Goodnight-SPC-181110.Pdf

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 Limited Culpeper Close Medway City Estate Rochester Kent ME2 4HU

8 MARKETING AUTHORISATION NUMBER(S)

THR 00904/0003 SUMMARY OF PRODUCT

9 DATE OF REGISTRATION CHARACTERISTICS (SPC)

16/11/2010

10 DATE OF REVISION

16/11/2010

Goodnight Bio-Health Ltd. Culpeper Close, Medway City Estate, Rochester, Kent ME2 4HU Goodnight Bio-Health Ltd. Culpeper Close, Medway City Estate, Rochester, Kent ME2 4HU Summary of Product Characteristics t +44 (0)1634 290 115 f +44 (0)1634 290 761 e [email protected] w www.bio-health.co.uk Summary of Product Characteristics t +44 (0)1634 290 115 f +44 (0)1634 290 761 e [email protected] w www.bio-health.co.uk 1 NAME OF THE MEDICINAL PRODUCT 4.5 Interaction with other medicinal products and other forms of interaction

GOODNIGHT Tablets Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolized 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 2 QUALITATIVE AND QUANTITATIVE COMPOSITION is not recommended as general precaution.

Each coated tablet contains: The effect of GOODNIGHT may be potentiated by alcohol. 60mg Verbena herb (Verbena officinalis L.) Excessive concomitant consumption of alcohol should therefore be avoided. 30mg Hop strobiles (Humulus lupulus L.) 36mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5:1) Extraction solvent: Ethanol60% v/v 4.6 Pregnancy and Lactation 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 The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Excipients: each coated tablet contains: 222mg of sucrose, 30mg lactose. For full list of excipients see section 6.1 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 3 PHARMACEUTICAL FORM or operate machinery.

Coated tablet. 4.8 Undesirable effects Grey, biconvex sugar coated tablet. Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known. 4 CLINICAL PARTICULARS One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with Passion 4.1 Therapeutic Indications flower. The frequency is not known.

A traditional herbal medicinal product used for the temporary relief of sleep disturbances based on traditional use only. There are no known adverse reactions with the other active ingredients.

4.2 Posology and method of administration If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

For oral short term use only. 4.9 Overdose

Adults and the elderly. Valerian root at a dose of approximately 20g (equivalent to 100 tablets) caused benign symptoms (fatigue, abdominal For the relief of sleep disturbances, take two tablets, 30 minutes before bedtime. cramp, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours. As treatment effects may not be apparent immediately, GOODNIGHT should be taken for 2-4 weeks continuously. If symptoms arise, treatment should be supportive.

Duration of use:- After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner 30g of the drug) withdrawal symptoms (delirium) have been reported. should be consulted. No cases of overdose have been reported for the other active ingredients. The use in children or adolescents under 18 years of age is not recommended (see section 4.4 Special Warnings and Precautions of Use). Symptomatic and supportive measures should be taken as appropriate.

4.3 Contraindications 5 PHARMACOLOGICAL PROPERTIES Hypersensitivity to the active substances Verbena, Hops, Valerian, Passion flower, Wild Lettuce or any of the excipients. 5.1 Pharmacodynamic Properties

4.4 Special Warnings and Precautions for Use Not required as per article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

Do not exceed the stated dose. 5.2 Pharmacokinetic Properties

The use of this product in children or adolescents under 18 years of age is not Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended. recommended because data are not sufficient and medical advice should be sought. 5.3 Preclinical safety data This product contains sucrose and lactose. One coated tablet contains a maximum of 222mg of sucrose and a maximum of 30mg of lactose. Test on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

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.