THR 14010/0033 Herbal Kalma

PATIENT INFORMATION LEAFLET Important Notes

•    Please read this leaflet carefully before you use this product as it contains important information

•    Keep this leaflet; you may need to read it again

•    Seek professional advice if you need more information

•    Please tell a Doctor or a qualified Healthcare Practitioner if your symptoms worsen or do not improve after 4 weeks of taking this product

•    Please tell a Doctor or a qualified Healthcare Practitioner if you suffer from side effects not listed in this leaflet and/or if any of the side effects become serious

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

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

This product contains Hops, extracts of Passion Flower and Valerian Root. It is a traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety and to aid sleep, based on traditional use only.

2. Before you take this product

Do not take this product if you are:

•    Under 18 years of age

•    Pregnant or breastfeeding

•    Allergic to any of the ingredients in this product

•    Already taking a medicine for sleep or anxiety

The effects of this product may be increased with alcohol. Therefore excessive alcohol consumption should be avoided.

Driving and using machines:

If you feel sleepy do not drive or use machines.

Taking other medicines.

Tell your doctor about any other medicines you are taking, including any bought without a prescription.

3. How to take this product Adults and the elderly:

For the temporary relief of mild anxiety - One to two tablets three times daily.

To aid sleep - one or two tablets earlier in the evening and one or two tablets at bedtime. Maximum daily dose: 6 tablets

Duration of use: As it may not improve your symptoms immediately, this medicine should be taken for at least 2 - 4 weeks continuously.

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

If you take too much of the product (overdose): Speak to a Doctor or a qualified Healthcare Practitioner immediately and take this leaflet and bottle with you.

If you forget to take this product: Do not take a double dose to make up for the missed dose(s). Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

4.    Possible side effects

Like all medicines Herbal Kalma can have side effects. Possible side effects are:

•    Gastrointestinal disorders such as stomach discomfort, nausea, vomiting, diarrhoea

•    Racing heart beat (tachycardia) and hypersensitivity (vasculitis).

If these persist for more than a few days, or become troublesome, stop taking this product.

Tell a Doctor or a qualified Healthcare Practitioner if you notice any other side effects.

You can help 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

5.    How to store this product

•    Keep the tablets in the bottle until it is time to take them

•    Do not take the tablets after the expiry date (see outer label)

•    Store the tablets below 25DC

•    Keep the bottle tightly closed

•    Keep the tablets out of sight and reach of children

6.    Further information

About this product: This is a traditional herbal medicinal product that contains Hops, extracts of Passion Flower and Valerian Root Each tablet contains:

Each tablet contains:

30 mg Hops strobiles (Humulus lupulus L.) 45 mg extract (as dry extract) from Passion Flower herb (Passiflora incarnata L.) (4-6:1) Extraction solvent: Ethanol 70 %v/v

42.5 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5-6:1) Extraction solvent: Ethanol 70%v/v

This product also contains the following inactive (excipient) ingredients: Maltodextrin, Colloidal anhydrous silica, Orange Flower Powder, Calcium Sulphate Dihydrate, Dibasic Calcium Phosphate, Potato Starch, Stearic acid, Ethylcellulose N100

After taking this product: You must speak to a Doctor or a qualified Healthcare Practitioner:

•    If your symptoms get worse

•    If your symptoms do not improve after 4 weeks

•    If side effects not listed in this leaflet occur

Registration Holder:

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

UK

Manufacturer of this product:

Nutrition Warehouse Limited

Samuel Ryder House Barling Way Eliot Park Nuneaton Warwickshire CV10 7RH UK

If you would like further information about this product, please contact:

Nutrition Warehouse Limited

Regulatory Services Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH UK

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400 Fax: +44 (0) 2476 215 452 Email: customerservices@nbtyeurope.com This leaflet was prepared on March 2013

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