SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

DiaBackpain Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

600 mg of extract (as dry extract aqueous) from Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500 mg of Devil’s Claw root).

Excipients: 1 film-coated tablet contains 170mg of lactose monohydrate and 20 mg of sucrose

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 short term use only. The patient should consult a doctor if symptoms worsen or do not improve after 8 weeks.

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.

This product is not indicated for use in patients less than 18 years old.

4.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance or one of the excipients.

Patients under 18 years of age.

Pregnancy.

Lactation.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens, or if symptoms persist for more than eight weeks, or if adverse effects not mentioned in the package leaflet occur, consult a healthcare practitioner.

The dosing and safety of Devil’s claw have not been studied thoroughly in children and adolescents, and safety is not established.

If articular pain accompanied by swelling of joint, redness or fewer are present, a doctor should be consulted.

This product contains sucrose.

1 film-coated tablet contains max. 20 mg of sucrose or 0.031 carbohydrate units.

This product contains lactose.

1 film-coated tablet contains max. 170 mg lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp Lactase deficiency or glucose-galactose malabsorption should not take this medicine.

As a general precaution, patients with gastric or duodenal ulcer should not use Devil’s claw preparations.

4.5 Interaction with other medicinal products and other forms of interaction

There is no evidence, from limited interaction studies, that Devil’s claw root extracts will interact with other medicinal products.

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.

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.

Some patients have experienced dizziness while taking Devil’s claw, which may impair ability to drive and use machines. Affected patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain. Central nervous system disorders: headache, dizziness.

Skin disorders: allergic skin reactions (rash and itching).

The frequency is not known.

4.9 Overdose

There are no data on human overdose with Devil’s claw. Symptomatic and supportive measures should be taken as appropriate.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The active constituents of Devil’s claw have not been definitively established.

However, the iridoid glycoside constituents, such as harpagoside, are considered to play an important role in its activity. It is thought that Devil’s claw root does not produce the biochemical effects on arachidonic acid metabolism characteristic of antiarthritic drugs such as the NSAIDs.

5.2 Pharmacokinetic properties

Non-clinical pharmacokinetic studies have not been conducted.

5.3 Preclinical safety data

The preclinical toxicology data available are limited. Tests on reproductive toxicity genotoxicity 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

The shelf life is 3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Original packages contain 30, 60, 90 or 100 film-coated tablets

DiaBackpain Tablets are packed in PVC/ PVDC- aluminium blisters and inserted into a carton.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 42340/0010

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/07/2009

10 DATE OF REVISION OF THE TEXT

06/08/2013