Package Leaflet: Information for the User

HarpagoCaps

Soft Capsules

The active substance is Devil's Claw root extract 225mg.

In this leaflet:

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

2.    Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

1. WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

This product is a traditional herbal medicinal product containing Devil’s claw root.

One soft capsule contains 225 mg of extract (as dry extract) from Devil's claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix) (3-5:1).

Extraction solvent: Ethanol 60% V/V.

HarpagoCaps is a traditional herbal medicinal product used for:

Indication (a) the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints

Indication (b) digestive disorders such as bloating and

flatulence and where there is loss of appetite This is based on traditional use only.

2. BEFORE YOU TAKE THIS PRODUCT Do not take this product if you

•    are allergic to Devil's claw or any of the other ingredients

•    are allergic to peanut or soya

•    are lactose-intolerant (react badly to lactose or milk)

•    are fructose-intolerant (react badly to some sugars)

•    have ever had or are suffering from stomach or duodenal ulcer

•    are under 18 years of age

Take special care with this product

Do not exceed the stated dose.

You must contact a doctor or qualified healthcare practitioner if

•    your joint pain is accompanied by swelling of the joint, redness or fever

•    you have heart problems and want to take HarpagoCaps

•    your symptoms persist for more than 2 weeks or worsen during the use of HarpagoCaps

This formulation is not suitable for children and adolescents under 18 years of age.

Taking other medicines

You can use HarpagoCaps with other medicines.

Pregnancy and breast-feeding

Do not take this product if you are pregnant or breast-feeding.

Driving and using machines

In rare cases HarpagoCaps may cause dizziness and drowsiness. If this happens to you, do not drive or use machines.

3. HOW TO TAKE THIS PRODUCT

You should speak to your doctor, pharmacist or healthcare practitioner if you are not sure if this product is suitable for you.

Adults

For full details of the indications (uses) see in Section 1 above. Indication (a)

Take 1 soft capsule 2-3 times daily, half an hour before a meal. Indication (b)

Take 1 soft capsule twice daily, half an hour before a meal.

The product is not for use in children and adolescents under 18 years.

For oral use only.

Duration of use

For full details of the indications (uses) see in Section 1 above.

Indication (a)

Do not take HarpagoCaps for more than 4 weeks.

Indication (b)

Do not take HarpagoCaps for more than 2 weeks.

If you take more of this product than you should

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 forgot to take this product

Continue to take your usual dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

4. POSSIBLE SIDE EFFECTS

HarpagoCaps can cause side effects, although not everybody gets them. Stop taking this product and check with your doctor, pharmacist or qualified healthcare practitioner if any of the following side effects occur:

Digestive disorders

•    diarrhoea

•    feeling sick

•    vomiting

•    abdominal pain

Central nervous system disorders

•    headache

•    dizziness

Skin disorders

•    allergic skin reactions (rash and itching)

The frequency of these side effects is not known.

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

5. HOW TO STORE THIS PRODUCT

Keep out of sight and reach of children.

Do not use HarpagoCaps after the expiry date which is stated on the blister. The expiry date refers to the last day of that month.

HarpagoCaps 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

6. FURTHER INFORMATION What this product contains

One soft capsule contains 225 mg of extract (as dry extract) from Devil's claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix) (3-5:1).

Extraction solvent: Ethanol 60% V/V.

This product also contains the following ingredients

Herbal preparation:

Lactose monohydrate, precipitated silicon dioxide Soft capsule:

Refined soya-bean oil, refined coconut oil, fractionated palm kernel oil, yellow beeswax, phospholipids from soya beans (lecithin), butter fat, gelatin, glycerol, anidrisorb 85/70 (partially dehydrated sorbitol), ferric (III)-hydroxide-oxide (ferric oxide yellow) (E 172), purified water.

What this product looks like and contents of the pack

HarpagoCaps are oval-shaped tawny-coloured soft capsules. They are available in packs of 30, 50, 60, 90 and 100 soft capsules. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder and Manufacturer

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

For any information about this product, please contact the local representative of the Marketing Authorisation Holder:

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

This leaflet was last approved in March 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)