RYTMONORM Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Rytmonorm, 150 mg, film coated tablets.
2. Qualitative and quantitative composition
Each Rytmonorm film coated tablet contains 150 mg of propafenone (as propafenone hydrochloride). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Rytmonorm 150 mg white to off-white, round, biconvex film coated tablets embossed on one face with 150. The other face is unmarked.
4.1. Therapeutic indications
For the treatment of supraventricular extrasystoles and supraventricular tachycardias, and in WolffParkinson-White (WPW) syndrome. Also for the treatment of life-threatening documented ventricular tachyarrhythmia. ...
4.2. Posology and method of administration
Dose The use of Rytmonorm should be initiated by a specialist physician. The individual maintenance dose should be determined under cardiological surveillance including repeated ECG monitoring and repeated ...
4.3. Contraindications
Rytmonorm is contraindicated in the presence of: Known hypersensitivity to the active ingredient, propafenone hydrochloride, or to any of the excipients listed in section 6.1. Known Brugada Syndrome (see ...
4.4. Special warnings and precautions for use
Brugada syndrome A Brugada syndrome may be unmasked or Brugada like electrocardiogram (ECG) changes may be provoked after exposure to Rytmonorm in previously asymptomatic carriers of the syndrome. After ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Quinidine Small doses of quinidine completely inhibit the hydroxylation metabolic pathway, making all patients, in effect, slow metabolisers (see ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. Propafenone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the ...
4.7. Effects on ability to drive and use machines
It is important to note that blurred vision, dizziness, fatigue or postural hypotension may affect the patients speed of reaction to the point where the patients ability to operate machinery or motor vehicles ...
4.8. Undesirable effects
The most common events were dizziness, cardiac conduction disorders and palpitations. About 20% of patients discontinued due to adverse reactions. Results from controlled trials and post-marketing experience ...
4.9. Overdose
Symptoms Myocardial symptoms The effects of propafenone hydrochloride overdose in the myocardium manifest as impulse generation and conduction disorders such as PQ prolongation, QRS widening, suppression ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiarrhythmics, class 1c <b>ATC code:</b> C01BC03 Rytmonorm (propafenone hydrochloride) is a class 1c antiarrhythmic drug with some structural similarities to beta-blocking ...
5.2. Pharmacokinetic properties
Propafenone is a racemic mixture of S- and R-propafenone. Absorption Rytmonorm is nearly completely absorbed after oral administration with peak plasma levels occurring approximately two to three hours ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential or toxicity to reproduction. Studies ...
6.1. List of excipients
<u>Rytmonorm 150 mg tablets also contain:</u> Microcrystalline cellulose Sodium croscarmellose Starch pregelantinised Hypromellose Magnesium stearate Macrogol Titanium dioxide
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
<u>Rytmonorm 150 mg:</u> 3 years.
6.4. Special precautions for storage
Store at or below 25°C.
6.5. Nature and contents of container
Blister packs. Pack size of 50 tablets.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND www.viatris.co.nz Telephone 0800 168 169
9. Date of first authorization / renewal of the authorization
Date of fisrt approval: 1 October 1992
10. Date of revision of the text
21 January 2022
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