Urostemol Femina Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urostemol femina capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
227.3 mg of Pumpkin seed oil (Cucurbitapepo L. convar. citrullina I. Greb. var.
styriaca I. Greb),
56 mg of extract (as dry extract) of Fragrant Sumach bark (Rhus aromatica Aiton) (57 : 1), extraction solvent water,
18 mg of extract (as dry extract) of Hop strobile (Humulus lupulus L.) (5.5-6.5 : 1), extraction solvent water.
Also contains: glucose syrup (24 mg) and partially hydrogenated soya-bean oil (47mg) (see Section 4.4. Special warnings and precautions for use).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Red-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 women related to an overactive bladder or bladder weakness, such as urgency to urinate, urinary incontinence, frequent urination based on traditional use only.
For oral use only
Adults and the elderly
One capsule to be taken three times per 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.
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 substances, to other members of the Cucurbitaceae family (such as watermelon, courgettes etc.), soya, peanuts, or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen after 7 days of use, or persist after 4 weeks of use, the patient should consult a doctor or a qualified healthcare practitioner.
If symptoms such as fever, spasms, blood in the urine, urinary retention, painful urination, loin pain, abdominal or back pain or vaginal discharge are present or develop during the use of this medicinal product, the patient should consult a doctor or a qualified healthcare practitioner, in order to exclude any underlying serious medical condition.
The use in children and adolescents under 18 years of age and pregnant women (see section 4.6) is not recommended, because lower urinary tract symptoms in these populations require medical supervision.
Patients with rare glucose-galactose malabsorption should not take this medicine.
This product contains soya-bean oil and should not be used by patients who are allergic to peanuts or soya.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
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
May impair ability to drive and use machines. Affected patients should not drive or operate machinery.
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.
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
No mutagenicity was observed in an Ames test conducted with this product. Studies on carcinogenicity and reproductive toxicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
RRR-alpha-Tocopheryl acetate
Partially hydrogenated soya-bean oil
Beeswax, yellow
Gelatin
Glycerol
Glucose liquid, spray dried
Lecithin
Maltodextrin
Titanium dioxide (E 171)
Iron oxide red (E172)
Iron oxide yellow (E172)
6.2 Incompatibilities
Not applicable.
36 months
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
PV C/PE/PVdC-aluminium-blister. Packs of 30, 60 or 120 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 02855/0242
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/04/2015
10 DATE OF REVISION OF THE TEXT
29/05/2015