AvenaCalm Avena sativa oral drops

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tincture from pressed juice from avena sativa l, herba rec (fresh oat herb),(1:1.2)

Available from:

A. Vogel Ireland Ltd,

INN (International Name):

Tincture from pressed juice from avena sativa l, herba rec (fresh oat herb),(1:1.2)

Dosage:

.

Pharmaceutical form:

Oral drops, solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

2016-07-01

Patient Information leaflet

A.Vogel Ireland Ltd
Avenaforce drops
IE - Dublin
CTD Module 1
June 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2521.e06
Page 1 of 5
_Avena sativa:_ Herba rec. T.
Art. no. 02323200
PATIENT INFORMATION LEAFLET
AVENACALM
_AVENA SATIVA _
oral drops
Expressed juice from oat herb
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.
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 AvenaCalm is and what it is used for
2.
What you need to know before you take AvenaCalm
3.
How to take AvenaCalm
4.
Possible side effects
5.
How to store AvenaCalm
6.
Contents of the pack and other information
1.
WHAT AVENACALM IS AND WHAT IT IS USED FOR
AvenaCalm is a traditional herbal medicinal product containing the
expressed juice from fresh oat herb.
It is used for the temporary relief of symptoms of:
•
Mild mental stress
•
To help sleep
This is exclusively based on long-standing use.
AvenaCalm is for use in adults.
A.Vogel Ireland Ltd
Avenaforce drops
IE - Dublin
CTD Module 1
June 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2521.e06
Page 2 of 5
_Avena sativa:_ Herba rec. T.
Art. no. 02323200
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVENACALM
DO NOT TAKE AVENACALM
•
If you are allergic to any of the ingredients of this product (listed
in section
6).
WARNINGS AND PRECAUTIONS
•
See your doctor BEFORE taking this product if you suffer from coeliac
disease. The protein content of this product is not known.
•
See your doctor if your symptoms worsen

Summary of Product characteristics

Health Products Regulatory Authority
02 August 2022
CRN00D09F
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AvenaCalm Avena sativa oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
30 drops contains 381 mg of expressed juice from _Avena sativa _L.,
herba rec. (fresh oat herb) in ethanolic solution.
1 ml is equivalent to 37 drops.
EXCIPIENTS WITH KNOWN EFFECT:
A maximum dose of 30 drops contains approximately 328 mg of ethanol
(alcohol).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution (oral drops)
Clear yellow-brown to green-brown liquid which may contain a fine
precipitation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the temporary relief
of symptoms of mild mental stress and to aid sleep
exclusively based on long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (18 years and over):
For relief of symptoms of mild mental stress:
Take 25-30 drops twice daily.
To aid sleep:
Take 30 drops in a little water half an hour before bedtime.
Maximum daily recommended dose is 90 drops.
Not recommended for use in children and adolescents under 18 years
(see Section 4.4 Special warnings and precautions for
use).
Do not exceed the stated dose.
DURATION OF USE
If symptoms persist, worsen or do not improve after 2 weeks a
qualified healthcare professional e.g. a doctor or pharmacist
should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
02 August 2022
CRN00D09F
Page 2 of 4
Do not use in cases of known hypersensitivity to Oats, Oat
preparations or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
The use in children and adolescents under 18 years of age has not been
established due to lack of adequate data.
If symptoms persist, worsen or do not improve after 2 weeks, or if new
symptoms develop whilst taking this medicinal p