Nimotop 30 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
16-10-2023
Summary of Product characteristics
(SPC)
21-11-2022
Active ingredient:
Nimodipine
Available from:
Bayer Limited
ATC code:
C08CA; C08CA06
INN (International Name):
Nimodipine
Dosage:
30 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Dihydropyridine derivatives; nimodipine
Authorization status:
Marketed
Authorization date:
1994-02-15
Patient Information leaflet
BP22036_REC30610 Not for commercial use
1
RESTRICTED
PACKAGE LEAFLET – INFORMATION FOR
THE USER
NIMOTOP 30 MG FILM-COATED TABLETS
NIMODIPINE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to
read it again.
If you have more 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 symptoms are
the same as yours.
If any of the side effects gets serious,
or if you notice any side effect not
listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT NIMOTOP TABLETS ARE
2.
BEFORE YOU TAKE NIMOTOP
TABLETS
3.
HOW YOU TAKE NIMOTOP TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NIMOTOP TABLETS
6.
FURTHER INFORMATION
1. WHAT NIMOTOP TABLETS ARE
Nimotop contains nimodipine, which
belongs to a group of medicines called
_calcium antagonists_.
NIMOTOP TABLETS ARE USED TO PREVENT
CHANGES IN BRAIN FUNCTION after
bleeding around the brain
(_subarachnoid haemorrhage). _
2. BEFORE YOU TAKE NIMOTOP TABLETS
DO NOT TAKE NIMOTOP TABLETS:
•
AT THE SAME TIME AS YOU ARE
GETTING NIMOTOP STERILE
CONCENTRATE THROUGH A DRIP. The
tablets have been prescribed as a
convenient way to continue your
treatment after the drip is stopped.
•
IF YOU ARE ALLERGIC TO NIMODIPINE
or any of the ingredients in this
product. The ingredients are listed
in section 6.
•
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
NIMOTOP TABLETS if any of these apply to
you.
YOUR DOCTOR WILL TAKE SPECIAL CARE:
•
WHILE YOU ARE HAVING A HEART
ATTACK.
•
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 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.
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nimotop 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg nimodipine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Yellow, film-coated tablet, about 10 mm in diameter, marked with the
Bayer cross on one face and with ‘SK’ on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nimotop tablets are recommended for the prevention of ischaemic
neurological deficits following aneurysmal subarachnoid
haemorrhage.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ANEURYSMAL SUBARACHNOID HAEMORRHAGE
POSOLOGY:
Unless otherwise prescribed the following dosage is recommended:
The recommended procedure is administration of Nimotop solution for
infusion for 5 to 14 days followed by a total daily dose
of 360 mg by taking 2 Nimotop tablets at 4 hourly intervals, i.e. 6
times a day.
Alternatively, prophylactic therapy may be initiated using Nimotop
tablets. The recommended total daily dose is 360 mg by
taking 2 Nimotop tablets at 4 hourly intervals, i.e. 6 times a day.
In patients who develop adverse reactions the dose should be reduced
as necessary or the treatment discontinued.
Upon co-administration with cytochrome P450 3A4 inhibitors or
inducers, a dose adaption may be necessary (see sections 4.4
and 4.5).
METHOD OF ADMINISTRATION:
Administration of Nimotop tablets is recommended for about 7 days
following the end of the 5 to 14 days intravenous therapy
with Nimotop solution for infusion.
Alternatively, prophylactic therapy may be initiated using Nimotop
tablets.
In general, the tablets should be swallowed whole with a little
liquid, with or without meals. Grapefruit juice is to be avoided
(see section 4.5).
The interval between successive doses must not be less than 4 hours.
DURATION OF USE:
Prophylactic Use
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 2 o
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