Package Insert: Information for the Patient

Hemicraneal 400 mg/100 mg/ 2 mg Suppositories

Paracetamol/Caffeine/Ergotamine Tartrate

Read this package insert carefully before starting to use the medication as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you personally and should not be given to others even if they have the same symptoms as you, as it may harm them.

1. What is Hemicraneal and how it is used

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

3. How to use Hemicraneal

4. Possible side effects

5. Storage of Hemicraneal

6. Contents of the package and additional information

Hemicraneal belongs to a group of medications called: Anti-migraine medications.

Hemicraneal is indicated for migraine crises, equivalent migraine-like symptoms, and vasomotor headaches.

No use Hemicraneal,

• If you are allergic to any of the components of this medication (listed in section 6).
• If you suffer from peripheral circulation disorders, vascular disease that reduces blood flow to arms and legs (obstructive vascular disease); heart disease due to reduced blood flow to the heart (ischemic cardiopathy); hypertension; generalized infection (sepsis); renal insufficiency; liver disease.
• If you are being treated with any other medication listed in the section“Other Medications and Hemicraneal”without consulting your doctor.
• If you are pregnant or breastfeeding.

Warnings and Precautions

Inform your doctor immediately if you experience any of the following during treatment with Hemicraneal suppositories:

Severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Consult your doctor or pharmacist before starting to useHemicraneal.

• Hemicraneal should only be used during acute migraine attacks or vascular-type headache (vasomotor headache) and not as a preventive treatment.
• Avoid prolonged use of Hemicraneal or use at doses higher than recommended, as high doses may cause blood vessel constriction, which can lead to cerebral or cardiac disorders (vasospasm), and prolonged treatment may cause changes in the pleura membrane, peritoneum membrane, or rarely, heart valves.
• If you experience tingling, numbness, or burning sensations in the skin or cold hands and feet, discontinue treatment and consult your doctor.
• If you are an athlete, be aware that this medication contains caffeine, which may result in a positive analytical test for doping control.
• Avoid excessive use of Hemicraneal Suppositories, as it may worsen and increase the frequency of your headaches.

Children and Adolescents:

Hemicraneal should not be used in children under 12 years old.

Other Medications and Hemicraneal

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

Especially if you are being treated with:

• Medications that are eliminated through the same route as ergotamine, which may increase the risk of ergotism, such as: other ergotamine preparations; other migraine medications like sumatriptan, almotriptan, and naratriptan.
• Medications for HIV infection, such as amprenavir, nelfinavir, ritonavir, saquinavir, and efavirenz.
• Macrolide antibiotics, medications used to treat bacterial infections (erythromycin, clarithromycin, and azithromycin).
• Medications for fungal infections, such as ketoconazole, itraconazole, or voriconazole.
• Sibutramine, used to treat obesity.

• With?-blockers, medications used to treat cardiac problems (nadolol, oxprenolol, propranolol, timolol).
• Dopamine
• Chloramphenicol, as it may increase its toxicity due to paracetamol.

Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Hemicraneal should not be used during pregnancy and breastfeeding.

Driving and Operating Machines

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

Follow exactly the administration instructions for this medication as 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 onset of the first symptoms of the crisis; if this does not subside, 1 suppository may be administered every hour. Do not exceed 3 suppositories in a day, or 5 suppositories in a week.

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

Children: Not recommended for children under 12 years.

Hemicraneal is for rectal use.

If you use more Hemicraneal than you should,

Go quickly to a Medical Center even if you do not have symptoms, as these can be very serious, and usually appear from the third day after ingestion.

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

A paracetamol overdose is considered, 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 on barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

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

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them:

Tickling, numbness, or burning sensation in the skin or coldness in hands and feet, pain and weakness in arms and legs, drowsiness, nausea, vomiting, diarrhea, skin rashes, facial swelling, difficulty breathing, increased blood pressure, and hematological alterations, such as a decrease in the number of white blood cells (neutropenia or leucopenia). Rarely, angina pectoris or acute myocardial infarction may appear.

Unknown frequency (cannot be estimated from available data): a serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Very rarely, severe skin reactions have been reported.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of sight and reach of children.

Do not store at a temperature above 25°C.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Hemicraneal

• The active principles are: paracetamol, caffeine, ergotamine tartrate

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

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

Appearance of the product and content of the packaging

Hemicraneal suppositories are presented in the form of suppositories

Each package contains 10 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Desma Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Left Staircase 3rd B

28046 Madrid, Spain

Responsible for manufacturing

Pharmaceutical Laboratory S.I.T. S.r.l.

Via Provinciale per Lecco 78

22038 Tavernerio (CO)- Italy

Date of the last review of thisleaflet:February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)