Betaxolol 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betaxolol hydrochloride

Available from:

FDC International Ltd

ATC code:

S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5050135001071

Summary of Product characteristics

OBJECT 1
BETAXOLOL 0.5% EYE DROPS
Summary of Product Characteristics Updated 10-Mar-2017 | FDC
International 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
Betaxolol 0.5% Eye Drops
2. Qualitative and quantitative composition
Active Ingredient
Betaxolol
5.0 mg/ml
(as Betaxolol
hydrochloride
5.6 mg/ml)
Excipient(s) with known effect
Benzalkonium chloride 0.01%w/v
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Eye drops, solution
4. Clinical particulars
4.1 Therapeutic indications
Reduction of elevated intraocular pressure in conditions such as
ocular hypertension and chronic open-
angle glaucoma.
4.2 Posology and method of administration
Adults (including the elderly): recommended therapy is one drop of
Betaxolol 0.5% Eye Drops to be
instilled into the affected eye(s) twice a day.
Children: No clinical studies have been performed to establish safety
and efficacy in children. Therefore,
this product is currently not recommended for use in childre