Patient Information Leaflet

PhytoCon Pelargonium Oral Drops

Pelargonium sidoides root extract

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 PhytoCon Pelargonium oral drops carefully to get best results from it.

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

•    Ask your doctor, pharmacist or qualified health care practitioner if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 7 days.

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

What is in this leaflet

1.    What PhytoCon Pelargonium oral drops is and what is it used for

2.    Before you take PhytoCon Pelargonium oral drops

3.    How to take PhytoCon Pelargonium oral drops

4.    Possible side effects

5.    How to store PhytoCon Pelargonium oral drops

6.    Further information

1.    WHAT PHYTOCON PELARGONIUM ORAL DROPS IS AND WHAT IS IT USED FOR

PhytoCon Pelargonium oral drops is a traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including the common cold, such as sore throat, cough and blocked or runny nose, based on traditional use only.

2.    BEFORE YOU TAKE PHYTOCON PELARGONIUM ORAL DROPS

Do not take PhytoCon Pelargonium oral drops:

-    if you are allergic (hypersensitive) to Pelargonium roots or any of the other ingredients of PhytoCon Pelargonium oral drops (see section 6)

-    if you suffer from severe liver or kidney disease

-    if you are pregnant or breast-feeding

-    you are taking a medicine which is affected by alcohol

Children

The use in children under 6 years of age is not recommended due to lack of adequate data.

Taking other medicines

Please tell your doctor, pharmacist or qualified healthcare practitioner if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you suffer from an increased tendency to bleed and/or take anti-coagulation drugs such as warfarin, there is a theoretical risk that taking PhytoCon Pelargonium oral drops may increase your risk of bleeding.

Taking PhytoCon Pelargonium oral drops with food and drink

No special precautions have to be taken

Pregnancy and breast-feeding

Do not take this medicine during pregnancy and beast-feeding.

Driving and using machines

This product has no known effect on your ability to drive or use machines. Make sure you know how it affects you before you drive or use machinery.

If affected do not drive.

Important information about some of the ingredients of PhytoCon Pelargonium oral drops

This medicine contains 12 Vol-% of ethanol (alcohol). This corresponds to:

0.133 ml alcohol equivalent to 2.7 ml beer or 1.1 ml wine per adult's single dose (30 drops).

0.089 ml alcohol equivalent to 1.8 ml beer or 0.7 ml wine per children's single dose (20 drops). This is harmful for those suffering from alcoholism, liver disease and conditions such as epilepsy.

3.    HOW TO TAKE PHYTOCON PELARGONIUM ORAL DROPS

Always take PhytoCon Pelargonium oral drops exactly according to the instructions in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

For oral use only.

Adults, elderly and children over 12 years:

Take 30 drops three times daily.

Children from 6 to 12 years:

Take 20 drops three times daily.

The drops can be taken undiluted from a spoon or mixed with half a glass of water.

Remove the cap and hold the bottle vertically. If the drops come out too quickly tilt the bottle to the side. Do not take for more than seven days without medical advice. See section 2 as well.

Continue treatment for a further 2-3 days after your symptoms have improved, to prevent a relapse. However, treatment should not exceed 2 weeks. Consult a doctor if your condition does not improve within one week, in case of fever lasting for several days or in cases of shortness of breath or blood in your saliva.

Do not exceed the stated dose.

The use in children under 6 years of age is not recommended (see section 2).

If you take more PhytoCon Pelargonium oral drops than you should (overdose)

If you take more than the recommended dose, speak to your doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take PhytoCon Pelargonium oral drops Do not take a double dose to make up for a forgotten dose, but continue to take your usual dose.

If you stop taking PhytoCon Pelargonium oral drops The use of the product can be stopped at any time.

If you have any further questions on the use of this product, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4. POSSIBLE SIDE EFFECTS

Like all medicines PhytoCon Pelargonium oral drops can cause side effects, although not everybody gets them. They are listed below.

Gastrointestinal complaints, such as stomach pain, heartburn, nausea or diarrhoea.

Mild bleeding from gums or nose.

Allergic reactions (e.g. skin rash, nettle rash, itching pruritus of the skin and mucous membranes). Serious hypersensitivity reactions with swelling of the face, breathlessness and fall in blood pressure. Single cases of changes in liver function have been reported but the causal relationship between these effects and the use of Pelargonium products has not been demonstrated.

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

Consult a doctor if your symptoms do not improve within one week, or if you have a fever, experience shortness of breath or have blood in your saliva.

5.    HOW TO STORE PHYTOCON PELARGONIUM ORAL DROPS

Keep the product out of the reach and sight of children.

Do not use PhytoCon Pelargonium oral drops after the expiry date which is stated on the carton and also on the label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not store above 30°C.

Keep the bottle tightly closed and stored in the original carton.

Shelf life after first opening of container

Once opened the product should be used within 3 months.

6.    FURTHER INFORMATION

What PhytoCon Pelargonium oral drops contains:

10 g (= 9.7 ml) of oral solution contains:

8.0 g extract from the roots of Pelargonium sidoides DC (1:8-10)

Extraction solvent: Ethanol 15% (V/V)

Other ingredients are: Glycerol

PhytoCon Pelargonium oral drops contains 12 Vol.% ethanol (alcohol) (see section 2.)

What PhytoCon Pelargonium oral drops looks like and contents of the pack

PhytoCon Pelargonium oral drops are available in packs of 20 ml.

Registration Holder

PhytoCon GmbH & Co. KG Koblenzer Str. 48-56 56626 Andernach Germany

Manufacturer

C.PM. Contract Pharma GmbH & Co. KG Fruhlingstr. 7

83620 Feldkirchen-Westerham Germany

Phytopharm Kleka Spolka Akcjna Kleka 1

63-040 Nowe Miasto nad Warta Poland

This package leaflet was last revised

06/2011

You can help to 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 (available 10am-2pm Monday to Friday).

The leaflet is available in large print or audio version.

Traditional Herbal Registration Number: 34863/0002

If you would like further information about this product, please contact:

PhytoCon GmbH & Co KG

Koblenzer Str. 48-56 56626 Andernach Germany

Telephone: +49 (0) 2632-924-310