DIARELAX TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

DiaRelax Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

112.5 mg of extract (as dry extract) from Melissa leaf (Melissa officinalis L.) (4–6:1) (equivalent to 450–675 mg of Melissa leaf).

Extraction solvent: Methanol 30% v/v

and

125 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3–6:1) (equivalent to 375 – 750 mg of Valerian root).

Extraction solvent: Ethanol 70% v/v,

and

80 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5–7:1) (equivalent to 400–560 mg of Passion flower herb).

Extraction solvent: Ethanol 50% v/v

Excipients: each coated tablet also contains187 mg of sucrose and 40 mg of glucose.

(See ‘Section 4.4. Special warnings and precautions for use’)

For full list of excipients, see section 6.1

Coated tablet.

Light-green, round, biconvex, smooth glossy surface.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety, to aid sleep and for mild digestive complaints, such as bloating and flatulence, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

For adults and the elderly:

For the temporary relief of symptoms of mild anxiety take 2 tablets two or three times a day.

For the relief of symptoms of mild digestive complaints, such as bloating and flatulence, take 2 tablets two or three times a day.

To aid sleep take 1 to 2 tablets half an hour before bedtime.

Tablets should be swallowed whole with a little liquid. The tablets should not be chewed.

As treatment effects may not be apparent immediately, DiaRelax should be taken for at least 2 – 4weeks continuously.

If symptoms worsen, or do not improve after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

The maximum recommended daily dose is 6 tablets

The use in children or adolescents under 18 years of age is not recommended (see

Section 4.4. Special warnings and precautions of use).

4.3 Contraindi­cations

Hypersensitivity to the active ingredients or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed stated dose

This product contains sucrose and glucose.

1 sugar-coated tablet contains max. 187 mg of sucrose and a max. 40 mg glucose.

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

The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

If symptoms worsen, or do not improve after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.

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

The effect of DiaRelax may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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

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

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known.

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

There are no known adverse reactions with Melissa leaf.

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

Valerian root at a dose of approximately 20 g (equivalent to 35 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

No cases of overdose have been reported for Passion flower or Melissa leaf. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not required as per Article 16 c (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.

Data from in vitro and animal studies indicate that the water extract of Melissa officinalis may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients of the herbal preparations:

Maltodextrin

Silica, colloidal anhydrous

Liquid glucose, spray dried

Excipients of the tablet:

Silica, colloidal anhydrous

Cellulose, powdered

Croscarmellose sodium

Stearic acid

Talc

Excipients of the coating

Sucrose

Talc

Calcium carbonate E170

Acacia

Tragacanth

Titanium dioxide E 171

Liquid glucose, spray dried

Quinoline yellow E 104

Indigotin 85 E 132

Beeswax, white

Carnauba wax

Shellac

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

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

DiaRelax coated 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 23056/0030

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

26/09/2017