NIMOTOP nimodipine 30 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nimodipine, Quantity: 30 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; povidone; maize starch; crospovidone; magnesium stearate; hypromellose; macrogol 4000; iron oxide yellow; titanium dioxide

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus (eg Hunt and Hess Grades I-III).

Product summary:

Visual Identification: Round, convex, yellow film-coated tablets embossed "SK" on top and the Bayer Cross on the bottom.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1993-06-09

Patient Information leaflet

NIMOTOP
®
CMI
1
NIMOTOP
®
(NEE·MOE·TOP)
_nimodipine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Nimotop. This
leaflet does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Nimotop
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again
WHAT NIMOTOP IS
USED FOR
Nimotop tablets and infusion
solution are 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).
This medicine belongs to a group of
drugs called calcium channel
blockers. Nimotop works by
relaxing the smooth muscle of the
small blood vessels in the brain.
This allows narrowed vessels to
open up, thereby increasing blood
flow, reducing blood pressure, and
improving circulation.
YOUR DOCTOR MAY PRESCRIBE THIS
MEDICINE FOR ANOTHER USE. IF YOU
WANT MORE INFORMATION, ASK YOUR
DOCTOR.
If you have any further questions on
your Nimotop treatment, or are
unsure of the information, please
see your doctor, nurse or dispensing
pharmacist, who will be able to
assist you.
BEFORE YOU TAKE
NIMOTOP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NIMOTOP TABLETS OR
INFUSION SOLUTION IF YOU HAVE AN
ALLERGY TO:
•
nimodipine, the active
ingredient in Nimotop
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
DO NOT TAKE BROKEN OR DISCOLOURED
TABLETS, OR CLOUDY OR DISCOLOURED
INFUSION SOLUTIONS.
DO NOT TAKE NIMOTOP TABLETS IF
YOU ARE TAKING ANOTHER MEDICINE
CONTAINING:
•
phenobarbito

Summary of Product characteristics

Nimotop PI VX3.0; CCDS 5
1
AUSTRALIAN PRODUCT INFORMATION – NIMOTOP® (NIMODIPINE)
1
NAME OF THE MEDICINE
Nimodipine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimodipine is a yellow crystalline substance, practically insoluble in
water.
Nimodipine is light sensitive but to a much lesser degree than
nifedipine.
Nimotop is available as tablets containing 30 mg nimodipine or a 0.2
mg/mL concentrated
intravenous infusion solution.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
Clear slightly yellowish solution containing 10 mg nimodipine/50 mL
and 10 g alcohol/ 50 mL.
NIMOTOP TABLETS
Round convex, yellow film-coated tablets containing 30 mg nimodipine
marked "SK" on top and the
Bayer cross on the bottom.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prophylaxis and treatment of ischaemic neurological deficits caused by
cerebral vasospasm after
subarachnoid haemorrhage following ruptured intracranial aneurysm, in
patients who are in good
neurological condition post-ictus, e.g., Hunt and Hess Grades I-III
(see Section 5 Pharmacological
properties).
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE: NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION
For single use in one patient only. Discard any residue.
_Continuous intravenous infusion: _
Nimotop concentrated intravenous infusion solution must be
administered by co-infusion via a three-
way stopcock to the central catheter. The initial dosage is 5 mL
Nimotop concentrated intravenous
solution (= 1 mg nimodipine) per hour infused continuously for the
first 2 hours (approximately
15 µg/kg body weight/hr). Co-infusion solution must be administered
at a rate of 20 mL per hour with
this initial dosage. If this dosage is tolerated, particularly if
there is no severe reduction in blood
pressure, the dosage should then be increased to 10 mL Nimotop
concentrated intravenous infusion
Nimotop PI VX3.0; CCDS 5
2
solution
per
hour
(= 2
mg
nimodipine/h)
(approximately
30
µg/kg
body