SEED PHARMA CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

carbimazole, Quantity: 5 mg

Διαθέσιμο από:

Seed Pharma Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet

Σύνθεση:

Excipient Ingredients: croscarmellose sodium; lactose; magnesium stearate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

100, 60, 30, 120

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Visual Identification: white, round, debossed 5 on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-09-21

Φύλλο οδηγιών χρήσης

SEED PHARMA CARBIMAZOLE 5 TABLET
1
SEED PHARMA CARBIMAZOLE 5 TABLET
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 SEED PHARMA CARBIMAZOLE?
SEED PHARMA CARBIMAZOLE contains the active ingredient carbimazole.
This medicine works by reducing the production of
thyroid hormones.
SEED PHARMA CARBIMAZOLE is used to treat hyperthyroidism or overactive
thyroid gland (a condition where the thyroid
gland produces too much thyroid hormone).
For more information, see Section 1. Why am I using SEED PHARMA
CARBIMAZOLE?
i
n the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SEED PHARMA CARBIMAZOLE?
Do not use if you have ever had an allergic reaction to carbimazole or
any of the ingredients listed at the end of the CMI.
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
SEED PHARMA CARBIMAZOLE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SEED PHARMA CARBIMAZOLE and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? i
n the full CMI.
4.
HOW DO I USE SEED PHARMA CARBIMAZOLE?
•
Take SEED PHARMA CARBIMAZOLE exactly as your doctor has prescribed.
•
Follow the instructions provided and use SEED PHARMA CARBIMAZOLE until
your doctor tells you to stop.
More instructions can be found in Section 4. How do I use SEED PHARMA
CARBIMAZOLE? i
n the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SEED PHARMA CARBIMAZOLE?
THINGS YOU
SHOULD DO
•
Tell your doctor if, for any reason, you have not taken your medicine
exactly as prescribed.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dose without checking
with your doctor.
DRIVING OR USING
MACHINES
•
The effects of this medicine on a person's ability to drive and

Αρχείο Π.Χ.Π.

SEED PHARMA CARBIMAZOLE 5
Version 2.0
1
AUSTRALIAN PRODUCT INFORMATION -
SEED PHARMA CARBIMAZOLE 5 (CARBIMAZOLE) TABLET
1
NAME OF THE MEDICINE
Carbimazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SEED PHARMA CARBIMAZOLE 5 tablet contains 5 mg of carbimazole as
the
active ingredient.
Excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SEED PHARMA CARBIMAZOLE 5 tablets are white, round, uncoated tablets,
debossed
“5” on one side and break line on other side.
Note:
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
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
NOTE:
THE BREAKLINE IS ONLY TO FACILITATE BREAKING FOR EASE OF SWALLOWING
AND NOT TO DIVIDE
INTO EQUAL DOSES.
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.
Version 2.0
2
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
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 carbimazole 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 the