UROMAX D Film-coated tablet (2013)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
URIMAX D Tablets (Tamsulosin hydrochloride + Dutasteride).
2. Qualitative and quantitative composition
Each film-coated tablet contains: Tamsulosin Hydrochloride: 0.4 mg (as modified-release tablets) Dutasteride: 0.5 mg The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder ...
3. Pharmaceutical form
Oral tablet.
4.1. Therapeutic indications
URIMAX D tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The tablets are not intended for use as an anti-hypertensive ...
4.2. Posology and method of administration
The recommended dose of URIMAX D is one tablet once daily with or without food. The tablet should be swallowed whole and should not be crushed or chewed. No dosage adjustment is required for subjects with ...
4.3. Contraindications
URIMAX D tablets are contraindicated for use in women of childbearing potential and during pregnancy. URIMAX D tablets are contraindicated for use in paediatric patients. URIMAX D tablets are contraindicated ...
4.4. Special warnings and precautions for use
General Evaluation of Other Urological Diseases Prior to initiating treatment with URIMAX D tablets, consideration should be given to other urological conditions that may cause similar symptoms. In addition, ...
4.5. Interaction with other medicinal products and other forms of interaction
Cytochrome P450 Inhibitors No clinical drug interaction trials have been performed to evaluate the impact of CYP3A enzyme inhibitors on dutasteride pharmacokinetics. However, based on in vitro data, blood ...
4.6. Pregnancy and lactation
Pregnancy Pregnancy Category X. URIMAX D tablets are not indicated for use in women. Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride is a 5 alpha-reductase ...
4.8. Undesirable effects
Clinical Trial Experience The clinical efficacy and safety of coadministered dutasteride and tamsulosin, have been evaluated in a multicenter, randomized, double-blind, parallel group trial (the Combination ...
4.9. Overdose
Overdosage with URIMAX D tablets could potentially lead to hypotension due to the tamsulosin hydrochloride component. In case of hypotension, support of the cardiovascular system is of first importance. ...
5.1. Pharmacodynamic properties
Tamsulosin Hydrochloride Mechanism of action Tamsulosin hydrochloride, an alpha1-adrenoceptor blocking agent, exhibits selectivity for alpha1-receptors in the human prostate. At least three discrete alpha1-adrenoceptor ...
5.2. Pharmacokinetic properties
Tamsulosin Hydrochloride Absorption Absorption of tamsulosin hydrochloride is essentially complete (>90%), following oral administration under fasting conditions. Tamsulosin hydrochloride exhibits linear ...
6.4. Special precautions for storage
Store in a cool, dry place.
6.5. Nature and contents of container
URIMAX D Tablets: Pack of 10 tablets.
10. Date of revision of the text
December 2013
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