Ursodeoxycholic acid 250mg capsules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Ursodeoxycholic acid

Disponível em:

Advanz Pharma

Código ATC:

A05AA02

DCI (Denominação Comum Internacional):

Ursodeoxycholic acid

Dosagem:

250mg

Forma farmacêutica:

Oral capsule

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 01090100; GTIN: 5021691036043

Características técnicas

OBJECT 1
URSODEOXYCHOLIC ACID 250 MG
CAPSULES
Summary of Product Characteristics Updated 22-Jun-2016 | ADVANZ Pharma
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Ursodeoxycholic acid 250 mg capsules, hard.
2. Qualitative and quantitative composition
Each capsule contains 250 mg ursodeoxycholic acid (UDCA).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, hard.
Hard gelatine capsules with white body and cap filled with powder
The length of the capsules is 21.7 ± 0.3 mm
4. Clinical particulars
4.1 Therapeutic indications
Ursodeoxycholic acid is indicated in the treatment of primary biliary
cirrhosis (PBC) and for the
dissolution of radiolucent gallstones in patients with a functioning
gall bladder.
_Paediatric population_
Hepatobiliary disorders associated with cystic fibrosis in children
aged 6 to 18 years.
4.2 Posology and method of administration
There are no age restrictions on the use of Ursodeoxycholic acid 250
mg hard capsules i