DIAPASSION TABLETS - summary of medicine characteristics

DiaPassion Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

425 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5–7:1) (equivalent to 2125–2975 mg of Passion flower herb).

Extraction solvent: Ethanol 50% v/v

Excipients: each coated tablet contains 187 mg of sucrose and 5 mg of glucose. (See ‘Section 4.4. Special warnings and precautions for use’)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Light-yellow, round, biconvex, smooth glossy surface without ruptures.

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

For adults and the elderly: take 1 tablet daily. Tablets should be swallowed whole with a little liquid. The tablet 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 any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

This product contains glucose.

1 coated tablet contains max. 5 mg glucose.

This product contains sucrose.

1 coated tablet contains max. 187 mg of sucrose or 0.29 carbohydra­te units.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or

sucrase-isomaltase insufficiency should not take this medicine.

The use in children or adolescents under 18 years of age has not been established due to lack of adequate data.

4.5 Interaction with other medicinal products and other forms of interaction

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established.

Use during pregnancy or lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and operate machines. Affected patients should not drive or operate machines.

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or 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 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. 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

Extract excipients:

Maltodextrin

Silica, colloidal anhydrous

Tablet core

Silica, colloidal anhydrous

Cellulose, powdered

Croscarmellose sodium

Magnesium stearate

Stearic acid

Talc

Coating

Sucrose

Talc

Calcium carbonate E170

Acacia

Tragacanth

Titanium dioxide E 171

Liquid glucose, spray dried

Iron oxide hydrate E 172 (= yellow iron oxide)

Hypromellose

Capol 600 T.S containing:

Beeswax, white

Carnauba wax

Shellac

6.2 Incompatibilities

Not applicable

6.3 Shelf life

4 years

6.4 Special precautions for storage

Do not store above 30° C. Store in the original packaging.

6.5 Nature and contents of container

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

DiaPassion 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 23056/0023

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

27/09/2017