Package leaflet: Information for the user Natracalm

Passion flower herb extract

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner have told 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.

If you get any side effects, talk to your doctor, pharmacist or qualified healthcare practitioner. This includes any possible side effects not listed in this leaflet.

You must consult a doctor if symptoms worsen or do not improve after 4 weeks.

In this leaflet

1.    What NATRACALM is and what it is used for

2.    Before you take NATRACALM

3.    How to take NATRACALM

4.    Possible side effects

5.    How to store NATRACALM

6.    Further information

1. WHAT NATRACALM IS AND WHAT IT IS USED FOR

NATRACALM is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

2. BEFORE YOU TAKE NATRACALM

DO NOT TAKE NATRACALM IF:

-    You are allergic to Passion flower or to the other ingredients of this product (see section 6 of this leaflet for further information.

-    You are under 18 years old

-    You are already taking a medicine for sleep or anxiety

WARNINGS AND PRECAUTIONS

-    Do not take more than the recommended dose.

-    This product contains lactose. If you have an intolerance to some sugars, consult your doctor before taking this product.

-    The effects of this product may be increased with alcohol. Therefore execssive alcohol use should be avoided.

TAKING OTHER MEDICINES

Tell your doctor, pharmacist or qualified healthcare practitioner if you are taking, have recently taken or might take any other medicines.

PREGNANCY AND BREAST-FEEDING

Do not use this medicine if you are pregnant or breast feeding

DRIVING AND USING MACHINES

NATRACALM may, in some people, cause drowsiness. If affected, do not drive or use machines.

3. HOW TO TAKE NATRACALM

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you. Check with your doctor, pharmacist or qualified healthcare practitioner if you are not sure.

For oral short term use only.

DO NOT EXCEED THE RECOMMENDED DOSE.

Adults and the elderly:

One tablet to be taken three times a day with meals. If required a further tablet may be taken at bedtime.

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

This product is not recommended for use in children or adolescents under 18 years of age.

IF YOU TAKE MORE NATRACALM THAN YOU SHOULD

If you take more than the recommended dose and feel ill, talk to your doctor or pharmacist.

IF YOU FORGET TO TAKE NATRACALM

Do not take a double dose to make up for a forgotten dose and continue to take the usual dose at the usual time.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of the side effects is not known.

Nausea, hypersensitivity (vasculitis), tachycardia (increased heart beat) may occur when using NATRACALM.

If you get any side effects, talk to your doctor, pharmacist or healthcare practitioner. This includes possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.mhra.sov.uk/yellowcard.

Alternatively you can get a Yellow Card from your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available from 10 am-2 pm Monday-Friday).

5.    HOW TO STORE NATRACALM

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

Do not use this medicine after the expiry date which is stated on the bottle after “Exp”. The expiry date refers to the last day of that month.

Store in the original package. Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    FURTHER INFORMATION What NATRACALM contains

Each film coated tablet contains 71.4 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (7:1) Extraction solvent: Ethanol 60% v/v

The other ingredients are Extract excipient: Maltodextrin. Tablet core: Lactose, Microcrystalline cellulose, Magnesium stearate, Stearic acid. Tablet coat : Talc, Colour Dispersion (containing Lactose, Hypromellose, Titanium Dioxide, Polyethylene Glycol 4000)

What NATRACALM looks like and contents of the pack

White circular film coated tablet in a blister pack containing 12, 48 or 100 tablets. Also available in a container containing 96 tablets.

Not all pack sizes may be marketed.

Traditional Herbal Registration Holder and Manufacturer

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom

This leaflet was last revised in March 2013.

Traditional Herbal Registration Number THR 02855/0036

For a large print, call 0203 598 9601

THR Certification Mark