VESOMNI Modified release tablets (2019)
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Περιεχόμενα
1. Name of the medicinal product
Vesomni 6 mg/0.4 mg modified release tablets.
2. Qualitative and quantitative composition
Each tablet contains a layer of 6 mg solifenacin succinate, corresponding to 4.5 mg solifenacin free base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base. ...
3. Pharmaceutical form
Modified release tablet Each tablet is round, approximately 9 mm in diameter, red film-coated and debossed with 6/0.4.
4.1. Therapeutic indications
Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding ...
4.2. Posology and method of administration
Adult males, including older people One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or without food. The maximum daily dose is one Vesomni tablet (6 mg/0.4 mg). The tablet must be swallowed ...
4.3. Contraindications
Patients with hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1, Patients undergoing haemodialysis (see section 5.2), Patients with severe hepatic impairment ...
4.4. Special warnings and precautions for use
Vesomni should be used with caution in patients with: severe renal impairment, risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, hiatus hernia/gastroesophageal ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant medication with any medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should ...
4.6. Fertility, pregnancy and lactation
Fertility The effect of Vesomni on fertility has not been established. Animal studies with solifenacin or tamsulosin do not indicate harmful effects on fertility and early embryonic development (see section ...
4.7. Effects on ability to drive and use machines
No studies on the effects of Vesomni on the ability to drive or use machines have been performed. However, patients should be informed about the possible occurrence of dizziness, blurred vision, fatigue ...
4.8. Undesirable effects
Summary of the safety profile Vesomni may cause anticholinergic undesirable effects of, in general, mild to moderate severity. The most frequently reported adverse reactions during the clinical studies ...
4.9. Overdose
Symptoms Overdosage with the combination of solifenacin and tamsulosin can potentially result in severe anticholinergic effects plus acute hypotension. The highest dose taken accidentally during a clinical ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: alpha-adrenoceptor antagonists ATC code: G04CA53 Mechanism of action <u>Vesomni</u> is a fixed dose combination tablet containing two active substances, solifenacin and tamsulosin. ...
5.2. Pharmacokinetic properties
Vesomni The information below presents the pharmacokinetic parameters after multiple dosing of Vesomni. A multiple dose relative bioavailability study demonstrated that the administration of Vesomni results ...
5.3. Preclinical safety data
Non-clinical studies have not been conducted with Vesomni. Solifenacin and tamsulosin have been extensively evaluated individually in animal toxicity tests and findings were consistent with the known pharmacological ...
6.1. List of excipients
Mannitol (E421) Maltose Macrogol 7.000.000 Macrogol 8000 Magnesium stearate (E470b) Butylhydroxytoluene (E321) Colloidal silica anhydrous (E551) Hypromellose (E464) Iron oxide red (E172)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
The medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Aluminium blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Astellas Pharma Ltd., SPACE, 68 Chertsey road, Woking, Surrey, GU21 5BJ, UK
8. Marketing authorization number(s)
PL 00166/0404
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 May 2013 Date of latest renewal: 06 May 2018
10. Date of revision of the text
11 November 2019
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