PHYSIOTENS Film-coated tablet (2016)
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Περιεχόμενα
1. Name of the medicinal product
Physiotens Tablets 200 micrograms.
2. Qualitative and quantitative composition
Each tablet contains 200 micrograms moxonidine. <u>Excipients:</u> 95.8 mg lactose per tablet. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets. Light pink, round, biconvex, film-coated tablets imprinted 0.2 on one face.
4.1. Therapeutic indications
Mild to moderate essential or primary hypertension.
4.2. Posology and method of administration
Adults (including the elderly) Treatment should be started with 200 micrograms of Physiotens in the morning. The dose may be titrated after three weeks to 400 micrograms, given as one dose or as divided ...
4.3. Contraindications
Physiotens should not be used in cases of: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 sick sinus syndrome or sino-atrial block 2nd or 3rd degree atrioventricular ...
4.4. Special warnings and precautions for use
Cases of varying degrees of AV block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on these case reports, the causative role of moxonidine in delaying ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent administration of other antihypertensive agents enhances the hypotensive effect of Physiotens. Since tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive ...
4.6. Pregnancy and lactation
Pregnancy There are no adequate data from use of moxonidine in pregnant woman. Studies in animals have shown embryo-toxicological effects (see section 5.3). The potential risk for humans is unknown. Moxonidine ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Somnolence and dizziness have been reported. This should be borne in mind when performing these tasks.
4.8. Undesirable effects
Most frequent side effects reported by those taking moxonidine include dry mouth, dizziness, asthenia and somnolence. These symptoms often decrease after the first few weeks of treatment. Undesirable Effects ...
4.9. Overdose
Symptoms of overdose In the few cases of overdose that have been reported, a dose of 19.6 mg was ingested acutely without fatality. Signs and symptoms reported included: headache, sedation, somnolence, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Imidazoline receptor agonists, moxonidine <b>ATC code:</b> C02AC05 In different animal models, Physiotens has been shown to be a potent antihypertensive agent. Available ...
5.2. Pharmacokinetic properties
Oral moxonidine treatment of rats and dogs resulted in rapid and almost complete absorption and peak plasma levels within <0.5 hours. Average plasma concentrations were comparable in both species after ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Chronic oral treatment for 52 ...
6.1. List of excipients
Lactose Povidone Crospovidone Magnesium stearate Hypromellose Ethylcellulose Polyethylene glycol 6000 Talc Red ferric oxide Titanium dioxide
6.2. Incompatibilities
No incompatibilities are known.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The tablets are packed in blister strips made of PVC/PVdC or PVC film with covering Aluminium foil, within cartons. Each carton contains 14, 28 or 84 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Mylan Products Ltd, 20 Station Close, Potters Bar, Herts, EN6 1TL, UK
8. Marketing authorization number(s)
PL 46302/0045
9. Date of first authorization / renewal of the authorization
15/09/1997
10. Date of revision of the text
28 October 2016
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