Avenacalm Avena Sativa Oral Drops
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AvenaCalm
Avena sativa oral drops
Important things you need to know
• This product is used for the temporary relief of the symptoms of mild stress such as mild anxiety and to help sleep.
• This product is suitable for adults over 18 years.
• Don't take this product if you are allergic to any of the ingredients: see section 6.
• Before you take this product: read section 2.
• Dosage instructions: see section 3.
• Talk to your doctor if your symptoms worsen or you do not feel any benefit from this product within 4 weeks.
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1. What this product is for
AvenaCalm is a traditional herbal medicinal product for the temporary relief of symptoms associated with mild stress such as:
• Mild anxiety
• To help sleep
This is based on traditional use only.
0® Do's & Don'ts
2. Before you use this product
Do not use this product:
• If you are under 18 years of age.
• If you are allergic to any of the ingredients in this product (see section 6 Further Information).
• If you are taking another medicine which is affected by alcohol.
• If you are pregnant or breast-feeding.
• If you suffer from coeliac disease consult your doctor before using this product.
The protein content of this product is not known.
You should also know
• This medicinal product contains 51 vol % ethanol (alcohol), i.e. up to 327 mg per 30 drop dose, equivalent to 8.26 ml beer (less than a tablespoon) or 3.44 ml wine (less than a teaspoon) per dose.
• If you suffer from alcoholism the alcohol content of this product may be harmful.
• If you are in a high-risk group (patients with liver disease or epilepsy) you should consider the alcohol content before taking this product.
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3. How to use this product
Adults and the elderly:
For mild stress and mild anxiety:
Take 25-30 drops in a little water twice daily. This product may also be used to help sleep: Take 30 drops in a little water half an hour before bedtime.
Do not take more than 90 drops a day.
Not for use in children or those under 18.
If you take too much
• If you take too much and feel ill, talk to your doctor. Taking too much is unlikely to be harmful.
• Overdose of this product may result in alcohol intoxication and should be treated accordingly (see section 2 'You should also know').
If you forget to take this product
• Don't worry about the missed dose. Take the next dose as usual.
If you feel this product isn't working
• See your doctor if your symptoms worsen or do not improve within 4 weeks.
Driving and using machines
• This product is intended to help you relax. If you feel drowsy do not drive or operate machinery.
• This product contains alcohol (see section 2 'You should also know' for alcohol content).
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Side effects 4. Possible side effects
No side effects have been reported with the use of products containing Avena sativa extract.
If you notice any side effects please tell your doctor or pharmacist.
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THR
Information
5. How to store this product
• Keep out of the reach and sight of children.
• Do not use this product after the expiry date on the packaging. The expiry date refers to the last day of that month.
• Use within 4 months of opening.
• This product does not require any special storage conditions.
• Do not use this product if you notice a change in colour. It should be a clear liquid that is yellow-brown to green-brown in colour.
6. Further Information
What this product contains
1 ml of oral liquid contains 940 mg of tincture from the pressed juice of fresh oat herb (Avena sativa L.) (1:1.2). Extraction solvent: ethanol 51% v/v.
1 ml of AvenaCalm oral drops is equivalent to 37 drops.
The other ingredients used for the liquid are ethanol and water.
What this product looks like and the contents of the pack
AvenaCalm is a clear liquid that is yellow-brown to green-brown in colour. AvenaCalm is available in 50 ml and 100 ml bottles. Not all pack sizes may be marketed.
Traditional Herbal Registration Holder and Manufacturer
Traditional Herbal Registration Holder and Batch Release:
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK KA11 5DD
Manufacturer:
Bioforce AG, CH-9325, Roggwil Switzerland
THR No. 13668/0023
Certification Mark
This leaflet was revised on 06/2012
What is Avena sativa?
Avena sativa is more commonly known as oats. It is the extract of the above-ground parts of the plant which is used to make AvenaCalm.
You should also know
Bioforce runs a helpline by phone and email which can provide you with further information.
Email: enquiries@avogel.co.uk
Phone: 0845 608 5858
You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your doctor's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).
You can get a larger print or audio version of this leaflet.
Call this number:
0845 608 5858.
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Avena sativa PIL UK RFI Response June 2012.indd 2 11/06/2012 14:50