UROSTEMOL CAPSULES

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PUMPKIN SEED, CRUSHED; PUMPKIN SEED OIL

Disponível em:

Chefaro Ireland DAC

DCI (Denominação Comum Internacional):

PUMPKIN SEED, CRUSHED; PUMPKIN SEED OIL

Dosagem:

400mg/340 Milligram

Forma farmacêutica:

Capsules Hard

Tipo de prescrição:

Product not subject to medical prescription

Status de autorização:

Authorised

Data de autorização:

2016-10-07

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
UROSTEMOL capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg of pumpkin seed, crushed (_Cucurbita
pepo_ L. convar._ citrullina_ I_._ Greb. var._ styriaca_ I.
Greb), 340 mg of pumpkin seed oil (_Cucurbita pepo_ L. convar._
citrullina_ I_._ Greb. var._ styriaca_ I. Greb).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Red-brown gelatin hard capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of lower
urinary tract symptoms related to an overactive
bladder or bladder weakness, such as urgency to urinate, urinary
incontinence or frequent urination. This is exclusively
based on long-standing use.
Prior to treatment, other serious conditions should have been ruled
out by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly patients_
One capsule to be taken three to five times a day.
_Paediatric population_
The use in children and adolescents under 18 years of age is not
recommended (see section 4.4).
Method of administration
For oral use only.
The capsules should be taken with sufficient fluids, ideally before
meals.
Due to a lack of data, the safety of this product for long term use
has not been established.
If symptoms worsen during use or persist after 4 weeks of use a
qualified healthcare professional e.g. a doctor or
pharmacist should be consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to other members of the
Cucurbitaceae family (such as watermelon,
courgettes etc.), or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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