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KIRA RESTFUL SLEEP

Active substance(s): VALERIAN DRY HYDROALCOHOLIC EXTRACT

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Patient Information Leaflet

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 or
anxiety

Restful sleep
tablets
Valerian root extract 300 mg

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.

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.

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

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

Driving and using machines
This product may cause drowsiness. If you are affected do not drive or use any tools or machines.

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Bezeichnung:

GI Kira® Restful sleep

Größe:

Inhalt:

25 überzogene Tabletten

Material:

Artikel-Nr.:

560173

Teile-Nr.:

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Druck-Kennz.:

0000000

Laetus-Code:

0000

EAN-Code:

Druckfarbe/
Winkelung bei
einer
Rasterweite
von 150 lpi

210 x 148 mm

Schwarz

45 °

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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.

Lackaussparung:

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.

3

Datum: 4.9.2017 Versions-Nr.: 00-02

Sachbearbeiter G+G

Verwendete Schriften:

I)-

Prüfung und Freigabe Köln:

Björn Sund

VAG Rounded

II)-

q Frei

überprüft durch:

Helvetica

III)-

Andreas Ueberschär
q Neuer Abzug erforderlich
Prüfung und Freigabe Berlin:
q Frei

PZN-Code:
Land:

Important information about some of the ingredients
Each tablet contains 218 mg sucrose, 64 mg liquid
glucose and 38 mg lactose.

Geprüft durch PPC:
q Ja

q Nein

EAN lesbar:
England

q Neuer Abzug erforderlich

q Ja

q Nein

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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.

If you would like further information about this
product, please contact:
Ceuta Healthcare Ltd.,
41 Richmond Hill,
BOURNEMOUTH BH2 6HS,
United Kingdom.

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.

Telephone: 0800 652 7150
Fax: 01202 780559
Email.: info@ceutahealthcare.com

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.

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.

Manufacturer of this product
Klosterfrau Berlin GmbH
Motzener Strasse 41
12277 Berlin
Germany

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.

5

GI Kira® Restful sleep

Größe:

Inhalt:

25 überzogene Tabletten

Material:

Artikel-Nr.:

560173

Teile-Nr.:

Mockup

Druck-Kennz.:

0000000

Laetus-Code:

0000

EAN-Code:

Druckfarbe/
Winkelung bei
einer
Rasterweite
von 150 lpi

210 x 148 mm

Schwarz

Cassella-med GmbH is a company of the

45 °

6

Datum: 4.9.2017 Versions-Nr.: 00-02

Sachbearbeiter G+G

Verwendete Schriften:

I)-

Prüfung und Freigabe Köln:

Björn Sund

VAG Rounded

II)-

q Frei

überprüft durch:

Helvetica

Lackaussparung:

III)-

Andreas Ueberschär
q Neuer Abzug erforderlich
Prüfung und Freigabe Berlin:
q Frei

PZN-Code:
Land:

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

Traditional herbal registration number:
THR 29860/0005

4

Bezeichnung:

This leaflet was prepared in September 2017.

Registration holder for this product
Cassella-med GmbH & Co.KG
Gereonsmuehlengasse 1
50670 Cologne
Germany

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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.

Geprüft durch PPC:
q Ja

q Nein

EAN lesbar:
England

q Neuer Abzug erforderlich

q Ja

q Nein

Seite: 2 von 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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