PATIENT INFORMATION LEAFLET AND INSTRUCTIONS FOR USE

PELARGONIUM COLD RELIEF DROPS

EXTRACT OF PELARGONIUM ROOT

PLEASE READ THESE INSTRUCTIONS BEFORE USE

2. BEFORE YOU TAKE POTTER'S PELARGONIUM COLD RELIEF DROPS:

Do not take Potter's Pelargonium Cold Relief Drops:

•    if you are allergic to Pelargonium roots or any of the ingredients (see Section 6)

•    if you are pregnant or breastfeeding

•    if you are under 12 years of age

•    if you suffer from severe liver or kidney disease

•    if you suffer from an increased tendency to bleeding and/or take anti-coagulant drugs such as Warfarin, there is a theoretical risk that taking this product may increase the risk of bleeding

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

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 Pelargonium Cold Relief Drops 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 Pelargonium Cold Relief Drops:

The product contains 12 % v/v Ethanol (alcohol). This corresponds to: 139.5 mg alcohol, equivalent to 3.6 ml beer or 1.5 ml wine, per adult's single dose (30 drops). 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 PELARGONIUM COLD RELIEF DROPS:

It is important that you follow these instructions carefully.

For oral use:

Adults, the elderly and children over 12 years: 30 drops three times per day.

The use in children under 12 years is not recommended.

The drops should be taken undiluted or with a small quantity of water, followed by a sufficient amount of liquid (preferably a glass of drinking water).

Remove the cap and hold the bottle vertically. If the drops come out too quickly, tilt the bottle to the side.

Do not exceed the stated dose.

After relief of symptoms, continuation of treatment for further 2 - 3 days is recommended in order to prevent a relapse, however treatment duration should not exceed 2 weeks.

If symptoms worsen or do not improve within 7 days, or if you experience a fever lasting for several days, shortness of breath or blood in your saliva, consult your doctor.

If you take too much Potter's Pelargonium Cold Relief Drops:

Stop taking the medicine and consult your doctor or pharmacist.

If you forget to take Potter's Pelargonium Cold Relief Drops:

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

•    gastrointestinal complaints, such as stomach pain, heartburn, nausea or diarrhoea

•    mild bleeding from the gums or nose

•    hypersensitivity (e.g. skin rash, nettle rash or itching of the skin and mucous membranes)

•    serious hypersensitivity reactions with swelling of the face, breathlessness and fall in blood pressure.

In single cases, signs indicating disturbances of liver function have been reported after intake of Pelargonium; the causal relationship between this effect and the application of the product has not been demonstrated.

Making medicines safer:

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

5.    HOW TO STORE POTTER'S PELARGONIUM COLD RELIEF DROPS:

Keep out of the reach and sight of children.

Do not use Potter's Pelargonium Cold Relief Drops after the expiry date. The expiry date is printed on the label and base of the carton.

Do not store above 30°C. Store in the original packaging.

Shelf life after first opening of the container:

Once opened, the product should be used within 3 months. Return any unused medicine to your pharmacist for safe disposal.

6.    FURTHER INFORMATION:

Potter's Pelargonium Cold Relief Drops contain:

10 g (= 9.75 ml) of oral solution contains 8 g extract from Pelargonium root (Pelargoniumsidoides DC) (1:8 - 10)

Extraction solvent: Ethanol 15% (v/v).

This product also contains:

Glycerol, Ethanol.

Potter's Pelargonium Cold Relief Drops are a clear, light brown to reddish brown solution and are available in a 20 ml bottle. Traditional Herbal Registration Holder and Manufacturer: Potters, Wigan WN5 0JZ Traditional Herbal Registration number:

THR 44893/0030