Valerian Complex Stress Relief Oral Drops

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Tincture of valerian root (valeriana officinalis l.) (1:10-11) extraction solvent: ethanol 58% v/v; Tincture of hop strobile (humulus lupulus l.) (1:12-13) extraction solvent: ethanol 65% v/v

Commercializzato da:

Bioforce (UK) Ltd

INN (Nome Internazionale):

Tincture of valerian root (valeriana officinalis l.) (1:10-11) extraction solvent: ethanol 58% v/v; Tincture of hop strobile (humulus lupulus l.) (1:12-13) extraction solvent: ethanol 65% v/v

Forma farmaceutica:

Oral drops, solution

Tipo di ricetta:

Product not subject to medical prescription

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2014-05-02

Foglio illustrativo

Read all of this leaflet carefully
before you start taking this
product because it contains
important information for you.
Always take this product exactly
as described in this leaflet or as
your doctor, pharmacist or nurse
has told you.
Keep this leaflet. You may
need to read it again.
Ask your pharmacist if you
need more information or
advice.
If you get any side effects,
talk to your doctor, pharmacist
or nurse. This includes any
possible side effects not listed
in this leaflet. See section 4.
You must talk to a doctor if
you do not feel better or if
you feel worse after 2 weeks.
What is in this leaflet
1. What Valerian Complex is and
what it is used for
2. What you need to know before
you take Valerian Complex
3. How to take Valerian Complex
4. Possible side effects
5. How to store Valerian Complex
6. Contents of the pack and other
information
Information
_Please turn over..._
Do's and Don'ts
Using
41512IN2
1. What Valerian
Complex is and what it
is used for
Valerian Complex is a traditional
herbal medicinal product containing
the tinctures of fresh Valerian root
and fresh Hops strobile.
It is used for the relief of symptoms
of:
Mild mental stress
This is exclusively based on long-
standing use.
Valerian Complex is for use in
adults.
2. What you need to
know before you take
Valerian Complex
Do not take Valerian Complex
If you are allergic to any of the
ingredients of this product (listed
in section 6).
Warnings and precautions
See your doctor if your
symptoms worsen or do not
improve within 2 weeks.
Children and adolescents
Do not give this product to
children or adolescents under 18
years of age as it is not known if
it is suitable for them.
Other medicines and
Valerian Complex
Do not take this product if you
are already taking another
medicine which can cause
drowsiness.
Do not take this product if you
are taking a medicine which is
affected by alcohol.
If you are speaking to your
doctor, pharmacist or nurse
always remember to tell them
about any medicines you are
taking, including herbal remedies
such as V

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valerian Complex Stress Relief Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 drops contains:
263 mg of tincture from Valerian root (_Valeriana officinalis_ L.)
(1:10-11). Extraction solvent: Ethanol 58% V/V.
and
263 mg of tincture from Hop Strobile (_Humulus lupulus_ L.) (1:12-13).
Extraction solvent: Ethanol 65% V/V.
1 ml is equivalent to 35 drops.
EXCIPIENTS WITH KNOWN EFFECT:
A maximum dose of 20 drops contains approximately 280 mg ethanol
(alcohol).
For the full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Oral drops, solution (Oral drops)
Green to brown, clear liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for the relief of symptoms of
mild mental stress, exclusively based on long-
standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and older people: Take 10-20 drops in a little water or fruit
juice once or twice a day.
Maximum daily recommended dose is 40 drops.
As treatment effects may not be apparent immediately, the product
should be taken for 2 weeks continuously.
DURATION OF USE
If symptoms persist, worsen or do not improve after 2 weeks use of
Valerian Complex a qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
Not recommended for children or adolescents under 18 years (see
Section 4.4 Special warnings and precautions for
use).
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to Valerian, Hops or any of the excipients listed in
section 6.1.
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