Medine.co.uk

Prostamen Soft Capsules

Document: leaflet MAH BRAND_THR 18397-0008 change

#

Saw palmetto soft capsules    SWISS CAPS GMBH    11.03.2010

Patient information Leaflet

PROSTAMEN soft capsules

Saw palmetto fruit extract

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

It contains some important information about Prostamen.

This medicine is available without prescription. It is for use in men only. However, before using Prostamen 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 Prostamen 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 healthcare practitioner.

What is in this leaflet:

1.    What Prostamen is and what it is used for

2.    Before you take Prostamen

3.    How to take Prostamen

4.    Possible side effects

5.    How to store Prostamen

6.    Further information

1. WHAT PRosTAMEN is AND WHAT iT is UsED FoR

Prostamen is a traditional herbal medicinal product used to relieve urinary discomfort in men with an enlarged prostate (also known as benign prostatic hypertrophy or BPH). 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.

Prostamen 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 prostamen

You must have been told by your doctor that you have BPH.

This product is not intended for use in women.

Do not take Prostamen if you

■    are allergic to Saw palmetto fruits or any of the other ingredients

■    are under 18 years of age

Take special care with Prostamen

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 Prostamen 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 Prostamen.

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 prostamen

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

Swallow them whole with some water.

Prostamen is not for use in children and adolescents less than 18 years.

if you take too much Prostamen (overdose)

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

Mock-up of the PIL

0004

Page 1 of 2

1 051997 Prostamen_mockup_E.indd 1

11.03.2010 13:47:25

#

Saw palmetto soft capsules    SWISS CAPS GMBH    11.03.2010

4. possible side-effects


certification mark


if you forget to take Prostamen

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

if you stop taking Prostamen

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.

Like all medicines, Prostamen 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 1000 people) can occur when using Prostamen:

■    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.

6. FURTHER iNFORMATiON

Each capsule of this product contains 160 mg of extract (as soft extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small fructus (Sabal serrulata (Michaux) Nichols fructus)) (10-14:1).

Extraction solvent: Ethanol 90 % (m/m).

Prostamen also contains the following ingredients: Succinylated gelatine, glycerol, purified water.

Each pack contains 50 or 100 soft capsules.

Not all pack sizes may be marketed.

Registration holder and manufacturer of Prostamen

Swiss Caps GmbH, GrassingerstraBe 9 D-83043 Bad Aibling, Germany

Traditional herbal registration number: THR 18397/0008

If you would like further information on this product, please contact:

Swiss Caps UK Ltd.

Suite 1 Old Coach House Robin Hoods Well Skelbrooke

Doncaster DN6 8LS - UK Tel: 44 (0) 1302 33 82 20 Fax: 44 (0) 1302 33 82 21

Remember to see your doctor if:

■    Your symptoms of urinary discomfort worsen

■    You have blood in your urine

■    You have a fever

5. how to store prostamen

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.

This leaflet was prepared in February 2010.

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).

Mock-up of the PIL

0004

Page 2 of 2

051997 Prostamen_mockup_E.indd 2

11.03.2010 13:47:25