Patient Information Leaflet

KALOBA syrup

Pelargonium root extract
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement, or if your symptoms worsen after 7 days.

Contents of this leaflet:

What KALOBA is and what it is used for
What you need to know before taking KALOBA
How to take KALOBA
Possible side effects
How to store KALOBA
Contents of the pack and other information

1. What KALOBA is and what it is used for

KALOBA is a traditional herbal medicinal product containing as active ingredient the extract
of Pelargonium root.
KALOBA is indicated for the symptomatic treatment of common cold in adults and children over 3 years of age.
The use of this traditional herbal medicinal product for the specified therapeutic indications is based exclusively on long-standing use.
Consult a doctor if you do not feel better or feel worse after 7 days.

2. What you should know before taking KALOBA

Do not take KALOBA

if you are allergic to Pelargonium or to any of the other ingredients of this medicine (listed in section 6);
if you have a tendency to bleeding;
if you are taking medicines that delay blood coagulation;
if you suffer from severe liver or kidney diseases (severe hepatic insufficiency and severe renal insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking KALOBA.
Treatment with KALOBA must be stopped immediately and you should consult your doctor if any of the following occur:

liver-related problems (hepatotoxicity);
increased respiratory rate (tachypnea); or
presence of blood in sputum (haemoptysis).

Other medicines and KALOBA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to its potential influence on blood coagulation parameters, KALOBA may enhance the effects of medicines that delay blood coagulation (anticoagulants), such as phenprocoumon and warfarin, when taken concomitantly.
No interaction studies with other medicines have been conducted.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of KALOBA during pregnancy and breastfeeding has not been established; therefore, its use is not recommended.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or use machinery.

3. How to take KALOBA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

Adults and adolescents over 12 years of age
The recommended dose is 7.5 ml of syrup three times a day.

Children aged between 6 and 12 years
The recommended dose is 5 ml of syrup three times a day.

Children aged between 3 and less than 6 years
The recommended dose is 2.5 ml of syrup three times a day.

Do not exceed the maximum recommended daily doses.

The safety and efficacy of KALOBA in children under 3 years of age have not yet been established.

Use in patients with impaired kidney and/or liver function
No data are available.

Duration of treatment
The maximum duration of treatment is 7 days. If symptoms persist, consult a doctor.

Method of administration
For oral use.

Use the graduated dosing cup supplied with the pack.

If you take more KALOBA than you should
There is no information on cases of overdose; however, overdose could increase the frequency and/or severity of adverse effects.

In case of accidental ingestion of an excessive dose of KALOBA, inform your doctor immediately or go to the nearest hospital.

If you forget to take KALOBA
Do not take a double dose to make up for the missed dose. Continue treatment with KALOBA as indicated in this patient information leaflet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The assessment of side effects is based on the following frequency categories:
Uncommon (may affect less than 1 in 100 but more than 1 in 1,000 people)
Stomach ache, heartburn, nausea, vomiting, dysphagia, and diarrhoea.
Rare (may affect less than 1 in 1,000 but more than 1 in 10,000 people)
Slight bleeding of the gums.
Slight nosebleeds.
Hypersensitivity reaction (type-I reactions with rash, urticaria, itching of the skin and mucous membranes; type-II reactions with antibody formation).
Very rare (may affect less than 1 in 10,000 people)
Severe hypersensitivity reactions with facial swelling, dyspnoea, and drop in blood pressure.
Not known (frequency cannot be estimated from the available data)
Hepatotoxicity, hepatitis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KALOBA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Note:
Since KALOBA is a natural product, slight variations in colour and taste may occur.

6. Package contents and other information

What KALOBA contains

The active substance is dried liquid extract of Pelargonium sidoides DC, radix (Pelargonium root) (1: 8 - 10) (EPs 7630).
The extraction solvent is ethanol 11% (m/m). 100 g (=93.985 ml) of syrup contain 0.251 g of Pelargonium extract.
The other components are: maltodextrin, xylitol, glycerol 85%, anhydrous citric acid, potassium sorbate, xanthan gum, purified water.

Description of the appearance of KALOBA and package contents
KALOBA is a viscous syrup with an orange to light brown colour, available in a 100 ml glass bottle with a dosing cup.
Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
D-76227 Karlsruhe (Germany)
Marketing Authorization Holder in Italy
Schwabe Pharma Italia S.r.l.
Via Silvio Menestrina 1
39044 Egna-Neumarkt (BZ)