FLOMAXTRA Film-coated prolonged-release tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Flomaxtra XL, 400 micrograms, film-coated prolonged-release tablet.
2. Qualitative and quantitative composition
Each tablet contains as active ingredient tamsulosin hydrochloride 400 micrograms, equivalent to 367 micrograms tamsulosin. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated prolonged-release tablet. Approximately 9 mm, round, bi-convex, yellow, film-coated tablets debossed with the code 04.
4.1. Therapeutic indications
Flomaxtra XL in indicated in adults for the treatment of functional symptoms of benign prostatic hyperplasia (BPH).
4.2. Posology and method of administration
Posology One tablet daily, to be taken with or without food. Paediatric Population The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described ...
4.3. Contraindications
A history of orthostatic hypotension; severe hepatic insufficiency. Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Flomaxtra XL, as a result of which, rarely, syncope can occur. At the first signs of orthostatic ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions have been seen when tamsulosin was given concomitantly with atenolol, enalapril, or theophylline. Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, and furosemide ...
4.6. Pregnancy and lactation
Flomaxtra XL is not indicated for use in women. Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation ...
4.7. Effects on ability to drive and use machines
No data is available on whether Flomaxtra XL adversely affects the ability to drive or operate machines. However, in this respect patients should be aware of the fact that drowsiness, blurred vision, dizziness ...
4.8. Undesirable effects
<b>Tabulated list of adverse reactions:</b> System Organ Class Common<br /> >1/100, <1/10 Uncommon<br /> >1/1000, <1/100 Rare<br /> >1/10,000, <1/1000 Very Rare<br /> <1/10,000 Not known<br /> (cannot ...
4.9. Overdose
Symptoms Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects, dizziness and malaise. Severe hypotensive effects have been observed at different levels of overdosing. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Alpha<sub>1</sub>-adrenoceptor antagonist <b>ATC code:</b> G04CA02. Preparations for the exclusive treatment of prostatic disease. Mechanism of action Tamsulosin binds ...
5.2. Pharmacokinetic properties
Absorption Flomaxtra XL is formulated as an Oral Controlled Absorption System (OCAS) and is a prolonged release tablet of the non-ionic gel matrix type. Tamsulosin hydrochloride administered as prolonged ...
5.3. Preclinical safety data
Single and repeat dose toxicity studies were performed in mice, rats and dogs. In addition, reproduction toxicity studies were performed in rats, carcinogenicity in mice and rats, and in vivo and in vitro ...
6.1. List of excipients
<u>Core:</u> Macrogol (containing butylhydroxytoluene) Magnesium stearate <u>Film-coat:</u> Hypromellose Macrogol Yellow iron oxide (E172)
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
There are no special storage instructions.
6.5. Nature and contents of container
Aluminium foil blister packs containing 30 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom
8. Marketing authorization number(s)
PL 00166/0199
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 July 2005 Date of latest renewal: 07 April 2009
10. Date of revision of the text
11 November 2019
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