KALOBA SYRUP

Introduction

Package Leaflet: Information for the Patient

KALOBA® SyrupExtract of Pelargonium sidoides

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What KALOBA syrup is and what it is used for
2. What you need to know before taking KALOBA syrup
3. How to take KALOBA syrup
4. Possible side effects
5. Storage of KALOBA syrup
6. Package contents and additional information

1. What KALOBA syrup is and what it is used for

KALOBA syrup is a liquid preparation of extract of the root of Pelargonium sidoidesDC (1:8-10) (EPs® 7630), dried. Extraction agent: Ethanol 11% (m/m). Therapeutic indications:KALOBA syrup is a traditional herbal medicinal product for the relief of common cold based on traditional use. It belongs to the pharmacotherapeutic group of cold medications. This medication is indicated in adults, adolescents, and children from 3 years of age.

2. What you need to know before taking KALOBA syrup

Do not take KALOBA syrup:

• If you are allergic (hypersensitive) to the extract of Pelargonium sidoides or to any of the ingredients of KALOBA syrup (see section 6).
• If you have severe liver disease, as there is not enough experience in these cases.

Warnings and precautionsConsult your doctor or pharmacist before starting to take KALOBA syrup.

If the symptoms do not improve or worsen after 1 week of treatment, in case of onset of fever, liver dysfunction of different origin, difficult breathing, or bloody sputum, consult your doctor immediately. ChildrenThere is not enough information available on treatment in children, so this medication should not be used in children under 3 years of age. Use of KALOBA syrup with other medicationsNo interactions with other medications are known to date.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription. Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

KALOBA syrup should not be taken during pregnancy and breastfeeding, as there is not enough data on the use of this medication in these circumstances.

Driving and using machinesIt is unlikely that KALOBA syrup will affect your ability to drive or use machinery.

3. How to take KALOBA syrup

KALOBA syrup is a liquid preparation for oral use (syrup). Follow the administration instructions contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist.

If your doctor does not prescribe otherwise, the daily dose is as follows:

• Adults and adolescents over 12 years: administer 7.5 ml of syrup 3 times a day

• Children from 6 to 12 years: administer 5 ml of syrup 3 times a day

• Children from 3 to 5 years: administer 2.5 ml of syrup 3 times a day

Take the syrup in the morning, at noon, and at night.

For the administration of KALOBA syrup, a dosing cap is provided. The dosing cap has different calibration marks. Open the bottle and fill the dosing cap slowly until you reach the desired milliliters (ml) according to the prescription. Administer the syrup directly from the dosing cap to the mouth. Make sure children are in a suitable position for ingestion so that they do not choke. Wash the dosing cap with water after each use and dry it.

If you prefer to use a spoon, use the dosing cap to measure the prescribed amount and then pour it into the spoon.

Close the bottle with the screw cap after each use.

How long to take KALOBA syrup

The recommended treatment duration is 7 days. Treatment can be continued for 2-3 days to prevent relapses. The treatment should not exceed 2 weeks as a maximum.

If you take more KALOBA syrup than you should

No cases of overdose are known to date.

If you forget to take KALOBA syrup

Do not take a double dose to make up for forgotten doses, but continue treatment with KALOBA syrup as indicated in this package leaflet or prescribed by your doctor.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

The following list of side effects includes all reactions that have occurred during treatment with KALOBA syrup:

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use. http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of KALOBA syrup

Keep this medication out of sight and reach of children. Do not use KALOBA syrup after the expiration date stated on the box and label after Exp.: The expiration date is the last day of the month indicated.

No special storage conditions are required. Discard the containers 6 months after the opening date.

After a long period of time since its manufacture, liquid plant extracts can become cloudy, although this has no effect on the product's effectiveness. Since KALOBA syrup is a natural product, small variations in color and taste may occur. Medications should not be thrown away through the sewers or into the trash. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of KALOBA syrup: The active ingredient is an extract of Pelargonium sidoidesDC (EPs® 7630), dried.

1 ml (1.06 g) of syrup contains 2.67 mg of extract (as dry extract) of root of Pelargonium sidoidesDC and/or Pelargonium reniformeCurt (DER 1:8-10) (EPs® 7630). Extraction solvent: ethanol 11% (m/m).

The other ingredients are: Maltodextrin, xylitol, glycerol 85%, anhydrous citric acid, potassium sorbate, xanthan gum, purified water.

Appearance of the product and package contents

KALOBA syrup is a viscous syrup with an orange-brown color. It is available in 100 ml containers.

Marketing authorization holder and manufacturer:

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Straße 4

76227 Karlsruhe / Germany

You can request information about this medication by contacting the local representative of the marketing authorization holder:

SCHWABE FARMA IBÉRICA, S.A.U. Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta.

28108 Alcobendas, Madrid

Date of the last revision of this package leaflet: October 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/