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DIAPELARGO TABLETS

Active substance(s): PELARGONIUM UNSPECIFIED

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1.3 – Product Information

May 2013

1.3.1 – Labelling

Page 5 / 9
DiaPelargo tablets - THR 42340/0018

Module 1.3.1 Package Leaflet
Patient Information Leaflet
DiaPelargo tablets
Active substance: Pelargonium root dry extract 20 mg
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 DiaPelargo
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 if your symptoms worsen or do not improve after one week.
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 DiaPelargo is and what it is used for
2. Before you take DiaPelargo
3. How to take DiaPelargo
4. Possible side effects
5. How to store DiaPelargo
6. Further information
1.

What DiaPelargo is and what it is used for

DiaPelargo is a traditional herbal medicinal product containing a dry extract from the roots of
Pelargonium.
It is a traditional herbal medicinal product used to relieve the symptoms of upper respiratory
tract infections including common cold, such as sore throat, cough and blocked or runny nose,
based on traditional use only.

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2.

Before you take DiaPelargo

Do not take DiaPelargo:
• if you are allergic (hypersensitive) to any of the ingredients of DiaPelargo film-coated
tablets (see section 6)
• if you suffer from severe liver or kidney disease
• if you are pregnant or breast-feeding
Children:
DiaPelargo is not suitable for children under the age of age of 12 years.
Taking other medicines
Please tell your doctor, pharmacist or 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 DiaPelargo may increase your risk of bleeding.
Pregnancy and breast-feeding
Do not take DiaPelargo if you are pregnant or breast-feeding.
Driving and using machines
DiaPelargo 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.

3.

How to take DiaPelargo

Always take DiaPelargo exactly according to the instructions in this package leaflet. You
should check with your doctor or pharmacist if you are not sure.
Adults and children over 12 years
Take 1 film-coated tablet 3 times daily (morning, midday, evening).
Swallow the film-coated tablet whole with some water. Do not chew.
Continue treatment for a further 2–3 days after your symptoms have improved, to prevent a
relapse. However, treatment should not exceed two weeks.
Consult a doctor if your condition does not improve within one week, in cases of fever lasting
for several days or in case of shortness of breath or blood in your saliva.
Do not exceed the stated dose.
DiaPelargo is not suitable for children under the age of 12 years.

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If you take more DiaPelargo than you should (overdose)
If you take more than the recommended dose, speak to your doctor, pharmacist or healthcare
practitioner and take this leaflet with you.
If you forget to take DiaPelargo
Do not take a double dose to make up for a forgotten dose, but continue to take your usual
dose at the usual time.
If you have any further questions on the use of DiaPelargo, or are unsure about
anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
4.

Possible side effects

Like all medicines, DiaPelargo can cause side effects, although not everybody gets them. They
are listed below.
Uncommon side-effects
Gastro-intestinal complaints such as stomach pain, heartburn, nausea or diarrhoea.
Rare side-effects
• mild bleeding from the gums or nose
• hypersensitivity reactions, e.g.
skin rash
nettle rash
itching of the skin and mucous membranes
Such reactions may occur when this product is first taken.
Very rare side effects
Serious hypersensitivity reactions with swelling of the face, breathlessness and drop in
blood pressure.
Frequency not known
Signs indicating changes in liver function have been reported after taking DiaPelargo;
however the causal relationship between these effects and the use of the product 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 condition does not improve within one week, in case of fever
lasting for several days or in case of shortness of breath or blood in your saliva.

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5.

How to store DiaPelargo

Do not use DiaPelargo after the expiry date which is stated on the carton and also on the
blister pack.. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater 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 25° C.
Keep the product out of the reach and sight of children.
6.

Further information

What DiaPelargo contains:
Each film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium reniforme/sidoides (4-7:1). Extraction solvent: 14% ethanol (v/v).
The other ingredients are:
Extract:
Cellulose powder,
Silica, colloidal anhydrous
Tablet core:
Cellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Film coating:
Hydroxypropyl methyl cellulose (= hypromellose)
Macrogol, type 6000
Iron oxide yellow E172
Iron oxide red E172
Titanium dioxide E171
Talc

What DiaPelargo looks like and contents of the pack
DiaPelargo are red-brown, round film-coated tablets packed in binary blisters made of
PVC/PVDC-aluminium.
Each pack contains 30, 50, 60, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

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Registration holder and Manufacturer
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany
Traditional herbal registration number: THR 42340/0018

Certification Mark
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG

Würzburger Straße 3
26121 Oldenburg
Germany
Telephone: + (49) 441–98344–0
Email: info@diapharm.de
This leaflet was prepared in May 2011.
You can help to make medicines safer by reporting any side-effects to the Yellow Card
Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from
your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am-2pm
Monday - Friday).

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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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