SOTACOR Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Sotacor 80 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 80mg sotalol hydrochloride. <u>Excipient with known effect:</u> Each tablet contains 53.8mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Tablets. Round, biconvex, white tablets with a break bar on each side. The tablet can be divided into equal halves.
4.1. Therapeutic indications
<u>Ventricular arrhythmias:</u> Treatment of life-threatening ventricular tachyarrhythmias; Treatment of symptomatic non-sustained ventricular tachyarrhythmias. <u>Supraventricular arrhythmias:</u> Prophylaxis ...
4.2. Posology and method of administration
Posology Paediatric population There is no relevant use of Sotacor in the paediatric population. The initiation of treatment or changes in dosage with Sotacor should follow an appropriate medical evaluation ...
4.3. Contraindications
Sotacor should not be used where there is evidence of sick sinus syndrome; second and third degree AV heart block unless a functioning pacemaker is present; congenital or acquired long QT syndromes; torsades ...
4.4. Special warnings and precautions for use
Abrupt Withdrawal Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial ...
4.5. Interaction with other medicinal products and other forms of interaction
Antiarrhythmics Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III antiarrhythmic drugs such as amiodarone and bepridil are not recommended as concomitant ...
4.6. Pregnancy and lactation
Pregnancy Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus. Although there are no adequate and well-controlled studies in pregnant ...
4.7. Effects on ability to drive and use machines
There are no data available, but the occasional occurrence of side-effects such as dizziness and fatigue should be taken into account (see section 4.8 Undesirable effects).
4.8. Undesirable effects
Sotacor is well tolerated in the majority of patients, with the most frequent adverse effects arising from its beta-blockade properties. Adverse effects are usually transient in nature and rarely necessitate ...
4.9. Overdose
Intentional or accidental overdosage with Sotacor has rarely resulted in death. Haemodialysis results in a large reduction of plasma levels of sotalol. Symptoms and treatment of overdosage: The most common ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta blocking agents, non-selective <b>ATC code:</b> C07AA07 D,l-sotalol is a non-selective hydrophilic β-adrenergic receptor blocking agent, devoid of intrinsic sympathomimetic ...
5.2. Pharmacokinetic properties
The bioavailability of oral sotalol is essentially complete (greater than 90%). After oral administration, peak levels are reached in 2.5 to 4 hours, and steady-state plasma levels are attained within ...
5.3. Preclinical safety data
No further particulars.
6.1. List of excipients
Colloidal anhydrous silica Lactose monohydrate Magnesium stearate Maize starch Mirocrystalline cellulose Stearic acid
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package to protect from light.
6.5. Nature and contents of container
Original packs of 28 or 30 tablets: blister strips of 2x 14 tablets or 3x 10 tablets, respectively, to a carton.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom
8. Marketing authorization number(s)
PL 45043/0047
9. Date of first authorization / renewal of the authorization
9<sup>th</sup> August 1989
10. Date of revision of the text
01/12/2020
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