HEMICRANEAL 400 MG/100 MG /2 MG SUPPOSITORIES

2. What you need to know before starting to use 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 (vascular occlusive disease); heart disease due to reduced blood flow to the heart (ischemic heart disease); hypertension; generalized infection (sepsis); kidney failure; liver disease.
• If you are being treated with any other medicine 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:

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 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 of discomfort (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 headache) and not as a treatment to prevent their appearance.
• You should avoid prolonged use of Hemicraneal 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 interrupt treatment and consult your doctor.
• If you are an athlete, you should know that this medicine contains caffeine, which may result in a positive doping test.
• Excessive use of Hemicraneal Suppositories should be avoided, as it may worsen and increase the frequency of your headaches.

Children and adolescents:

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

Other medicines and Hemicraneal

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Especially if you are being treated with:

• those medicines that are eliminated by the same route as ergotamine, as they may favor the appearance of ergotism: 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, medicines used in the treatment of bacterial infections (erythromycin, clarithromycin, and azithromycin).
• medicines for the treatment of fungal infections such as ketoconazole, itraconazole, or voriconazole.
• sibutramine, used for the treatment of obesity.

• with beta-blockers, medicines used in the treatment of heart problems (nadolol, oxprenolol, propranolol, timolol).
• 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

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

Hemicraneal should not be used during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.

3. How to use Hemicraneal suppositories

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

The recommended dose is:

Adults: Start with 1 suppository at the time of appearance of the first symptoms of the crisis; if it does not subside, 1 suppository can be administered every hour. Do not exceed 3 suppositories in a day, or 5 suppositories in a week.

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

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

Hemicraneal is for rectal use.

If you use more Hemicraneal than you should,

Go quickly 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.

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

Paracetamol overdose is considered to be the ingestion of 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 during 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.

In case of accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them:

Tingling, numbness, or burning sensation in the skin or coldness of hands and feet, pain and weakness in arms and legs, drowsiness, nausea, vomiting, diarrhea, skin rash, swelling of the face, difficulty breathing, increased blood pressure, and hematological alterations, such as decreased white blood cell count (neutropenia or leucopenia). Rarely, angina pectoris or acute myocardial infarction may occur.

Frequency not known (cannot be estimated from available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

With high doses or prolonged treatments, liver function disorders (hepatitis) may be observed.

Very rare cases of severe skin reactions have been reported.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Hemicraneal

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

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

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

Appearance of the product and package contents

Hemicraneal suppositories are presented in the form of suppositories.

Each package 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 last revision of this leaflet:February 2025.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).