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SPC, UK: VESICARE Oral suspension (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Vesicare 1 mg/ml oral suspension.

Qualitative and quantitative composition

Vesicare oral suspension contains 1 mg/ml solifenacin succinate, equivalent to 0.75 mg/ml solifenacin. Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.6 mg/ml. Propyl parahydroxybenzoate ...

Pharmaceutical form

Oral suspension. A white to off-white coloured aqueous, homogeneous suspension with an orange flavour.

Therapeutic indications

Overactive bladder in adults Vesicare oral suspension is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive ...

Posology and method of administration

Posology Overactive bladder Adults, including elderly The recommended dose is 5 mg (5 ml) solifenacin succinate once daily. If needed, the dose may be increased to 10 mg (10 ml) solifenacin succinate once ...

Contraindications

When used for treatment of overactive bladder solifenacin is contraindicated in patients with urinary retention. When used for treatment of overactive bladder or neurogenic detrusor overactivity solifenacin ...

Special warnings and precautions for use

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should ...

Interaction with other medicinal products and other forms of interaction

Pharmacological interactions Concomitant medication with other medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval ...

Fertility, pregnancy and lactation

Pregnancy No clinical data are available from women who became pregnant while taking solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal/foetal development or parturition ...

Effects on ability to drive and use machines

Since solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue (see Section 4.8. Undesirable effects), the ability to drive and use machines may be negatively ...

Undesirable effects

Summary of the safety profile Due to the pharmacological effect of solifenacin, solifenacin may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic ...

Overdose

Symptoms Overdosage with solifenacin can potentially result in severe anticholinergic effects. The highest dose of solifenacin accidentally given to a single patient was 280 mg in a 5-hour period, resulting ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals, Drugs for urinary frequency and incontinence ATC code: G04BD08 Mechanism of action Solifenacin is a competitive, specific cholinergic-receptor antagonist. The urinary ...

Pharmacokinetic properties

Absorption After oral intake of solifenacin by adults, maximum solifenacin plasma concentrations (C<sub>max</sub>) are reached after 4 to 12 hours. The t<sub>max</sub> is independent of the dose. The C ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryofetal development, genotoxicity, and carcinogenic potential. ...

List of excipients

Polacrilin potassium Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Propylene glycol (E1520) Simethicone emulsion 30%; consisting of simethicone, polyethylene glycol sorbitan tristearate ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or food.

Shelf life

Shelf life: 2 years. After first opening of the bottle, the oral suspension can be stored for 28 days.

Special precautions for storage

Store in the original bottle in order to protect from light. This product does not require any special temperature storage conditions.

Nature and contents of container

150 ml Vesicare oral suspension in amber polyethylene terephthalate (PET) bottle with polyethylene (PE) screw-cap with a pulp and vinylseal liner, packed in a carton.

Special precautions for disposal and other handling

No special requirements. Discard any medicine remaining after 28 days after opening the bottle. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Marketing authorization number(s)

PL 00166/0406

Date of first authorization / renewal of the authorization

28/06/2015

Date of revision of the text

02/2018

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