Patient Information Leaflet

Aspar Herbal Sleep Aid Tablets

Extracts of Valerian root, Verbena herb and Gentian root with Scullcap herb.

Please read this information carefully

before you start taking these tablets. It contains important information about this product. Keep this leaflet with these tablets. You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet?

1.    What is Aspar Herbal Sleep Aid and what it is used for.

2.    Before you take Aspar Herbal Sleep Aid tablets

3.    How to take Aspar Herbal Sleep Aid tablets

4.    Possible Side Effects

5.    How to store Aspar Herbal Sleep Aid tablets

6.    Further information

1.    What is Aspar Herbal Sleep Aid and what it is used for

This product is a traditional herbal medicinal product containing extracts of Valerian root, Verbena herb and Gentian root with Scullcap herb. Each tablet contains 50 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5:1) Extraction solvent: ethanol 45% v/v 50 mg of extract (as dry extract) from Verbena herb (Verbena officinalis L.) (3:1) Extraction solvent: water; 24 mg of extract (as dry extract) from Gentian root (Gentiana lutea L.) (5:1) Extraction solvent: ethanol 100 % v/v; and 30 mg of Scullcap herb (Scutellaria lateriflora L.)

What Aspar Herbal Sleep Aid is used for

Aspar Herbal Sleep Aid is a traditional herbal medicinal product used for the temporary relief of sleep disturbances and mild anxiety, based on traditional use only.

2.    Before you take Aspar Herbal Sleep Aid

Do not take this product if you:

•    are allergic to any of the ingredients (see section 6 for list of ingredients)'

•    are pregnant or breastfeeding

•    are under 18 years of age

•    are already taking a medicine for sleep or anxiety

Take special care with this product

The effects of alcohol may be increased by this product. Excessive alcohol should therefore be avoided.

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor or qualified healthcare practitioner before taking this product.

Taking other medicines

If you are taking any other medicines, tell your doctor or qualified healthcare practitioner before starting to take this medicine.

Driving and using machines

This product my cause drowsiness. If you are affected, do not drive or operate machines.

3. How to take Aspar Herbal Sleep Aid

For oral short term use only

Adults and the elderly:

For mild anxiety: - Three tablets to be taken three times daily with the last dose being taken one hour before bedtime.

For sleep disturbances: Three tablets to be taken one hour before bedtime.

Maximum daily dose: 9 tablets

Do not exceed the stated dose.

As the effects of this product may not occur immediately, the tablets should be taken every day for 2-4 weeks.

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

If you take too much of this product (overdose)

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

If you forget to take this product

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

If you have any questions or are not sure about anything, consult your doctor, pharmacist or qualified healthcare practitioner for advice.

4. Possible side effects

Like all medicines, this product can have side effects. The following side effects have been reported: Gastrointestinal symptoms e.g. nausea, stomach cramps may occur after ingestion of Valerian root preparations. Gastrointestinal disorders and headaches have been reported with

Gentian root. In rare cases an abnormally fast resting heart rate and itchy skin have been reported. The frequency is not known.

If any of the above side effects become serious or if other side effects not mentioned above occur, a doctor or pharmacist should be consulted.

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 Yellowcard from your GP's surgery or call freephone 0808 100 3352 (available 10am -2pm Monday - Friday)

5. How to store Aspar Herbal Sleep Aid

Do not use after the expiry date..

The expiry date is printed on the box and the blister pack. The expiry date refers to the last day of the month.

Do not store above 25 ^oC. Store in the original package.

Keep all medicines out of the reach and sight of children

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist to dispose of medicines no longer required

6. Further Information Active Ingredients

Each coated tablet contains 50 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L. )(5:1) Extraction solvent: ethanol 45% v/v; 50 mg of extract (as dry extract) from Verbena herb (Verbena officinalis L.) (3:1) Extraction solvent: water; 24 mg of extract (as dry extract) from Gentian root (Gentiana lutea L.) (5:1) Extraction solvent: ethanol 100% v/v; and 30 mg of Scullcap herb (Scutellaria lateriflora L.)

Also contains

Tablet core: Sucrose, Talc, magnesium stearate, Sodium starch glycolate Type A, Powdered gum asafoetida

Tablet coating : Titanium dioxide (E171), Iron oxide black (E172), Yellow ferric oxide (E172),Syrup.

What these tablets look like

Pale green-grey, round biconvex coated tablet

This product is available in containers of 100 and 200 tablet and blister packs of 24 and 60 tablets.

Not all pack sizes may be marketed.

Traditional Herbal Registration Number: 08977/0066 Registration holder and Manufacturer for this product :

Aspar Pharmaceuticals limited, Colindale London, NW9 0EQ

This leaflet was last revised in March 2013

THR certification mark

If you would like further information about this product or a version of this leaflet in large print or audio format, please contact Aspar Pharmaceuticals limited, Colindale London, NW9 0EQ....'