KIWIHERB VALERIAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

VALERIANA OFFICINALIS

Available from:

Phytomed (UK) Ltd

ATC code:

N05CM09

INN (International Name):

VALERIANA OFFICINALIS

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Valerianae radix

Authorization status:

Authorised

Authorization date:

2017-10-06

Patient Information leaflet

                                READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However you still need to use Kiwiherb Valerian
carefully to get the best results from it.
Keep this leaflet. You may want to read it again.
Ask your healthcare professional, e.g. a doctor
or pharmacist, if you need more information or
advice.
If the condition worsens or symptoms do not
improve after 2 weeks, a qualified healthcare
professional, e.g. a doctor or pharmacist, should be
consulted.
If any of the side effects get serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET?
1. What this product is and what it is used for
2. Before you take this product
3. How to take this product
4. Possible side effects
5. How to store this product
6. Further information
1. WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR
Kiwiherb Valerian contains Valerian root extract
(see section 6 for full details).
Kiwiherb Valerian is a Traditional herbal medicinal
product for relief of symptoms of mild mental
stress and to aid sleep, exclusively based on long
standing use.
2. BEFORE YOU TAKE THIS PRODUCT
DO NOT TAKE THIS PRODUCT IF YOU ARE:
•
Allergic to Valerian or any other ingredients
in this product (see section 6)
•
Under 18 years of age
•
Pregnant or breast feeding
•
Taking medicines known to interact with
alcohol (e.g. metronidazole)
•
Already taking a medicine for sleep or
anxiety
TAKING OTHER MEDICINES
Tell your healthcare professional, e.g. a doctor or
pharmacist, if you are taking any other medicines
including herbal medicines or medicines that did
not require a prescription.
DRIVING AND USING MACHINES
This product may cause drowsiness. If affected, do
not drive or operate machinery
TAKE SPECIAL CARE WITH THIS PRODUCT
This product contains alcohol (45% ethanol), i.e.
up to 2.25 ml per 5 ml dose, (equivalent to 45
ml beer or 18.8 ml wine), and may be harmful to
those suffering from alcoholism.
To be taken in
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kiwiherb Valerian Oral Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 5ml liquid extract from_ Valeriana officinalis_
radix (corresponding to 2.5 g of valerian root) DER
1:2.
Extraction solvent: ethanol 45% v/v.
A maximum dose of 15ml contains up to 6.75ml ethanol.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral liquid.
A brown liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kiwiherb Valerian is a Traditional herbal medicinal product for relief
of symptoms of mild mental stress and to aid
sleep, exclusively based on long standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short term use only
Adults and the elderly:
To aid sleep:
Take two or three 5ml spoonfuls half an hour before bedtime in a small
amount of juice or water.
To relieve symptoms of mild mental stress:
Take one 5ml spoonful up to three times a day in a small amount of
juice or water.
Maximum daily dose: Three doses per day (total of 15 ml).
This product is not recommended in patients less than 18 years.
Duration of use:
If the condition worsens or symptoms do not improve after 2 weeks, a
qualified healthcare professional e.g. a doctor or
pharmacist should be consulted
4.3 CONTRAINDICATIONS
Hypersensitivity to Valerian or any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of this product is not recommended in children and adolescents
below the age of 18 years because data is not
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