Valerina DT UK Mandarin 10-11-11    08.30 Sida 1

Package leaflet: Information for the user

Valerina Day-Time

film-coated tablets

Extracts of valerian root and lemon balm leaf

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Valerina Day-Time carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after 4 weeks.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or qualified healthcare practitioner.

In this leaflet:

1.    What Valerina Day-Time is and what it is used for

2.    Before you take Valerina Day-Time

3.    How to take Valerina Day-Time

4.    Possible side effects

5.    How to store Valerina Day-Time

6.    Further information

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1. What Valerina Day-Time is and what it is used for

Valerina Day-Time is a traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety

based on traditional use only.

The tablets contain extracts of valerian root and lemon balm leaf.

For full details see section 6.

2. Before you take Valerina Day-Time

Do not take Valerina Day-Time if you are:

•    allergic (hypersensitive) to valerian, lemon balm or any of the other ingredients of Valerina Day-Time.

•    already taking other medicines for anxiety or sleep.

•    under 1 8 years of age.

•    pregnant or breast feeding.

This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars do not take Valerina Day-Time.

Taking other medicines

Please tell your doctor or qualified healthcare practitioner if you are taking any other medicines.

Alcohol

The effects of Valerina Day-Time may be increased by alcohol. Therefore, you should not drink excessive amounts of alcohol.

Driving and using machines

Valerina Day-Time may cause drowsiness. If after taking Valerina Day-Time you feel drowsy, do not drive, use tools or operate machinery.

3. How to take Valerina Day-Time

For oral short term use only.

Take Valerina Day-Time as advised in this leaflet. You should check with your doctor or qualified healthcare practitioner if you are not sure.

Do not exceed the stated dose.

Adults and the elderly

Take 2 tablets 3 times a day.

Swallow the tablets whole with water.

You may need to take the tablets for 2 to 4 weeks continuously to get the effect from the treatment.

Stop taking Valerina Day-Time and contact your doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after 4 weeks.

Children and adolescents

Do not use in children and adolescents under 1 8 years of age.

If you take more Valerina Day-Time 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 Valerina Day-Time

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 for forgotten tablets.

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

4. Possible side effects

Like all medicines, Valerina Day-Time can cause side effects, although not everybody gets them.

Stop taking Valerina Day-Time and contact your doctor if you experience any of the following:

• Rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue, feeling faint. These could be signs of an allergic reaction.

Other side effects include feeling sick and stomach cramps.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or qualified healthcare practitioner.

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Valerina DT UK Mandarin 10-11-11    08.30 Sida 3

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme atwww.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy, or call freephone 0808 100 3352 (available 10 am-2 pm Monday-Friday).

5. How to store Valerina Day-Time

Do not store above 25°C. Keep in the original package to protect the tablets from light and moisture.

Keep out of the reach and sight of children.

Do not use Valerina Day-Time after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Take the medicines no longer required to your pharmacist who will dispose of them. These measures will help to protect the environment.

6. Further information

What Valerina Day-Time contains

•    Each film-coated tablet contains:

1 00 mg of extract (as dry extract) (4:1) equivalent to 400 mg of Valerian root (Valeriana officinalis L.).

Extraction solvent: Ethanol 60% V/V.

50 mg of extract (as dry extract) (6.5:1) equivalent to 325 mg of Lemon Balm leaf (Melissa officinalis L.).

Extraction solvent: Ethanol 60% V/V.

•    The other ingredients are 319 mg of lactose monohydrate, cellulose, colloidal anhydrous silica, potato starch, calcium hydrogen phosphate, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (El 71) and B-carotene (El 60a).

What Valerina Day-Time looks like and contents of the pack

The film-coated tablets are pale yellow and round.

Pack sizes: 40, 60, 80 tablets in blisters. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder

Pharbio Medical International AB,

Box 715, SE-194 27 Upplands Vasby, Sweden.

Telephone: +46 8 590 963 00 E-mail: regulatory@cederroth.com

Manufacturer

Cederroth International Production Paramedical A/S, Vassingenzdvej 3-7, DK-3540 Lynge, Denmark.

This leaflet was last approved in November 2010

Self-Help Health education to Relieve Stresses and Strains

•    Exercise: gentle exercise can help the body burn up excess energy caused by the adrenaline released at times of stress.

•    Self massage: rubbing a tense forehead or neck is a common relaxation method.

•    Healthy eating: a varied well balanced diet will help ensure the body receives the essential vitamins and minerals it needs to function at its best. Try to avoid excess intake of coffee, tea or alcohol.

•    Heat: some people find saunas or Turkish baths relaxing but simply allowing time for a long hot bath can be an ideal way to relax.

•    Meditation: setting aside time to read a book or listen to music can often help direct your thoughts away from your problems. Yoga or other forms of meditation can also be beneficial.

•    Organising time: can help you take control of your life, set priorities and plan for busy times, allowing you to pace yourself with less unexpected time pressures.

•    Supportive conversation: the backup, encouragement and advice we get from people who are close to us and whose judgement or opinion we respect, provides valuable support to all and should be a two way exchange of talking and listening.

CERTIFICATION MARK