 1 tablet may be administered every hour. Do not exceed 6 tablets in a day, or 10 tablets in a week.

Children: Not recommended in children under 12 years.

If you take more Hemicraneal tablets than you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone: 915620420), indicating the medicine and the amount ingested. The symptoms can be very serious and usually appear from the third day after ingestion.

The most characteristic symptoms of paracetamol overdose include dizziness, vomiting, loss of appetite, yellowing of the skin (jaundice), and abdominal pain.

Paracetamol overdose is considered to be a single dose of more than 6 g in adults and more than 100 mg per kg of body weight in children. Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Treatment consists of gastric aspiration and lavage, oral activated charcoal, intravenous administration of N-acetylcysteine at adequate doses, and, if necessary, hemodialysis. The period in which treatment offers the greatest guarantee of efficacy is within 12 hours after ingestion of the overdose.

Ergotamine may add a picture of peripheral ischemia that should be treated with peripheral vasodilators, local heat, and heparin.

If you forget to take Hemicraneal tablets

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hemicraneal tablets can cause side effects, although not everybody gets them:

Frequent(May affect up to 1 in 10 people):

Dizziness

Nausea and vomiting not related to migraine

Abdominal pain

Uncommon(May affect up to 1 in 100 people):

Numbness and tingling of fingers and toes

Bluish discoloration of skin and mucous membranes

Diarrhea

Pain and weakness in arms and legs

Vasoconstriction

Rare(May affect up to 1 in 1,000 people):

Vertigo

Acceleration or slowing of heart rate

Increased blood pressure

Skin rash, facial edema, urticaria

Muscle pain

Headache

Lack of pulse

Breathing difficulties

Hypotension (decreased blood pressure)

Increased levels of liver transaminases (markers of liver function)

Discomfort

Fibrotic changes in heart valves after prolonged treatments

Ergotism (poisoning by ergot alkaloids)

Very rare(May affect up to 1 in 10,000 people):

Myocardial infarction or angina pectoris

Gangrene

Changes in blood cell count, such as leukopenia or neutropenia

Hypoglycemia (decreased blood glucose levels)

Jaundice (yellowing of skin and eyes)

Cloudy urine

Severe skin reactions

Frequency not known(cannot be estimated from the available data):

Retroperitoneal fibrosis after prolonged treatments

Hepatitis after prolonged treatments

Coldness of hands and feet

Pleural fibrosis after prolonged treatments

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Hemicraneal tablets

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Hemicraneal tablets

• The active substances are: paracetamol, caffeine, ergotamine tartrate.
• The other ingredients are: microcrystalline cellulose (E-460), povidone (E-1201), corn starch, magnesium stearate (E-470b), tartaric acid (E-334), quinoline yellow (E-104), orange yellow S (E-110), copovidone, talc (E-553b), titanium dioxide (E-171), macrogol 6,000, hydroxypropyl cellulose (E-464), carnauba wax (E-903), and purified water.

Appearance of the product and pack contents

Hemicraneal tablets are presented as orange-yellow, oval, scored tablets.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Each pack contains 20 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid,

Tel: +34913238792

Manufacturer:

Laboratorio Farmaceutico S.I.T. Srl.

Via Cavour, 70

27035 Mede (PV) Italy

Date of last revision of this leaflet: February 2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

http://www.aemps.gob.es/