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Active ingredient
- pumpkin seed oil
- pumpkin seed, crushed
Legal Category
GSL: General Sales List
This information is intended for use by health professionals
1. Name of the medicinal product
Urostemol capsules
2. Qualitative and quantitative composition
Each hard 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
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 related to an overactive bladder or bladder weakness, such as urgency to urinate, urinary incontinence, frequent urination, based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adults and the elderly
One capsule to be taken three to five times 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.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 water melon, 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 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 the use in pregnant women (see section 4.6) 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 reactionsVery 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
No mutagenicity was observed in Ames tests conducted with this product.
Studies on carcinogenicity and reproductive toxicity have not been performed.
6. Pharmaceutical particulars
6.1 List of excipients
GelatinTitanium dioxide (E 171)
Iron oxide red (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
PVC-aluminium-blister.Packs of 50, 100 or 160 hard capsules.Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
Omega Pharma Ltd.
1st Floor32 Vauxhall Bridge Road LONDON, SW1V 2SAUnited Kingdom
8. Marketing authorisation number(s)
THR 02855/0239
9. Date of first authorisation/renewal of the authorisation
24/04/2015
10. Date of revision of the text
29/05/2015
