Hemicraneal 400 mg/100 mg/2 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hemicraneal 400 mg/100 mg/2 mg suppositories

Paracetamol/Caffeine/Ergotamine tartrate

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

Leaflet contents

1. What Hemicraneal is and what it is used for
2. What you need to know before using Hemicraneal
3. How to use Hemicraneal
4. Possible side effects
5. How to store Hemicraneal
6. Contents of the pack and other information

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

Hemicraneal belongs to a group of medicines called antimigraine agents.

Hemicraneal is indicated for migraine attacks, migraine equivalents, and vasomotor headaches.

2. What you need to know before using Hemicraneal

Do not use Hemicraneal,

• If you are allergic to any of the components of this medicine (listed in section 6).
• If you suffer from peripheral circulation disorders, vascular 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; systemic infection (sepsis); renal failure; liver disease.
• If you are taking any other medicines listed in the section "Other medicines and Hemicraneal" without consulting your doctor.
• If you are pregnant or breastfeeding.

Warnings and precautions

During treatment with Hemicraneal suppositories, 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 are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Consult your doctor or pharmacist before starting to use Hemicraneal.

• Hemicraneal should only be used during acute migraine attacks or vascular-type headaches (vasomotor cephalalgia), and not as a preventive treatment.
• Avoid prolonged use of Hemicraneal or use at doses higher than recommended, as doses exceeding those recommended may cause arterial constriction, potentially leading to cerebral or cardiac disorders (vasospasm). After prolonged treatment, changes may occur in the membrane lining the lungs (pleura), the membrane lining the intestines (peritoneum), or, more rarely, in the heart valves.
• If you experience tingling, numbness, burning sensation in the skin, or coldness in hands and feet, stop treatment and consult your doctor.
• If you are an athlete, you should be aware that this medicine contains caffeine, which may lead to a positive result in doping control tests.
• Excessive use of Hemicraneal suppositories should be avoided, as it may worsen and increase the frequency of your headaches.

Children and adolescents:

Hemicraneal must not be used in children under 12 years of age.

Other medicines and Hemicraneal

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Especially if you are taking:

• Medicines eliminated via the same route as ergotamine, as they may promote the occurrence of ergotism, such as: other ergotamine-containing preparations; other migraine treatments like sumatriptan, almotriptan, naratriptan

• Medicines for HIV infection treatment such as amprenavir, nelfinavir, ritonavir, saquinavir, efavirenz

• Macrolide antibiotics, medicines used to treat bacterial infections (erythromycin, clarithromycin, azithromycin)

• Medicines for fungal infections such as ketoconazole, itraconazole, or voriconazole

• Sibutramine, used for the treatment of obesity

• With β-blockers, medicines used to treat heart conditions (nadolol, oxprenolol, propranolol, timolol)

• 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Hemicraneal must not be used during pregnancy or breastfeeding.

Driving and using machines

No studies have been conducted on the ability to drive or operate machinery.

3. How to use Hemicraneal suppositories

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: Start with 1 suppository at the onset of the first symptoms of the attack; if the attack does not subside, 1 suppository may be administered every hour. Do not exceed 3 suppositories in one day or 5 suppositories in one week.

NOTE: In hot weather, it is advisable to cool the suppositories before use.

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

Hemicraneal is for rectal use only.

If you use more Hemicraneal than you should,

Go immediately to a Medical Center even if there are no symptoms, as they can be very serious and usually appear from the third day after ingestion.

Symptoms of paracetamol overdose include dizziness, vomiting, loss of appetite, yellowing of the skin (jaundice), and abdominal pain.

A paracetamol overdose is considered to occur when a single dose exceeding 6 g is ingested in adults, or 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 aspiration and gastric lavage, oral activated charcoal, intravenous administration of N-acetylcysteine at appropriate doses, and, if necessary, hemodialysis. The period during which treatment offers the greatest assurance of efficacy is within the first 12 hours following ingestion of the overdose.

Ergotamine may cause peripheral ischemia, which should be treated with peripheral vasodilators, local heat, and heparin.

In case of accidental ingestion, go to a medical center or contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them:

Tingling, numbness, or burning sensation of the skin, coldness of hands and feet, pain and weakness in arms and legs, drowsiness, nausea, vomiting, diarrhoea, skin rashes, swelling of the face, difficulty breathing, increased blood pressure, and haematological disorders such as decreased number of white blood cells (neutropenia or leucopenia). Rarely, angina pectoris or acute myocardial infarction may occur.

Frequency not known (cannot be estimated from available data): a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

With high doses or prolonged treatment, disturbances in liver function (hepatitis) may be observed.

Very rarely, serious skin reactions have been reported.

If you notice any other adverse reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 System for Pharmacovigilance of 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 suppositories

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

Do not store above 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 should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Hemicraneal

• The active substances are: paracetamol, caffeine, ergotamine tartrate.

Each suppository contains: 400 mg paracetamol, 100 mg caffeine, 2 mg ergotamine tartrate.

• The other components (excipients) are: massa estarinum B, soybean lecithin, tartaric acid, carmine red A (E-124), titanium dioxide (E-171), caprylic-capric acid triglycerides, and disodium edetate.

Appearance of the medicinal product and contents of the pack

Hemicraneal suppositories are presented as suppositories.

Each pack contains 10 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

Laboratorio Farmaceutico S.I.T. S.r.l.
Via Provinciale per Lecco 78
22038 Tavernerio (CO) - Italy

Date of the most recent revision of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)