Package leaflet: Information for the patient

NIMODIPINE PENSA 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 other people, even if their symptoms are the same 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:

What NIMODIPINE PENSA is and what it is used for
What you need to know before taking NIMODIPINE PENSA
How to take NIMODIPINE PENSA
Possible side effects
How to store NIMODIPINE PENSA
Contents of the pack and other information

1. What NIMODIPINA PENSA is and what it is used for

NIMODIPINA PENSA 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.
NIMODIPINA PENSA is used for the prevention and treatment of brain damage caused by insufficient blood flow to the brain due to narrowing of blood vessels.

2. What you should know before taking NIMODIPINE PENSA

Do not take NIMODIPINE PENSA

if you are allergic to nimodipine or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant, think you might be pregnant, or are breastfeeding (see section Pregnancy, breastfeeding and fertility);
if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections;
if you are taking antiepileptic medicines such as phenobarbital, phenytoin, or carbamazepine (see section “Other medicines and NIMODIPINE PENSA”);

Warnings and precautions
Talk to your doctor or pharmacist before taking NIMODIPINE PENSA.
Your doctor will carefully consider whether treatment with NIMODIPINE PENSA 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 liver cirrhosis;
if you suffer from 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 have chest pain and tightness at rest (unstable angina) or have had a heart attack less than 4 weeks ago;
if you are taking other medicines that may increase nimodipine levels in the blood. In this case, your doctor must closely monitor your blood pressure and, if necessary, reduce the dose of the medicine (see section “Other medicines and NIMODIPINE PENSA”).

Children and adolescents
The use of NIMODIPINE PENSA 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 NIMODIPINE PENSA
Tell 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;
phenobarbital, phenytoin, and carbamazepine, medicines used for epilepsy (see section “Do not take NIMODIPINE PENSA”).

Concomitant use of these medicines may significantly reduce the oral efficacy of nimodipine (see section “Do not take NIMODIPINE PENSA”).
Be especially careful and inform your doctor if you are taking 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;
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 epilepsy;
cimetidine, used for stomach disorders;
medicines known as beta-blockers or other medicines used to treat high blood pressure (diuretics, ACE inhibitors, A1 antagonists, other calcium antagonists, alpha-blockers, PDE5 inhibitors, alpha-methyldopa).

If these medicines are taken together with nimodipine, frequent monitoring of blood pressure is required. Your doctor will consider adjusting the dosage of NIMODIPINE PENSA or of the other medicine.
The concomitant administration of the following medicines does not interfere with nimodipine:

haloperidol (a medicine with sedative action on the nervous system),
diazepam (a medicine that reduces anxiety and promotes sleep),
digoxin (a medicine for the heart),
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 PENSA with food and drinks
Grapefruit and grapefruit juice must not be consumed by anyone taking NIMODIPINE PENSA. This is because grapefruit and grapefruit juice may increase nimodipine concentrations in the blood, which could lead to an unpredictable increase in the blood pressure-lowering effect of NIMODIPINE PENSA. This effect may last for at least 4 days after the last intake of grapefruit juice (see “How to take NIMODIPINE PENSA”).

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 PENSA during pregnancy. Consult your doctor if you are pregnant or wish to plan a pregnancy.
If your doctor considers treatment with NIMODIPINE PENSA 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 NIMODIPINE PENSA”).

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 and consult your doctor.

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

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

NIMODIPINE PENSA contains ethanol (alcohol)
This medicine contains 48.06% vol ethanol (alcohol), i.e. 721 mg per maximum single dose (60 mg – 1.5 ml), equivalent to 18 ml of beer and 7.2 ml of wine, and up to 4.3 g of ethanol per daily dose (9 ml). The amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.

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

3. How to take NIMODIPINE PENSA

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).
Method of administration
NIMODIPINE PENSA must be taken on an empty stomach. Dilute the drops in a small amount of water before
taking. Do not take it with grapefruit juice (see section “NIMODIPINE PENSA with food,
drinks and alcohol”).
Do not immerse the dropper in water and do not rinse it. After placing the drops into 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 adverse reactions, such as low blood pressure,
may be greater in these patients. In such cases, your doctor will evaluate whether to reduce the dose or discontinue treatment.
If you take more NIMODIPINE PENSA than you should
If you (or someone else) have swallowed an excessive amount of drops, or if you think a child has ingested
any drops, consult a doctor immediately. An overdose may cause: facial flushing,
headache, severe drop in blood pressure, changes in heart rhythm, stomach and intestinal disturbances, and nausea.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Take this leaflet, the bottle and its packaging with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take NIMODIPINE PENSA
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 the missed 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:
Regarding the prevention and treatment of brain damage caused by reduced blood flow to the brain related to narrowing of blood vessels

Uncommon (may affect up to 1 in 100 people)

reduction in blood platelets (thrombocytopenia);
allergic reactions;
skin rash;
headache;
fast heartbeat (tachycardia);
low blood pressure (hypotension);
widening of blood vessels (vasodilation);
nausea.

Rare (may affect up to 1 in 1000 people)

slow heartbeat (bradycardia);
intestinal blockage (ileus);
temporary increase in liver enzymes.

Reporting of side effects
If you experience any side effects, 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 PENSA

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 and to the product stored correctly in its original packaging.
The shelf life after first opening of the bottle is 1 month. Remember to record the date of first opening in the designated space on the carton.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What NIMODIPINA PENSA 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 NIMODIPINA PENSA and package contents
Pack containing one 25 ml bottle with dropper for oral drops, solution.
Marketing Authorization Holder
Pensa Pharma S.p.A., Via Ippolito Rosellini 12, 20124 Milano
Responsible manufacturer for batch release
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012, Anagni (FR)