URAPLEX Coated tablet (2016)

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

Περιεχόμενα

1. Name of the medicinal product

Uraplex 20mg Coated Tablets.

2. Qualitative and quantitative composition

The active ingredient is trospium chloride. Each coated tablet contains 20 mg trospium chloride. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Coated tablet. Brownish-yellow, glossy coated, biconvex tablets.

4.1. Therapeutic indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).

4.2. Posology and method of administration

For oral administration. One coated tablet twice daily (equivalent to 40 mg of trospium chloride per day). In patients with severe renal impairment (creatinine clearance between 10 and 30 mL/min/1.73 m²) ...

4.3. Contraindications

Uraplex is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia. Uraplex is ...

4.4. Special warnings and precautions for use

Uraplex should be used with caution by patients: with obstructive conditions of the gastrointestinal tract such as pyloric stenosis with obstruction of urinary flow with the risk of formation of urinary ...

4.5. Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions The following potential pharmacodynamic interactions may occur: potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants), ...

4.6. Pregnancy and lactation

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). In rats, placental transfer ...

4.7. Effects on ability to drive and use machines

Principally, disorders of accommodation can lower the ability to drive and to use machines. However, examinations of parameters characterising the ability to drive (visual orientation, general ability ...

4.8. Undesirable effects

Undesirable effects observed with trospium chloride such as dry mouth, dyspepsia and constipation mainly reflect the typical anticholinergic properties of the active ingredient. In clinical studies, dry ...

4.9. Overdose

After the administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Urinary Antispasmodic ATC code: G04BD09 Trospium chloride is a quaternary derivative of nortropane and therefore belongs to the class of parasympatholytic or anticholinergic ...

5.2. Pharmacokinetic properties

After oral administration of trospium chloride maximum plasma levels are reached at 4-6 hours. Following a single dose of 20 mg the maximum plasma level is about 4 ng/ml. Within the tested interval, 20 ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and toxicity to reproduction. Placental ...

6.1. List of excipients

Tablet core: Wheat starch Microcrystalline cellulose Lactose monohydrate Povidone Croscarmellose sodium Stearic acid Silica colloidal anhydrous Talc Tablet coat: Sucrose Carmellose sodium ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC foiled aluminium blister. Pack sizes approved: 2, 20, 28, 30, 40, 50, 56, 60, 90, 100, 120, 150, 200, 500, 600, 1000, 1200, 2000. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, United Kingdom

8. Marketing authorization number(s)

PL 15142/0287

9. Date of first authorization / renewal of the authorization

14/03/2011

10. Date of revision of the text

May 2016

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf