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Napiers Herbal Sleep Aid

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PATIENT INFORMATION LEAFLET English Herbal Medicines Passionflower Sleep Aid Complex

or

Napiers Herbal Sleep Aid

Please read this information carefully

before you start taking this medicine. It contains important information about this product. Keep this leaflet with this medicine 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 Passionflower Sleep Aid Complex and what it is used for.

2.    Before you take English Herbal Medicines Passionflower Sleep Aid Complex

3.    How to take English Herbal Medicines Passionflower Sleep Aid Complex

4.    Possible Side Effects

5.    How to store English Herbal Medicines Passionflower Sleep Aid Complex

6.    Further information

1. What is English Herbal Medicines Passionflower Sleep Aid Complex and what it is used for

This product is a traditional herbal medicinal product containing extracts Passion flower herb, Wild lettuce leaf, Jamaica Dogwood bark and White willow bark.

Each 5ml of oral liquid contains 0.25 ml of liquid extract from Passiflora herb* (Passiflora incarnata L.) (1:1); 0.125 ml of liquid extract from Wild Lettuce herb* (Lactuca virosa L.) (1:1); 0.125 ml of liquid extract from Jamaica Dogwood bark (Piscidia erythrina L.) (1:1); 0.27 ml of liquid extract from White Willow bark* (Salix alba L.) (1:1). *Certified organically produced herbal ingredient

What English Herbal Medicines Passionflower Sleep Aid Complex is used for

English Herbal Medicines Passionflower Sleep Aid Complex is a traditional herbal medicinal product used for the temporary relief of sleep disturbances, based on traditional use only

2. Before you take English Herbal Medicines Passionflower Sleep Aid Complex

Do not take this product if you:

•    are under 18 years of age

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

•    are pregnant or breastfeeding

•    are allergic to any of the ingredients or to plants    of the Asteraceae/    Compositae family

•    are allergic to salicylates (have had a serious allergic reaction    causing swelling e.g.    of the

face and throat, difficulty breathing, hives or nettle rash after taking salicylates or other non steroidal anti-inflammatory drugs (NSAIDs))

•    have asthma

•    have a peptic ulcer

•    are already taking another medicine for sleep or anxiety

Consult you doctor before taking this medicine if you have:

-    severe liver or kidney disorders

-    blood coagulation problems

-    a gastric/duodenal ulcer

-    glucose-6-phosphate dehydrogenase deficiency

Taking other medicines

This product should not be taken with non steroidal anti-inflammatory drugs (NSAIDs) or other salicylate medicines or any anticoagulant medicines such as heparin and coumarin medicines.

Tell your doctor before taking this medicine if you are taking any other medicines, including any bought without a prescription.

Important information about some of the ingredients in this product:

This product contains up to 1.2 g ethanol (alcohol) per 5 ml dose (equivalent to 30 ml of beer or 13 ml of wine).

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver-disease, or epilepsy

Driving and using machines:

This product contains alcohol (see above) and may affect your ability to drive or use machines. If affected do not drive or use machines.

3. How to take English Herbal Medicines Passionflower Sleep Aid Complex

Adults and the elderly - Take one 5ml teaspoonful in the early evening and take two 5ml teaspoonfuls at bedtime. Take with water or other liquids.

Maximum daily dose: 30 mls (3 doses)

If symptoms worsen or persist for more than 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

Do not exceed the stated dose.

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. Overdose of this product may cause alcohol intoxication (see section 2 Important information about some of the ingredients in this product)

If you forget to take this product

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

If your condition worsens or if symptoms persist for more than 4 weeks after taking the product or if side effects become serious or if side effects not mentioned in the patient information leaflet occur, consult a doctor or qualified healthcare practitioner.

4. Possible side effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia (increased heartbeat) have been reported in patients taking Passiflwer herb. The frequency is not known.

Willow bark may cause allergic reactions such as itching, hives or nettle rash,, asthma and gastrointestinal symptoms such as nausea, vomiting, abdominal pain, indigestion, heartburn,and diarrhoea. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

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).

5. How to store English Herbal Medicines Passionflower Sleep Aid Complex

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 deg C. Store in the original package.

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

6. Further Information

Active Ingredients

Each 5ml of oral liquid contains

0.5 ml of liquid extract from Passiflora herb * (Passiflora incarnata L.) (1:1) Extraction solvent: ethanol 21% v/v.

0.125 ml of liquid extract from Wild Lettuce leaf * (Lactuca virosa L.) (1:1).

Extraction solvent: ethanol 21% v/v.

0.125 ml of liquid extract from Jamaica Dogwood bark (Piscidia erythrina L.) (1:1).

Extraction solvent: ethanol 56% v/v.

0.27 ml of liquid extract from White Willow bark * (Salix alba L.) (1:1).

Extraction solvent: ethanol 21% v/v.

*Certified organically produced herbal ingredient

This product also contains the following ingredients: Ethanol, orange oil, quillaia bark liquid extract, glycerol and water

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

Traditional Herbal Registration Number THR 28255/0029

Registration holder and Manufacturer for this product :

Rutland Biodynamics Ltd.,

Town Park Farm Brooke,

Rutland, LE15 8DG

This leaflet was last revised in April 2013

THR certification mark