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Hri Night Tablets

Document: spc-doc_THR 02231-0016 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

HRI Night Tablets.

HRI Herbal Sleep Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

60 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 240 mg of Valerian root).

Extraction solvent: ethanol 50 % v/v.

45 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L. )(equivalent to 241 mg of Passion Flower herb).

Extraction solvent: methanol 80 % v/v.

25 mg of extract (as dry extract) from Wild lettuce leaf (Lactuca virosa L. ) (equivalent to 100 mg of Wild Lettuce leaf).

Extraction solvent: methanol 80 % v/v.

Each tablet also contains 91 mg of sucrose.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet

Dark grey round biconvex

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used to aid sleep based on traditional use only.

4.2    Posology and method of administration

For oral use only.

Adults and the elderly

3-4 tablets to be taken half to one hour before bedtime. An earlier dose may be taken in the evening if required.

As treatment effects may not be apparent immediately, the tablets should be taken 2 -4 weeks continuously.

Children and adolescents under 18 years

Not recommended for children and adolescents under 18 years (See Section 4.4 Special warnings and precautions for use).

If symptoms worsen, or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substances, to plants of the Asteraceae (Compositae) family or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

If symptoms worsen, or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

This product contains sucrose. One tablet contains 91 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 interactions with drugs metabolised by the CYP2D6, CYP 3AA4/5, CYP1A2 or CYP2E1 pathway have not been observed. Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

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

4.6    Fertility, Pregnancy and lactation

Safety during human pregnancy and lactation has not been established.

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

Studies 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. Patients who are affected should not drive or use machines.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root.

The frequency is not known.

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

If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted.

4.9 Overdose

Valerian root at a dose of approximately 20g (equivalent to 40 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headaches, 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

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet Core

Microcrystalline cellulose Dicalcium phosphate Croscarmellose sodium Magnesium stearate Stearic acid

Tablet Coating Sucrose

Calcium carbonate Talc

Mastercote Grey SPO933

Acacia

Shellac

Titanium dioxide (E171)

Wax polish (solids)

6.2 Incompatibilities

None known

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

Amber glass bottle with foil tamper evident seal and white polypropylene screw cap. Pack sizes: 30, 40, 45, 50, 60, 80, 100.

Al/PVC/PVDC blister strip

Pack sizes: 30, 40, 45, 50, 60, 80, 100.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

The Herbal Research Company Limited 27 Old Gloucester Street London WC1N 3 XX

8    MARKETING AUTHORISATION NUMBER(S)

THR 02231/0016

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/03/2013

10    DATE OF REVISION OF THE TEXT

25/10/2016