HRI HERBAL SLEEP TABLETS, HRI NIGHT TABLETS, HRI GOOD SLEEP TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

HRI Night Tablets.

HRI Herbal Sleep Tablets

HRI Good Sleep Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains:

43. 6 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5–6:1) (equivalent to 218.2 – 261.8 mg of Valerian root).

Extraction solvent: ethanol 70 % v/v.

48. 2 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (3–7:1) (equivalent to 144.6 – 337.4 mg of Passion Flower herb). Extraction solvent: ethanol 70 % v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated tablet

White round biconvex, 9 mm in diameter

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

Take 3 tablets half to one hour before bedtime. An additional tablet may be taken earlier 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.

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.

Reporting of suspected adverse reactions

Reporting of 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: 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 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

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.

AMES-tests on mutagenicity with Valerian root dry extracts, representing the two extremes of the polarity range did not give any reason for concern

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract Excipients

Maltodextrin

Colloidal anhydrous silica

Tablet Core

Microcrystalline cellulose

Calcium hydrogen phosphate dihydrate Croscarmellose so­dium

Magnesium stearate Stearic acid

Colloidal hydrated silica

Tablet Coating

Titanium dioxide (E171)

Purified talc

Hypromellose

Glycerol

6.2 Incompatibilities

None known

6.3 Shelf life

2 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

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

7   MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

THR 02231/0016

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/03/2020