NIMOBRAIN 30 mg /0.75 Ml Oral Drops, Solution

Зміст інструкції

1. NIMOBRAIN 30 mg/0.75 ml oral drops, solution
   1. What is NIMOBRAIN and what is it used for
   2. What you need to know before you take NIMOBRAIN
   3. How to take NIMOBRAIN
   4. Possible side effects
   5. How to store NIMOBRAIN
   6. Contents of the pack and other information

NIMOBRAIN 30 mg/0.75 ml oral drops, solution

Nimodipine
Equivalent Medicinal Product

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take NIMOBRAIN
• 3. How to take NIMOBRAIN
• 4. Possible side effects
• 5. How to store NIMOBRAIN
• 6. Contents of the pack and other information

1. What is NIMOBRAIN and what is it used for

NIMOBRAIN contains the active ingredient nimodipine which belongs to a group of
medicines called calcium channel blockers (calcium antagonists).
Nimobrain is used for the prevention and treatment of brain damage caused by a
reduced blood flow to the brain related to the narrowing of blood vessels.

2. What you need to know before you take 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, think you may be pregnant or if you are breastfeeding (see section Pregnancy, breastfeeding and fertility);
• if you are taking a medicine containing rifampicin, an antibiotic used to treat some types of infections (see “Other medicines and Nimobrain”);
• if you are taking medicines for epilepsy such as phenobarbital, phenytoin or carbamazepine (see “Other medicines and Nimobrain”).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIMOBRAIN
Take this medicine with caution and always under the control of your doctor in the following
cases:

• if you are elderly and suffer from multiple illnesses;
• if you have severe kidney problems;
• if you have severe liver problems, such as cirrhosis of the liver;
• if your heart function is severely reduced;
• if you have high pressure inside the skull or if you have an accumulation of fluid in the 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;
• if you are taking other medicines that can cause an increase in the levels of nimodipine in the blood. In this case, your doctor will need to carefully monitor your blood pressure and, if necessary, reduce the dose of the medicine (see section “Other medicines and NIMOBRAIN”).

Children and adolescents
This medicine should not be used in children under 18 years of age as there is no
data available on safety and efficacy in this age group.

Other medicines and NIMOBRAIN
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 some types of infections, and with medicines used for epilepsy such as phenobarbital, phenytoin
and carbamazepine.
Taking these medicines at the same time can significantly reduce the effectiveness
of nimodipine orally (see section “Do not take Nimobrain”).
Be particularly careful and tell your doctor if you are taking the following medicines:

• antibiotics belonging to the macrolide class, such as erythromycin;
• medicines used for the treatment of AIDS, such as ritonavir and zidovudine;
• medicines used for the treatment of fungal infections, such as ketoconazole;
• medicines used for the treatment of depression such as fluoxetine, nefazodone and nortriptyline;
• medicines used for the treatment of infections such as quinupristin and dalfopristin;
• valproic acid, used for the treatment of epilepsy;
• cimetidine, used for stomach disorders;
• medicines called beta-blockers or other medicines used for the treatment of high blood pressure (diuretics, β-blockers, ACE-inhibitors, A1 antagonists, other calcium antagonists, alpha-blockers, PDE5 inhibitors, alpha-methyldopa).

In case of concomitant administration of these drugs with nimodipine, frequent
monitoring of blood pressure is necessary. The doctor will evaluate an adjustment of
the dosage of Nimobrain or the other medicine.
The simultaneous administration of the following drugs does not interfere with nimodipine

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

NIMOBRAIN with food and drink
Grapefruit juice and grapefruit should not be consumed by those taking
NIMOBRAIN. This is because grapefruit and grapefruit juice can lead to an
increase in the concentrations of nimodipine in the blood, which can cause an
unpredictable increase in the blood pressure lowering effect of NIMOBRAIN.
This effect can last for at least 4 days after the last ingestion of grapefruit juice (see “How to take Nimobrain”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine

Pregnancy
Do not take NIMOBRAIN during pregnancy.
If your doctor considers it necessary to administer Nimobrain during pregnancy, they must
carefully consider the expected benefits and 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.
Stop breastfeeding if you need to take this medicine and consult your doctor.

Fertility
In single cases of in vitro fertilization (experimental procedure to assess the effects of certain
substances on fertilization), calcium antagonists, such as nimodipine,
may impair sperm function. The consequences of this effect are not known in short-term treatment.

Driving and using machines
The use of NIMOBRAIN may affect your ability to drive vehicles and operate machinery
because it can cause side effects such as dizziness. If this happens to you, avoid
driving vehicles or using machinery.

NIMOBRAIN contains ethanol (alcohol)
This medicine contains 48.06 vol % ethanol (alcohol) e.g. up to 721 mg per dose (1.5
ml) equivalent to 15 ml of beer, 6 ml of wine per dose. This may be harmful to
alcoholics. To be taken into consideration in pregnant or breastfeeding women, in
children and in high-risk groups such as people suffering from liver or
epilepsy diseases.

NIMOBRAIN contains macrogolglycerol hydroxystearate
This medicine contains macrogolglycerol hydroxystearate (a derivative of castor oil)
which can cause stomach upset and diarrhea.

3. How to take NIMOBRAIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist
In the prevention and treatment of brain damage caused by reduced blood flow to the brain due to narrowing of the blood vessels induced by subarachnoid hemorrhage (bleeding that occurs between the 2 membranes surrounding the
brain), after completing parenteral therapy (with injections), your doctor will continue the
administration of nimodipine orally for about 7 days (60 mg - 1.5 mL of solution
corresponding to 2 droppers filled to the mark - 6 times a day, at intervals of 4
hours). The doctor may decide to modify the dose and duration of treatment, or to
suspend treatment, as needed.
Take Nimobrain away from meals, taking the drops diluted in a little water.
Do not take with grapefruit juice (see “Nimobrain with food and beverages”).
Do not immerse the dropper in water and do not rinse it. After putting the drops
in the water, replace the dropper in the bottle.
The interval between single administrations must not be less than 4 hours.

Use in patients with liver problems
If you have severe liver problems, such as cirrhosis, the concentration of nimodipine in
the blood may increase. The effects of the medicine and the side effects, such as
lowering of blood pressure, may be greater in these patients. In
these cases, the doctor may decide to reduce the dose or, if necessary, suspend the
treatment.

If you take more NIMOBRAIN than you should
If you (or someone else) have ingested an excessive amount of drops, or if you think a
child has ingested some drops, consult a doctor immediately or go to the
Emergency Room of the nearest hospital.
An overdose may cause: flushing of the face, headache, severe reduction of
blood pressure, altered heart rhythm, stomach and intestinal disorders and
nausea.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take NIMOBRAIN
If you forget to take a dose of the medicine, take it as soon as you remember, unless
it is almost time to take the next dose. Do not take a double dose to
compensate for the missed dose.

4. Possible side effects

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

• reduction of platelets in the blood (thrombocytopenia);
• allergic reactions (swelling of the face, lips, tongue or throat, difficulty breathing, skin rashes, itching, nausea or vomiting);
• skin rash;
• headache;
• fast heartbeat (tachycardia);
• low blood pressure (hypotension);
• dilation of blood vessels (vasodilation, including hot flashes and sweating);
• nausea.

Rare(may affect up to 1 in 1000 people)

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

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,
please inform your doctor or pharmacist. You can also report side effects
directly through 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 which is 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 a refrigerator.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of NIMOBRAIN and contents of the pack
Pack containing a 25 ml bottle with dropper of 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)