AGNUS CASTUS Oral Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TINCTURE FROM AGNUS CASTUS FRUITS

Available from:

Bioforce (UK) Ltd

INN (International Name):

TINCTURE FROM AGNUS CASTUS FRUITS

Pharmaceutical form:

Oral Drops Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

2014-12-12

Patient Information leaflet

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 3 months.
What is in this leaflet
1.  What Agnus castus is and 
what it is used for
2.  What you need to know 
before you take Agnus castus 
3.  How to take Agnus castus 
4.  Possible side effects
5.  How to store Agnus castus 
6.  Contents of the pack and other 
information
Information
Package Leaflet:
Information for the user
_Please turn over..._
Do's and Don'ts for taking Agnus castus 
Agnus castus

oral drops
Agnus castus tincture
31454IN1

1. What Agnus castus is 
and what it is used for
Agnus castus is a traditional herbal 
medicinal product containing the 
extract of Agnus castus fruit. 
It is used to relieve the minor 
symptoms of 
premenstrual 
syndrome. This is exclusively based 
on long-standing use.
Agnus castus is for use in women 
over 18 years of age. 
Premenstrual syndrome (PMS) 
consists of the symptoms that can 
occur in the two weeks before a 
monthly period. It is also known 
as premenstrual tension (PMT). 
Symptoms can be both physical 
and emotional and can include 
irritability, mood swings, breast 
tenderness, bloating and menstrual 
cramps.
2. What you need to 
know before you take 
Agnus castus 
Do not take Agnus castus 
  If you are allergic to any of the 
ingredients of this product (listed 
in section 6).
  If you have a pituitary disorder.
  If you are pregnant, trying to 
become pregnant or bre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agnus castus oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (15-20 drops) contains 407 – 542 mg of tincture from Agnus castus fruits (_Vitex agnus-castus _L.) (1:10).
Extraction solvent: ethanol 69.5% v/v.
1 ml of oral drops contains 895 mg of tincture (equivalent to 33 drops).
Excipients with known effect:
Each dose (15 -20 drops) contains approximately 252 – 336 mg of ethanol (alcohol).
For the 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 traditional herbal medicinal product for the relief of minor symptoms of premenstrual syndrome, exclusively based
upon long-standing use.
This product is indicated for use in women over 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Women experiencing minor premenstrual symptoms: Take 15-20 drops in a little water twice daily.
As treatment effects may not be apparent immediately, the product may need to be taken up to 3 months continuously.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and
precautions for use’).
DURATION OF USE
If symptoms worsen during use or do not improve after a continued use over 3 months, a qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral use only.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Agnus castus fruit or to any of the excipients listed in section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/12/2014_
_CR