NEO-MERCAZOLE carbimazole 5 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbimazole, Quantity: 5 mg

Available from:

Amdipharm Mercury Australia Pty Ltd

INN (International Name):

Carbimazole

Pharmaceutical form:

Tablet, multilayer

Composition:

Excipient Ingredients: lactose monohydrate; sucrose; Acacia; maize starch; purified talc; magnesium stearate; Gelatin; iron oxide red

Administration route:

Oral

Units in package:

100

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Therapy of hyperthyroidism. Definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. Preparation for thyroidectomy. Before and after radioactive iodine treatment.

Product summary:

Visual Identification: A pale pink, circular biconvex tablet embossed with Neo 5 on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2012-05-23

Patient Information leaflet

NEO-MERCAZOLE
_Carbimazole Tablets 5 mg_
CONSUMER MEDICINE INFORMATION
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 they
expect it will have 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.
This medicine is used to treat
hyperthyroidism or overactive
thyroid gland (a condition where the
thyroid gland produces too much
thyroid hormone).
There are different types of
medicines used to treat
hyperthyroidism.
This medicine belongs to a group of
medicines called anti-
hyperthyroidism agents. These
medicines work by reducing the
production of thyroid hormones.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
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 YOU
HAVE AN ALLERGY TO:
•
any medicine containing
carbimazole
•
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 NEO-MERCAZOLE IF YOU
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
growth of the thyroid gland
downwards from the neck into the
chest (retrosternal goitre)
•
serious blood disorder
•
severe liver disorder
•
airway obstruction
•
inflammation of the pancreas
(acute pancreatitis) after

Summary of Product characteristics

NEO-MERCAZOLE
®
1
AUSTRALIAN PRODUCT INFORMATION
NEO-MERCAZOLE
®
CARBIMAZOLE
TABLET
1
NAME OF THE MEDICINE
Carbimazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Neo-Mercazole tablet contains 5 mg of carbimazole as the active
ingredient.
Excipients with known effect: lactose monohydrate and sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Neo-Mercazole 5 mg tablets are pale pink, circular biconvex tablet
embossed with Neo 5 on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy of hyperthyroidism. Definitive therapy: induction of a
permanent remission, in
either primary or secondary thyrotoxicosis. Preparation for
thyroidectomy. Before and after
radioactive iodine treatment.
4.2 DOSE AND METHOD OF ADMINISTRATION
It is customary to begin therapy with a dosage that will fairly
quickly control the
thyrotoxicosis and render the patient euthyroid, and later to reduce
this.
The tablets are for oral administration.
ADULTS
Usual initial dosages
Mild cases, 15 to 20 mg/day in divided doses; moderate cases, 30
mg/day in divided doses;
severe cases, 40 to 45 mg (up to 60 mg) /day in divided doses and
should be titrated against
NEO-MERCAZOLE
®
2
thyroid function until the patient is euthyroid in order to reduce the
risk of over-treatment
and resultant hypothyroidism.
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 three to four
days.
Maintenance dosage
When symptoms are controlled the dosage should be reduced to a
maintenance level, which
will usually be between 10 and 15 mg daily.
Experience has shown there is a wide variation of sensitivity to the
medicine from time to
time in a particular patient. Serial thyroid function monitoring is
recommended, together
with appropriate dosage modification in order to maintain a euthyroid
state. Fo