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Napiers Herbease Digestive Relief

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THR 28255- 0031 PIL Text only final

PATIENT INFORMATION LEAFLET English Herbal Medicines Herbal Indigestion Mixture

or

Napiers Herbease Digestive Relief

Please read this information carefully before you start taking this medicine. It contains important information about this product. Keep this leaflet with this medicine tablets. You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet?

1.    What is English Herbal Medicines Herbal Indigestion Mixture and what it is used for.

2.    Before you take English Herbal Medicines Herbal Indigestion Mixture

3.    How to take English Herbal Medicines Herbal Indigestion Mixture

4.    Possible Side Effects

5.    How to store English Herbal Medicines Herbal Indigestion Mixture

6.    Further information

1. What is English Herbal Medicines Herbal Indigestion Mixture and what it is used for

This product is a traditional herbal medicinal product containing extracts of Oat seed, Peppermint leaf, Lemon Balm leaf and Southern Prickly Ash berries Each 5ml of oral liquid contains:-

0.21 ml of liquid extract from Oat seed* (Avena sativa L.) (1:1). Extraction solvent: ethanol 25% v/v; 0.21 ml of liquid extract from Peppermint leaf * (Mentha piperita L.) (1:1). Extraction solvent: ethanol 45% v/v; 0.21 ml of liquid extract from Lemon balm leaf * (Melissa officinalis L.) (1:1) Extraction solvent: ethanol 45% v/v; 0.107 ml of liquid extract from dried Southern Prickly Ash berries (Zanthoxylum clava-herculis L.) (1:1). Extraction solvent: ethanol 45% v/v.

* Certified organically produced ingredients

What English Herbal Medicines Herbal Indigestion Mixture is used for

English Herbal Medicines Herbal Indigestion Mixture is a traditional herbal medicinal product used for the symptomatic relief of indigestion, heartburn and stomach ache, based on traditional use only.

2. Before you take English Herbal Medicines Herbal Indigestion Mixture Do not take this product if you:

•    are under 18 years old

•    are taking other medication known to interact with alcohol (e.g. metronidazole).

•    are pregnant or breastfeeding

•    are allergic to oats or oat preparations, to peppermint leaf preparations or to menthol or to any of the ingredients

If you suffer from coeliac disease consult your doctor before taking this product. The protein content of this product is not known.

Before you take this product consult your doctor if:

-    You already have heartburn as Peppermint leaf preparations may cause an increase in heartburn

-    You have gallstones or any other diseases of the bile ducts Important information about some of the ingredients:

This product contains ethanol (alcohol) up to 225 mg of ethanol per dose (equivalent to 6.4 ml of beer or 2.4 ml of wine). 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.

Also contains glucose and sucrose. Consult your doctor before taking this product if you have been told that you have an intolerance to sugar.

Also contains 35.5 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Driving and using machines:

This product contains alcohol (ethanol) and extract of Lemon balm which may affect your ability to drive or use machines. If affected, do not drive or use machines.

3. How to take English Herbal Medicines Herbal Indigestion Mixture

For oral use only

Adults and the elderly - Take one 5ml teaspoon three times a day. May be taken with water or fruit juice if desired.

Do not exceed the stated dose.

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

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor or pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time. Do not take a double dose to make up for the missed dose. It does not matter if you have missed a dose.

4. Possible side effects

Skin reactions may occur in atopic patients and in patients with contact dermatitis with Oat preparations. The frequency is not known.

Peppermint leaf preparations may make heartburn worse.

If any of the above side effects become serious or if other side effects not mentioned above occur, a doctor or pharmacist should be consulted.

5. How to store English Herbal Medicines Herbal Indigestion Mixture

Do not use after the expiry date.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist to dispose of medicines no longer required.

The expiry date is printed on the box and the bottle label. The expiry date refers to the last day of the month.

Do not store above 25 0 C. Store in the original package.

Keep all medicines out of the reach and sight of children Store your medicine in the original container.

6. Further Information Active Ingredients

Each 5ml of oral liquid contains 0.21 ml of liquid extract from Oat seed* (Avena sativa L.) (1:1). Extraction solvent: ethanol 25% v/v; 0.21 ml of liquid extract from Peppermint leaf * (Mentha piperata L.) (1:1). Extraction solvent: ethanol 45% v/v; 0.21 ml of liquid extract from Lemon balm leaf * (Melissa officinalis L.) (1:1) Extraction solvent: ethanol 45% v/v; 0.107 ml of liquid extract from dried Southern Prickly Ash berries (Zanthoxylum clava-herculis L.) (1:1). Extraction solvent: ethanol 45% v/v.

* Certified organically produced ingredients This product also contains the following ingredients:

Orange Oil, Concentrated Cinnamon Water (Cinnamon bark oil, ethanol and water),

Glycerol, Ethanol, Sodium Bicarbonate, Liquid Glucose, Compound Cardamom Tincture (cochineal (E120), cardamom oil, caraway oil, cinnamon bark oil, glycerol, water)), Nutmeg Oil, Clove Oil, Liquorice Liquid Extract, Caramel (E150), Sucrose ,Water.

This product is available in 100ml, 200ml or 250ml bottle sizes. Not all pack sizes may be marketed.

Traditional Herbal Registration Number 28255/0031 Registration holder and Manufacturer for this product :

Rutland Biodynamics Ltd., Brooke, Rutland, LE15 8DG

This leaflet was last revised in March 2013

THR certification mark