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Potters Extracalm Mixture

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PATIENT INFORMATION LEAFLET

Potter’s Herbals ( logo)

EXTRACALM MIXTURE

VALERIAN AND SCULLCAP

PLEASE READ THESE INSTRUCTIONS BEFORE USE

This medicine is available without prescription. However, you still need to take Potter’s Extracalm Mixture 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 a pharmacist if your symptoms worsen or do not improve.

•    If you experience any of the side effects listed in the leaflet, or if you notice any other side effects, please consult your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Potter’s Extracalm Mixture is and what it is used for

2.    Before you take Potter’s Extracalm Mixture

3.    How to take Potter’s Extracalm Mixture

4.    Possible side effects

5.    How to store Potter’s Extracalm Mixture

6.    Further information

1. WHAT POTTER’S EXTRACALM MIXTURE IS AND WHAT IT IS USED FOR:

Potter’s Extracalm Mixture is a traditional herbal medicinal product used for the short term relief of symptoms associated with stress such as mild anxiety, tenseness or irritability, based on traditional use only.

Containing Valerian and Scullcap.

For full details, see Section 6.

2. BEFORE YOU TAKE POTTER’S EXTRACALM MIXTURE:

Do not take Potter’s Extracalm Mixture:

•    if you are allergic to any of the ingredients

•    if you are pregnant or breastfeeding

•    if you are under 18 years of age

•    if you are taking any other medicines for anxiety or sleep.

•    if you are taking medicines known to interact with alcohol e.g. metronidazole.

Alcohol may increase the effect of this product. Therefore, excessive alcohol consumption should be avoided whilst taking Potter’s ExtraCalm Mixture.

Taking other medicines:

Please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding:

You should not use Potter’s Exracalm Mixture if you are pregnant or breastfeeding because there is no evidence that it is safe to do so.

Driving and using machines:

This product contains Ethanol (alcohol) and therefore it is advised that you do not take this medicine if you are going to drive or use machinery.

Important information about some of the ingredients in Potter’s Extracalm Mixture:

This product contains Glucose, Sucrose (syrup) and Sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This product also contains 15.7% v/v Ethanol (alcohol), i.e. up to 628 mg per dose (5 ml), equivalent to 15.7 ml beer or 6.5 ml wine per dose. It may be harmful for those suffering from alcoholism and high-risk groups such as pregnant or breastfeeding women, children and patients with liver disease or epilepsy.

3. HOW TO TAKE POTTER’S EXTRACALM MIXTURE:

It is important that you follow these instructions carefully.

Shake the bottle well before use.

For oral use: Adults and the elderly: Take one 5ml teaspoonful three times a day.

Not recommended for children and adolescents under 18 years of age.

Do not exceed the stated dose.

If your condition worsens or symptoms persist for more than 4 weeks , consult your doctor or pharmacist.

This product should be taken for 2 - 4 weeks continuously.

If you take too many Potter’s Extracalm Mixture:

Stop taking the medicine and consult your doctor or pharmacist.

If you forget to take Potter’s Extracalm Mixture:

If you miss a dose, take your next dose at the usual time. Do not take two doses at the same time to make up for a missed dose. Always consult your doctor or pharmacist if you need further advice.

4. POSSIBLE SIDE EFFECTS:

Like all medicines this product can cause side effects, but not everyone gets them.

If the following or any other side effects occur, stop taking this product and consult your doctor or pharmacist:

• Gastrointestinal symptoms such as nausea, abdominal cramps may occur after ingestion of Valerian root preparations. The frequency is not known.

Making medicines safer:

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 doctors surgery or a pharmacy, or call freephone 0808 100 3352 (available 10am - 2pm, Monday to Friday).

5. HOW TO STORE POTTER’S EXTRACALM MIXTURE:

Keep out of the reach and sight of children.

Do not use Potter’s Extracalm Mixture after the expiry date. The expiry date is printed on the label and base of the carton.

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

Return any unused medicine to your pharmacist for safe disposal.

6. FURTHER INFORMATION:

Each 5 ml of oral liquid contains:

1.25 ml Tincture of Valerian Root (Valeriana officinalis) (1:5) Extraction solvent: Ethanol 25% v/v,

0.65 ml Tincture of Scullcap (Scutellaria lateriflora L.) (1:5) Extraction solvent: Ethanol 45% v/v

This product also contains:

Glucose Liquid, Sucrose Syrup, Glycerol, Cardamom Compound Tincture (cochineal, cardamom oil, caraway oil, cinnamon bark oil, glycerol, water), Nutmeg Oil, Clove Oil, Cinnamon Bark Oil, Liquorice Liquid Extract (liquorice root, sorbitol, glucose liquid, caramel, ethanol, water), Ethanol, Caramel (E150), Water.

Potter’s Extracalm Mixture is a dark brown liquid and is available in a 150 ml bottle.

Traditional Herbal Registration Holder and Manufacturer:

Potters, Wigan WN5 0JZ

Traditional Herbal Registration number:

THR 33656/0067

For further information, call 01202 449752

If you would like a version of this leaflet in an alternative format, please call 01942 219960 Product code:

Leaflet last revised: 21/03/2013

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