OMSULA Prolonged-release capsule, hard (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Omsula 0.4 mg prolonged-release capsules, hard.
2. Qualitative and quantitative composition
Each prolonged-release capsule, hard contains 0.4 mg tamsulosin hydrochloride. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release capsule, hard. White or off-white pellets are filled in the capsules with size No. 2 (about 18 mm lengthwise and 6.3 mm in external diameter), which upper part is brown opaque, lower ...
4.1. Therapeutic indications
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
4.2. Posology and method of administration
Posology One capsule daily. Use in renal impairment No dose adjustment is warranted in renal impairment (see section 4.4). Use in hepatic impairment No dose adjustment is warranted in patients with mild ...
4.3. Contraindications
Hypersensitivity to the active substance, including drug-induced angioedema or to any of the excipients listed in section 6.1. A history of orthostatic hypotension. Severe hepatic insufficiency.
4.4. Special warnings and precautions for use
As with other α<sub>1</sub>-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin as a result of which, rarely, syncope can occur. At the ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril, or theophylline. Concomitant ...
4.6. Fertility, pregnancy and lactation
Omsula 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 and ejaculation ...
4.7. Effects on ability to drive and use machines
No data is available on whether Omsula 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
The adverse reactions are described according to the MedDRA system organ class in the table below. MedDRA<br />System Organ Class Common<br />(≥1/100 to <1/10) Uncommon<br />(≥1/1,000 to <1/100) Rare ...
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> Urologicals, Alpha-adrenoreceptor antagonists (preparations for the exclusive treatment of prostatic disease) <b>ATC code:</b> G04CA02 Mechanism of action Tamsulosin binds ...
5.2. Pharmacokinetic properties
Absorption Tamsulosin is absorbed from the intestine and is almost completely bioavailable. Absorption of tamsulosin is reduced by a recent meal. Uniformity of absorption can be promoted by the patient ...
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 <em>in vivo</em> and ...
6.1. List of excipients
<u>Capsule content:</u> Microcrystalline cellulose Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent (including: polysorbate 80 sodium laurylsulfate) Talc Triethyl citrate Calcium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters. The blisters are packed into folding box with a package leaflet. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
8. Marketing authorization number(s)
PL 04854/0134
9. Date of first authorization / renewal of the authorization
14/12/2012
10. Date of revision of the text
07/01/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
