Nimodipine EG

Patient Information Leaflet

NIMODIPINE EG 30 mg/0.75 ml oral drops, solution

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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NIMODIPINE EG is and what it is used for

NIMODIPINE EG contains the active substance nimodipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists) with a predominant effect of dilating blood vessels.
NIMODIPINE EG 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 NIMODIPINE EG

Do not take NIMODIPINE EG if

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

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

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

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

Other medicines and NIMODIPINE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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.

Taking these medicines together may significantly reduce the effectiveness of oral nimodipine (see section "Do not take NIMODIPINE EG").

Be especially careful 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).

If any of these medicines are taken together with nimodipine, frequent monitoring of blood pressure is required. Your doctor will assess whether a dose adjustment of NIMODIPINE EG or of the other medicine is necessary.

The following medicines do not interfere with nimodipine when taken concomitantly:

• 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).

NIMODIPINE EG with food and drink
Do not drink grapefruit juice or eat grapefruit during treatment with NIMODIPINE EG, 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 NIMODIPINE EG").

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 NIMODIPINE EG during pregnancy.
If your doctor considers it necessary to administer NIMODIPINE EG 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 NIMODIPINE EG").

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 individual cases of in vitro fertilization (an experimental test used to evaluate 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 NIMODIPINE EG may affect your ability to drive or operate machinery, as it may cause side effects such as dizziness. If this occurs, avoid driving or operating machinery.

NIMODIPINE EG contains ethanol (alcohol)
This medicine contains 721 mg of alcohol (ethanol) per dose (1.5 ml), equivalent to 48.06% w/v. The amount in 1.5 ml of this medicine is equivalent to 12 ml of beer or 5 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents. However, the alcohol in this medicine may alter the effects of other medicines. Speak with your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, or if you have alcohol dependence, speak with your doctor or pharmacist before taking this medicine.

NIMODIPINE EG contains macrogol glycerol hydroxystearate
This medicine contains macrogol glycerol hydroxystearate (a derivative of castor oil) which may cause gastrointestinal disturbances and diarrhoea.

3. How to take NIMODIPINE EG

Take this medicine exactly as instructed 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 continue your 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 your individual needs.
Take Nimodipine EG on an empty stomach, taking the drops diluted in a small amount of water.
Do not take it with grapefruit juice (see “Nimodipine EG with food and drink”).
Do not immerse the dropper in water and do not rinse it. After adding the drops to 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 more pronounced in these patients.
In such cases, your doctor will assess whether the dose should be reduced or, if necessary, treatment discontinued.
If you take more NIMODIPINE EG than you should
Overdose may cause: severe drop in blood pressure, accelerated or slowed heartbeat, stomach and intestinal disturbances, and nausea.
In case of accidental ingestion or overdose of Nimodipine EG, contact your doctor immediately or go to the nearest hospital.
If you forget to take NIMODIPINE EG
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

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,
• dizziness,
• feeling of vertigo,
• tremors,
• hyperkinesia (uncontrolled body movements),
• awareness of heartbeat (palpitations),
• fainting (syncope),
• swelling due to fluid accumulation in tissues (edema),
• fast heartbeat (tachycardia),
• low blood pressure (hypotension),
• dilation of blood vessels (vasodilation, including flushing, sweating, hot flushes),
• constipation,
• diarrhoea,
• flatulence,
• nausea.

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

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

Other adverse 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 NIMODIPINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nimodipine EG contains
The active substance is nimodipine. 0.75 ml of Nimodipine EG oral drops contains 30 mg of nimodipine.
The other components are: macrogol glycerol hydroxystearate, ethanol (96%).
Description of the appearance of Nimodipine EG and contents of the pack
1 bottle of 25 ml oral drops, with dropper.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6 - 20136 Milan
Manufacturer
Special Product's Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)