Summary of Product Characteristics (SmPC) - Kira Restful Sleep
1 NAME OF THE MEDICINAL PRODUCT
Kira Restful Sleep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains: 300 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 900-1800 mg of Valerian root)
Extraction solvent: Ethanol 70 % v/v
One coated tablet contains 218 mg of sucrose, 64 mg of glucose and 38 mg of lactose monohydrate. (See ‘Section 4.4. Special warnings and precautions for use’)
For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet.
White, glossy, round, biconvex.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety based on traditional use only.
4.2 Posology and method of administration
For oral short-term use only.
Adults and the elderly take 1 to 2 tablets half an hour before bedtime. If necessary, an additional dose can be taken earlier in the evening. The tablets should not be chewed.
As treatment effects may not be immediately apparent, Kira Restful Sleep should be taken for 2-4 weeks continuously.
If symptoms worsen, or do not improve after 4 weeks 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 ingredient or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
This product contains sucrose, glucose and lactose monohydrate.
One coated tablet contains 218 mg sucrose, 64 mg glucose and 38 mg lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take this medicine.
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.
If symptoms worsen, or do not improve after 4 weeks 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. Additive effects with hypnotics and other sedative drugs 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
Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.
No studies on the effect on fertility have been performed.
4.7 Effects on ability to drive and use machines
May cause dizziness and impair the ability to drive and use machines. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
Gastrointestinal symptoms, such as nausea, vomiting, abdominal cramps and diarrhoea may occur. Dizziness, headaches and nightmares or vivid dreams may also 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 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 the 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 20 g (equivalent to about20 tablets) caused symptoms suchas fatigue, abdominal cramp, chest tightness, lightheadedness, 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.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract:
Liquid glucose
Colloidal anhydrous silica
Tablet core:
Lactose monohydrate
Cellulose powdered
Hydrophobic colloidal silica
Magnesium stearate
Coating:
Sucrose
Talc
Hypromellose
Castor oil, virgin
Povidone
Macrogol 6000
Colloidal anhydrous silica
Gelatin
Titanium dioxide (E 171)
Carnauba wax
6.2 Incompatibilities
Not applicable
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
Original packages containing 25, 30 or 60 coated tablets.
Kira Restful Sleep tablets are packed in PVC/PVDC-aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Precision Healthcare Limited
89, High Street
Hadleigh
Ipswich
Suffolk, IP7 5EA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 43546/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/06/2017
10 DATE OF REVISION OF THE TEXT
15/09/2023