Nimotop 0.02% w/v Concentrate for Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-11-2022
Summary of Product characteristics
(SPC)
21-11-2022
Active ingredient:
Nimodipine
Available from:
Bayer Limited
ATC code:
C08CA; C08CA06
INN (International Name):
Nimodipine
Dosage:
0.02 percent weight/volume
Pharmaceutical form:
Concentrate for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Dihydropyridine derivatives; nimodipine
Authorization status:
Marketed
Authorization date:
1994-02-15
Patient Information leaflet
BP22036_REC30610
1
PACKAGE LEAFLET: INFORMATION FOR
THE USER
NIMOTOP 0.02% W/V CONCENTRATE FOR
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, pharmacist or nurse.
-If you get any side effects, talk to your
doctor, pharmacist or nurse.
This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nimotop is and what it is
used for
2.
What you need to know before
you are given Nimotop
3.
How you are given Nimotop
4.
Possible side effects
5.
How to store Nimotop
6.
Contents of the pack and other
information
1._ _WHAT NIMOTOP IS_ _AND WHAT IT IS
USED FOR_ _
Nimotop contains nimodipine, which
belongs to a group of medicines called
_calcium antagonists_.
NIMOTOP 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
DO NOT TAKE NIMOTOP
YOU WILL NOT BE GIVEN NIMOTOP:
•
IF YOU ARE ALLERGIC TO nimodipine or
any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse
before taking Nimotop
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.
•
IF YOU HAVE LIVER DISEASE. You will
probably need to have your blood
pressure measured regularly.
•
IF YOU HAVE KIDNEY PROBLEMS
and/or you have been given drugs
which may alter kidney function (e.g.
aminoglycosides, cephalosporins,
furosemide). Your doctor may need
to monitor your kidney functi
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nimotop 0.02% w/v Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 ml vial contains 10 mg of nimodipine (0.2 mg/ml).
Excipients with known effect:
Each 50 ml vial also contains 10 g of ethanol (0.2 g/ml) and 23 mg of
sodium (as sodium citrate dihydrate). Please see section
4.4 for further information.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
A clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nimotop solution 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 micrograms/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 micrograms/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).
_Aneurysmal subarachnoid haemorrhage_
_ _
PROPHYLACTIC USE
Intravenous therapy should be started no later than 4 days after the
haemorrhage, and be continued during the period of
maximum risk of vasospasm, i.e. up to 10‑14 days after the
haemorrhage. This should continue for at least five days up to a
maximum of 10‑14 days.
If during prophylactic administration of Nimotop, the source of the
haemorrhage is treated surgically, intravenous treatment
with Nimotop should be continued post-operatively for at least 5 days.
After the end of the
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