Leaflet: information for the user

Nimodipine Stadafarma 30 mg film-coated tablets

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 is Nimodipine Stadafarma and what is it used for.

2. What you need to know before starting to take Nimodipine Stadafarma.

3. How to take Nimodipine Stadafarma.

4. Possible side effects.

5. Storage of Nimodipine Stadafarma.

6. Contents of the pack and additional information.

Nimodipino Stadafarma is a medication that contains a substance called nimodipine and belongs to a group of medications called calcium antagonists. These substances are able to dilate arteries and prevent them from constricting and the brain from lacking oxygen.

Nimodipine is used for the prevention of neurological damage caused by a lack of blood flow, as a result of the constriction of cerebral arteries following a subarachnoid hemorrhage (a type of cerebral hemorrhage 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 Nimodipino Stadafarma

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

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

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

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

• If you have generalized cerebral edema (increase in the amount of fluid in the brain).(increase in the amount of fluid in the brain).
• If you have severe intracranial hypertension (increase in the pressure inside the head).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

-If you have blood pressure alterations 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 (disease in which the heart is unable to pump enough blood to meet the needs of the body), 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 nimodipino dose appropriately.

If you are taking any of the medications indicated in the section “Taking Nimodipino Stadafarma with other medications” your doctor will monitor your blood pressure and adjust your nimodipino dose.

Taking Nimodipino Stadafarma with other medications

Inform your doctor or pharmacist if you are taking,have takenrecentlyor could have to take any 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 nimodipino (see section “Do not take Nimodipino Stadafarma”).

-Medications to treat epilepsy such as phenytoin, phenobarbital or carbamazepine with previous chronic administration before treatment with nimodipino (see section “Do not take Nimodipino Stadafarma”).

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

-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 nimodipino.

-Antibiotics (medications to treat infections) such as erythromycin, quinupristin and dalfopristin.

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

-Antimycotic medications (used to treat fungal infections) such as ketoconazole.

-Depression medications such as nefazodone, fluoxetine and nortriptyline.

Taking Nimodipino Stadafarmawith food and drinks

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

If you feel dizzy after taking nimodipino, 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.indications for 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 the 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 this medication 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. Nimodipineshould be taken outside of meals (see section “Taking Nimodipine Stadafarma with food and drinks”).

Liver disease:Do not take this medication in case of severe liver disease (see section “Do not take Nimodipine Stadafarma”). 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 nimodipine in children and adolescents is not recommended.

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

If you take more Nimodipine Stadafarma than you should

If you have taken more nimodipine 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 Nimodipine Stadafarma

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 forgotten tablet and take the next one at the scheduled time.

If you interrupt treatment with Nimodipine Stadafarma

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

Like all medicines, this medicine can 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 possible side effects have been described:

Common(can 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(can 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
• edema periférico (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(can 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
• decrease in blood pressure, especially when the initial value is high, gamma-

glutamiltransferase increased, elevated transaminases (a type of liver enzyme indicator of liver function)

• 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 leaflet. You can also report it directly through the Spanish System of 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.

Remove the tablet from the original packaging immediately before administration.

Do not use this medicationafter 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. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofNimodipino Stadafarma

-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

The coated tablets are white or slightly yellowish, round, biconvex, scored on one face and with the letter B on the opposite face. Free of visible impurities.

Nimodipino Stadafarma 30 mg coated tabletsare presented in packs of 30 and 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

International Medicines Laboratories, S.A.

Solana, 26

28850 Torrejón de Ardoz (Madrid) Spain

Date of the last review of this leaflet:September 2024

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