Nimobrain

Package leaflet: Information for the patient

NIMOBRAIN 30 mg/0.75 ml oral drops, solution

Nimodipine
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NIMOBRAIN is and what it is used for

2. What you need to know before taking NIMOBRAIN

3. How to take NIMOBRAIN

4. Possible side effects

5. How to store NIMOBRAIN

6. Contents of the pack and other information

7. What NIMOBRAIN is and what it is used for
   NIMOBRAIN contains the active substance nimodipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists) that mainly act by dilating blood vessels.

Nimobrain is used for the prevention and treatment of brain damage caused by reduced blood flow to the brain due to narrowing of blood vessels.

2. What you should know before taking NIMOBRAIN

Do not take NIMOBRAIN

• if you are allergic to nimodipine or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see "Pregnancy and breastfeeding");
• if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections (see "Other medicines and Nimobrain");
• if you are being treated with antiepileptic medicines such as phenobarbital, phenytoin, or carbamazepine (see "Other medicines and Nimobrain").

Warnings and precautions
Talk to your doctor or pharmacist before taking NIMOBRAIN.
Your doctor will carefully consider whether treatment with Nimobrain is necessary and will monitor you regularly:

• if you are elderly and have multiple medical conditions;
• if you have severe kidney problems;
• if you have severe liver problems such as hepatic cirrhosis;
• if you have severely impaired cardiovascular function;
• if you have increased intracranial pressure or accumulation of fluid in brain tissue;
• if you have low blood pressure;
• if you experience chest pain and tightness at rest (unstable angina) or have had a heart attack within the last 4 weeks.

Children and adolescents
The use of Nimobrain is not recommended in children and adolescents, as the safety and efficacy of this medicine in patients under 18 years of age has not been established.

Other medicines and NIMOBRAIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine in combination with:

• rifampicin, an antibiotic used to treat certain types of infections;
• certain antiepileptic medicines such as phenobarbital, phenytoin, and carbamazepine.

Concomitant use of these medicines may significantly reduce the oral efficacy of nimodipine (see section "Do not take NIMOBRAIN").

Use particular caution and inform your doctor if you are taking any of the following medicines:

• antibiotics belonging to the macrolide class, such as erythromycin;
• certain medicines used to treat AIDS, such as zidovudine (AZT) or antiretroviral medicines like indinavir, ritonavir, nelfinavir, or saquinavir;
• certain medicines used to treat fungal infections, such as ketoconazole;
• fluoxetine, nefazodone, and nortriptyline, used to treat depression;
• quinupristin and dalfopristin, used to treat infections;
• valproic acid, used to treat seizures;
• cimetidine, used for stomach disorders;
• medicines known as beta-blockers or other medicines used to treat high blood pressure (diuretics, β-blockers, ACE inhibitors, A1 antagonists, other calcium antagonists, alpha-blockers, PDE5 inhibitors, alpha-methyldopa).

Frequent monitoring of blood pressure is required when these medicines are taken concomitantly with nimodipine. Your doctor will evaluate whether a dosage adjustment of Nimobrain or the other medicine is needed.

The following medicines do not interfere with nimodipine when administered concurrently:

• haloperidol (a medicine with sedative action on the nervous system),
• diazepam (a medicine that reduces anxiety and promotes sleep),
• digoxin (a medicine for heart conditions),
• glibenclamide (a medicine used in the treatment of diabetes),
• indomethacin (a non-steroidal anti-inflammatory drug that reduces inflammation, pain, and fever),
• ranitidine (a medicine that reduces gastric acid secretion),
• warfarin (a medicine that thins the blood).

NIMOBRAIN with food and drinks
Do not drink grapefruit juice or eat grapefruit during treatment with Nimobrain, as it may increase the concentration of nimodipine in the blood and thereby enhance and prolong its blood pressure-lowering effect. This effect may last for at least 4 days after the last intake of grapefruit juice (see "How to take Nimobrain").

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take NIMOBRAIN during pregnancy.
If your doctor considers Nimobrain treatment necessary during pregnancy, they must carefully weigh the expected benefits against the possible risks in relation to the severity of your condition (see "Do not take NIMOBRAIN").

