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OMEGA PASSIFLORA TABLETS

Active substance(s): PASSIFLORA DRY EXTRACT 7:1

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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.
2.
3.
4.
5.
6.

1.

What NATRACALM is and what it is used for
Before you take NATRACALM
How to take NATRACALM
Possible side effects
How to store NATRACALM
Further information

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.gov.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.
1st 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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