Neo-Mercazole

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Osta kohe

Laadi alla Infovoldik (PIL)
18-01-2021
Laadi alla Toote omadused (SPC)
31-01-2021

Toimeaine:

Carbimazole 5mg;  ; Carbimazole 5mg

Saadav alates:

AFT Pharmaceuticals Ltd

INN (Rahvusvaheline Nimetus):

Carbimazole 5 mg

Annus:

5 mg

Ravimvorm:

Tablet

Koostis:

Active: Carbimazole 5mg   Excipient: Acacia Gelatin Iron oxide red Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Propyl hydroxybenzoate Purified talc Sucrose Active: Carbimazole 5mg Excipient: Acacia Gelatin Iron oxide red Lactose monohydrate Magnesium stearate Maize starch Purified talc Sucrose

Ühikuid pakis:

Bottle, plastic, HDPE with LDPE cap, 100 tablets

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Euticals SAS

Näidustused:

Primary thyrotoxicosis, even in pregnancy. Secondary thyrotoxicosis - toxic nodular goitre. However, Neo-Mercazole really has three principal applications in the therapy of hyperthyroidism: 1. Definitive therapy - induction of a permanent remission. 2. Preparation for thyroidectomy. 3. Before and after radio-active iodine treatment.

Toote kokkuvõte:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap with integrated silica gel desiccant - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with LDPE cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with LDPE cap - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

1969-12-31

Infovoldik

                                NEO-MERCAZOLE
®
CARBIMAZOLE 5 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about NEO-MERCAZOLE
®
tablets.
It 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
NEO-MERCAZOLE
®
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT NEO-MERCAZOLE
® IS USED FOR
NEO-MERCAZOLE
®
contains the active ingredient carbimazole.
NEO-MERCAZOLE
®
is used to reduce the formation of thyroid hormones in people
with an over- active thyroid gland. The condition is called
hyperthyroidism. NEO-
MERCAZOLE
®
may
be
used
alone
or
together
with
other
treatments
for
hyperthyroidism.
NEO-MERCAZOLE
®
may also be used to restore the normal function of the thyroid
before its partial removal by surgery, and before and after
radio-active iodine
treatment.
Your doctor, however, may have prescribed NEO-MERCAZOLE
®
for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY NEO-MERCAZOLE
® HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor's prescription.
BEFORE YOU TAKE NEO-MERCAZOLE
®
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NEO-MERCAZOLE
® IF:
1.
you have had an allergic reaction to NEO-MERCAZOLE
®
or any ingredients
listed at the end of this leaflet
2.
you have a serious blood condition
3.
you have a severe liver condition
4.
you have swelling on the neck caused by enlargement of the thyroid
gland
5.
you had inflammation of the pancreas (acute pancreatitis) after
administration
of carbimazole or thiamazole in the past.
6.
the package is torn or shows signs of tampering
7.
the expiry date printed on the pack has passed. If you take this
medicine after
the expiry date has passed, it may not work as well
8.
you are not sure if you should be taking NEO-MERCAZOLE
®
, talk to your docto
                                
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Toote omadused

                                NEW ZEALAND DATA SHEET
Page 1 of 12
1 NEO-MERCAZOLE
Carbimazole 5mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of carbimazole.
Excipients with known effect:
Sucrose
Lactose
For a full list of excipients see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
A pale pink tablet, shallow bi-convex tablet with a white centrally
located core, one face
plain, with Neo 5 imprinted on the other.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Primary thyrotoxicosis, even in pregnancy.
Secondary thyrotoxicosis - toxic nodular goitre.
However, Neo-Mercazole really has three principal applications in the
therapy of
hyperthyroidism:
1. Definitive therapy - induction of a permanent remission.
2. Preparation for thyroidectomy.
3. Before and after radio-active iodine treatment.
4.2
Dose and method of administration
Neo-Mercazole should only be administered if hyperthyroidism has been
confirmed by
laboratory tests.
Adults
Initial dosage
It is customary to begin Neo-Mercazole therapy with a dosage that will
fairly quickly control
the thyrotoxicosis and render the patient euthyroid, and later to
reduce this.
The usual initial dosage for adults is 60 mg per day given in divided
doses. Thus:
NEW ZEALAND DATA SHEET
Page 2 of 12
Mild cases
20 mg
Daily in
divided
dosage
Moderate cases
40 mg
Severe cases
40-60 mg
The initial dose should be titrated against thyroid function until the
patient is euthyroid in
order to reduce the risk of over-treatment and resultant
hypothyroidism.
Three factors determine the time that elapses before a response is
apparent:
(a) The quantity of hormone stored in the gland.
(Exhaustion of these stores usually takes about a fortnight).
(b) The gland secretory rate.
(c) The degree of inhibition of hormone synthesis achieved by
Neo-Mercazole.
If large stores of hormone are present, as in nodular goitre, response
to Neo-Mercazole may
be delayed for several weeks or months, whereas in severe
thyrotoxicosis, when very little
hormone is stored, improvement may be detected within
                                
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