Document: leaflet MAH BRAND_THR 14404-0004 change

• leaflet MAH BRAND_THR 02231-0016
• leaflet MAH BRAND_THR 14404-0004

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PACKAGE LEALET: INFORMATION FOR THE PATIENT

HRI Night Tablets

Valerian root extract, Passion flower herb extract, Wild lettuce herb extract

What is in this leaflet:

1.    What HRI Night is and what it is used for

2.    What you need to know before you take HRI Night

3.    How to take HRI Night

4.    Possible side effects

5.    How to store HRI Night

6.    Contents of the pack and other information

1. WHAT HRI NIGHT IS AND WHAT IT IS USED FOR

This medicine contains three herbal extracts Valerian root extract, Passion flower extract and Wild lettuce extract, which are the active ingredients.

HRI Night is a traditional herbal medicinal product used to aid sleep based on traditional use only.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HRI NIGHT Do not take HRI Night:

•    If you are allergic to Valerian, Passion flower, Wild lettuce, plants of the Asteraceae (Compositae) family such as daisies, marigolds or artichokes, or any of the other ingredients (see section 6)

•    You are already taking a medicine to help you sleep

•    If you are under the age of 18 years

•    If you are pregnant or breast-feeding.

Taking other medicines

Tell your doctor or pharmacist before use if you are taking any other medicines particularly any other medicines which may make you drowsy, including those obtained without a prescription.

Use with alcohol

Avoid excessive drinking while taking this medicine as alcohol increases the effects. Pregnancy and breast-feeding

This medicine is not recommended during pregnancy or breast-feeding.

Ask your doctor for advice before taking any medicine.

Driving and using machines

This medicine may affect your ability to drive or using machines. Do not drive or use machines if you are affected.

Important information about some of the ingredients

If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

3. HOW TO TAKE HRI NIGHT

Do not exceed the stated dose.

For oral use only Adults, and the elderly

Take 3 - 4 tablets half to one hour before bedtime. An earlier dose may be taken in the evening if required.

Take for 2 - 4 weeks continuously, as any effects may not be seen immediately.

If your symptoms wosren or do not improve after 4 weeks, speak to your doctor or qualified healthcare practitioner.

If you take more HRI Night than you should

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you

If you forget to take HRI Night

Continue to take your usual dose at the usual time. Do not take a double dose to make up for the missed dose.It does not matter if you have missed a dose, just take the next dose at the right time.

If you have any further questions on taking this medicine, ask your doctor, pharmacist or qualified healthcare practitioner.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Nau sea or stom ach cramp s may o ccur after taking Valerian root . The frequency i s not known.

There has been a single case of allergy (vasulitis) and a single case of fast heartbeat (tachycardia) reported after taking Passion flower. The frequency is not known.

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 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 GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am - 2pm Monday to Friday).

5. HOW TO STORE HRI NIGHT

Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton and labels. The expiry date refers to the last day of that month.

Do not store above 25 °C. Store in the original packaging.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION What HRI Night contains

Each tablet contains 60 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 240 mg of Valerian root), Extraction solvent: ethanol 50 % v/v, 45 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (equivalent to 241 mg of Passion Flower herb), Extraction solvent: methanol 80 % v/v, and extract (as dry extract) from Wild lettuce leaf (Lactuca virosa L. ) (equivalent to 100 mg of Wild Lettuce leaf),

Extraction solvent: methanol 80 % v/v.

The other ingredients are:

•    Tablet core: microcrystalline cellulose, dicalcium phosphate, croscarmellose sodium, magnesium stearate, stearic acid

•    Tablet coating: sucrose, calcium carbonate, talc, Mastercote Grey SP0933, acacia, shellac, titanium dioxide (E171), wax polish (solids).

What HRI Night looks like and contents of the pack

HRI Night are dark grey round biconvex tablets. The tablets are available in glass bottles with a polypropylene screw cap and blister strips.

This product is available in glass bottles: 30, 40, 50, 60, 80 and 100 pack sizes.

This product is available in blister strips: 30, 40, 45, 50, 60, 80 and 100 pack sizes.

Not all pack sizes may be marketed.

Traditional Herbal Registration Holder:

Jessup Health Ltd (trading as Jessup Marketing), 27 Old Gloucester Street, London WC1N 3XX, UK

Manufacturer:

Surepharm Services Ltd, Bretby Business Park, Bretby, Burton on Trent, Derby, DE15 0YZ, UK.

If you would like further information about this product please contact Jessup Marketing Email: info@iessup.co.uk

For a large print, Braille or audio version of this leaflet call 01932 854825.

This leaflet was last revised in March 2013.