Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betaxolol hydrochloride
DE Pharmaceuticals
S01ED02
Betaxolol hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000
OBJECT 1 BETAXOLOL 0.5% EYE DROPS Summary of Product Characteristics Updated 10-Mar-2017 | FDC International Ltd • 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 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 Read the complete document