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VALERINA NIGHT-TIME FILM-COATED TABLETS

Active substance(s): DRY EXTRACT OF HOPS STROBILES / LEMON BALM DRY EXTRACT / VALERIAN ROOT DRY EXTRACT

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 Package leaflet:
 Information for the user

 1. What Valerina Night-Time
is and what it is used for

Valerina Night-Time

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

film-coated tablets

Extracts of valerian root, hops strobile and
lemon balm leaf.

Read all of this leaflet carefully
because it contains important
information for you.

The dose for this medicine has changed –
please see section 3 for details. This medicine is available without p
­ rescription.
However, you still need to t­ake Valerina
Night-Time carefully to get the best results
from it.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor or qualified
healthcare practitioner if your s­ ymptoms
worsen or do not improve a
­ fter 4 weeks.
• If any of the side effects gets serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
qualified healthcare practitioner.

In this leaflet:

1. What Valerina Night-Time is and what
it is used for
2.  Before you take Valerina Night-Time
3.  How to take Valerina Night-Time
4.  Possible side effects
5.  How to store Valerina Night-Time
6.  Further information

187

Alcohol

The effects of Valerina Night-Time may be
­increased by alcohol. Therefore, you
should not drink excessive amounts of
­alcohol.

Driving and using machines

For full details see section 6.

Valerina Night-Time may cause drowsiness.
If after taking Valerina Night-Time you feel
drowsy, do not drive, use tools or operate
machinery.

 2. Before you take Valerina
Night-Time

 3. How to take Valerina
Night-Time

The tablets contain extracts of Valerian
root, Hop strobile and Lemon Balm leaf.

Do not take Valerina Night-Time
if you are:
• allergic (hypersensitive) to Valerian,
Hops, Lemon Balm or any of the other
­ingredients of Valerina Night-Time.
• already taking other medicines for
­anxiety or sleep.
• under 18 years of age.
• pregnant or breast feeding.

This product contains lactose monohydrate.
If you have been told by your doctor that
you have an intolerance to some sugars do
not take Valerina Night-Time.

Taking other medicines

Please tell your doctor or qualified healthcare practitioner if you are taking any
­other medicines.

For oral short term use only.
Take Valerina Night-Time as advised in this
leaflet. You should check with your doctor
or qualified healthcare practitioner if you
are not sure.
Do not exceed the stated d
­ ose.

Adults and the elderly
Take 2 tablets half an hour to 1 hour
­before bed time.
If necessary, you can take 1–2 additional
tablets earlier in the evening.
Swallow the tablets whole with water.
You may need to take the tablets for 2 to 4
weeks continuously to get the effect from
the treatment.
Stop taking Valerina Night-Time and
­contact your doctor or qualified healthcare
practitioner if your symptoms w
­ orsen or do
not improve after 4 weeks.

Children and adolescents

Do not use in children and adolescents
under 18 years of age.

If you take more Valerina
Night-Time than you should

If you take more than the recommended
dose, speak to a doctor, pharmacist or
qualified healthcare practitioner and take
this leaflet with you.
If you have any further questions on the
use of this product, ask your doctor or
qualified healthcare practitioner.

 4. Possible side effects
Like all medicines, Valerina Night-Time can
cause side effects, although not everybody
gets them.
Side effects include feeling sick
and stomach cramps. The frequency is
not known.

Reporting of side effects

If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.

22100208-001

 5. How to store Valerina
Night-Time
Do not store above 25°C. Keep in original
package to protect the tablets from light
and moisture.
Keep out of the reach and sight of
­children.
Do not use Valerina Night-Time after the
expiry date which is stated on the carton.
The expiry date refers to the last day of
that month.
Medicines should not be disposed of via
wastewater or household waste. Take the
medicines no longer required to your
­pharmacist who will dispose of them.
­These measures will help to protect the
­environment.

 6. Further information
What Valerina Night-Time
­contains
• ­Each film-coated tablet contains:
60 mg of extract (as dry extract)
equivalent to 420–600 mg of Valerian
root (Valeriana officinalis L.).
Extraction solvent: Ethanol 60% V/V.
65 mg of extract (as dry extract)
equivalent to 293–553 mg of Hops
strobile (Humulus lupulus L.). Extraction
solvent: Ethanol 70 % V/V.

17.5 mg of extract (as dry extract)
equivalent to 124–200 mg of Lemon
Balm ­leaf (Melissa officinalis L.).
Extraction solvent: Ethanol 60% V/V.
• ­The other ingredients are 278 mg
of lactose monohydrate, cellulose,
­colloidal anhydrous silica, potato
starch, magnesium ­stearate, hypro­
mellose, macrogol 6000, t­itanium
dioxide (E171) and paraffin.

What Valerina Night-Time looks
like and contents of the pack
The film-coated tablets are off-white and
round.

Pack sizes: 40, 60, 80 tablets in blisters.
Not all pack sizes may be marketed.

Traditional Herbal Registration
Holder

Pharbio Medical International AB,
Box 715, SE-194 27 Upplands Väsby,
Sweden.
Telephone: +46 8 590 963 00
E-mail: regulatory@cederroth.com

Manufacturer

Cederroth International Production
Paramedical A/S, Vassingerødvej 3-7,
DK-3540 Lynge, Denmark.
This leaflet was last revised in
February 2015.

Self-Help Health Education to
Promote Natural Sleep

• Exercise: gentle exercise can help the
body burn up excess energy.
• Healthy eating: a varied well
­balanced diet will help ensure the body
receives the essential vitamins and
­minerals it needs to function at its best.
Try to avoid excess intake of coffee, tea
or alcohol from late afternoon.
•  Daylight: try to arrange some exposure
to daylight at least once a day to help
your natural body clock maintain its
­balance. Turn out lights before going
to sleep.
•  Daytime naps: try to avoid having
naps during the day since this will affect
your evening pattern.
• Unwind: construct a relaxed pre-bed
routine so that you stop all stressful
­activities an hour and a half before you
plan to go to bed. Try some relaxation
techniques such as yoga or other forms
of meditation.
• Organising time: can help you take
control of your life, set priorities and
plan ahead allowing time for relaxation.
• In bed: don’t read or watch television
in bed, these are waking activities.
• Getting up: rise each morning at a
­regular, convenient hour.

CERTIFICATION MARK

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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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