Dicycloverine 10mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Dicycloverine hydrochloride

Dostupno od:

Flamingo Pharma (UK) Ltd

ATC koda:

A03AA07

INN (International ime):

Dicycloverine hydrochloride

Doziranje:

10mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 01020000; GTIN: 5060464501739

Svojstava lijeka

OBJECT 1
Dicycloverine 10 mg Tablets
Summary of Product Characteristics Updated 16-Jun-2021 | Flamingo
Pharma (UK) Ltd
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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
Dicycloverine Hydrochloride 10 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg of Dicycloverine hydrochloride.
Excipient(s) with known effect:
Each tablet contains 67.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off white, circular, flat beveled edge, uncoated tablet
debossed with “S10” on one side and plain on
other side.
4. Clinical particulars
4.1 Therapeutic indications
Smooth muscle antispasmodic primarily indicated for treatment of
functional conditions involving smooth
muscle spasm of the gastrointestinal tract.
4.2 Posology and method of administration
Posology
Adults: 10-20 mg three times daily before or after meals.
Children (2-12 years): 10 mg three times daily.
Method of administration
Or