NIMODIPINE DOC GENERICI

Package leaflet: Information for the patient

NIMODIPINE DOC Generics 30 mg/0.75 ml oral drops, solution

Generic Medicine
Please read this leaflet carefully before taking this medicine, as 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 may 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 NIMODIPINE DOC Generics is and what it is used for
2. What you need to know before taking NIMODIPINE DOC Generics
3. How to take NIMODIPINE DOC Generics
4. Possible side effects
5. How to store NIMODIPINE DOC Generics
6. Contents of the pack and other information

1. What NIMODIPINA DOC Generici is and what it is used for

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

2. What you need to know before taking NIMODIPINE DOC Generics

Do not take NIMODIPINE DOC Generics

• 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 DOC Generics).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIMODIPINE DOC Generics.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly and suffer from 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 very low blood pressure;
• if you have chest pain and a feeling of tightness in the chest at rest (unstable angina), or if you have had a heart attack less than 4 weeks ago.

For athletes: the use of medicines containing ethanol may result in positive anti-doping tests according to the alcohol concentration limits specified by certain sports federations (see NIMODIPINE DOC GENERICS contains ethanol (alcohol)).
Children and adolescents
The use of NIMODIPINE DOC Generics 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 DOC Generics
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, and with phenobarbital, phenytoin, and carbamazepine, medicines used for epilepsy (see section Do not take NIMODIPINE DOC Generics).
Concomitant use of these medicines may significantly reduce the oral efficacy of nimodipine (see section Do not take NIMODIPINE DOC Generics).
Be especially careful and inform your doctor if you are taking the following medicines:

• antibiotics belonging to the macrolide class, such as erythromycin;
• 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, β-blockers, A1 antagonists, other calcium antagonists, alpha-blockers, PDE5 inhibitors, alpha-methyldopa).

If these medicines are taken together with NIMODIPINE DOC Generics, blood pressure should be monitored and, if necessary, a dosage adjustment should be considered.
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 DOC Generics with food and drink
Grapefruit and grapefruit juice must not be consumed by individuals taking NIMODIPINE DOC Generics. This is because grapefruit and grapefruit juice can increase the concentration of nimodipine in the blood, potentially causing an unpredictable increase in the blood pressure-lowering effect of NIMODIPINE DOC Generics. This effect may last for at least 4 days after ingestion of grapefruit or grapefruit juice.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take NIMODIPINE DOC Generics during pregnancy. If your doctor considers it necessary to administer Nimotop during pregnancy, they must carefully weigh the expected benefits against the possible risks in relation to the severity of your condition (see section Do not take NIMODIPINE DOC Generics).
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 men experiencing infertility with in vitro fertilization (an assisted reproductive technique), and for whom no other causes can be identified, it is advisable to consider the possibility that calcium antagonist medicines such as nimodipine may be contributing to the problem.
Driving and using machines
The use of NIMODIPINE DOC Generics may affect your ability to drive or operate machinery, as it may cause side effects such as dizziness, partly due to its alcohol content. If this occurs, avoid driving or operating machinery.
NIMODIPINE DOC GENERICS contains ethanol (alcohol) and a castor oil derivative
This medicine contains 721 mg of alcohol (ethanol) per dose (60 mg - 1.5 ml), equivalent to 72.09% weight/volume. The amount of this medicine is equivalent to 18 ml of beer and 7.2 ml of wine per dose. It may be harmful for alcoholics. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains macrogol glycerol hydroxystearate (a castor oil derivative) which may cause gastrointestinal disturbances and diarrhoea.

3. How to take NIMODIPINE DOC Generici

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 continue nimodipine treatment orally for approximately 7 days (60 mg, equivalent to 1.5 ml of solution corresponding to 2 droppers filled up to the mark, 6 times daily every 4 hours).
Your doctor may decide to adjust the dose, duration of treatment, or discontinue treatment according to your individual needs.
Contact your doctor if you experience adverse reactions, as it may be necessary to discontinue treatment with this medicine or reduce the dose.

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 therefore be greater in these patients.
In such cases, your doctor will evaluate whether the dose should be reduced or whether treatment should be discontinued.

Use in children and adolescents
Safety and efficacy have not been established in patients under 18 years of age.

Method of administration
NIMODIPINE DOC Generici should be taken on an empty stomach. Dilute the drops in a small amount of water before taking. Do not take with grapefruit juice (see section NIMODIPINE DOC Generici with food and drink).
The interval between individual doses must not be less than 4 hours.
Do not immerse the dropper in water and do not rinse it. After dispensing the drops into water, return the dropper to the bottle.

If you take more NIMODIPINE DOC Generici than you should
If you (or someone else) have ingested an excessive amount of drops, or if you suspect that a child has swallowed any drops, contact a doctor immediately.
An overdose may cause: severe drop in blood pressure, changes in heart rhythm, gastrointestinal 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.

If you forget to take NIMODIPINE DOC Generici
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 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:
Common (may affect up to 1 in 10 people)

• lowering of blood pressure;
• dilation of blood vessels.

Uncommon (may affect up to 1 in 100 people)

• reduction in blood platelets (thrombocytopenia);
• allergic reactions (swelling of the face, lips, tongue or throat, difficulty breathing, skin rash, itching, nausea or vomiting);
• skin rash;
• headache;
• dizziness, tremors, dizziness;
• disorder characterized by excessive movements (hyperkinesia);
• increased heart rate, heightened awareness of heartbeat (tachycardia);
• temporary loss of consciousness due to low blood pressure (syncope);
• swelling caused by fluid accumulation (edema);
• nausea, constipation, excessive intestinal gas, diarrhea.

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

• slowing of heart rate (bradycardia);
• severe intestinal obstruction (ileus);
• transient increase in liver enzymes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The shelf life after first opening 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 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. Package contents and other information

What NIMODIPINE DOC Generici 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 NIMODIPINE DOC Generici and package contents
Pack containing one 25 ml bottle with dropper for oral drops, solution.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)