Hemicraneal tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Hemicraneal 300 mg/100 mg/1 mg film-coated tablets

Paracetamol / Caffeine / Ergotamine tartrate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

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

Hemicraneal tablets are indicated for migraine attacks, migraine-like equivalents, and vasomotor headaches.

2. What you need to know before starting to use Hemicraneal tablets

Do not take Hemicraneal tablets

• If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine.
• If you have peripheral circulatory disorders, blood vessel disease that reduces blood flow to arms and legs (obliterative vascular disease); heart disease due to reduced blood flow to the heart (ischaemic heart disease); hypertension; generalized infection (sepsis); renal failure; liver disease.
• If you are being treated with any other medicine listed in the section “Using other medicines” without consulting your doctor.
• If you are pregnant or breastfeeding.

Warnings and precautions

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breaths, drowsiness, malaise (nausea), and vomiting.

• This medicine should only be taken during acute migraine attacks or vascular-type headaches (vasomotor headache), and not as a preventive treatment to avoid their occurrence.

• You should avoid prolonged use of this medicine or use at doses higher than recommended, as doses exceeding those recommended may cause constriction of the arteries, potentially leading to cerebral or cardiac disorders (vasospasm). After prolonged treatment, changes may also appear in the membrane lining the lungs (pleura), the membrane covering the intestinal loops (peritoneum), or, more rarely, in the heart valves.

• If you experience tingling, numbness, burning sensation in the skin, or coldness in hands and feet, you must stop treatment and consult your doctor.

• Excessive use of Hemicraneal tablets should be avoided, as it may worsen your headaches and increase their frequency.

Use of Hemicraneal in athletes

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

Use of Hemicraneal with other medicines

Inform 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:

• Medicines that are eliminated through the same pathway as ergotamine, as they may promote the occurrence of ergotism, such as: other preparations containing ergotamine; other migraine treatments like sumatriptan, almotriptan, naratriptan; antiviral medicines for HIV infection such as amprenavir, nelfinavir, ritonavir, saquinavir, efavirenz; macrolide antibiotics (erythromycin, clarithromycin, azithromycin); antifungal medicines such as ketoconazole, itraconazole, or voriconazole; and sibutramine, used for the treatment of obesity.
• Beta-blockers (nadolol, oxprenolol, propranolol, timolol) and dopamine.
• Chloramphenicol, as paracetamol may increase its toxicity.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Pregnancy and breastfeeding

Hemicraneal tablets must not be used during pregnancy and breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

It should be noted that some symptoms such as drowsiness, dizziness, and weakness, caused by the migraine attack itself, may affect your ability to drive or operate machinery.

Important information about some of the components of Hemicraneal tablets

This medicine may cause allergic reactions as it contains sunset yellow FCF (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Hemicraneal tablets

Follow exactly the instructions for use of Hemicraneal tablets as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Children: Not recommended for children under 12 years of age.

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 medication and the amount ingested. 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.

An overdose of paracetamol is considered to occur with ingestion of a single dose exceeding 6 g in adults and more than 100 mg per kg of body weight in children. Patients undergoing treatment 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 an appropriate dose of N-acetylcysteine, and, if necessary, hemodialysis. The period during which treatment offers the greatest likelihood of effectiveness is within the first 12 hours following ingestion of the overdose.

Ergotamine may add a picture of peripheral ischemia, which 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Hemicraneal tablets may cause adverse effects, although not everyone experiences 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 in fingers of hands and feet

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

Increased or decreased heart rate

Elevated blood pressure

Skin rash, facial swelling, urticaria

Muscle pain

Headache

Absence of pulse

Difficulty breathing

Hypotension (decrease in blood pressure)

Increased levels of liver transaminases (markers of liver function)

Malaise

Fibrotic changes in heart valves after prolonged treatment

Ergotism (toxicity due to 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 leucopenia or neutropenia

Hypoglycemia (decrease in blood glucose levels)

Jaundice (yellowing of skin and eyes)

Cloudy urine

Severe skin reactions

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

Retroperitoneal fibrosis after prolonged treatment

Hepatitis after prolonged treatment

Coldness of hands and feet

Pleural fibrosis after prolonged treatment

A serious condition that may increase blood acidity (called metabolic acidosis) in severely ill patients using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hemicraneal tablets

Keep this medicine out of sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hemicraneal tablets

• The active substances are: paracetamol, caffeine, ergotamine tartrate.
• The other components 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 contents of the pack

Hemicraneal tablets are yellow-orange, oval, film-coated tablets with a score line on one side.

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

Each pack contains 20 tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Desma Laboratorio Farmacéutico SL
Paseo de la Castellana 121, Escalera Izquierda 3ºB
28046 Madrid, Spain
Tel: +34913238792

Manufacturer:

Laboratorio Farmaceutico S.I.T. Srl.
Via Cavour, 70
27035 Mede (PV) Italy

Date of latest review of this leaflet: February 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

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