Nimotop

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nimodipine 30mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Nimodipine 30 mg

Dosage:

30 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Nimodipine 30mg Excipient: Crospovidone Hypromellose Iron oxide yellow Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Titanium dioxide

Units in package:

Blister pack, PP/Al, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

After a preceding infusion of Nimotop concentrated intravenous infusion solution, for:- Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin. Patients should be in good neurological condition post-ictus.

Product summary:

Package - Contents - Shelf Life: Blister pack, PA/Al/PVC/Al - 100 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 100 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, PP/Al - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1991-09-30

Patient Information leaflet

NIMOTOP®
1
NIMOTOP
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NIMOTOP?
NIMOTOP contains the active ingredient nimodipine. NIMOTOP is used to
prevent or to treat a lack of blood supply in the
brain caused by narrowing of the blood vessels after a haemorrhage
(burst blood vessel in the brain).
For more information, see Section 1. Why am I using NIMOTOP? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NIMOTOP?
Do not use if you have ever had an allergic reaction to nimodipine or
any of the ingredients listed at the end of the CMI.
NIMOTOP infusion solution contains alcohol. Tell your doctor if you
suffer from alcoholism or impaired alcohol metabolism.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NIMOTOP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NIMOTOP and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NIMOTOP?
•
Your doctor will decide the appropriate dose for you. Follow all
instructions given to you by your doctor and pharmacist.
•
A doctor or nurse will prepare and administer the infusion.
More instructions can be found in Section 4. How do I use NIMOTOP? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NIMOTOP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NIMOTOP.
•
Keep all of your doctor’s appointments so that your progress can be
checked.
•
Tell your doctor straightaway if you become pregnant while taking this
medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING OR USING
MACHINES
•
NIMOTOP may cause diz

Summary of Product characteristics

NIMOTOP DS XV3.0; CCDS 5
1
DATA SHEET
1. NIMOTOP
®
Nimotop 10 mg/ 50 mL concentrated intravenous infusion solution
Nimotop 30 mg tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
Each bottle of 50 mL Nimotop concentrated intravenous infusion
solution contains 10mg
nimodipine in 50 mL alcoholic solvent.
NIMOTOP TABLETS
Each Nimotop tablet contains 30mg nimodipine.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
Clear intravenous solution for infusion.
NIMOTOP TABLETS
Round, convex, yellow film coated tablets marked with “SK” on top
and the Bayer cross
on the bottom.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
Prophylaxis and treatment of ischaemic neurological deficits caused by
cerebral
vasospasm following subarachnoid haemorrhage of aneurysmal origin.
Patients should
be in good neurological condition post-ictus.
NIMOTOP TABLETS
After a preceding infusion of Nimotop concentrated intravenous
infusion solution, for:-
Prophylaxis and treatment of ischaemic neurological deficits caused by
cerebral
vasospasm following subarachnoid haemorrhage of aneurysmal origin.
Patients should
be in good neurological condition post-ictus.
NIMOTOP DS XV3.0; CCDS 5
2
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
Unless otherwise prescribed, the following dose is recommended:
NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
_ _
_Intravenous infusion _
At the beginning of treatment 1mg/hr nimodipine (= 5 mL Nimotop
concentrated
intravenous infusion solution/h) for 2 hours (about 15µg/kg body
weight/h). If this is well
tolerated, and particularly if there is no marked reduction in blood
pressure, the dose is
increased after 2 hours to 2mg/hr nimodipine (= 10 mL Nimotop
concentrated
intravenous infusion solution/h) (about 30µg/kg body weight/h).
Patients whose body
weight is appreciably below 70kg or who have labile blood pressure
should be started
w