DIASLEEP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

DiaSleep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

150 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 450–900 mg of Valerian root).

Extraction solvent: Ethanol 70% v/v.

One coated tablet contains 35 mg of glucose and 136 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

Coated tablet.

White, glossy, round, biconvex.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of 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 to 2 tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening. The tablets should not be chewed.

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

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

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

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

This product contains glucose.

1 coated tablet contains max. 35 mg of glucose.

This product contains sucrose.

1 coated tablet contains max. 136 mg of sucrose or 0.21 carbohydra­te units.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 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.

If symptoms worsen, or do not improve after 4 weeks, 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. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.

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

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, 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 machinery.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur.

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

Valerian root at a dose of approximately 20 g (equivalent to 10 tablets) caused symptoms such as fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis, which disappeared within24 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.

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

Liquid glucose, spray dried Silica, colloidal anhydrous Cellulose, powdered Croscarmellose sodium Stearic acid

Talc

Sucrose

Calcium carbonate E170

Acacia

Tragacanth

Titanium dioxide E 171

Capol 600 T.S. containing: Beeswax, white

Carnauba wax Shellac

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 coated tablets

DiaSleep 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