Summary of medicine characteristics - GOOD-NITE CAPSULES
1 NAME OF THE MEDICINAL PRODUCT
GOOD-NITE Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400mg of Valerian root. (Valeriana officinalis L.)
For list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Clear size 0 hard capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
GOOD-NITE is a traditional herbal medicinal product used to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults and the elderly:
To aid sleep, take one capsule 30 minutes before bedtime with an earlier dose during the evening if necessary.
As treatment effects may not be apparent immediately, GOOD-NITE should be taken 2–4 weeks continuously.
Duration of use:-
If symptoms persist, worsen or do not improve after 4 weeks during the use of GOOD-NITE a doctor or a qualified healthcare care practitioner should be consulted.
Not recommended for children or adolescents under 18 years.
(See Section 4.4. Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to Valerian or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen, or do not improve after 4 weeks of taking GOOD-NITE a doctor or a qualified healthcare care practitioner should be consulted.
The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.
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, CYP 1A2 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 Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.
4.6 Fertility, pregnancy and lactation
The safety of GOOD-NITE 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 effect on fertility have not been performed.
4.7 Effects on ability to drive and use machines
GOOD-NITE may impair ability to drive and use machines.
Patients who are affected should not drive or operate machinery.
4.8 Undesirable effects
Gastrointestinal symptoms such as nausea, vomiting, abdominal cramps and diarrhoea 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 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
4.9 OverdoseIf symptoms arise, treatment should be supportive.
Valerian root at a dose of approximately 20g (equivalent to 50 GOOD-NITE capsules) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis), which disappeared within 24 hours.
After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g 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
5.3 Preclinical safety dataExtracts with ethanol and the essential oil of Valerian root have shown low toxicity in rodents during acute tests and from repeated dose toxicity over periods of 4–8 weeks.
Test on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hypromellose (capsule shell)
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
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap.
GOOD-NITE pack contains 50 Capsules.
6.6 Special precautions for disposal
6.6 Special precautions for disposalThere are no special precautions for disposal of GOOD-NITE capsules.
7 MARKETING AUTHORISATION HOLDER
Bio-Health Limited
Culpeper Close
Medway City Estate
Rochester
Kent
ME2 4HU
8 MARKETING AUTHORISATION NUMBER(S)
THR 15817/0011