Patient Information Leaflet

ISKIDROP 30 mg/0.75 ml oral drops, solution

Nimodipine
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ISKIDROP is and what it is used for

ISKIDROP 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.
ISKIDROP 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 need to know before taking ISKIDROP

Do not take ISKIDROP

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 ISKIDROP");
if you are being treated with antiepileptic medicines such as phenobarbital, phenytoin or carbamazepine (see "Other medicines and ISKIDROP").

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

if you have generalized cerebral edema (rapid swelling of brain tissue) or a marked increase in pressure inside the skull (intracranial pressure);
if you have low blood pressure;
if you are very elderly and suffer from multiple conditions;
if you have severe heart problems or circulatory disorders;
if you experience chest pain and tightness at rest (unstable angina) or have had a heart attack less than 4 weeks ago;
if you have severe kidney problems;
if you have severe liver problems such as liver cirrhosis;
if you are taking other medicines that affect the enzyme system involved in the metabolism of nimodipine (see section "Other medicines and ISKIDROP"). Your doctor will assess whether your blood pressure needs to be monitored and, if necessary, may reduce your dose of nimodipine.

For athletes
ISKIDROP contains ethanol which may lead to a positive result in anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
Do not administer this medicine to children and adolescents aged 0 to 18 years, as the safety and efficacy of this medicine have not yet been established.
Other medicines and ISKIDROP
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,
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 ISKIDROP").
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;
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, beta-blockers, ACE inhibitors, A1 antagonists, other calcium antagonists, alpha-blockers, PDE5 inhibitors, alpha-methyldopa).

If you take any of these medicines together with nimodipine, frequent monitoring of your blood pressure is required. Your doctor will consider adjusting the dose of ISKIDROP or the other medicine.
The following medicines do not interfere with nimodipine when taken at the same time:

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 stomach acid secretion),
warfarin (a medicine that thins the blood).

ISKIDROP with food and drink
Do not drink grapefruit juice or eat grapefruit during treatment with ISKIDROP,
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 ISKIDROP").
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ISKIDROP during pregnancy.
If your doctor considers it necessary to prescribe ISKIDROP during pregnancy, they will carefully weigh the expected benefits against the possible risks in relation to the severity of your condition (see "Do not take ISKIDROP").
Breastfeeding
Do not take this medicine if you are breastfeeding, as nimodipine passes into breast milk.
You must stop breastfeeding if you need to take this medicine.
Fertility
In isolated 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
ISKIDROP may affect your ability to drive or operate machinery because it may cause side effects such as dizziness. If this occurs, avoid driving or using machinery.
ISKIDROP contains ethanol (alcohol)
This medicine contains 1.152 g of alcohol (ethanol) in each 1.5 ml (60 drops). The amount in 60 drops of this medicine is equivalent to less than 28.8 ml of beer or 11.52 ml of wine per dose. The amount of alcohol in this medicine is unlikely to have an effect in adults.
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.
ISKIDROP contains macrogolglycerol hydroxystearate (a derivative of castor oil)
It may cause gastrointestinal disturbances and diarrhoea.

3. How to take ISKIDROP

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 intravenous administration, your doctor will continue nimodipine treatment orally for approximately 7 days (60 mg, corresponding to 60 drops of solution, six 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 ISKIDROP away from meals, by diluting the drops in a small amount of water.
Do not take ISKIDROP with grapefruit juice (see “ISKIDROP with food and drink”).
Do not immerse the dropper in water and do not rinse it. After dispensing 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 more pronounced in these patients.
In such cases, your doctor may decide to reduce the dose of ISKIDROP or discontinue treatment.

If you take more ISKIDROP than you should
If you accidentally ingest/overdose on ISKIDROP, inform your doctor immediately or go to the nearest hospital, where appropriate treatment will be provided.
Symptoms of overdose caused by excessive intake of ISKIDROP include:

marked decrease in blood pressure (hypotension)
increased heart rate (tachycardia)
slowed heart rate (bradycardia)
gastrointestinal disturbances
nausea. In these cases, stop taking the medicine immediately.

If you forget to take ISKIDROP
Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience one or more of the following side effects, contact your doctor, who will assess whether a dose reduction or discontinuation of treatment is necessary.

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):

decrease in the number of platelets in the blood (thrombocytopenia)
allergic reaction (swelling of the face, lips, tongue or throat, breathing difficulties, skin rash, itching, nausea or vomiting)
skin rash
headache
fast heartbeat (tachycardia)
nausea
dizziness
sensation of vertigo
hyperkinesia (nervous system disorder characterized by involuntary and uncoordinated movements)
tremors
palpitations (intense perception of heartbeat)
syncope (transient, sudden loss of consciousness)
edema (fluid accumulation in the spaces surrounding organs and tissues)
constipation (difficulty with bowel movements)
diarrhea
flatulence (excessive gas formation in the stomach or intestine)

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

bradycardia (slowing of the heartbeat)
ileus (intestinal obstruction)
transient increase in liver enzymes

Other events reported with unknown frequency include vertigo.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 ISKIDROP

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect the medicine from light. Do not store in the refrigerator.
Do not use this medicine after the expiry date stated on the bottle after EXP.
The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 1 month (record the date of first opening in the designated space on the carton).
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 ISKIDROP contains

the active substance is nimodipine; 30 drops of solution (corresponding to 0.75 ml) contain 30 mg of nimodipine
the other components are: macrogol glycerol hydroxystearate and ethyl alcohol 96%

Description of the appearance of ISKIDROP and contents of the pack
ISKIDROP is a clear, slightly yellow solution supplied as oral drops. The solution is contained in a 25 ml bottle equipped with a dropper.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan
Italy

Manufacturer
Lisapharma S.p.A.
Via Licinio, 11
22036 Erba (CO) - Italy
Or
Francia Farmaceutici Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milan (MI) - Italy