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Kaloba Syrup – SPC

Summary of Product Characteristics

1. Name of the medicinal product

Kaloba Pelargonium Cough and 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

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.

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

  • 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 due to lack of adequate data

4.4 Special warnings and special precautions for use

In the patient information leaflet, the patient is advised to consult a doctor immediately if his or her 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.

On theoretical grounds Kaloba should not be used where there is a likelihood of increased tendency to bleeding or use of coagulation-inhibiting drugs.

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

The use of this product in children or adolescents under 6 years of age is not recommended because data are not sufficient and medical advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

Drug interactions have not been reported to date.

However, due to the potential effect of Kaloba 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).

4.6 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.

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 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. Such reactions may occur after the first intake of the product.

In very rare cases (≤ 1/10,000) serious hypersensitivity reaction with swelling of the face, dyspnoea and drop in blood pressure may occur.

In single cases, signs indicating disturbances of liver function have been reported after the intake of Kaloba; the causal relationship between this effect and the use 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.

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

Pharmacotherapeutic group: cough and cold preparations, ATC code: R 05

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars

6.1 List of excipients

Extract:

Maltodextrin

Syrup:

Xylitol

Glycerol 85%

Citric acid anhydrous

Potassium sorbate

Xanthan gum

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 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 sizes of 100 ml syrup.

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

Distributed in the UK by:

Schwabe Pharma (UK) Ltd

Alexander House

Mere Park

Dedmere Road

Marlow

Buckinghamshire

SL7 1PD

8. Marketing authorisation number(s)

THR 05332/0006

9. Date of first authorisation/renewal of the authorisation

11th June 2010

10 Date of revision of the text

3rd September 2013

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