Kira Restful Sleep – patient leaflet, side effects, dosage

1. What this product is and what it is used for

This product is a traditional herbal medicine containing Valerian root extract. 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.

This product is a traditional herbal medicinal product used for the relief of temporary sleep disturbances due to symptoms of mild anxiety based on traditional use only.

2. Before you take this product

Do not take this product if:

• You are pregnant or breastfeeding

• You are allergic (hypersensitive) to any of the ingredients (see section 6)
• You are under 18 years of age
• You are already taking a medicine for sleep, anxiety or stress or that makes you sleepy

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking with food and drink

The effects of this product may be increased by alcohol. Do not drink excessive amounts of alcohol.

Driving and using machines

This product may make you feel sleepy or dizzy. If you are affected do not drive or use any tools or machines.

Important information about some of the ingredients

Each tablet contains 218 mg sucrose, 64 mg liquid glucose and 38 mg lactose.

Tell your doctor before taking this product if:

• You have an intolerance to some sugars (see section 6)

3. How to take this product

Always take the product exactly as your doctor, pharmacist or qualified healthcare practitioner has told you. You should check with your practitioner if you are not sure.

The usual dose for adults and the elderly is 1 to 2 tablets half an hour before bedtime. If necessary, an additional dose can be taken earlier in the evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

As the effects of the product may not occur immediately, the tablets may be taken continuously for 2-4 weeks.

Do not take more than the leaflet tells you to take.

Duration of use

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

If you take more Kira^® Restful Sleep than you should

Speak to a doctor, pharmacist or qualified healthcare practitioner and show them this leaflet. Patient Information Leaflet

Certification

Mark

If you forget to take Kira^® Restful Sleep Continue to take your usual dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4. Possible side effects

Like all medicines, this product can have side-effects, although not everybody gets them. The following side effects have been reported:

• Nausea (feeling sick)
• Vomiting
• Abdominal Cramps
• Abdominal pain
• Diarrhoea
• Dizziness
• Headache
• Nightmares or vivid dreams

If these persist for more than a few days or become troublesome, stop taking this product.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store this product

Store the product in a cool, dry place below 25 °C.

Keep out of the reach and sight of children.

Do not use the product after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

Each Kira^® Restful Sleep 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.

The other ingredients are sucrose, glucose, talc, lactose, cellulose powder, colloidal anhydrous silica, hypromellose, castor oil, hydrophobic colloidal silica, magnesium stearate, povidone, macrogol 6000, gelatin, titanium dioxide (E 171) and carnauba wax.

What Kira^® Restful Sleep looks like and contents of the pack

The tablets are white, round, biconvex and glossy.

Each pack contains 25 coated tablets.

Registration holder for this product

Precision Healthcare Limited

89 High Street

Hadleigh

Ipswich

Suffolk IP7 5EA

United Kingdom

Manufacturer of this product

Artesan Pharma GmbH & Co. KG Wendlandstrasse 1

29439 Luechow

Germany

Traditional herbal registration number: THR 43546/0003

If you would like further information about this product, please contact:

Precision Marketing Group

Precision House

Lamdin Road

Bury St Edmunds

Suffolk IP32 6NU

Telephone: 01284 715295

Fax: 01284 718920

Email.: info@precisionhealthcare.co.uk

This leaflet was prepared in August 2023.

For a large print, Braille or audio version of this leaflet, call Precision Healthcare Ltd.