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1. Kaloba Syrup
2. Kaloba Syrup

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Kaloba Pelargonium Cough & Cold Relief syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

100 g (= 93.985 ml) syrup contain 0.2506 g dried liquid extract from the roots of Pelargonium sidoides DC (1 : 8 - 10) (EPs® 7630). The extraction agent is 11% ethanol (w/w).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Syrup

Kaloba is an orange to light brown, viscous syrup.

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

Shake the bottle well before use.

Adults, the elderly and adolescents over 12 years of age:

Take 7.5 ml of the syrup three times per day.

Children aged between 6-12 years:

Take 5 ml of the syrup three times per day.

Syrup is to be taken in the morning, midday and evening.

The use in children under 6 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 health care 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.

The use in children under 6 years of age has not been established due to lack of adequate data.

If symptoms worsen or do not improve after one week, a doctor or 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).

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 use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects 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: less than 1 out of 10 but more than 1 out of 100 treated persons
Uncommon: less than 1 out of 100 but more than 1 out of 1000 treated persons	Rare: less than 1 out of 1000 but more than 1 out of 10 000 treated persons
Very rare: less than 1 out of 10 000 treated persons including cases with unknown frequency

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 reaction with swelling of the face, dyspnoea and decrease in blood pressure may occur.

Hepatotoxicity (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

Syrup:

Xylitol Glycerol 85%

Citric acid anhydrous Potassium sorbate Xanthan gum

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

The shelf-life of the syrup after the container has been opened is 6 months Note for the patient:

Since Kaloba syrup is a natural product, slight variations in colour and taste may occur.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container

Amber glass bottles, hydrolytic class III (Ph. Eur.), with pourer as dosage aid (LDPE), screw cap (PP) with seal (PEHD/PELD) and a measuring cup (PP), in pack size of 100 ml syrup.

6.6    Special precautions for disposal

No special requirements.