Carbimazole 15mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
25-12-2022
Shusha Tabia za bidhaa (SPC)
10-03-2021
Shusha MMR (MMR)
25-12-2022

Viambatanisho vya kazi:

Carbimazole

Inapatikana kutoka:

Advanz Pharma

ATC kanuni:

H03BB01

INN (Jina la Kimataifa):

Carbimazole

Kipimo:

15mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06020200; GTIN: 5060337262026

Taarifa za kipeperushi

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBIMAZOLE 5 MG, 10 MG, 15 MG AND 20 MG TABLETS
carbimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU:
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Carbimazole is and what it is used for
2. What you need to know before you take Carbimazole
3. How to take Carbimazole
4. Possible side effects
5. How to store Carbimazole
6. Contents of the pack and other information
1. WHAT CARBIMAZOLE IS AND WHAT IT IS USED FOR
Carbimazole belongs to a group of medicines called 'anti-thyroid'
medicines.
It is used for adults and children with an over-active thyroid gland
(called 'hyper-thyroidism')
• It works by reducing the amount of thyroid hormones made in your
thyroid gland.
• It can be used on its own, or with other treatments for an
over-active thyroid gland.
• It can also be used before part of the thyroid gland has been
removed by surgery. It helps the thyroid gland
work properly before the surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIMAZOLE
DO NOT TAKE CARBIMAZOLE IF:
• You are allergic to carbimazole or any of the other ingredients of
this medicine (listed in Section 6).
• You have a severe liver disorder.
• You have a serious blood disorder.
• If you had inflammation of the pancreas (acute pancreatitis) after
administration of carbimazole or
thiamazole in the past.
Do not take Carbimazole tablets if any of the above
apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Carbimazole.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
                                
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Tabia za bidhaa

                                OBJECT 1
CARBIMAZOLE 15 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 15 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 15 mg of carbimazole.
Excipient(s) with known effect
Lactose Anhydrous (130.395 mg per tablet)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale pink to pink, uncoated, round, biconvex tablets marked with C15
on one side and plain on the reverse.
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 method of administration
Carbimazole should only be administered if hyperthyroidism has been
confirmed by
                                
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