Nimotop 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nimodipine

Available from:

Dowelhurst Ltd

ATC code:

C08CA06

INN (International Name):

Nimodipine

Dosage:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200

Patient Information leaflet

PMR 85991779 (AB/01-C) Pantone: Black, 021
85991779
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
NIMOTOP
® 30 MG 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 only.
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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT NIMOTOP TABLETS ARE AND WHAT THEY ARE
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NIMOTOP TABLETS
3
HOW TO TAKE NIMOTOP TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE NIMOTOP TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT NIMOTOP TABLETS ARE AND
WHAT THEY ARE USED FOR
Nimotop tablets 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
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NIMOTOP TABLETS
DO NOT TAKE NIMOTOP TABLETS:
•
AT THE SAME TIME AS YOU ARE GETTING NIMOTOP
SOLUTION THROUGH A DRIP. The tablets have been
prescribed as a convenient way to continue your
treatment after the drip is stopped.
•
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 ALLERGIC TO NIMODIPINE or any of the
ingredients of this medicine (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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nimotop

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nimotop 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg nimodipine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round biconvex tablets with “SK” marked on one side and
the Bayer
cross marked on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Nimodipine 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 at 4-hourly intervals (total daily
dose 360 mg)
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 Nimotop
tablets should be
continued (dosage as above) to complete the 21 days treatment period.
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:
_Patients 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
adaption may be necessary (see section 4.5).
_Elderly _
There are no special dosage requirements for use in the elderly.
_Paediatric