Avenacalm Avena Sativa Oral Drops
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AvenaCalm Avena sativa oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral liquid contains:
940 mg of tincture from the pressed juice of fresh oat herb (Avena sativa L., herba rec.) (1:1.2)
Extraction solvent: Ethanol 51% V/V (43% m/m)
1 ml is equivalent to 37 drops.
1 ml of oral liquid contains approximately 404 mg of ethanol (alcohol) equivalent to 10.2 ml beer or 4.25 ml wine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear yellow-brown to green-brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of symptoms associated with mild stress such as mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adults and the elderly (18 years and over):
For relief of symptoms of mild stress and mild anxiety:
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 children or adolescents under 18 years (see Section 4.4 Special warnings and precautions for use).
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Oats or Oat preparations or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed stated dose.
Caution is advised when used in patients with coeliac disease because data on the protein content is not available.
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
The use of this product is not recommended in children or adolescents under 18 years because data are not sufficient and medical advice should be sought.
This product contains 51 % vol ethanol (alcohol).
This corresponds to
• 275 mg alcohol equivalent to 6.94 ml beer or 2.89 ml wine (25 drop dose).
• 327 mg alcohol, equivalent to 8.26 ml beer or 3.44 ml wine (30 drop dose)
Harmful for those suffering from alcoholism. To be taken into account in pregnant, or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
4.5 Interaction with other medicinal products and other forms of interaction
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
May impair ability to drive and use machines.
Affected patients should not drive or operate machinery.
This product contains alcohol (see Section 4.4. for details of alcohol content).
4.8 Undesirable effects
None known.
If adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (20.2 g in 50 ml: 40.4 g in 100 ml: equivalent to approximately 2 or 4 glasses of wine, respectively) may result in intoxication and should be treated accordingly.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.2
Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.3 Preclinical safety data
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years unopened.
Use within 4 months of opening.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Brown glass dropper bottles (Type III glass) with a twist-off cap.
Pack sizes: 50 ml
100 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bioforce (UK) Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0023
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/06/2012
10 DATE OF REVISION OF THE TEXT
14/06/2012