VASCOTEN Film-coated tablet (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vascoten 50 mg, film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 50mg of atenolol. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. White, round, convex, scored, film-coated tablet, embossed MC. The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Management of hypertension. Management of angina pectoris. Management of cardiac arrhythmias. Early intervention in the acute phase of myocardial infarction.
4.2. Posology and method of administration
Posology Adults Hypertension Usual dose is 100mg once a day, to which most patients will respond. Some patients will respond to 50mg given as a single daily dose. It takes one to two weeks to establish ...
4.3. Contraindications
Hypersensitivity to the active substance, or any of the excipients listed in section 6.1. In patients with: uncontrolled heart failure, second or third degree heart block, bradycardia (<45bpm), cardiogenic ...
4.4. Special warnings and precautions for use
Although contraindicated for uncontrolled heart failure, Vascoten may be used with caution in patients whose signs of heart failure have been controlled; especial caution should be used with patients with ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of beta-adrenoreceptor blockers with negative inotropic effect calcium channel blockers, such as diltiazem or verapamil, can lead to exaggeration of the effects. This happens especially ...
4.6. Pregnancy and lactation
Pregnancy Atenolol crosses the placenta and appears in the cord blood. There are no studies on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol ...
4.7. Effects on ability to drive and use machines
The ability to drive or operate machines is unlikely to be impaired by atenolol, although dizziness or fatigue may occasionally occur.
4.8. Undesirable effects
Atenolol is usually well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological action of atenolol. The following undesired events, listed by body ...
4.9. Overdose
Symptoms These may include bradycardia, hypotension, bronchospasm and acute cardiac insufficiency. Management In general terms it requires close supervision and hospitalization. Drug absorption should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta blocking agents, selective, Beta Blocking Agents <b>ATC code:</b> C07AB03 It is a beta-adrenoceptor blocking drug which acts preferentially on beta1-adrenergic receptors ...
5.2. Pharmacokinetic properties
Absorption of atenolol following oral administration is consistent, with some subject variability, but incomplete, being some 40-50%, with peak plasma concentrations occurring 2-4 hours post dose. The ...
5.3. Preclinical safety data
As atenolol is a well established drug, and no novel pharmaceutical excipients are used in this formulation, there is no additional preclinical safety data.
6.1. List of excipients
<u>Vascoten 50mg contains:</u> Sodium lauryl sulphate Silica colloidal anhydrous Sodium starch glycolate (Type A) Maize starch Microcrystalline cellulose-102 Calcium hydrogen phosphate dehydrate Powdered ...
6.2. Incompatibilities
None.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light.
6.5. Nature and contents of container
Polyvinylchloride film and aluminium foil blisters of ten tablets. Packs of Packs of 20, 30 or 100 tablets are available with a patient information leaflet are available. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
12706
9. Date of first authorization / renewal of the authorization
13/03/1990
10. Date of revision of the text
02/2014
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