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Flexiherb Muscle & Joint Pain Relief Tablets

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FlexiHerb PIL 05-2014 5953-01 20/05/2014 18:45 Page 1

6: Further information

Each film-coated tablet contains 600mg of a dry aqueous extract of Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500mg of Devil’s Claw root)

This product also contains the following ingredients:

Powdered cellulose, lactose monohydrate, sodium starch glycolate (Type A), silica colloidal anhydrous, magnesium stearate, sucrose, titanium dioxide (E171), hypromellose, microcrystalline cellulose, stearic acid.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

Each film-coated tablet contains 170mg of lactose and 20mg of sucrose.

Each pack contains 40 or 60 film-coated table Not all pack sizes may be marketed..

Registration holder for this product

Schwabe Pharma (UK) Ltd Alexander House, Mere Park,

THR'


Dedmere Road, Marlow, Bucks SL7 1FX

Manufacturer of this product

Certification

Mark


Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenbiiren, Germany

Traditional herbal registration number:

THR 23056/0001

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

Schwabe Pharma (UK) Ltd

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX Telephone: 01628 401980 Email: info@schwabepharma.co.uk

This leaflet was revised 05/2014

For a large print, Braille or audio version of this leaflet, call 01628 401980 o

Patient Information Leaflet

FlexiHerb®AAuscle and Joint Pain Relief tablets

Devil's Claw root extract 600mg

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

It contains some important information about FlexiHerb Muscle and Joint Pain Relief tablets.

Keep this leaflet with the tablets.

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


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

2: Before you take this product......................................................................page    2

3: How to take this product............................................................................page    2

4: Possible side-effects....................................................................................page    3

5: How to store this product............................................................................page    3

6: Further information......................................................................................page    4

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

This product is a traditional herbal medicinal product containing Devil’s Claw root. Each film-coated tablet of this product contains 600mg of a dry aqueous extract of Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500mg of Devil’s Claw root).

FlexiHerb Muscle and Joint Pain Relief 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 usage is based on evidence of traditional use only.

DO NOT TAKE this product if you:

2: Before you take this product

4: Possible side-effects

Like all medicines, this product can have side-effects. These are listed below.


Side-effects

•    nausea or feeling sick

•    diarrhoea

•    abdominal pain

•    headache, dizziness

If these persist for more than a few days, or become troublesome, stop taking this product. These side-effects are often only temporary.

• mild allergic skin reactions

itching and/or rash of the skin

Stop taking this product immediately if you experience any allergic skin reaction.

Other side-effects

Devil's claw may make you feel dizzy. If you are affected do not drive or operate machines. Tell your doctor or pharmacist if you notice any other side-effect.


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.


•    have a stomach or duodenal ulcer

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

•    are pregnant or breast-feeding

•    are allergic to any of the ingredients (see section 6)

•    are under 18 years of age

Tell your doctor before taking this product if:

•    you have an intolerance to some sugars (see section 6)

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

3: How to take this product

Adults and the elderly

Take 1 tablet twice daily - the dose can be increased to 2 tablets twice daily if you do not obtain relief after 3-5 days.

Take one dose in the morning and one dose in the evening. You can take the tablets with or without food. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

Do not exceed the stated dose.

If you take too much of this product (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 this product

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

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

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after eight weeks, or if side-effects not mentioned in this leaflet occur.

5: How to store this product

Do not use your tablets after the expiry date.

Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the tablets in a cool dry place.

Do not store the tablets in a place where the temperature goes above 25oC. Keep the tablets out of the reach and sight of children.

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