Urostemol Prosta Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urostemol Prosta capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
500 mg of Pumpkin seed soft extract (Cucurbitapepo L. convar. citrullina I. Greb. var. styriaca I. Greb) (15-25 : 1), Extraction solvent: ethanol 92% (m/m).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Brown gelatin capsules, hard.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men related to an overactive bladder, such as urgency to urinate and frequent urination, or who have a confirmed diagnosis of benign prostatic hyperplasia (BPH), based on traditional use only.
Prior to treatment, other serious conditions should have been ruled out by a doctor.
4.2 Posology and method of administration
For oral use only.
Adults and the elderly:
One capsule to be taken twice a day.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use.’).
Method of administration
The capsules should be taken with water, ideally before meals.
Duration of use
Long-term use is possible on the advice of a doctor or qualified healthcare practitioner (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to the active substance, to other members of the Cucurbitaceae family (such as watermelon, courgettes etc.), or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen, or if symptoms such as fever, spasms, blood in urine, painful urination, urinary retention, loin pain, abdominal or back pain occur during the use of the medicinal product, the patient should consult a doctor or qualified healthcare practitioner.
Patients with confirmed benign prostatic hyperplasia (BPH)
This product is intended for men who have had benign prostatic hyperplasia (BPH) already diagnosed by a medical practitioner. Patients taking medication for benign prostatic hyperplasia (BPH) should consult their doctor before taking this product.
The use in children and adolescents under 18 years of age is not recommended, because lower urinary tract symptoms in these populations require medical supervision.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No studies on the effects on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
The following convention has been used for the classification of the adverse reactions.
Very common (>1/10)
Common (>1/100 to <1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10,000)
not known (cannot be estimated from the available data)
Mild gastrointestinal complaints such as abdominal pain, dyspepsia, nausea, vomiting, stomach discomfort, dysphagia, oesophageal pain and diarrhoea have been reported. The frequency is common (4%).
There have been post marketing reports of allergic reactions such as rash, urticaria, erythema, pruritus, oedema and anaphylactic shock. The frequency is not known. If these occur, discontinue use.
If other adverse reactions not mentioned above occur, the patient should consult a doctor or pharmacist.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
No cases of an overdose were reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Tests on reproductive toxicity, carcinogenicity and genotoxicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica, hydrophobic colloidal Gelatin
Iron oxide, black (E 172)
Iron oxide, red (E 172)
Iron oxide, yellow (E 172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original package.
6.5 Nature and contents of container
PV C/PV dC-aluminium-blister.
Packs of 20, 40, 80 or 140 hard capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 02855/0241
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/04/2015
10 DATE OF REVISION OF THE TEXT
29/05/2015