Patient Information Leaflet for Aspar Herbal Sleep Aid Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet as you may want to read it again. If you get any side effects talk to your doctor, pharmacist or qualified healthcare practitioner. This includes any possible side effects not iisted in this leaflet

What is in this leaflet?

1.    What Aspar Herbal Sleep Aid Tablets are and what they are 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 Aspar Herbal Sleep Aid Tablets are and what they are used tor

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

This product contains extracts of Valerian root, Verbena herb and Gentian root with Scullcap herb.

2. Before you take Aspar Herbal Sleep Aid Tablets

Do not take this product it 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 another medicine for sleep or anxiety

Warnings and Precautions The effects of alcohol may be increased by this product. Drinking excessive alcohol should be avoided whilst taking this product.

This product contains sucrose. If you have an intolerance to some sugars, talk to your doctor or qualified healthcare practitioner before taking this product.

Taking other medicines

Do not take this product if you are already taking a medicine for sleep or anxiety.

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

Driving and using machines

This product may cause drowsiness. If you are affected, do not drive or operate machines. Pregnancy and Breastfeeding Do not take this medicine if you are pregnant or breastfeeding, think you may be pregnant or are pfenning to have a baby Talk to your doctor or pharmacist for advice.

3. How to take Aspar Herbal Sleep Aid Tablets

This product is for short term oral use only. Adults and the elderly

For mild anxiety: Take three tablets three times a day.Take the last dose one hour before bedtime.

For sleep disturbances: Take three tablets one hour before bedtime.

The maximum daily dose is 9 tablets.

Do not exceed the stated dose.

This product should not be taken by children or adolescents under 18 years of age.

This product may not work immediately. The tablets should be taken every day for 2-4 weeks.

If symptoms get worse, or do not go away after 4 weeks, talk to your doctor or a qualified healthcare practitioner.

If you take too many tablets

If you lake mote than the recommended dose, talk to a doctor, pharmacist or qualified heathcare practitioner and take this leaflet with you.

If you forget to take this product Continue to take your normal dose at the usual time. It does not matter if you have missed a dose. Do not take a double dose to make up for the forgotten dose.

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

4. Possible Side Effects

Like all medicines, this product can cause side effects. The following side effects have been reported:

•    Nausea or stomach cramps

•    Headaches

•    Fast resting heart rate

•    Itchy skin

The frequency of these side effects occurring is not known.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.ukyellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspar Herbal Sleep Aid Tablets

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the box and the blister pack The expiry date refers to the last day of the month.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Further Information

What this product contains

Each coated tablet contains the following active ingredients:

50 mg of extract (as dry extract) from Valerian root (Valerana officinalis L.) (5:1)

Extraction solvent: ethanol 45% v/v

50 mg of extract (as dry extract) from Verbena

herb (Verbena officinals L.) (3:1)

Extraction solvent: water

24 mg of extract (as dry extract) from Gentian

root (Geniana lutea L.) (5:1)

Extraction solvent ethanol 100% v/v

30 mg of Scullcap herb (Scutellaria lateriflora L.)

The other ingredients are:

Sucrose, Talc, Magnesium stearate, Sodium starch glycollate Type A, Powdered gum asafoetida, Titanium dioxide (E171), Iron oxide black (E172), Yellow ferric oxide (E172), Syrup. What these tablets look like Aspar Herbal Sleep Aid Tablets are pale green-grey round biconvex coated tablets.

This product is available in 100 or 200 tablets in containers and 24 or 60 tablets in blisters.

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 July 2015 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