Weleda Relaxing oral drops

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Hops extract; Ethanol; Avena; Passion flower extract; Coffea tosta; Valerian extract

Доступна с:

Weleda (UK) Ltd

код АТС:

n/a

ИНН (Международная Имя):

Hops extract; Ethanol; Avena; Passion flower extract; Coffea tosta; Valerian extract

Фармацевтическая форма:

Homeopathic drops

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Never Valid To Prescribe As A VMP

Обзор продуктов:

BNF: 19020300; GTIN: 5013455060128

тонкая брошюра

READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR
YOU. KEEP THIS LEAFLET AS YOU MAY NEED TO READ IT AGAIN.
Ask your qualified healthcare practitioner or healthcare professional
e.g. a
doctor or pharmacist if you need more information or advice.
You must talk to a doctor if you feel worse, or do not feel better
after seven
days. If you get any side-effects, talk to your qualified healthcare
practitioner
or healthcare professional e.g. a doctor or pharmacist. This includes
any
possible side-effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What this product is and what it is used for
2. What you need to know before taking this product
3. How to take this product
4. Possible side-effects
5. How to store this product
6. Contents of the pack and other information
WELEDA RELAXING ORAL DROPS IS A HOMEOPATHIC MEDICINAL PRODUCT USED
WITHIN THE HOMEOPATHIC TRADITION FOR THE TEMPORARY RELIEF OF MILD
SYMPTOMS
ASSOCIATED WITH STRESS AND TO AID SLEEP.
• DO NOT TAKE:

if you are allergic to any of the ingredients (see Section 6)
 if you are under 18 years of age
 if you are taking any other medicines that interact with alcohol
e.g. metronidazole,
disulfiram
 if you are taking any other medicines to help you sleep or to help
relieve anxiety.
• WARNINGS AND PRECAUTIONS:
This product is intended for the temporary relief of symptoms
associated with
mild stress. Consumers with signs and symptoms of depression should
seek
medical advice for appropriate treatment.
T
alk to your doctor or pharmacist before taking this product:
 if you are suffering from alcoholism or are in a high risk group
of patients
suffering with liver disease or epilepsy as this medicinal product
contains
alcohol. The amount of alcohol in each 1ml (20 drops) is 357mg.
The maximum recommended dose of this medicinal product (100 drops)
will increase the concentration of alcohol in your body by
approximately 380mg/L.
This is equivalent to drinking 47.5ml of beer or 19.5ml of wine.
Alcohol may in

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Weleda Relaxing Oral Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of oral liquid contains:
_Avena sativa_ mother tincture 0.25ml [equivalent to 121mg fresh Avena
sativa
herb].
Extraction solvent: Ethanol 62% w/w
_Humulus lupulus_ mother tincture 0.04ml [equivalent to 3mg Hops
Strobile].
Extraction solvent: Ethanol 86% w/w
_Passiflora incarnata_ mother tincture 0.075ml [equivalent to 23mg
fresh
Passion Flower herb].
Extraction solvent: Ethanol 86% w/w
_Valeriana officinalis_ mother tincture 0.3ml [equivalent to 26mg
Valerian root].
Extraction solvent: Ethanol 43% w/w
Coffea tosta 60X 0.15ml
1 ml is equivalent to 20 drops
1 ml of oral liquid contains approximately 357 mg of ethanol (alcohol)
equivalent to
9.5 ml beer or 3.9 ml wine.
For full list of excipients see Section 6.1
3
PHARMACEUTICAL FORM
Oral drops, solution
Clear, yellow-brown liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A homeopathic medicinal product used within the homeopathic tradition
for
the temporary relief of mild symptoms associated with stress and to
aid sleep.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly:
For the temporary relief of mild stress symptoms: 15-20 drops in a
small glass
of water, three times a day.
To aid sleep: 20-40 drops in a small glass of water, half an hour
before retiring
to bed.
MAXIMUM DAILY DOSE IS 100 DROPS.
Not recommended for use in children and adolescents under 18 years of
age
(see Section 4.4 ‘Special warnings and precautions for use’).
Method of administration
For oral, short term use only.
Duration of use
If the symptoms worsen, or persist after one week, a doctor or
qualified
healthcare practitioner should be consulted.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
If the symptoms worsen, or persist after one week, a doctor or
qualified
healthcare practitioner sh