Leaflet: information for the user

Brainal 30 mg film-coated tablets

Nimodipine

Read this 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 for you alone, and you must not give it to others, even if they have the same symptoms as you, 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 Brainal is and what it is used for.

2. What you need to know before you start taking Brainal.

3. How to take Brainal.

4. Possible side effects.

5. Storage of Brainal.

6. Contents of the pack and additional information.

Brainal is a medication that contains a substance called nimodipine and belongs to a group of medications called calcium antagonists. These substances are capable of dilating arteries and preventing them from constricting and the brain from lacking oxygen.

Brainal is used for the prevention of neurological injuries produced by a lack of blood flow, as a consequence of the constriction of cerebral arteries after a subarachnoid hemorrhage (a type of cerebral bleeding produced by the rupture of an aneurysm, which is an abnormal enlargement or bulging of a portion of an artery in which the wall is weakened).

Do not take Brainal

-If you are allergic (hypersensitive) to nimodipine or any of the other components of this medication listed in section 6.

-If you are taking any of the following medications to treat epilepsy: phenobarbital, phenytoin, or carbamazepine.

-If you are taking rifampicin (an antibiotic used in the treatment of tuberculosis).

-If you have any severe liver disease (e.g. cirrhosis).

• If you have generalized cerebral edema(an increase in the amount of fluid in thebrain).
• If you have severe intracranial hypertension(a significant increase in pressure within the head).

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 blood pressure.

-If you have any kidney or liver disease.

-If you have suffered a head injury that causes intracranial bleeding.

-If you have heart problems, for example arrhythmias and heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs), in these circumstances your doctor will perform regular checks.

-If you weigh less than 70 kg.

In all these situations, your doctor should perform a series of checks to adjust your Brainal dose appropriately.

If you are being treated with any of the medications listed in the section “Use of other medications”, your doctor will monitor your blood pressure and adjust your Brainal dose.

Brainal with other medications

Inform your doctor or pharmacist if you aretaking,have takenrecentlyor may need to takeany other medication.

Certain medications may interact with this medication; in these cases, your doctor should adjust the dose or discontinue treatment with one of the medications. This is especially important when taking:

-Rifampicin (medication for the treatment of tuberculosis) as it may reduce the effectiveness of nimodipine (see section “Do not take Brainal”).

-Medications for treating epilepsy such as phenytoin, phenobarbital, or carbamazepine with previous chronic administration before treatment with nimodipine (see section “Do not take Brainal”).

-Medications to lower blood pressure,as they may potentiate the hypotensive effect of nimodipine.

-Cimetidine (medication used in the management of stomach ulcers) or valproic acid (used in the treatment of epilepsy), as they may potentiate the hypotensive effect of nimodipine.

-Antibiotics (medications for treating infections) such as erythromycin, quinupristin, and dalfopristin.

-Antiretroviral medications (used in the treatment of HIV infection) such as ritonavir and zidovudine.

-Antifungal medications (used for the treatment of fungal infections) such as ketoconazole.

-Depression medications such as nefazodone, fluoxetine, and nortriptyline.

Brainal with food and drinks

It is not recommended to consume grapefruit juice with nimodipine, as it may result in a change in its effectiveness. Brainal should be taken outside of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before using this medication.

Brainal should not be used during pregnancy and breastfeeding, unless prescribed by a doctor. If it is necessary to use nimodipine, your doctor will assess the possibility of administering this medication.

Driving and operating machinery

If you feel dizzy after taking nimodipine, you should not drive vehicles or operate machinery, especially if you consume alcohol during treatment, so you should not consume alcohol during treatment.

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

The recommended doseto prevent neurological injuries due to lack of blood flow caused by contraction of cerebral arteries after a subarachnoid hemorrhage,should be (after a previous infusion of nimodipine 0.2 mg/ml solution for perfusion during5 to14 days) a daily dose of 2 tablets of Brainal 6 times a day (6 times x 60 mg of nimodipine daily), for a maximum total period of approximately three weeks. The interval between administrations should not be less than four hours.

In general, the tablet is ingested whole without chewing with the help of a little liquid (e.g.: a glass of water), except for orange juice. Brainal should be taken outside of meals (see section “Taking Brainal with food and drinks”)

Liver disease:Do not take this medication in case of severe liver disease (see section “Do not take Brainal”). Inform your doctor if you suffer or have suffered from any liver disease so that your doctor can adjust the dose accordingly.

Kidney disease:Inform your doctor if you suffer or have suffered from any kidney disease, it may be necessary to adjust the dose of nimodipine.

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

Your doctor will indicate the duration of treatment with nimodipine. Do not suspend the treatment before or abruptly, as it may be harmful to the evolution of your disease.

If you take more Brainal than you should

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

The symptoms you may experience are: marked decrease in blood pressure, increase or decrease in heart rate, gastrointestinal disturbances (e.g. nausea) and effects on the central nervous system.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Brainal

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

In case of forgetting a dose, you should ingest the tablet as soon as possible and continue treatment as prescribed. However, when it is close to the next dose, it is better not to take the missed tablet and take the next one at the scheduled time.

If you interrupt the treatment with Brainal

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects, more or less bothersome, appear in some patients, especially at the beginning of treatment.

The following possible side effects have been described:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• seizures
• changes in heart rate: bradycardia (decrease), tachycardia (increase),

palpitations, heart failure

• anemia, decrease in platelets in the blood
• peripheral edema (swelling of legs or hands), dizziness, hematomas (bruises), ,

vasoconstriction (narrowing of blood vessels) and increased blood pressure,

thrombosis

• diarrhea, constipation, vomiting, flatulence, gastrointestinal bleeding
• headache, dizziness, involuntary movements, tremors, depression, sweating
• difficulty breathing
• itching, urticaria, petechiae (small purple spots)
• allergic reaction
• hepatitis, jaundice (yellowing of skin and mucous membranes)

Rare(may affect up to 1 in 1000 people)

• decrease in sodium levels in the blood
• ileus (intestinal obstruction)
• increase in liver enzyme values, indicators of liver function, (including increased alkaline phosphatase and lactate dehydrogenase)

Unknown frequency(cannot be estimated from available data)

• nausea

• decreased blood pressure, especially when the initial value is high, gamma-glutamiltransferase increased, elevated transaminases (a type of liver enzyme indicator)

• low oxygen levels in body tissues

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 prospectus. You can also report it directly to the Spanish System for Pharmacovigilance of Medicines 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 in the original packaging.

Remove the tablet from the original packaging immediately before administration.

Do not use this medication after the expiration date that appears on the packaging after 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 medicines. By doing so, you will help protect the environment.

Composition ofBrainal

-The active ingredient is nimodipine. Each coated tablet contains 30 mg of nimodipine.

-The other components are microcrystalline cellulose (E-460), pregelatinized cornstarch, crospovidone, povidone (E-1201), magnesium stearate (E-572), hydroxypropylmethylcellulose, polyethylene glycol 400, titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Brainal 30 mg coated tabletsare presented in packs of 30 or 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

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

Responsible for manufacturing:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26 – 28850 Torrejón de Ardoz (Madrid)

Last review date of this leaflet:August 2024

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