Brainal 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Brainal 30 mg film-coated tablets

Nimodipine

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, ask your doctor or pharmacist.
• This medicine has been prescribed only for you; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Brainal is and what it is used for

Brainal is a medicine containing a substance called nimodipine, which belongs to a group of medicines known as calcium antagonists. These substances are capable of dilating arteries and preventing them from constricting, thereby avoiding oxygen deficiency in the brain.

Brainal is used to prevent neurological damage caused by impaired blood flow due to constriction of cerebral arteries following a subarachnoid hemorrhage (a type of brain bleed caused by rupture of an aneurysm, which is an abnormal bulging or dilation of a portion of an artery where the wall is weakened).

2. What you need to know before taking Brainal

Do not take Brainal

• If you are allergic (hypersensitive) to nimodipine or to any of the other components of this medicine listed in section 6.
• If you are taking any of the following medicines for epilepsy: phenobarbital, phenytoin, or carbamazepine.
• If you are taking rifampicin (an antibiotic used in the treatment of tuberculosis).
• If you have severe liver disease (e.g., cirrhosis).
  • If you have generalized cerebral edema (increased fluid in the brain).
  • If you have severe intracranial hypertension (markedly increased pressure inside the skull).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Brainal.

• If you have blood pressure disorders or are being treated to lower your blood pressure.
• If you have kidney or liver disease.
• If you have suffered a head injury causing intracranial bleeding.
• If you have heart problems, e.g., cardiac arrhythmias or heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs). In such cases, your doctor will perform periodic monitoring.
• If you weigh less than 70 kg.

In all these situations, your doctor must carry out a series of checks to appropriately adjust your dose of Brainal.

If you are being treated with any of the medicines mentioned in the section "Use with other medicines", your doctor will monitor your blood pressure and adjust the dose of Brainal accordingly.

Taking Brainal with other medicines

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

Certain medicines may interact with this medicine; in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines. This is especially important when taking:

• Rifampicin (a medicine used to treat tuberculosis), as it may reduce the efficacy of nimodipine (see section "Do not take Brainal").
• Medicines for epilepsy such as phenytoin, phenobarbital, or carbamazepine, if previously administered chronically before starting nimodipine treatment (see section "Do not take Brainal").
• Medicines to lower blood pressure, as they may enhance the hypotensive effect of nimodipine.
• Cimetidine (a medicine used in the management of stomach ulcers) or valproic acid (used in the treatment of epilepsy), as they may enhance the hypotensive effect of nimodipine.
• Antibiotics (medicines used to treat infections) such as erythromycin, quinupristin, and dalfopristin.
• Antiretroviral medicines (used in the treatment of HIV infection) such as ritonavir and zidovudine.
• Antifungal medicines (used to treat fungal infections) such as ketoconazole.
• Medicines for depression such as nefazodone, fluoxetine, and nortriptyline.

Taking Brainal with food and drink

Grapefruit juice should not be consumed together with nimodipine, as it could alter its efficacy. Brainal should be taken apart from meals.

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.

Brainal must not be used during pregnancy or breastfeeding, unless prescribed by a doctor. If the use of nimodipine is essential, your doctor will assess whether administration of this medicine is appropriate.

Driving and use of machines

If you feel dizzy after taking nimodipine, you should not drive or operate machinery. This is particularly important if you consume alcohol during treatment; therefore, you must not drink alcohol while taking this medicine.

3. How to take Brainal

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

The recommended dose to prevent neurological damage due to reduced blood flow caused by cerebral artery constriction after subarachnoid hemorrhage is (following an initial infusion of nimodipine 0.2 mg/ml solution for infusion for 5 to 14 days) a daily dose of 2 Brainal tablets 6 times a day (6 times x 60 mg of nimodipine daily), up to a maximum total duration of approximately three weeks. The interval between doses should not be less than four hours.

In general, the tablet should be swallowed whole without chewing, with a small amount of liquid (e.g., a glass of water), except grapefruit juice. Brainal should be taken on an empty stomach (see section “Taking Brainal with food and drinks”).

Liver disease: You must not take this medicine if you have severe liver disease (see section “Do not take Brainal”). Inform your doctor if you have or have had any liver disease so that your doctor can adjust the dose appropriately.

Kidney disease: Inform your doctor if you have or have had any kidney disease, as a dose adjustment of nimodipine may be necessary.

Use in children and adolescents: The use of Brainal in children and adolescents is not recommended.

Your doctor will determine the duration of treatment with nimodipine. Do not stop the treatment prematurely or abruptly, as this could be harmful to the course of your illness.

If you take more Brainal than you should

If you have taken more Brainal than you should, consult your doctor or pharmacist immediately.

Symptoms you may experience include: marked decrease in blood pressure, increased or decreased heart rate, gastrointestinal disturbances (e.g., nausea), and effects on the central nervous system.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Brainal

Do not take a double dose to make up for missed doses.

If you forget a dose, take the tablet as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed tablet and to take the next one at the scheduled time.

If you stop taking Brainal

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects, more or less bothersome, may occur in some patients, especially at the beginning of treatment.

The following possible adverse effects have been reported:

Frequent (may affect up to 1 in 10 people)

• hypotension (low blood pressure), vasodilation (widening of blood vessels)
• indigestion, abdominal cramps
• dermatitis, rashes, acne
• muscle cramps

Uncommon (may affect up to 1 in 100 people)

• hot flushes
• changes in heart rate: bradycardia (decrease), tachycardia (increase), palpitations, heart failure
• anaemia, decreased platelet count in blood
• peripheral edema (swelling of legs or hands), fainting, bruising, vasoconstriction (narrowing of blood vessels) and increased blood pressure, thrombosis
• diarrhoea, constipation, vomiting, flatulence, gastrointestinal bleeding
• headache, dizziness, involuntary movements, tremor, depression, sweating
• difficulty breathing
• itching, urticaria, petechiae (small purplish spots)
• allergic reaction
• hepatitis, jaundice (yellowing of skin and mucous membranes)

Rare (may affect up to 1 in 1,000 people)

• decreased levels of sodium in blood
• ileus (intestinal obstruction)
• increased liver enzyme levels indicating liver function (includes increased alkaline phosphatase and lactate dehydrogenase)

Frequency not known (cannot be estimated from available data)

• nausea
• decreased blood pressure, especially when initial value is high, increased gamma-glutamyltransferase, elevated transaminases (a type of liver enzyme indicating liver function)
• low oxygen levels in body tissues

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 it directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Brainal

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Remove the tablet from the original packaging immediately before administration.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry 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 medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Brainal

• The active substance is nimodipine. Each film-coated tablet contains 30 mg of nimodipine.
• The other components are microcrystalline cellulose (E-460), pregelatinized corn starch, crospovidone, povidone (E-1201), magnesium stearate (E-572), hydroxypropylmethylcellulose, polyethylene glycol 400, titanium dioxide (E-171).

Appearance of the product and contents of the container

Brainal 30 mg film-coated tablets are available in packs of 30 or 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26. 28850-Torrejón de Ardoz (Madrid)

Manufacturer:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26 – 28850 Torrejón de Ardoz (Madrid)

Date of the most recent revision of this leaflet: August 2024

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