Nemotan tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nimodipine

Available from:

Medochemie Ltd (Factory AZ)

ATC code:

C08CA06

INN (International Name):

nimodipine

Dosage:

30mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-08-09

Patient Information leaflet

PILnimotab5.0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
NEMOTAN 30 MG FILM COATED TABLETS
Nimodipine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor ar pharmacist. This
includes any possibleside effects not
listed in this leaflet. See section 4.
WHAT IS IN IN THIS LEAFLET:
1.
What Nemotan is and what it is used for
2.
What you need to know before you use Nemotan
3.
How to use Nemotan
4.
Possible side effects
5.
How to store Nemotan
6.
Contents of the pack and other information
1.
WHAT NEMOTAN IS AND WHAT IT IS USED FOR
Nemotan contains nimodipine, which belongs to a group of medicines
called calcium antagonists.
Nemotan tablets are used to prevent changes in brain function after
bleeding around the brain (subarachnoid
haemorrhage).
2.
WHAT YOU NEED TO KNOW BEFORE BEFORE YOU USE NEMOTAN
2
DO NOT USE NEMOTAN:

If you are allergic to nimodipine or any of the other ingredients in
this medicine (listed in section 6).

If you have had a heart attack within the last month.

If you suffer from angina and notice an increase in the frequency and
severity of attacks.

If you are taking rifampicin (an antibiotic), phenobarbital, phenytoin
or carbamazepine (three medicines
most commonly used to treat epilepsy).
Tell your doctor and do not take Nemotan tablets if any of these apply
to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Nemotan:

If you had a head injury, which caused bleeding around the brain
(traumatic subarachnoid haemorrhage).

If you have fluid in the brain or severely raised pressure in your
skull. Your doctor will be able to advise
you about this.

If you have low blood pressure.
�

Summary of Product characteristics

SPCNIMOTABS3.0-CY
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nemotan 30mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg of nimodipine
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, white, film coated tablets for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
“Nemotan” is indicated for the prevention of ischaemic
neurological deficits following
aneurysmal subarachnoid haemorrhage.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ANEURYSMAL SUBARACHNOID HAEMORRHAGE:_
PROPHYLACTIC ADMINISTRATION
ADULTS:
The recommended dose is two tablets (60mg) at 4-hourly intervals
(total daily dose 360mg)
to be taken with water. Prophylactic administration should commence
within four days of
onset of subarachnoid haemorrhage and should be continued for 21 days.
In the event of surgical intervention, administration of the Nemotan
tablets should be
continued (dosage as mentioned above) to complete the 21 days
treatment period.
SPCNIMOTABS3.0-CY
2
In patients who develop adverse reactions the dose should be reduced
as necessary or the
treatment discontinued.
_TRAUMATIC SUBARACHNOID HAEMORRHAGE:_
Not recommended as a positive benefit to risk ratio has not been
established (see Section
4.4).
SPECIAL POPULATIONS:
_Patient with hepatic impairment_
Severely disturbed liver function, particularly liver cirrhosis, may
result in an increased
bioavailability of nimodipine due to a decreased first-pass capacity
and a reduced metabolic
clearance. The effects and side-effects, e.g. reduction in blood
pressure, may be more
pronounced in these patients.
In such cases, the dose should be reduced (depending on the blood
pressure) or, if necessary,
discontinuation of the treatment should be considered..
Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a
dose adaptation
may be necessary (see Section 4.5).
_ _
_Elderly_
There are no special dosage requirements for use in the elderly.
_ _
_Pediatric population_
Safety and effica