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Napiers Oral Skin Soother Herbal Relief

6. FURTHER INFORMATION Each 5 ml of oral liquid contains:

0.05 ml liquid extract Burdock root

(Arctium lappa L.) (1:1) (equivalent to 50 mg Burdock root). Extraction solvent: Ethanol 21% v/v

0.10 ml liquid extract Burdock root

(Arctium lappa L.) (1:1)

(equivalent to 100 mg Burdock root). Extraction solvent: Ethanol 17% v/v 0.05 ml liquid extract Sarsaparilla root (Smilax aristolochiaefolia) (1:1) (equivalent to 50 mg Sarsaparilla). Extraction solvent: Ethanol 22% v/v

0.195 ml liquid extract Red Clover flower

(Trifolium pratense) (1:1) (equivalent to 195 mg Red Clover). Extraction solvent: Ethanol 22% v/v

0.05 ml liquid extract Queen's Delight

root (Stillingia sylvatica L.) (1:1) (equivalent to 50 mg Queens Delight). Extraction solvent: Ethanol 22% v/v

0.10 ml liquid extract Cascara bark

(Rhamnus purshiana L.) (1:1)

(equivalent to 100 mg Cascara bark) Extraction solvent: Ethanol 13%

0.05 ml liquid extract Poke root (Phytolacca decandra) (1;1)

(equivalent to 5 mg Poke root)

Extraction solvent: Ethanol 22% v/v 0.03 ml liquid extract Prickly Ash bark (Zanthoxylum americanum) (1:1) (equivalent to 3 mg Prickly Ash bark) Extraction solvent: Ethanol 22% v/v

This product also contains:

Sucrose, ethanol. caramel (E150), glycerin (E422), orange oil and water.

This product comes in a glass bottle of 100 ml, or 200 ml with a child-resistant safety cap. Not all sizes may be marketed. This product is a brown liquid.

Traditional herbal registration holder:

Highland Herbs Ltd,

10 Payne Street, Glasgow G4 0LF

Product manufacturer

Potters, Wigan WN5 0JZ.

Traditional herbal registration number:

THR 43751/0005

Certification mark

Making medicines safer

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 a pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

Further Enquiries

If you would like more information about this product please contact:

Napiers the Herbalists 10 Payne Street,

Glasgow G4 0LF

Telephone: 0845 002 1860

Patient Information Leaflet

Napiers Oral Skin Soother Herbal Relief

Please read this leaflet carefully before you start taking this product. It contains important information for you about this product that may affect you.

Keep this leaflet as you may wish to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner. If you have further questions, ask your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet?

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

2.    Before you take this product

3.    How to take this product

4. Possible side effects

5.    How to store this product

6. Further information

This leaflet was revised on 20/01/2015 NAP05LEA1


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EDINBURGH 1860 HERB & PLANT REMEDIES


1.    WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

Napiers Oral Skin Soother Herbal Relief is a traditional herbal medicinal product containing extracts of Burdock root, Sarsaparilla root, Red Clover flower, Queens Delight root, Cascara bark, Poke root and Prickly Ash bark. For full details see Section 6.

Napiers Oral Skin Soother Herbal Relief is a traditional herbal medicinal product used for the symptomatic relief of minor skin conditions causing skin irritation, including allergic conditions, dermatitis, mild acne and mild eczema, based on traditional use only.

2.    BEFORE YOU TAKE THIS PRODUCT Do not take this product if you:

•    are under the age of 12

•    are pregnant or breast-feeding

•    are hypersensitive or allergic to any of the ingredients (See Sections 4 and 6) or plants of the Asteraceae (Compositae) family such as daisies, marigolds or artichokes

•    are taking medicines known to interact with alcohol i.e. metronidazole


Special warnings

If not treated adequately, acne may cause scarring. Do not use this product and consult your doctor or qualified healthcare practitioner if; you have widespread redness, oozing or infected skin sores, infected or inflamed spots, if the skin is broken, or if the affected area has suddenly become inflamed.

Important information about some of the ingredients in this medicine

Each 5 ml of oral liquid contains approximately 3.19 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains 8.3 % v/v ethanol (alcohol). Each 5 ml dose contains around 0.415 ml of alcohol, i.e. up to 332 mg per dose, equivalent to 8.3 ml beer or 3.46 ml wine per dose. This is harmful for those suffering from alcoholism and high-risk groups such as patients with liver disease or epilepsy.

Taking other medicines

If you are taking any other medication, including medicines obtained without a prescription, consult your doctor or pharmacist before taking this product.

Driving and using machines

This product contains alcohol which may impair your ability to drive or operate machines. If affected, do not drive or operate machines.

3. HOW TO TAKE THIS PRODUCT

For oral use only. For adults, the elderly and adolescents over the age of 12.

Take one 5 ml teaspoonful three times a day.

Do not exceed the recommended dose of 3 single doses a day.

If your symptoms worsen or persist for more than two weeks, tell your doctor, pharmacist or qualified healthcare practitioner.

If you take too much (overdose)

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

Overdose of this product may result in alcohol intoxication and should be treated accordingly.

If you forget to take this product

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

If you have any questions, or are unsure of anything, please speak to your doctor, pharmacist or qualified healthcare practitioner.

4.    POSSIBLE SIDE EFFECTS

Anaphylactic shock has been reported with Burdock root. This is rare and the frequency is not known.

If this adverse effect or reactions not mentioned above occur, stop taking this product and contact your doctor or qualified healthcare practitioner.

5.    HOW TO STORE THIS PRODUCT

Do not use this product after the expiry date printed on the label and carton. This product does not require special storage conditions. Return any unused medicine to your pharmacist for safe disposal.

Keep this product out of the reach and sight of children.