Nature’s Bounty Valerian Hard Capsules

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Διαθέσιμο από:

Holland & Barrett Limited

Φαρμακολογική κατηγορία (ATC):

N05CM; N05CM09

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Capsule, hard

Θεραπευτική περιοχή:

Other hypnotics and sedatives; Valerianae radix

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2013-02-01

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMPORTANT NOTES
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE
THIS TRADITIONAL HERBAL MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU:
•
Always take this traditional herbal medicine exactly
as described in this leaflet or as your doctor or
pharmacist has told you
•
Keep this leaflet. You may need to read it again
•
Ask a healthcare professional e.g. a doctor or
pharmacist if you need more information or advice
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet
•
You must talk to a doctor if you feel worse or do not feel
better after 2 weeks of taking this traditional herbal medicine
WHAT IS IN THIS LEAFLET
1
What this traditional herbal medicine is and what it
is used for
2
What you need to know before you take this
traditional herbal medicine
3
How to take this traditional herbal medicine
4
Possible side effects
5
How to store this traditional herbal medicine
6
Contents of the pack and other information
Nature’s Bounty Valerian Hard Capsules is a traditional
herbal medicine used for the relief of symptoms of mild
mental stress and to aid sleep. This is exclusively based
upon long-standing use.
DO NOT TAKE THIS TRADITIONAL HERBAL MEDICINE IF YOU ARE:
•
Under 18 years of age
•
Pregnant or breastfeeding
•
Allergic to Valerian or any of the inactive ingredients
in this traditional herbal medicine (listed in section
6 of this leaflet)
•
Already taking a medicine which can cause drowsiness
WARNINGS AND PRECAUTIONS
The effects of this traditional herbal medicine may be
increased by alcohol. Excessive use of alcohol should
therefore be avoided.
CHILDREN AND ADOLESCENTS
Do not give this traditional herbal medicine to children
or adolescents under the age of 18 years as it is not
known if it is safe to do so.
OTHER MEDICINES AND NATURE’S BOUNTY VALERIAN HARD
CAPSULES INCLUDING TRADITIONAL HERBAL MEDICINES
Tell your doctor or pharmacist if you are taking,

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
26 February 2021
CRN00C3FW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nature’s Bounty Valerian Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 337mg of extract (as dry extract) from
_Valeriana officinalis _L. radix (equivalent to 1683mg – 2020mg
of Valerian root). Extraction solvent: Ethanol 70%v/v.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard Capsules (Capsules)
Two piece clear, hard capsules with grey/brown fill.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of symptoms
of mild mental stress and to aid sleep, exclusively based
upon long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short-term use only
_ADULTS AND OLDER PEOPLE:_
FOR THE RELIEF OF SYMPTOMS OF MILD MENTAL STRESS: take 1 capsule 3
times daily. Swallow the whole capsule with water
TO AID SLEEP: Take one capsule 30 minutes before bedtime with an
earlier dose during the evening if necessary.
As the treatment effects of this product may not be apparent
Immediately, Nature’s Bounty Valerian Hard Capsules should be taken
for 2 weeks continuously.
MAXIMUM DOSE: 4 CAPSULES PER DAY.
Do not exceed the stated dose
DURATION OF USE:
If symptoms persist, worsen or do not improve after 2 weeks use of
Nature’s Bounty Valerian Hard Capsules,a qualified
healthcare professional, e.g. a doctor or a pharmacist should be
consulted.
Not recommended for children or adolescents under 18 years.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Valerian root or any
of the excipients listed in section 6.1
Valerian should not be used in children and adolescents under 18 years
because sufficient data is not available and medical
advice should be sought.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed stated dose.
Health Products Regulatory Authority
26 February 2021
CRN00C3FW
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL