SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Goodnight

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

60mg Verbena herb (Verbena officinalis L.).

30mg Hops strobiles (Humulus lupulus L.)

36mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5:1) Extraction solvent: Ethanol 60% v/v

30mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (3:1) Extraction solvent: Ethanol 60% v/v

18mg of extract (as dry extract) from Wild Lettuce herb (Lactuca virosa L.) (5:1) Extraction solvent: Water

Excipients: each coated tablet contains: 222mg of sucrose, 30mg lactose For full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Grey, biconvex sugar coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

Adults and the elderly.

For the relief of sleep disturbances take two tablets 30 minutes before bedtime. As treatment effects may not be apparent immediately, GOODNIGHT should be taken for 2-4 weeks continuously.

Duration of use:-

If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to the active substances Verbena, Hops, Valerian, Passion flower, Wild Lettuce or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed stated dose

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.

This product contains sucrose and lactose. One coated tablet contains a maximum of 222mg of sucrose and a maximum of 30mg of lactose.

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

If symptoms persist or worsen after 4 weeks of using the 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 interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 pathway has 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 GOODNIGHT may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6 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.

4.7 Effects on ability to drive and use machines

GOODNIGHT may impair ability to drive and use machines. Patients who are affected should not drive or operate machinery

4.8 Undesirable effects

Gastrointestinal symptoms (eg 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 the other active ingredients.

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

4.9 Overdose

Valerian root at a dose of approximately 20g (equivalent to 100 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, 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 the other active ingredients.

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

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Excipients of the herbal preparations:

Calcium hydrogen phosphate, maltodextrin.

Tablet core:

Sucrose, lactose, sodium starch glycollate, magnesium stearate, talc. Tablet coating: Sucrose, talc, ferric oxide, titanium oxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C. Store in the original package.

6.5 Nature and contents of container

100ml HDPE plastic container and tamper evident cap.

Pack contains 50 tablets

6.6 Special precautions for disposal

There are no special precautions for disposal. When the container is empty the label should be removed and the container placed in a recycling bin

7 MARKETING AUTHORISATION HOLDER

Kerbina Limited

T/A Bio-Health Culpeper Close Medway City Estate Rochester Kent

ME2 4HU

8    MARKETING AUTHORISATION NUMBER(S)

THR 00904/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/11/2010

10    DATE OF REVISION OF THE TEXT

16/11/2010