Package Leaflet: Information for The User

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Puncto® Prosta capsules

Pumpkin seed extract 122.5 mg

In this leaflet:

1.    What Puncto® Prosta is and what it is used for

2.    Before you take Puncto® Prosta

3.    How to take Puncto® Prosta

4.    Possible side effects

5.    How to store Puncto® Prosta

6.    Further information

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1.    What Puncto Prosta is and what

it is used for

Puncto® Prosta is a traditional herbal medicinal product used for the relief of lower urinary tract symptoms such as frequent urge to urinate with or without pain, urine incontinence, and inability of urine retention, in women who suffer from irritable bladder symptoms. Prior to treatment other serious conditions should have been ruled out by a doctor.

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2.    Before you take Puncto Prosta

2.1    Do not take Puncto® Prosta

If you are allergic (hypersensitive) to

•    the active substance or other members of the Cucurbitaceae family,

•    any of the excipients,

•    peanut or soya as this product contains soya oil.

(see section 6: Further information).

2.2    Take special care with Puncto® Prosta

For oral administration.

Do not exceed the stated dose.

This product is intended for use in men who have had benign prostatic hyperplasia (BPH) already diagnosed by a medical practitioner.

If symptoms worsen a doctor or qualified healthcare practitioner should be consulted. You must see your doctor immediately if:

• you have blood in your urine

• you have fever.

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.

2.3    Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

2.4    Pregnancy and breast-feeding

Do not take this product if you are pregnant or breast feeding. It is for use in men only.

2.5    Driving and using machines

No special precautions are needed. This medicine should have no effect on your ability to drive and use machines.

3. How to take Puncto Prosta

Always use Puncto® Prosta exactly as instructed. You should check with your doctor or pharmacist if you are not sure.

3.1 How much Puncto® Prosta to take

Remember to always take this medicine with 1-2 glasses of water. The capsules should be swallowed whole and not chewed.

Please ask your doctor or pharmacist if you think that Puncto® Prosta may be too strong or weak for you.

3.2    Adults and the elderly:

One capsule to be taken three times a day.

Children and adolescents under 18 years of age:

This medicine is not recommended in children and adolescents under 18 years.

3.3    If you take more Puncto® Prosta than

you should

If you have accidentally taken more than the recommended dosage of Puncto® Prosta this usually will not have any side effects. Continue to take the usual dose at the usual time.

3.4    If you forget to take Puncto® Pumpkin

Never take a double dose to make up for a missed dose. Take the next dose at the usual time. Always take with 1-2 glasses of water.

If you have any further questions about taking this medicine, please ask your doctor, pharmacist, or qualified healthcare practitioner.

4. Possible side effects

Like all medicines, Puncto® Prosta can cause side effects, although not everybody gets them.

Allergic reactions may occur in rare cases. The frequency is not known.

If you get any of these signs you must not take any more of this medicine. Usually if you stop taking the medicine any side effects will disappear.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. How to store Puncto Prosta

Keep out of the reach and the sight of children.

Do not use the capsules after the expiry date on the carton and the blister strip. The expiry date is the last day of that month.

Do not store above 25°C. Store in the original package.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Further Information

What Puncto® Prosta contains

122.5 mg of extract (as dry extract) (26-31:1) from pumpkin seeds (Cucurbits pepo L.), Extraction solvent: Ethanol 60% m/m.

Also contains: Soya bean oil (108 mg) and sorbitol (6.4 mg).

The other ingredients are:

Maltodextrin, palm kernel oil, lecithin, coconut oil, yellow beeswax, gelatin, glycerol, purified water, titanium dioxide E 171, iron oxide yellow E172.

What Puncto® Prosta looks like and contents of the pack

Puncto® Prosta are yellow-beige colour capsules with gloss and seams, odourless.

Puncto® Prosta comes in blister packs of 40, 60 or 120 capsules per package.

Marketing Authorisation Holder and Manufacturer

THR Holder:

PlantaPhile Ltd., 18 Hyde Gardens, Eastbourne, East Sussex, BN21 4PT, UK

Manufacturer: Grunwalder Gesundheits-produkte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.

THR 32294/0018 certification mark

You can help to make medicines safer by reporting any side effects to the YellowCard Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper YellowCard form from your GP's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).

For a large print, Braille or audio version of this leaflet, please contact: PlantaPhile Ltd., 18 Hyde Gardens, Eastbourne, East Sussex, BN21 4PT, UK.

This leaflet was last revised in May 2012.

® Registered Trade Mark