SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

DiaPelargo tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 20 mg of extract (as dry extract) from Pelargonium root (Pelargonium sidoides DC and/or Pelargonium reniforme Curt. (4-7:1) Extraction solvent: Ethanol 14% (v/v).

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

Red-brown, smooth round, biconvex curved

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

For oral use only.

Adult, elderly and adolescents above 12 years of age:

Take 1 tablet three times daily (morning, midday, evening).

Tablets should be swallowed whole with a little water. The tablets should not be chewed.

The use in children under 12 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”)

Duration of use:

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

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

DiaPelargo is not to be used in the following cases: -hypersensitivity to the active substance or to any of the excipients, -increased tendency to bleeding,

-patients using coagulation-inhibiting drugs,

-severe hepatic and renal diseases

4.4 Special warnings and precautions for use

Do not exceed the stated dose

A doctor should be consulted if the 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 the sputum.

Based on theoretical reasons, DiaPelargo should not be used in cases of an increased tendency to bleeding or use of coagulation-inhibiting drugs.

DiaPelargo should not be used in cases of severe hepatic and renal diseases, due to lack of adequate data.

This formulation is not suitable for children under 12 years of age and medical advice should be sought

4.5 Interaction with other medicinal products and other forms of interaction

Drug interactions have not been reported

However, due to the potential influence of DiaPelargo on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin. Therefore, it should not be taken concomitantly with these drugs (see section 4.3 “Contraindications”).

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to lack of sufficient data, the use during pregnancy and lactation is not recommended.

No studies on the effect on fertility have been performed

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

The following adverse reactions have been reported. The frequency is not known.

Gastrointestinal disorders	Stomach pain, heartburn, nausea, diarrhoea
Skin and subcuteanous disorders		mild bleeding from the gums or nose; hypersensitivity reactions (e. g. exanthema, urticaria, pruritus of skin and mucous membranes)
Vascular disorders			Swelling of the face
Respiratory, thoracic and mediastnal disorders			Dyspnoea
Cardiac disorders			Hypotension
Hepatobiliary disorders			Disturbances of the liver function (any causal relation-ship between this effect and the use of the product has not been demonstrated)

If other adverse reactions not mentioned above occur, a doctor should be consulted.

4.9 Overdose

No case of overdose has been reported.

Symptomatic and supportive measures should be taken as appropriate

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

The extract was negative in an Ames test for mutagenicity.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract:

Cellulose powder Silica, colloidal anhydrous

Tablet core:

Cellulose, microcrystalline Silica, colloidal anhydrous Magnesium stearate

Film coating:

Hypromellose Macrogol, type 6000 Iron oxide yellow E172 Iron oxide red E172 Titanium dioxide E171 Talc

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

DiaPelargo is available in packs with 30, 50, 60, 90 or 100 tablets.

The tablets are sealed into PVC/PVDC-aluminium blisters. The blisters are packed into folding cartons.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 42340/0018

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/06/2011

DATE OF REVISION OF THE TEXT

30/07/2013

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