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Package leaflet: Information for the user

PHYTORELAX capsules

Valerian root 350 mg

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 PHYTORELAX is and what it is used for

2.    Before you take PHYTORELAX

3.    How to take PHYTORELAX

4.    Possible side effects

5.    How to store PHYTORELAX

6.    Further information

1. WHAT PHYTORELAX IS AND WHAT IT IS USED FOR

PHYTORELAX is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety and to aid sleep.

This is based on traditional use only.

2. BEFORE YOU TAKE PHYTORELAX

DO NOT TAKE PHYTORELAX IF:

-    You are allergic to valerian root or to the other ingredient 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.

-    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

PHYTORELAX may, in some people, cause drowsiness making it dangerous to drive vehicles and use machines. If affected, do not drive or use machines.

3. HOW TO TAKE PHYTORELAX

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:

For mild anxiety: Take 2 capsules 2 or 3 times a day.

To aid sleep: Take 2 capsules half an hour before going to bed.

Maximum daily dose: 6 capsules

As treatment effects may not be apparent immediately, the capsules should be taken 2-4 weeks continuously.

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 PHYTORELAX 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 PHYTORELAX

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

IF YOU STOP TAKING PHYTORELAX

You can stop taking PHYTORELAX at any time.

If you have any further questions on the use of this medicine, ask you doctor, pharmacist or qualified healthcare practitioner.

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.

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur when using PHYTORELAX.

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 PHYTORELAX

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 PHYTORELAX contains

-    Each hard capsule contains 350 mg of Valerian root (Valeriana officinalis L.).

-    The other ingredient is hypromellose (capsule shell).

What PHYTORELAX looks like and contents of the pack

Each pack contains 45 or 150 colourless and transparent hard capsules containing clear brownish powder. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder and Manufacturer LABORATOIRES ARKOPHARMA LID de Carros Le Broc - 1ere avenue, 2709 m 06510 CARROS - France

Tel : +33 (0) 4 93 29 11 28 - Fax: +33 (0) 4 93 29 11 62

Distributed in UK by

World Foods Brand Management Ltd

Unit 7 Decade Close

High Carr Business Park

Newcastle under Lyme

ST5 7UH - Tel: + 44 (0) 1782 564512

This leaflet was last revised in March 2013.

Traditional Herbal Registration Number THR 12297/0020

For a large print, call +44 (0) 1782 564512 or email to enquiries@wfbm.co.uk