XATRAL XL Prolonged release tablets (2017)
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Περιεχόμενα
Name of the medicinal product
Xatral XL 10 mg prolonged release tablets.
Qualitative and quantitative composition
Each tablet contains 10mg alfuzosin hydrochloride. Excipient: Hydrogenated castor oil For a full list of excipients, see section 6.1.
Pharmaceutical form
Prolonged release tablet. Round biconvex, three layer tablet: one white layer between two yellow layers.
Therapeutic indications
Treatment of the functional symptoms of benign prostatic hypertrophy (BPH). For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.
Posology and method of administration
Xatral XL should be swallowed whole (see section 4.4). BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal. AUR: In patients 65 years and older, one 10 mg tablet daily after ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients); history of orthostatic hypotension; combination with other alpha-1 receptor blockers; hepatic ...
Special warnings and precautions for use
As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may ...
Interaction with other medicinal products and other forms of interaction
Combinations contra-indicated: Alpha-1-receptor blockers (see Section 4.3 Contraindications). Combinations to be taken into account: Antihypertensive drugs (see Section 4.4 Special warnings and precautions ...
Pregnancy and lactation
Due to the type of indication this section is not applicable.
Effects on ability to drive and use machines
There are no data available on the effect on driving vehicles. Adverse reactions such as vertigo, dizziness and asthenia may occur essentially at the beginning of treatment. This has to be taken into account ...
Undesirable effects
Classification of expected frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated ...
Overdose
In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place. In case of significant hypotension, the appropriate ...
Pharmacodynamic properties
Pharmacotherapeutic group: alpha-adrenoreceptor antagonists ATC code: G04CA01 Alfuzosin is an orally active quinazoline derivative. It is a selective, peripherally acting antagonist of postsynaptic alpha-1-adrenoceptors. ...
Pharmacokinetic properties
Prolonged-release formulation The mean value of the relative bioavailability is 104.4% versus the immediate release formulation (2.5 mg tid) in middle-aged healthy volunteers and the maximum plasma concentration ...
Preclinical safety data
No data of therapeutic relevance.
List of excipients
Ethylcellulose Hydrogenated Castor Oil Hypromellose Yellow Ferric Oxide (E172) Magnesium Stearate Microcrystalline Cellulose Povidone Silica Colloidal Hydrated Mannitol
Incompatibilities
None known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
No special precautions for storage. Store in the original container.
Nature and contents of container
Boxes with 10, 30, 50, 100 and 500 tablets in pvc/foil blister strips. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 04425/0657
Date of first authorization / renewal of the authorization
02 April 2009
Date of revision of the text
16/06/2017
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