Patient leaflet - A VOGEL AGNUS CASTUS ORAL DROPS
1. What this product is for
A.Vogel Agnus castus oral drops is a traditional herbal medicinal product used to help relieve premenstrual symptoms such as:
- Irritability
- Mood swings
- Breast tenderness
- Bloating
- Menstrual cramps
This is based on traditional use only.
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2. Before you use this product
3. How to use this product
Do not take 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 have a pituitary disorder.
- If you are pregnant, trying to become pregnant or breast-feeding.
Take special care with this product
See your doctor before taking this product if:
- You suffer from or have suffered from an oestrogen-sensitive cancer
- You have suffered from a pituitary disorder
- You are taking any of the following medicines:
-
■ Dopamine agonists or antagonists
-
■ Oestrogens
-
■ Antioestrogens
You should also know
- This medicinal product contains 69.5 vol % ethanol (alcohol), i.e. up to 341 mg per 20 drop dose, equivalent to 8.4 ml beer (around half a tablespoon) or 3.5 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.
Women experiencing premenstrual symptoms: Take 15–20 drops in a little water twice daily.
The effects of this product may not be felt immediately. For best results you may need to take this product for up to 3 months.
For oral use only. Don't take more than 40 drops a day.
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‘).
- Don't worry about the missed dose. Take the next dose as usual.
- See your doctor if your symptoms persist, worsen or do not improve after 3 months.
- This product contains alcohol (see section 2 ‚You should also know‘ for alcohol content). If affected do not drive or use machines.
Please turn over…
Information
4. possible side effects
Like all medicines, this product can cause side effects, although not everybody gets them.
Side effects
The following side effects can occur when using this product.
Severe allergic reactions
- Swelling of the face, breathlessness and difficulty swallowing
Stop taking the product immediately if these occur. Seek medical advice and take this leaflet with you.
Allergic skin reactions
- Rash
- Red, itchy spots (urticaria)
Stop taking the product if these occur.
Digestive symptoms
- Feeling sick (nausea)
- Abdominal pain
Other reactions
- Headache
- Dizziness
- Acne
- Menstrual disorders
These are often short-lived and should go away by themselves. However if they are troubling you, talk to your doctor or pharmacist.
The frequency of these side effects is not known. This means it is not known how often these reactions occur as there has not been enough reports to allow this information to be calculated.
If you are concerned about any side effect or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at. 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).
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 3 months of opening.
- Store in the original packaging.
- Do not use this product if you notice a change in colour. It should be a clear liquid that is yellow-brown in colour.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Further Information
What this product contains
1 ml (33 drops) contains 895 mg of tincture from Agnus castus fruits (Vitex agnus-castus L.) (1:10). Extraction solvent: ethanol 69.5% v/v.
The other ingredients used for the liquid are ethanol and water.
What this product looks like and the contents of the pack
A.Vogel Agnus castus oral drops is a clear liquid that is yellow-brown in colour. It is available in 50 ml bottles.
Traditional Herbal Registration Holder and Manufacturer
Traditional Herbal Registration Holder and Batch Release:
A.Vogel Ltd,
2 Brewster Place, Irvine, Ayrshire, UK KA11 5DD
Manufacturer:
A.Vogel AG, CH-9325, Roggwil, Switzerland
THR 13668/0029
THR" Certification Mark
Leaflet revision date: 01/2020
What is Agnus castus?
Agnus castus is a flowering plant which is native to the Mediterranean. It is the extract of the fruit which is used to make A.Vogel Agnus castus oral drops.
You should also know
A.Vogel runs a helpline by phone and email which can provide you with further information.
Email:
Phone: 0845 608 5858
You can get a larger print or audio version of this leaflet.
Call this number:
0845 608 5858.
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Agnus castus PIL UK THR Jan 2020_alt1.indd 2
18/02/2020 11:44