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Natures Garden Devils Claw Capsules

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Document: leaflet NATURES GARDEN_THR 21710-0005 change

PATIENT INFORMATION LEAFLET


| NATURE’S GARDEN] Devil’s Claw Capsules Devil’s Claw Root Extract 427mg


Consult a Doctor or a qualified Healthcare Practitioner if you have:

U Heart problems and want to take Devil's Claw Capsules

U Joint pain accompanied by swelling of the joint, redness or fever


Important notes

U Please read this leaflet carefully before you use this product because it contains important information

U Keep this leaflet; you may need to read it again

U Seek professional advice if you need more information

U Please tell a Doctor or a qualified Healthcare

Practitioner if your symptoms worsen or do not improve after 4 weeks of taking this product

U Please tell a Doctor or a qualified

Healthcare Practitioner if you suffer from side effects not listed in this leaflet and/or if any of the side effects become serious


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 contains Devil's Claw root extract. It is a traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain and general aches and pains in the muscles and joints. This is based on traditional use only.


3 - How to take this product

For oral use only Adults and elderly:

Take 1 capsule 2 times daily.

Swallow the whole capsule with water. Take one capsule in the morning and one in the evening.

Do not exceed the stated dose.

If you take too much of the product (overdose): speak to a Doctor or a qualified Healthcare Practitioner immediately and take this leaflet and bottle with you.

If you forget to take this product: Do not take a double dose to make up for the missed dose(s).

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

Duration of use: If symptoms worsen or do not improve after 4 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.


2 - Before you take this product

Do not take this product if you are:

U Under 18 years of age U Pregnant or breastfeeding U Allergic to Devil's Claw or any of the ingredients listed in section 6 of this leaflet U Suffering from or have had duodenal or stomach ulcers

Effects on ability to drive and use machines:

Some patients may experience dizziness or drowsiness while taking Devil's claw root products, which may affect the ability to drive and use machines. If affected, do not drive or use machines.


4 - Possible side effects

Like all medicines, this product can have side effects. Possible side effects are:

U Gastrointestinal effects such as nausea (feeling sick), abdominal pain, diarrhoea and vomiting U Central nervous system effects such as headache and dizziness U Skin effects such as allergic skin reactions such as itching and/or rash

If any of the above side effects become serious or if you experience any other side effects not listed above, consult your Doctor, Pharmacist or a qualified Healthcare Practitioner.

If you experience any allergic reactions, stop taking this product and consult your Doctor.


More information on back panel


5 - How to store this product

U Keep the capsules in the bottle until it is time to take them

U Do not take the capsules after the expiry date (see outer label). The expiry date refers to the last day of the month.

U Do not store above 25°C U Store in the original packaging U Keep the bottle tightly closed U Keep the capsules out of sight and reach of children


6 - Further information

Each hard capsule contains 427mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix) (equivalent to I493mg-2l33mg of Devil’s Claw root).

Extraction solvent: Ethanol 60% v/v.

This product also contains the following inactive (excipient) ingredients: Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Silica colloidal hydrated. Excipients in the extract: Maltodextrin, Silica colloidal anhydrous.

Capsule shell: Hypromellose.

Each bottle contains 50 or I00 clear, hard, two piece capsules with grey/brown powder.

After taking this product: You must speak to a Doctor or a qualified Healthcare Practitioner if:

U Your symptoms get worse U Your symptoms do not improve after 4 weeks U Side effects not listed in this leaflet occur


THR 21710/0005

Traditional Herbal Registration Holder

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Manufacturer

NBTY Europe Limited Vitality House Sixth Avenue Centrum I00 Burton-on-Trent Staffordshire, DEI4 2WP United Kingdom

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

NBTY Europe Limited

Regulatory Services Department Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@NBTYeurope.com

You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call freephone 0808 100 3352

This leaflet was prepared on: 24/08/2011

THR

CERTIFICATION MARK


BM510-000 00A I38209-000