Nimotop 0.02% Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NIMODIPINE

Available from:

Bayer PLC

ATC code:

C08CA06

INN (International Name):

NIMODIPINE

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

NIMODIPINE 0.02 % (W/V)

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Authorised

Authorization date:

2006-12-21

Patient Information leaflet

PMR 85991671 (AB/01-C/MU-201710621) Pantone: Black, 021
85991671
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
NIMOTOP
®
0.02% SOLUTION
FOR INFUSION
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.
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 SOLUTION IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIMOTOP SOLUTION
3
HOW YOU ARE GIVEN NIMOTOP SOLUTION
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE NIMOTOP SOLUTION
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT NIMOTOP SOLUTION IS AND WHAT
IT IS USED FOR
Nimotop solution contains nimodipine, which belongs to a group of
medicines called_ calcium antagonists_.
NIMOTOP SOLUTION IS USED TO PREVENT CHANGES IN BRAIN FUNCTION
AFTER BLEEDING AROUND THE BRAIN (_SUBARACHNOID HAEMORRHAGE)._
2
WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN NIMOTOP SOLUTION
DO NOT TAKE NIMOTOP SOLUTION
YOU SHOULD NOT BE GIVEN NIMOTOP SOLUTION:
•
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).
TELL YOUR DOCTOR AND DO NOT TAKE NIMOTOP SOLUTION if any of these
apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before receiving Nimotop solution
•
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.
•
IF YOU HAVE LIVER DISEASE. You will probably need to have

Summary of Product characteristics

1.3.1
1
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Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nimotop 0.02% Solution for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A sterile solution containing 10 mg nimodipine in 50 ml vials of
aqueous alcoholic solvent (0.02%).
Excipients with known effect
Ethanol and sodium citrate
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Clear yellow sterile solution for intravenous use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nimodipine is indicated for the treatment of ischaemic neurological
deficits following aneurysmal
subarachnoid haemorrhage.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose - Aneurysmal Subarachnoid Haemorrhage
For the first two hours of treatment 1 mg of nimodipine, i.e. 5 ml
Nimotop solution, (about 15

g/kg
bw/h), should be infused each hour via a central catheter. If it is
well tolerated, the dose should be
increased after two hours to 2 mg nimodipine, i.e. 10 ml Nimotop
solution per hour (about 30

g/kg
bw/h), providing no severe decrease in blood pressure is observed.
Patients of body weight less than 70 kg or with unstable blood
pressure should be started on a
dose of 0.5 mg nimodipine per hour (2.5 ml of Nimotop solution), or
less if necessary.
Duration of treatment
_Aneurysmal subarachnoid haemorrhage_
_ _
Intravenous treatment should begin as early as possible after
neurological deficit occurs due to
arterial spasm, post subarachnoid haemorrhage. This should continue
for at least five days up to
a maximum of 14 days.
In the event of surgical intervention during treatment, administration
of nimodipine should be
continued (dose as above) for at least five days.
Nimotop solution may be used with or without pre-treatment with
Nimotop tablets. In the event of
Nimotop tablets and Nimotop solution being administered sequentially
the total duration of
treatment should not exceed 21 days. Nimotop solution should not be
administered for longer
than 14 days. Nimotop solution and tablets should