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PHYTOCON PELARGONIUM ORAL DROPS

Active substance(s): PELARGONIUM ROOT TINCTURE (1:10)

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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 30ºC.
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.P.M. Contract Pharma GmbH & Co. KG
Frühlingstr. 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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