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PATIENT INFORMATION LEAFLET

Kalms tablets

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 Kalms tablets carefully to get the best results from them.

•    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 symptom s worsen or do not improve after 4 weeks.

•    If any of the side effects become serious, or if you notice any si de effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Kalms tablets are and what they are used for

2.    Before you take Kalms tablets

3.    How to take Kalms tablets

4.    Possible side effects

5.    How to store Kalms tablets

6.    Further information

1.    What Kalms is and what it is used for

Kalms contains Hops, Valerian root and Gentian root and is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety and irritability including symptoms associated with menopause such as flushings and cold sweats and for the temporary relief of sleep disturbances, based on traditional use only.

2.    Before you take Kalms tablets Do not take Kalms if you:

•    are allergic to any of the ingredients (see Section 6 for a complete list of ingredients).

•    are pregnant or breast feeding

•    are under 18

•    are already taking a medicine for sleep or anxiety Taking other medicines

Please tell your doctor or pharm acist if you are taking or have recently taken any other medicines, including:

•    medicines obtained without a prescription.

Important information about some if the ingredients:

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

Driving and using machines: If you feel sleepy, do not drive or operate machines.

Additional information: The effects of this medicine may be increased by alcohol. Therefore alcohol should be avoided whist taking this medicine.

3.    How to take Kalms tablets

For the temporary relief of the symptoms of stress, mild anxiety and irritability including symptoms associated with menopause such as flushings and cold sweats

Adults and the elderly : Take 2 tablets twice a day after meals plus 3 tablets at bedtime.

For the temporary relief of sleep disturbances

Adults and the elderly : Take 2 tablets 30-60 minutes before bedtime. One additional tablet can be taken earlier during the evening if necessary.

The tablets should be swallowed whole with some water or other liquid.

The use in children and adolescents under 18 years of age is not recommended

The maximum daily dose is 6 tablets

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

If symptoms worsen or do not improve after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

If you take more Kalms tablets than you should

If you take too many tablets, consult your doctor or qualified healthcare practitioner as soon as possible. Take this leaflet to show them.

If you forget to take Kalms tablets

Do not take a double dose to make up for a missed dose.

If you are unsure about anything, consult your doctor or qualified healthcare practitioner for advice.

4.    Possible side effects

Like all medicines, Kalms tablets can cause side effects, although not everybody gets them.

Gastrointestinal effects such as nausea, stomach cramps have been reported with Valerian root preparations. The frequency is not known.

If any of the side effects becom e serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

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 Yellow Card form from your GP's surgery or pharmacy or call freephone 0808 100 3352

5.    How to store Kalms tablets

Keep out of the reach and sight of children.

Do not take Kalms tablets after the expiry date which is stated on the packaging.

Do not store above 25°C.

Store in the original package.

6.    Further Information What Kalms tablets contains

The active substance per tablet is:

Hop strobiles (Humulus lupulus L.)..................................................................................45mg

Dry extract from Valerian root (Valeriana officinalis L.)

(equivalent to 135 to 167mg of Valerian root)

Extraction solvent: Ethanol 60%v/v........................................................................... 33.75mg

Dry extract from Gentian root (Gentiana lutea L.)

(equivalent to 90mg of Gentian root)

Extraction solvent: Ethanol 50% v/v..............................................................................22.5mg

The other ingredients are:

Extract: Maltodextrin, Colloidal anhydrous silica, Dicalcium Phosphate

Core: Acacia, Icing Sugar, Magnesium Stearate, Silicon Dioxide, Sodium Starch Glycolate,

Stearic Acid.

Coating: Acacia, Calcium Carbonate (Light), Carnauba Wax, Mastercote Pink SP0415G, Talc, Shellac, Sucrose, Titanium Dioxide, Yellow Beeswax

What Kalms tablets looks like and contents of the pack

Kalms tablets are white circular su gar coated tablets. They are availab le in am ber glass bottles containing 100 or 200 tablets. Kalm s ta blets are also availa ble in blister packs containing 84 tablets.

Certification Mark


Traditional Herbal Registration Holder and Manufacturer

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Email: info@laneshealth.com

This leaflet was last revised 02/2013

For a large print, Braille or audio versions of this leaflet please telephone: 01452 524012.