Carbimazole 5mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
15-01-2023
Hent Produktets egenskaber (SPC)
10-03-2021
Hent MMR (MMR)
15-01-2023

Aktiv bestanddel:

Carbimazole

Tilgængelig fra:

Advanz Pharma

ATC-kode:

H03BB01

INN (International Name):

Carbimazole

Dosering:

5mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 06020200; GTIN: 5060064172025

Produktets egenskaber

                                OBJECT 1
CARBIMAZOLE 5 MG TABLETS
Summary of Product Characteristics Updated 20-Apr-2021 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Carbimazole 5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of carbimazole.
Excipients with known effect:
Lactose Anhydrous (140.485 mg per tablet)
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Pale pink, uncoated, round, biconvex tablets marked with LINK C5 on
one side and a scoreline on the
reverse.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Carbimazole is an anti-thyroid agent. It is indicated in adults and
children in all conditions where reduction
of thyroid function is required.
Such conditions are:
1. Hyperthyroidism.
2. Preparation for thyroidectomy in hyperthyroidism.
3. Therapy prior to and post radio-iodine treatment.
4.2 Posology and metho
                                
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