EMFORAL Film-coated tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Emforal 10 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg propranolol hydrochloride. <u>Excipient(s) with known effect:</u> This product contains 60.9 mg lactose and 0.093 mg carmoisine E122. For the full list of excipients, ...
3. Pharmaceutical form
Film-coated tablet. Pink, round, film-coated tablets.
4.1. Therapeutic indications
Emforal is indicated in: the control of hypertension. the management of angina pectoris. long term management against re-infarction after recovery from acute myocardial infarction. the control of most ...
4.2. Posology and method of administration
Posology Adults Hypertension A starting dose of 80 mg twice daily may be increased at weekly intervals according to response. The usual dose range is 160 to 320 mg per day. With concurrent diuretic or ...
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Emforal must not be used if there is a history of bronchial asthma or bronchospasm. The product label states ...
4.4. Special warnings and precautions for use
Emforal as with other beta-blockers: although contraindicated in uncontrolled heart failure (see section 4.3), may be used in patients whose signs of heart failure have been controlled. Caution must be ...
4.5. Interaction with other medicinal products and other forms of interaction
Propranolol modifies the tachycardia of hypoglycaemia. Caution must be exercised in the concurrent use of propranolol and hypoglycaemic therapy in diabetic patients. Propranolol may prolong the hypoglycaemic ...
4.6. Pregnancy and lactation
Pregnancy As with all other drugs, Emforal should not be given during pregnancy unless its use is essential. There is no evidence of teratogenicity with propranolol hydrochloride. However beta-blocker ...
4.7. Effects on ability to drive and use machines
Emforal has no negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.
4.8. Undesirable effects
Emforal is usually well tolerated. In clinical studies the undesired events reported are usually attributable to the pharmacological actions of propranolol. The following undesired events, listed by body ...
4.9. Overdose
The symptoms of overdose may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm. General treatment should include: close supervision, treatment in an intensive care ward, the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta blocking agents <b>ATC Code:</b> C07AA05 Propranolol is a competitive antagonist at both the beta<sub>1</sub>- and beta<sub>2</sub>-adrenoceptors. It has no agonist ...
5.2. Pharmacokinetic properties
Following intravenous administration the plasma half-life of propranolol is about 2 hours and the ratio of metabolites to parent drug in the blood is lower than after oral administration. In particular ...
5.3. Preclinical safety data
Propranolol is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
6.1. List of excipients
<u>Core:</u> Cellulose, microcrystalline Sodium starch glycolate (type A) Lactose monohydrate Maize starch Povidone Silica, colloidal anhydrous Magnesium stearate Talc <u>Coating:</u> Hypromellose Polyethylene ...
6.2. Incompatibilities
None.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack-size of 50 film-coated tablets. PP containers with PE closure. Pack-sizes of 500 and 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19733
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 08 November 2005 Date of latest renewal: 15 March 2011
10. Date of revision of the text
03/06/2019
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