OPILON Film-coated tablet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Opilon 40mg tablets.
Qualitative and quantitative composition
Each tablet contains moxisylyte hydrochloride 45.22mg (equivalent to moxisylyte base 40mg).
Pharmaceutical form
A pale yellow film-coated tablet.
Therapeutic indications
Moxisylyte is an alpha-adrenergic blocking agent. Opilon tablets are indicated in the short term control of the symptoms of primary Raynauds phenomenon.
Posology and method of administration
Oral administration. Adults Initially one tablet to be taken four times a day. This may be increased to two tablets four times a day if initial response is poor. For patients exposed to the cold during ...
Contraindications
Opilon tablets are contraindicated in those with a hypersensitivity to any of the ingredients or who have active liver disease.
Special warnings and precautions for use
The alpha-adrenergic blocking action of Opilon tablets will produce a vasodilating effect which may theoretically potentiate the effect of a number of drugs used in the management of hypertension. In practice, ...
Interaction with other medicinal products and other forms of interaction
See section 4.4 (Special Warnings and Precautions for Use).
Pregnancy and lactation
The safety of Opilon tablets for use during pregnancy and lactation has not been established. Opilon tablets should not, therefore, be used by women who are pregnant or breast-feeding.
Effects on ability to drive and use machines
None known.
Undesirable effects
Occasionally, mild nausea, diarrhoea, vertigo, headache, facial flushing and rash may be encountered. These are, however, rare and transient. There have also been rare reports of hepatotoxicity, including ...
Overdose
In excessive overdosage a fall in blood pressure is the main symptom. The patient should be nursed in the supine position until the blood pressure has been restored to normal.
Pharmacodynamic properties
Moxisylyte is an alpha-adrenergic blocking agent which is used for the treatment of the symptoms of Raynauds phenomenon.
Pharmacokinetic properties
Moxisylyte is rapidly absorbed after oral administration. In plasma, the drug is rapidly converted to desacetylmoxisylyte (metabolite I) and desmethyldesacetylmoxisylyte (metabolite II) which are pharmacologically ...
Preclinical safety data
There are no pre-clinical safety data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
List of excipients
Lactose Colloidal silicon dioxide Microcrystalline cellulose Magnesium stearate Maize starch The film coating contains: Methylhydroxypropylcellulose Propylene glycol Opaspray M-1-22900 (E464, E171, E104, ...
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Store at a temperature not exceeding 30°C.
Nature and contents of container
Blister pack comprising white PVC and aluminium foil backing containing 112 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom
Marketing authorization number(s)
PL 16508/0060
Date of first authorization / renewal of the authorization
1 May 1999
Date of revision of the text
November 2017
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