Document: leaflet HEALTHSPAN_THR 18397-0008 change

• leaflet HEALTHSPAN_THR 18397-0008
• leaflet MAH BRAND_THR 18397-0008

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•You have blood in your urine • You have a fever

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

5: How to store this product

Do not use your capsules after the expiry date. Return any out-of-date capsules to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

This product does not require any special storage conditions.

Keep the capsules out of the reach and sight of children.

Keep your capsules in the blister pack until it is time to take them.

6: Further information

Each soft capsule of this product contains 160mg of extract (as soft extract) from Saw Palmetto Fruit (Serenoa repens (Bartram) Small fructus (Sabalserrulata (Michaux) Nichols fructus)) (10-14:1). Extraction solvent: Ethanol 90% m/m. This product also contains the following ingredients:

Succinylated gelatine, glycerol, purified water.

Each pack contains 90 soft capsules.

Registration holder and manufacturer of this product

Swiss Caps GmbH, Grassingerstrafte 9 D-83043 Bad Aibling, Germany.

Traditional herbal registration number:THR 18397/0008.

If you would like further information about this product, please contact: Healthspan Ltd, PO Box 64, Guernsey, GY1 1BT

Patient Information Leaflet

Healthspan Saw Palmetto ProstAid*

Capsules

Saw Palmetto Fruit Extract 160mg

Please read this leaflet carefully before you start taking these capsules.

It contains some important information about Healthspan Saw Palmetto ProstAid.

This medicine is available without prescription. It is for use in men only. However, before using Healthspan Saw Palmetto ProstAid you must have been told by your doctor that you have an enlarged prostate (also known as benign prostatic hypertrophy or BPH).You need to take Healthspan Saw Palmetto ProstAid carefully to get the best results from it.

Keep this leaflet with the capsules.

You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet

1: What this product is and what it is used for    page 2

2: Before you take this product    page 2

3: How to take this product    page 3

4: Possible side-effects    page 3/4

5: How to store this product    page 4

6: Further information    page 4

07.04.2011 Proposed PIL

1: What this product is and what it is used for

Healthspan Saw Palmetto ProstAid is a traditional herbal medicinal product used to relieve urinary discomfort in men with an enlarged prostate (also known as benign prostatic hypertrophy or BPHj.This is based on traditional use only.

Used to help relieve symptoms including:

•    the need to urinate frequently (especially at night)

•    weak or interrupted urinary flow

•    a feeling that you cannot empty your bladder completely

Healthspan Saw Palmetto ProstAid is for use in men only. An enlarged prostate is also known as BPH. The prostate gland is found just below the bladder in men. As men get older this gland may enlarge causing urinary discomfort.

2: Before you take this product

You must have been told by your doctor that you have BPH. This product is not intended for use in women.

Do not take Healthspan Saw Palmetto ProstAid if you:

•    are allergic to Saw Palmetto fruits or any of the other ingredients

•    are under 18 years of age

Take special care with Healthspan Saw Palmetto ProstAid.

Do not exceed the stated dose.You must contact your doctor if:

•    your symptoms of urinary discomfort worsen

•    you have blood in your urine

•    you have fever

Tell your doctor you are taking Healthspan Saw Palmetto ProstAid if you are due to undergo surgery.

Taking other medicines

If you are taking medication for an enlarged prostate talk to your doctor before using Healthspan Saw Palmetto ProstAid.

Pregnancy and breast-feeding

Do not use this product. It is for use in men only.

Driving and using machines

This product has no known effect on your ability to drive or use machines. Make sure you know how it affects you before you drive or use machinery.

3: How to take this product

Adults and the elderly

Take 1 capsule twice daily (in the morning and evening).

Swallow them whole with some water.

Healthspan Saw Palmetto ProstAid is not for use in children and adolescents less than 18 years.

If you take too much Healthspan Saw Palmetto ProstAid (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take Healthspan Saw Palmetto ProstAid

Continue to take your usual dose at the usual time; it doesn't matter if you have missed a dose.

If you stop taking Healthspan Saw Palmetto ProstAid

You can stop taking this product at any time.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

You must see your doctor or a qualified healthcare practitioner if your symptoms worsen, or if side effects not mentioned in this leaflet occur.

4: Possible side-effects

Like all medicines, Healthspan Saw Palmetto ProstAid can cause side effects, although not everybody gets them.

The following rare side effects (affecting more than 1 in 10,000 but fewer than 1 in 1,000 people) can occur when using Healthspan Saw Palmetto ProstAid:

•    Belching

•    Stomach discomfort

•Allergic reactions such as skin rashes

If any of these side effects become troublesome or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or qualified healthcare practitioner.

Remember to see your doctor if:

•Your symptoms of urinary discomfort worsen

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