Patient Information Leaflet

Kira ®

Restful sleep

tablets

Valerian root extract 300 mg

Please read this leaflet carefully before you start taking these tablets. It contains some important information about Kira® Restful Sleep.

Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

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What is in this leaflet

Si 1. What this product is and what it is used for _m 2. Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

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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. This usage is 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 which makes you feel drowsy

Tell your doctor before taking this product if :

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

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.

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Driving and using machines

This product may cause drowsiness. 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.

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 exceed the stated dose.

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.

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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, Kira® Restful Sleep can cause side effects, although not everybody gets them.

Possible side-effects are nausea or abdominal cramps. If these persist for more than a few days, or become troublesome, stop taking the product.

This product may cause drowsiness. If you are affected do not drive or operate machines.

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. By reporting side effects you can help provide more information on the safety of this medicine.

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m 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 9001800 mg of Valerian root (Extraction solvent: ethanol 70 % v/v) as active ingredient.

The other ingredients are sucrose, glucose, talc, lactose, cellulose powder, colloidal anhydrous silica, hypromellose, castor oil, hydrophobic colloidal silica, magnesium stearate, povidone, macro-gol 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, 30 or 60 coated tablets.

Manufacturer of this product

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

Traditional herbal registration number:

THR 29860/0005

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

Ceuta Healthcare Ltd.,

41 Richmond Hill,

BOURNEMOUTH BH26HS,

United Kingdom.

Telephone: 01202 780558

Fax: 01202 780559

Email.: info@ceutahealthcare.com

This leaflet was prepared in May 2015.

For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd. on 08006527150

Registration holder for this product

Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50670 Cologne Germany

Cassella-med GmbH is a company of the

KLOSTERFRAU

HEALTHCARE CROUP

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