PACKAGE LEAFLET: INFORMATION FOR THE USER

PhytoCon SABAL FORTE Capsules

Saw palmetto fruit extract 320 mg

In this leaflet:

1: What PhytoCon SABAL FORTE Capsules are and what these are used for 2: Before you take

PhytoCon SABAL FORTE Capsules 3: How to take

PhytoCon SABAL FORTE Capsules 4: Possible side-effects 5: How to store

PhytoCon SABAL FORTE Capsules 6: Further information

1.    What PhytoCon SABAL FORTE Capsules are and what these are used for

A traditional herbal medicinal product used to relieve the symptoms of urinary tract discomfort in men who have been told that they have an enlarged prostate (benign prostatic hypertrophy or BPH). This is based on traditional use only.

Used to help relieve symptoms including:

-    Feeling like you need to pass urine more often, especially at night

-    When you pass urine, the flow of urine is weak or interrupted

-    Feeling that you cannot empty your bladder completely

Enlargement of the prostate is also termed benign prostatic hypertrophy (BPH).The prostate gland is only present in men and is located just below the bladder. This gland may be enlarged as men get older and cause urinary discomfort.

2.    Before you take

PhytoCon SABAL FORTE Capsules

Do not take PhytoCon SABAL FORTE Capsules if you:

•    are allergic (hypersensitive) to Saw palmetto or any of the other ingredients of PhytoCon SABAL FORTE Capsules (see section 6 for a full list of ingredients)

•    are under 18 years of age. This product is not suitable for this age group.

Take special care with PhytoCon SABAL FORTE Capsules

Before you take PhytoCon SABAL FORTE Capsules a doctor must have told you that you have an enlarged prostate (benign prostatic hypertrophy or BPH). Other serious conditions should have been ruled out by your doctor.

You should see your doctor if your symptoms of urinary discomfort worsen or persist.

Your doctor may have done a blood test for prostatic specific antigen (PSA). It is unlikely that this product will alter your levels of PSA.

Contact your doctor immediately:

•    if there is blood in your urine

•    if you have a fever

Tell your doctor that you are taking PhytoCon SABAL FORTE Capsules if you are due to undergo surgery.

Taking other medicines

If you are already taking medicines for an enlarged prostate (BPH) consult your doctor before taking PhytoCon SABAL FORTE Capsules as this product may not be suitable for you.

You can use this product with any other medicines.

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. If affected do not drive.

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3. How to take

PhytoCon SABAL FORTE Capsules

For oral use only.

Adults and the elderly

1 capsule daily.

Swallow the capsule with food.

Not suitable for use in children and adolescents under 18 years of age.

Do not exceed the stated dose.

If you take more PhytoCon SABAL FORTE Capsules than you should

If you take more than the recommended dose, speak to a doctor and take this leaflet with you. It is not likely to be harmful if you take too much of this product.

If you forget to take

PhytoCon SABAL FORTE Capsules

Continue to take your usual dose at the usual time, it does not matter if you have missed a dose.

If you stop taking

PhytoCon SABAL FORTE Capsules

The use of this product can be stopped at any time.

If you have any further questions on the use of this product, ask your doctor or qualified healthcare practitioner or pharmacist.

4. Possible side-effects

Like all medicines, PhytoCon SABAL FORTE Capsules can cause side-effects, although not everybody gets them. They are listed below.

•    Belching

•    Stomach discomfort

•    Allergic reactions such as skin rashes

Discontinue use if the side effects are troubling.

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

Remember to see your doctor:

-    if your symptoms of urinary discomfort worsen or persists

-    if there is blood in your urine

-    if you have a fever

5. How to store

PhytoCon SABAL FORTE Capsules

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

-    Do not use this product after the expiry date which is stated on the box and the blister pack.

-    Do not use the product when you notice a change in the colour of the capsules.

-    This product does not require any special storage conditions.

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What PhytoCon SABAL FORTE Capsules contain

The active substance is Saw palmetto fruit extract.

Each soft capsule contains 320 mg of extract (as soft extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small) (9-11:1). Extraction solvent: ethanol 96 % (V/V).

The other ingredients are:

Gelatin polysuccinate, Glycerol, Purified water, Titanium dioxide (E 171), Ferric oxide (E 172)

What PhytoCon SABAL FORTE Capsules look like and contents of the pack

PhytoCon SABAL FORTE Capsules are oval-shaped, ochre coloured soft capsules containing a yellow-brown, oily mass.

Each pack contains 15, 20, 30, 60, 90, or 100 capsules.

Not all pack sizes maybe marketed.

Traditional Registration holder

PhytoCon GmbH & Co KG Koblenzer Str. 48-56 56626 Andernach Germany

Manufacturer of the finished product and batch release site:

C.PM. ContractPharma GmbH & Co. KG Fruhlingstrasse 7 83620 Feldkirchen-Westerham Germany

Traditional herbal registration number: THR 34863/0003

THR Certification Mark

If you would like further information

about this product, please contact:

PhytoCon GmbH & Co KG

Koblenzer Str. 48-56

56626 Andernach

Germany

Telephone: +49 (0) 2632-924-310

This leaflet was last approved in Februar 2011.

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 to Friday).

The leaflet is available in large print or audio version.