DIABACKPAIN TABLETS - summary of medicine 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) from Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900–1500 mg of Devil’s Claw root). Extraction solvent: water

Excipients: 1 film-coated tablet 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.

4.1

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 or adolescents under 18 years is not recommended (See Section 4.4. ‘Special warnings and precautions for use

If symptoms worsen, or do not improve after 4 weeks, a doctor or qualified healthcare practitioner should be consulted

4.3 Contraindications

Hypersensitivity to the active substance or to any 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 under 18 years of age has not been established 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. 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.

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.

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.

Hypersensitivity reactions: rash, hives, facial oedema

The frequency is not known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

No case of overdose has been reported.

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 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

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road,

Marlow SL7 1FX

8 MARKETING AUTHORISATION NUMBER(S)

THR 23056/0016

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/09/2017