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HALF BETA-PROGRANE

80 Milligram Prolonged Release Capsules

Lexon (UK) LtdPPA1097/018/001

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Lexon (UK) Ltd

Unit 18

Oxleasow Road

East Moons Moat

Redditch

Worcestershire

B98 0RE

United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/018/001
1 NAME OF THE MEDICINAL PRODUCT

Half Beta-Prograne 80 mg Prolonged-Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains Propranolol Hydrochloride 80 mg

Excipients with known effects - Contains Sucrose and Sulphur Dioxide (E220)

For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM

Prolonged release capsules, hard.

Product imported from UK

Capsules with opaque white cap and colourless, transparent body containing white microgranules.
4 CLINICAL PARTICULARS As per PA0644/001/002
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 As per PA0644/001/002
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Neutral microgranules.

Povidone.

Ethylcellulose.

Talc.

Capsule components:

Gelatin.

Titanium Dioxide (E171)

Sulphur Dioxide (E220)
6.2 Incompatibilities

Not applicable.
6.3 Shelf life

The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin.
6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light and moisture.<?xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" />
6.5 Nature and contents of container

Blister packs: 28 capsules per pack, 14 capsules per blister strip.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26th September 2017
10 DATE OF REVISION OF THE TEXT
6.6 Special precautions for disposal and other handling

No special requirements.
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