Breastfeeding
Do not take this medicine if you are breastfeeding, as nimodipine passes into breast milk.
Discontinue breastfeeding if you need to take this medicine.

Fertility
In isolated cases during in vitro fertilization (an experimental test evaluating the effects of certain substances on fertilization), calcium antagonists such as nimodipine may impair sperm function. The consequences of this effect are unknown with short-term treatment.

Driving and using machines
The use of NIMOBRAIN may affect your ability to drive or operate machinery, as it may cause adverse effects such as dizziness. If this occurs, avoid driving or using machinery.

NIMOBRAIN contains ethanol (alcohol)
This medicine contains 720.9 mg of alcohol (ethanol) per 60 mg dose, equivalent to 480.6 mg/ml (48.06% vol). The amount in each dose (1.5 ml) is equivalent to less than 10 ml of beer or 6 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

NIMOBRAIN contains macrogol glycerol hydroxystearate
This medicine contains macrogol glycerol hydroxystearate, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take NIMOBRAIN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
For the prevention and treatment of brain damage caused by reduced blood flow to the brain due to narrowing of blood vessels following subarachnoid haemorrhage (bleeding occurring between the two membranes surrounding the brain), after completion of parenteral therapy (by injection), your doctor will instruct you to continue nimodipine treatment orally for approximately 7 days (60 mg - 1.5 mL of solution corresponding to 2 droppers filled up to the mark - 6 times daily, at 4-hour intervals).
Your doctor may decide to adjust the dose and duration of treatment, or to discontinue treatment, according to individual needs.
Take Nimobrain away from meals, taking the drops diluted in a small amount of water.
Do not take with grapefruit juice (see "Nimobrain with food and drink").
Do not immerse the dropper in water and do not rinse it. After placing the drops in water, return the dropper to the bottle.
The interval between individual doses must not be less than 4 hours.

Use in patients with liver problems
If you have severe liver problems such as hepatic cirrhosis, the concentration of nimodipine in the blood may increase. The effects of the medicine and side effects, such as low blood pressure, may be greater in these patients.
In such cases, your doctor will evaluate whether the dose should be reduced or, if necessary, the treatment discontinued.

If you take more NIMOBRAIN than you should
Overdose may cause: severe drop in blood pressure, accelerated or slowed heartbeat, stomach and intestinal disturbances, and nausea.
In case of overdose, immediately stop administration of nimodipine.
In the event of accidental ingestion/overdose of Nimobrain, contact your doctor immediately or go to the nearest hospital.

If you forget to take Nimobrain
Do not take a double dose to make up for the missed dose.

If you stop taking Nimobrain
If you have any doubts about using this medicine, consult your doctor or pharmacist.

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Related to the prevention and treatment of brain damage caused by reduced blood flow to the brain associated with narrowing of blood vessels.
Uncommon (may affect up to 1 in 100 people)

• low platelet count in the blood (thrombocytopenia),
• allergic reaction (swelling of the face, lips, tongue or throat, difficulty breathing, skin rash, itching, nausea or vomiting),
• skin rash,
• headache,
• fast heartbeat (tachycardia),
• low blood pressure (hypotension),
• dilation of blood vessels (vasodilation, including flushing, sweating, hot flushes),
• nausea.

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

• slow heartbeat (bradycardia),
• intestinal blockage (ileus),
• transient increase in liver enzymes.

Not known (frequency cannot be estimated from the available data)

• low oxygen levels in body tissues

Other events reported with unknown frequency include dizziness.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIMOBRAIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
After 1 month from the first opening of the bottle, the medicine must be discarded, even if not completely used.
Store in the original packaging to protect the medicine from light. Do not store in the refrigerator.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NIMOBRAIN contains
The active substance is nimodipine. 20 drops of solution (corresponding to 0.75 ml) contain 30 mg of
nimodipine.
The other components are: macrogol glycerol hydroxystearate, ethanol (96%).

Description of the appearance of NIMOBRAIN and contents of the pack
Pack containing one 25 ml bottle with dropper for oral drops, solution.

MARKETING AUTHORISATION HOLDER
DYMALIFE PHARMACEUTICAL S.R.L.
VIA BAGNULO 95, 80063
PIANO DI SORRENTO
NAPOLI (NA)

MANUFACTURER
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (Frosinone)