SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Kaloba Pelargonium Cough & Cold Relief tablets Higher Nature Pelargonium Cold Relief film-coated tablets Healthspan Pelargonium Cold Relief tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 - 10) (EPs® 7630)

Extraction solvent 11% ethanol (w/w).

Excipient:

One film-coated tablet contains 20 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

Round, reddish-brown, smooth surface film coating without ruptures.

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

Adults and adolescents over 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:

If symptoms worsen, or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients, Severe hepatic diseases.

4.4 Special warnings and precautions for use Do not exceed the stated dose.

This formulation is not suitable for children under 12 years of age.

If symptoms worsen, or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

If fever, shortness of breath or blood in the sputum occurs, a doctor or qualified healthcare practitioner should be consulted.

Hepatotoxicity and hepatitis cases have been reported in association with the administration of the medicinal product. The causal relationship between this finding and the use of the product has not been demonstrated. Patients should stop taking this product immediately and consult their doctor if they develop signs and symptoms that suggest liver dysfunction (fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine.)

One film-coated tablet contains 20 mg lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Kaloba should not be used in case of severe hepaticdiseases.

4.5    Interaction with other medicinal products and other forms of interaction

None reported.

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.

No studies on the effects on fertility have been performed.

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 evaluation of adverse reactions is based on the following information on frequency:

Very common: more than 1 out of 10 treated persons	Common: more than 1 out of 100 treated persons
Uncommon: more than 1 out of 1000 treated persons	Rare: more than 1 out of 10 000 treated persons
Very rare: 1 or less out of 10 000 treated persons including single cases

Gastro-intestinal complaints such as stomach pain, heartburn, nausea, vomiting, dysphagia or diarrhoea may occur uncommonly (> 1/1,000 to < 1/100) during treatment with Kaloba.

In rare cases (>1/10,000 to < 1/1,000), mild bleeding from the gums or nose may occur. Furthermore, hypersensitivity reactions (e.g. exanthema, urticaria, pruritus of skin and mucous membranes) have been described in rare cases. In very rare cases (< 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnoea and decrease in blood pressure may occur.

Hepatotxicity (including hepatitis, liver dysfunction of different origin) has been reported. The causal relationship between this finding and the use of the product has not been demonstrated. The frequency is not known.

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

The effects of overdose are unknown.

Although there are no data on cases of overdose, overdose is likely to increase side-effects. Thus, treatment should be symptomatic and as clinically indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not required as per Article 16 c (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

Extract:

Maltodextrin

Tablet core:

Maltodextrin Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium,

Precipitated silica Magnesium stearate

Film-coating:

Hypromellose 5 mPas Macrogol 1500 Iron oxide yellow E172 Iron oxide red E172 Titanium dioxide E171 Talc

Simeticone Methylcellulose Sorbic acid.

Incompatibilities

Not applicable.

6.3 Shelf life

4 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Original packages containing 16, 21 or 30 film coated tablets (Kaloba Pelargonium Cough & Cold Relief tablets) or 30 (Healthspan Pelargonium Cold Relief tablets) or 21 (Higher Nature Pelargonium Cold Relief film-coated tablets). Not all pack sizes may be marketed.

The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.

6.6 Special precautions for disposal No special requirements.

7 MARKETING AUTHORISATION HOLDER

Dr. Willmar Schwabe GmbH & Co. KG Willmar-Schwabe-Str. 4 D-76227 Karlsruhe Germany

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1PD

8    MARKETING AUTHORISATION NUMBER(S)

THR 05332/0005

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/03/2009

10    DATE OF REVISION OF THE TEXT

05/04/2011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/03/2009

10    DATE OF REVISION OF THE TEXT

18/02/2015

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