Summary of medicine characteristics - PUNCTO PROSTA CAPSULES
Puncto Prosta capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
122.5 mg of extract (as dry extract) (26–31:1) from pumpkin seeds (Cucurbita pepo L.), Extraction solvent: Ethanol 60% m/m.
Also contains: Soya bean oil (108 mg) and sorbitol (6.4 mg).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, soft.
Yellow-beige colour capsules with gloss and seams, odourless.
4.1 Therapeutic indications
Traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of enlarged prostate (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 administration.
The capsules should be swallowed whole with 1–2 glasses of water. Do not chew the capsules.
Adults and the elderly
One capsule to be taken three times a day.
Children and adolescents under 18 years of age
This product is not indicated in patients under 18 years of age.
4.3 Contraindications
Hypersensitivity to the active substance or other members of the Cucurbitaceae family.
Hypersensitivity to any of the excipients.
Hypersensitivity to peanut or soya as this product contains soya oil.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
This product is intended for use in men who have had benign prostatic hyperplasia already diagnosed by a medical practitioner.
If symptoms worsen a doctor or qualified healthcare practitioner should be consulted.
If symptoms include haematuria or pyrexia medical advice must be sought immediately.
Patients taking medication for Benign Prostatic Hyperplasia should consult their doctor before using the product.
This product contains soya oil and should not be used by patients who are allergic to peanut or soya.
This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this product.
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
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.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Allergic reactions may occur in rare cases. Discontinue immediately if hypersensitivity occurs.
The frequency is not known.
If other adverse effects not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
4.9 OverdoseNo cases of overdose have been reported. Supportive and symptomatic treatment should be provided as appropriate.
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
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6.1
Extract:
maltodextrin
Capsule filling: soy-bean oil, palm kernel oil, lecithin, coconut oil, yellow beeswax
Capsule shell: gelatin, glycerol, purified water, sorbitol, titanium dioxide E 171, iron oxide yellow E172
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
6.5 Nature and contents of containerPVC/PVDC-Al blister strips in cardboard carton.
Packs of 40, 60 or 120 capsules per package.
6.6 Special precautions for disposal No special requirements.
7 MARKETING AUTHORISATION HOLDER
PlantaPhile Ltd.,
18 Hyde Gardens,
Eastbourne, East Sussex,
BN21 4PT,
UK.
8 MARKETING AUTHORISATION NUMBER(S)
THR 32294/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
23/05/2012