SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Pelargonium Cold Relief Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Extraction solvent: Ethanol 15% (V/V)

1 ml (approximately 20 drops) of the product contains 93 mg ethanol (alcohol) equivalent to 2.4 ml of beer or 1.0 ml of wine

For a full list of Excipients see section 6.1

3 PHARMACEUTICAL FORM

Oral drops, solution.

Clear, light brown to reddish brown solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including the common cold, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Adults, the elderly and children over 12 years: 30 drops three times per day. The use in children under 12 years of age is not recommended (see Section 4.4 Special warnings and precautions for use).

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).

30 drops is equivalent to approximately 1.5 ml.

Duration of use:

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 the symptoms persist during the use of this product, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with increased tendency to bleeding.

Patients using coagulation-inhibiting drugs.

Patients with severe hepatic and renal diseases.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Medical advice should be sought if the symptoms persist for more than one week, or in cases of fever lasting for several days or in case of shortness of breath or bloody sputum.

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 adults' single dose (30 drops)

Harmful for those suffering from alcoholism. To be taken into account in children and high-risk groups such as patients with liver disease, or epilepsy. The use in children under 12 years of age is not recommended due to lack of adequate data.

4.5 Interaction with other medicinal products and other forms of interaction

Drug interactions have not been reported.

However, due to the potential effect of the product on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin and should not be taken concomitantly with these drugs (see section

4.3 Contraindications).

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Studies on fertility have not 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.

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section

4.4 ‘Special warnings and precautions for use’.)

4.8 Undesirable effects

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

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

Mild bleeding from the gingival or nose may occur.

Hypersensitivity (e.g. oedemas, rash or pruritus on the skin or mucosa).

Serious hypersensitivity reactions with swelling of the face, dyspnea 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.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (1.86 g in 20 ml: equivalent to 1/10 glass of wine, respectively) may result in intoxication and should be treated accordingly.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Pharmacokinetic properties

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

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol

Ethanol

6.2    Incompatibilities

None known.

6.3 Shelf life

Unopened: 2 years.

In use stability after first opening of the container: 3 months.

6.4 Special precautions for storage

Do not store above 30 °C.

6.5 Nature and contents of container

A printed carton containing a hydrolytic Class III (PhEur.) brown glass bottle, incorporating a dropper insert (PE) and a white screw cap (PP), in pack sizes of 20 ml, oral solution.

6.6 Special precautions for disposal

There are no special precautions for disposal.