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Muscle & Joint Pain Relief

image descriptionFlexiHerb Muscle & Joint Pain Relief Tablets

Devil’s Claw root extract 600mg

40 tablets

Traditionally used for:

  • Backache
  • Rheumatic pain
  • Muscular pain
  • General aches and pains
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A traditional herbal medicinal product used for the relief of aches and pains in muscles and joints exclusively based upon long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herble active
Devil’s Claw (Harpagophytum procumbens)
Strength
600mg of dried root extract (equivalent to 900-1500mg of Devil’s Claw root)
Dose
One tablet twice daily

FlexiHerb 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, based on traditional use only.

Taking one to two tablets twice daily can be used help to relieve general aches and pains. If symptoms worsen or there is no improvement seen after taking Flexiherb for eight weeks, a doctor should be consulted.

A licensed herbal medicine means a safe, high quality product

FlexiHerb Muscle & Joint Pain Relief Tablets have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • FlexiHerb is a regulated herbal product and meets specific standards of safety and quality
  • FlexiHerb is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. FlexiHerb’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that FlexiHerb has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade coated tablet is foil blister packed to retain its freshness and maintain its potency.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe to see why we’re the leaders in traditional herbal medicine, worldwide.

FlexiHerb contains Devil’s Claw, a perennial shrub that grows in the desert countries of Southern Africa, most notably in the Kalahari sands of Namibia. After heavy rain it develops luscious leaves and beautiful red–violet, trumpet-shaped flowers. The name originates from the hooked, claw-like seed pods attached to the flowers.

Also available from…

Holland & Barrett and other independent pharmacies and health food stores nationwide.

About Devil's Claw

The name ‘Devil’s Claw’ originates from the hooked, claw-like seed pods attached to the flowers.

Visit Vitfacts.co.uk

About aches and pains

We all suffer from aches and pains from time to time. Find out more about the natural remedies available.

FlexiHerb Guide

Download your FREE FlexiHerb Guide ‘Back to Basics’.

Take a health check

Check your proneness to back pain using our simple questionnaire and get some useful tips on what might help.

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 extract of Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500mg of Devil’s Claw root). Extraction solvent: water.

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.

Before you take this product

DO NOT TAKE this product if you:

  • have a stomach ulcer or duodenal ulcer
  • are lactose-intolerant (react badly to lactose or milk)
  • are pregnant or breastfeeding
  • are allergic to any of the ingredients (see further information below)
  • are under 18 years of age

Tell your doctor before taking this product if you have:

  • you have gallstones
  • an intolerance to some sugars (see further information below)
  • your joint pain is accompanied by swelling of the joint, redness or fever.

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 healthcare practitioner and take the 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 healthcare practitioner.

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. 

  • Allergic reactions (rash, raised itchy rash, facial swelling)

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

Other side-effects

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.

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 25°C.

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.

Further information

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

Extraction solvent: water.

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 film-coated tablets or 60 film-coated tablets. Not all pack sizes may be marketed.

Registration holder for this product

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1FX

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, 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 SL71FX
Telephone : 01628 401 980
Email : info@schwabepharma.co.uk

This information was revised 03/2017

1 Name of the medicinal product

  • Flexiherb Muscle & Joint Pain Relief tablets
  • Jointlieve Devil’s Claw film-coated tablets
  • Higher Nature Devil’s Claw Muscle & Joint Pain Relief film-coated tablets
  • Zipvit Devil’s Claw Joint Relief tablets
  • Simply Supplements Devil’s Claw Muscle and Joint Pain Relief tablets

2 Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500 mg of Devil’s Claw root). Extraction solvent: water Also contains 170mg of lactose monohydrate and 20 mg of sucrose (See Section 4.4 ‘Special warnings and precautions for use.’) For full list of excipients, see section 6.1

3 Pharmaceutical form

Film-coated tablet. White, oblong, smooth surface film coating without ruptures.

4 Clinical particulars

4.1 Therapeutic indications

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, based on traditional use only.

4.2 Posology and method of administration

For oral use only. For adults and the elderly, take 1 tablet twice daily. Take one dose in the morning and one in the evening. The dose can be increased to 2 tablets twice daily if the patient does not obtain relief after 3-5 days. Tablets should be swallowed whole with a little liquid. The tablets should not be chewed. The use in children and adolescents under 18 years of age is not recommended. (See Section 4.4 Special warnings and precautions for use). If the symptoms worsen, or do not improve after four weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance or one of the excipients. Patients with active gastric or duodenal ulcer

4.4 Special warnings and precautions for use

Do not exceed the stated dose. If the symptoms worsen, or do not improve after four weeks a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents less than 18 years old is not recommended due to lack of adequate data If articular pain accompanied by swelling of joint, redness or fever are present, a doctor should be consulted. This product contains sucrose. 1 film-coated tablet contains max. 20mg of sucrose or 0,031 carbohydrate units. This product contains lactose. 1 film-coated tablet contains max. 170 mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with gallstones should consult a doctor prior to taking Devils Claw.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed. In rare cases some patients have experienced dizziness and somnolence while taking Devil’s claw. If affected, patients should not drive or use machinery.

4.8 Undesirable effects

Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdomina pain. Central Nervous system disorders: headache, dizziness. Hypersensitivity reactions: rash, hives , facial oedema. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

No case of overdose has been reported. Symptomatic and supportive measures should be taken as appropriate.

5 Pharmacological properties

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. Tests on reproductive toxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

  • Cellulose, powdered
  • Lactose monohydrate
  • Sodium Starch Glycolate (Type A)
  • Silica, colloidal anhydrous
  • Magnesium stearate
  • Sucrose
  • Titanium dioxide E 171
  • Hypromellose
  • Cellulose, microcrystalline
  • Stearic acid.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging.

6.5 Nature and contents of container

Original packages containing 40 film-coated tablets (Jointlieve Devil’s Claw film-coated tablets, Higher Nature Devil’s Claw Muscle & Joint Pain Relief film-coated tablets, ZipVit Devil’s Claw Joint Relief tablets). The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 Marketing authorisation holder

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1FX

8 Marketing authorisation number

THR 23056/0001

9 Date of first authorisation/renewal of the authorisation

02/06/2017

10 Date of revision for the text

02/06/2017

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