Product Information for the Patient

Hemicraneal 300 mg/100 mg/1 mg Coated Tablets

Paracetamol/Caffeine/Ergotamine Tartrate

Read this entire leaflet carefully before you start taking the medicine, as 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 must not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Hemicraneal Tablets

3. How to take Hemicraneal Tablets

4. Possible side effects

5. Storage of Hemicraneal Tablets

6. Contents of the pack and additional information.

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Hemicraneal tablets belongs to a group of medicines called anti-migraine medications.

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

Do not take Hemicraneal tablets

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication.
• If you have circulatory disorders, vascular disease that reduces blood flow to arms and legs (obstructive arterial 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 "Use of other medications" section 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 tablets:

If you have 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.

• This medication should only be taken during acute migraine attacks or vascular-type headache (vasomotor headache) and not as a preventive treatment.
• Avoid prolonged use of this medication or taking doses higher than recommended, as high doses may cause blood vessel constriction, leading to cerebral or cardiac disorders (vasospasm), and prolonged treatment may cause alterations in the pleura membrane, peritoneal membrane, or rarely, heart valve membranes.
• If you experience tingling, numbness, or burning sensations in the skin or cold hands and feet, discontinue treatment and consult your doctor.

• 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, be aware that this medication contains caffeine, which may result in a positive test in doping control tests.

Use of Hemicraneal with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially if you are being treated with:

• Medications that are eliminated through the same route as ergotamine, as it may increase the risk of ergotism, such as: Other ergotamine preparations; other migraine medications like sumatriptan, almotriptan, naratriptan; HIV infection medications like amprenavir, nelfinavir, ritonavir, saquinavir, efavirenz; macrolide antibiotics (erythromycin, clarithromycin, and azithromycin); antifungal medications like ketoconazole, itraconazole, or voriconazole, and sibutramine, used for obesity treatment.
• With beta-blockers (nadolol, oxprenolol, propranolol, timolol) and 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

Hemicraneal tablets should not be used during pregnancy and breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Be aware that some symptoms, such as drowsiness, dizziness, and weakness, caused by the migraine itself, may affect your ability to drive or operate machinery.

Important information about some components of Hemicraneal tablets

This medication may cause allergic reactions because it contains Yellow No. 5 (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for Hemicraneal tablets as indicated by your doctor. In case of 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 crisis; if this 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 Toxicological Information Service (phone: 915620420), indicating the medication and the amount ingested. The symptoms can be very severe, and usually appear from the third day after ingestion.

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

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 undergoing 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.

If you forgot to take Hemicraneal tablets

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Hemicraneal tablets can cause side effects, although not everyone will experience them:

Common(Can affect up to 1 in 10 people):

Dizziness

Unrelated nausea and vomiting

Abdominal pain

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

Numbness and tingling of the fingers and toes

Blue discoloration of skin and mucous membranes

Diarrhea

Pain and weakness in arms and legs

Vasoconstriction

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

Dizziness

Acceleration or slowing of heart rate

Increased blood pressure

Rash on the skin, edema on the face, urticaria

Muscle pain

Headache

Loss of pulse

Difficulty breathing

Hypotension (decreased blood pressure)

Increased levels of liver transaminases (liver function markers)

Discomfort

Fibrotic changes in heart valves after prolonged treatment

Ergotism (ergot alkaloid poisoning)

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

Myocardial infarction or angina pectoris

Gangrene

Alterations in blood cell count such as leucopenia or neutropenia

Hypoglycemia (decreased blood glucose levels)

Ictericia (yellow discoloration 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

Chilliness of hands and feet

Pleural fibrosis after prolonged treatment

A severe disease that can make blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of unused medications and packaging through the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hemicraneal tablets

• The active principles are: paracetamol, caffeine, ergotamine tartrate.
• The other components are: microcrystalline cellulose (E-460), povidone (E-1201), cornstarch, magnesium stearate (E-470b), tartaric acid (E-334), quinoline yellow (E-104), sunset 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 content of the packaging

Hemicraneal tablets are presented in the form of coated yellow-orange oval tablets with a groove on one side.

The groove is only for breaking the tablet if it is difficult to swallow whole.

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Desma Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Escalera Izquierda 3ºB

28046 Madrid,

Tel: +34913238792

Responsible for manufacturing:

Pharmaceutical Laboratory S.I.T. Srl.

Via Cavour, 70

27035 Mede (PV) Italy

Date of the last review of this leaflet: February 2025.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

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