HALF BETA-PROGRANE Sustained release capsule (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Half Beta Prograne 80mg Sustained Release Capsules.

2. Qualitative and quantitative composition

Each capsule contains 80 mg of propranolol hydrochloride. Excipients with known effect: The capsule contains Neutral micogrananules (sugar-starch) and Sulfur Dioxide (E220). For the full list of ...

3. Pharmaceutical form

Sustained Release Capsule. Size 3 capsules with opaque white caps and colourless transparent bodies filled with regular creamy white microgranules.

4.1. Therapeutic indications

Control of hypertension Management of angina Management of essential tremor Management of situational anxiety and generalised anxiety symptoms Adjunctive management of thyrotoxicosis Prophylaxis of migraine ...

4.2. Posology and method of administration

Posology Adults Hypertension The usual starting dose is one 160 mg Beta-Prograne Sustained-Release capsule daily, taken either morning or evening. An adequate response is seen in most patients at this ...

4.3. Contraindications

Beta-Prograne 160 mg Sustained-Release Capsules and Half Beta-Prograne 80 mg Sustained-Release Capsules, as with other beta-adrenoceptor blocking drugs, must not be used in patients with any of the following ...

4.4. Special warnings and precautions for use

Beta-Prograne 160 mg Sustained-Release Capsules or Half Beta-Prograne 80 mg Sustained-release Capsules as with other beta-adrenoceptor blocking drugs: although contra-indicated in uncontrolled heart failure ...

4.5. Interaction with other medicinal products and other forms of interaction

Beta-Prograne 160 mg Sustained-Release Capsules and Half Beta-Prograne 80 mg Sustained-Release Capsules modify the tachycardia of hypoglycaemia. Caution must be exercised in the concurrent use of Beta-Prograne ...

4.6. Pregnancy and lactation

Pregnancy As with all drugs, Beta-Prograne 160 mg Sustained-Release Capsules and Half Beta-Prograne 80 mg Sustained-Release Capsules should not be given during pregnancy unless their use is essential. ...

4.7. Effects on ability to drive and use machines

The use of Beta-Prograne 160 mg Sustained-Release Capsules or Half Beta-Prograne 80 mg Sustained-Release Capsules is unlikely to result in any impairment of the ability of patients to drive or operate ...

4.8. Undesirable effects

Beta-Prograne 160 mg Sustained-Release Capsules and Half Beta-Prograne 80mg Sustained-Release Capsules are usually well tolerated. In clinical studies, the undesired events reported are usually attributable ...

4.9. Overdose

Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic Group: Beta Blocking Agents, Non-Selective and other Hypertensives ATC Code: C07AA05 Propranolol is a competitive antagonist at both beta1 and beta2-adrenoceptors. It ...

5.2. Pharmacokinetic properties

Sustained release form. The coating of the multiple microgranules provides a sustained release of the active principle, propranolol, and allows a 24 hours sustained action. Propranolol is completely absorbed ...

5.3. Preclinical safety data

Propranolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in this Summary of Product Characteristics.

6.1. List of excipients

Neutral microgranules Povidone Ethylcellulose Talc Capsule Components Gelatine Titanium Dioxide Sulfur Dioxide (E220)

6.2. Incompatibilities

None known.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light and moisture.

6.5. Nature and contents of container

Blister packs: PVC: Colourless 250 micron thickness Aluminium: 25 microns thickness 28 capsules per pack, 14 capsules per blister strip. Not all packs sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Tillomed Laboratories Ltd, 220 Butterfield, Great Marlings, Luton, LU2 8DL

8. Marketing authorization number(s)

PL 11311/0017

9. Date of first authorization / renewal of the authorization

25/02/2009

10. Date of revision of the text

23/03/2020

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