Package leaflet: Information for the user

Valerina Night-Time

film-coated tablets

Extracts of valerian root, hops strobile and lemon balm leaf.

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

The dose for this medicine has changed -please see section 3 for details. This medicine is available without prescription. However, you still need to take Valerina Night-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 Night-Time is and what it is used for

2.    Before you take Valerina Night-Time

3.    How to take Valerina Night-Time

4.    Possible side effects

5.    How to store Valerina Night-Time

6.    Further information

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

Valerina Night-Time is a traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety based on traditional use only.

The tablets contain extracts of Valerian root, Hop strobile and Lemon Balm leaf. For full details see section 6.

2. Before you take Valerina Night-Time

Do not take Valerina Night-Time if you are:

•    allergic (hypersensitive) to Valerian, Hops, Lemon Balm or any of the other ingredients of Valerina Night-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 Night-Time.

Taking other medicines

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

Alcohol

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

Driving and using machines

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

3. How to take Valerina Night-Time

For oral short term use only.

Take Valerina Night-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 half an hour to 1 hour before bed time.

If necessary, you can take 1-2 additional tablets earlier in the evening.

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 Night-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 18 years of age.

If you take more Valerina Night-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 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 Night-Time can cause side effects, although not everybody gets them.

Side effects include feeling sick

and stomach cramps. The frequency is

not known.

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.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

22100208-001

5. How to store Valerina Night-Time_

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

Keep out of the reach and sight of children.

Do not use Valerina Night-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 Night-Time contains

• Each film-coated tablet contains:

60 mg of extract (as dry extract) equivalent to 420-600 mg of Valerian root (Valeriana officinalis L.).

Extraction solvent: Ethanol 60% V/V. 65 mg of extract (as dry extract) equivalent to 293-553 mg of Hops strobile (Humulus lupulus L.). Extraction solvent: Ethanol 70% V/V.

1 7.5 mg of extract (as dry extract) equivalent to 1 24-200 mg of Lemon Balm leaf (Melissa officinalis L.). Extraction solvent: Ethanol 60% V/V.

• The other ingredients are 278 mg of lactose monohydrate, cellulose, colloidal anhydrous silica, potato starch, magnesium stearate, hypro-mellose, macrogol 6000, titanium dioxide (El 71) and paraffin.

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

The film-coated tablets are off-white 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 590963 00 E-mail: regulatory@cederroth.com

Manufacturer

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

This leaflet was last revised in February 2015.

Self-Help Health Education to Promote Natural Sleep

•    Exercise: gentle exercise can help the body burn up excess energy.

•    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 from late afternoon.

•    Daylight: try to arrange some exposure to daylight at least once a day to help your natural body clock maintain its balance. Turn out lights before going

to sleep.

•    Daytime naps: try to avoid having naps during the day since this will affect your evening pattern.

•    Unwind: construct a relaxed pre-bed routine so that you stop all stressful activities an hour and a half before you plan to go to bed. Try some relaxation techniques such as yoga or other forms of meditation.

•    Organising time: can help you take control of your life, set priorities and plan ahead allowing time for relaxation.

•    In bed: don't read or watch television in bed, these are waking activities.

•    Getting up: rise each morning at a regular, convenient hour.