Dormeasan Sleep Valerian-Hops oral drops

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

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

Dostupné z:

Bioforce (UK) Ltd

INN (Medzinárodný Name):

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

Dávkovanie:

Unknown

Forma lieku:

Oral drops, solution

Typ predpisu:

Product not subject to medical prescription

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2014-05-02

Príbalový leták

Information
Package Leaflet:
Information for the user
_Please turn over..._
Do's and Don'ts
Dormeasan
®
Using
41530IN1
1. What Dormeasan
Sleep is and what it is
used for
Dormeasan Sleep is a traditional
herbal medicinal product containing
the tinctures of fresh Valerian root
and fresh Hop strobiles.
It is used to aid sleep. This is
exclusively based on long-standing
use.
Dormeasan Sleep is for use in
adults.
2. What you need to
know before you take
Dormeasan Sleep
Do not take Dormeasan Sleep
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
Dormeasan Sleep
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 Dormeasan Sleep.
Pregnancy and breast-feeding
Do not take this product if you
are pregnant or breast-feeding
as it may not be suitable for you.
Driving and using machines
This product is intended to
help you fall asleep. If you feel
drowsy do not drive or operate
machinery.
The effects of this product
may be increased by alcohol.
Excessive use of alcohol should
therefore be avoided.
This product contains alcohol
(see below for alcohol content).
Overdose of this product may
result in alcohol intoxication.
Dormeasan Sleep contains
alcohol
This medicinal product contains
62 vol % ethanol (alcohol), i.e.
up to 420 mg per 30 drop dose,
equivalent to 11 ml beer (less
than a tablespoon) or 4 ml wine
(less than a teaspoon) per dose.
Harmful for those suffering from
alcoholism.
To be taken into account in
pregnant or breast-feeding
women, children

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dormeasan Sleep Valerian-Hops oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
30 drops contains:
394 mg of tincture from Valerian root (_Valeriana officinalis_ L.)
(1:10-11). Extraction solvent: ethanol 58% v/v
and
394 mg of tincture from Hop strobile (_Humulus lupulus_ L.) (1:12-13).
Extraction solvent: ethanol 65% v/v.
A maximum dose of 30 drops contains approximately 420 mg ethanol
(alcohol).
1 ml is equivalent to 35 drops.
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
Traditional herbal medicinal product to aid sleep exclusively based on
long standing use.
This product is indicated for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and older people:
Take 30 drops in a little water or fruit juice half an hour before
bedtime.
As treatment effects may not be apparent immediately, Dormeasan Sleep
should be taken for 2 weeks
continuously.
Duration of use:
If symptoms persist, worsen or do not improve after 2 weeks use of
Dormeasan Sleep 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.
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