I/7085293

IWELEDR DIGESTION CALMING DROP5 I

Traditional Herbal Medicinal Product

Weleda Digestion Calming Drops contains the following ingredients: liquid extracts from Angelica Root, Cinnamon bark, WELEDA    Melissa Leaf, Nutmeg seed.

PATIENT INFORMATION

Read this leaflet carefully because it contains important information for you. Keep this leaflet. You may need to read it again.

Ask your pharmacist or qualified healthcare practitioner if you need more information or advice.

You must contact a doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after one week.

If any of the side-effects get serious, or if you notice any side-effect not listed in this leaflet, please tell your doctor or qualified healthcare practitioner.

In this leaflet:

1.    What this product is and what it is used for

2.    Before taking this product

3.    How to take this product

4.    Possible side-effects

5.    How to store this product

6.    Further information

1. What this product is and what it is used for

Weleda Digestion Calming Drops is a traditional herbal medicinal product used for the symptomatic relief of nausea, stomach ache and upset stomach. Based on traditional use only.

2. Before taking this product

Do not take Weleda Digestion Calming Drops if you are allergic to any of the ingredients or to Peru balsam (see Section 6), if you are pregnant or breastfeeding, or if you are taking any other medicines known to interact with alcohol eg. metronidazole.

•    Special warnings and precautions for use:

This medicinal product contains 62% v/v of ethanol (alcohol) i.e. up to 984mg per dose (before dilution). This is equivalent to 24.48ml of beer or 8.8ml of wine. This may be harmful for those suffering from alcoholism and should be taken into account in pregnant and breastfeeding women, children and high risk groups such as patients with liver disease and epilepsy

•    Driving and Using Machines

Weleda Digestion Calming Drops may cause drowsiness. If you are affected do not drive or use machinery.

3. How to take this product

Directions: Weleda Digestion Calming Drops are for oral use.

Adults, the elderly and children over 12 years of age:

Unless otherwise directed: 10-20 drops to be taken in a little water every hour as required up to 8 times a day.

Weleda Digestion Calming Drops is not recommended for children under 12 years of age DO NOT EXCEED THE STATED DOSE

If the symptoms worsen or persist after one week consult a doctor or qualified healthcare practitioner.

OVERDOSE

If you take too much of this product (overdose) this may result in alcohol intoxication and should be treated accordingly. See Section 2 - Special warnings and precautions for use. Consult your doctor or pharmacist and take this leaflet with you.

The amount in a full bottle of Weleda Digestion Calming Drops (12.28g in 25ml and 24.56g in 50ml), is equivalent to 110/220ml of wine or 306/612ml of beer. WHAT TO DO IF YOU MISS A DOSE

If you miss a dose of Weleda Digestion Calming Drops, just take the next dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side-effects

Weleda Digestion Calming Drops may cause mouth irritation.

If you experience any unwanted effects consult your doctor, pharmacist or qualified healthcare practitioner.

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 GP'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 store above 25°C

•    do not use after the expiry date on the carton

•    store in the original container

•    return any unused medicine to your pharmacist for safe disposal

6. Further Information

Each ml (corresponding to 0.91 g) of Weleda Digestion Calming Drops contains 0.37ml of liquid extract from: Angelica root (Angelica archangelica L.) (equivalent to 11 mg Archangelica root); Cinnamon bark (Cinnamon zeylanicum Nees.) (equivalent to 15mg Cinnamon bark); Nutmeg seed (Myristica fragrans Houtt.) (equivalent to 22mg Nutmeg seed); Melissa leaf (Melissa officinalis L.) (equivalent to 45mg Melissa leaf).

Extraction solvent: Ethanol 34% v/v.

The other ingredients are: Ethanolic distillate from Coriander and Clove; Lemon oil; Ethanol; Purified Water.

Pack Description: Weleda Digestion Calming Drops are clear, colourless oral drops presented in an amber glass bottle. Each bottle contains 25ml or 50ml. Not all pack sizes may be marketed.

THR holder and manufacturer: Weleda (UK) Ltd., Heanor Road, Ilkeston, Derbyshire DE7 8DR, UK.

THR 00298/0289.    Certification Mark

Braille version

To request a copy of this leaflet in Braille or large print, or to listen to an audio version, please call free of charge: 0800 198 5000 (UK only). Please be ready to give the following information:

Product name: Weleda Digestion Calming Drops.

Reference number THR 00298/0289.

This service is provided by the Royal National Institute for Blind people.

Leaflet last revised May 2013 I/708529/3