KALOBA ORAL DROPS

Introduction

Package Leaflet: Information for the Patient

KALOBA® Oral DropsExtract 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 it worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

1. What KALOBA oral drops are and what they are used for

KALOBA oral drops are a liquid extract solution of the root of Pelargonium sidoidesDC (1:8-10) (EPs® 7630) (extraction agent: Ethanol 11% (m/m)) that is taken in drops.Therapeutic Indications:KALOBA oral drops are a traditional herbal medicinal product for the relief of the 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 oral drops

Do not take KALOBA oral drops:

• If you are allergic (hypersensitive) to the extract of Pelargonium sidoides or to any of the ingredients of

KALOBA oral drops (see section 6).

• If you have severe liver diseases, as there is not enough experience in these cases.

Warnings and PrecautionsConsult your doctor or pharmacist before starting to take KALOBA oral drops.

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.ChildrenThis medication is not suitable for use in children under 3 years of age.Use of KALOBA oral drops 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

KALOBA oral drops 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 oral drops will affect your ability to drive or use machinery.

KALOBA oral drops contain 12% (v/v) ethanol (alcohol)

This medication contains 125 mg of alcohol (ethanol) per single dose of 30 drops for adults, which is equivalent to 1.5 ml of KALOBA oral drops.

The amount of alcohol (ethanol) in 30 drops of this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to take KALOBA oral drops

KALOBA oral drops are a liquid preparation for oral use.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, adolescents, and children over 12 years: 30 drops 3 times a day

• Children from 6 to 12 years: 20 drops 3 times a day

• Children from 3 to 5 years: 10 drops 3 times a day

Take the drops with some liquid in the morning, at noon, and at night.

To facilitate the release of the drops, keep the bottle vertical and, if necessary, give a slight tap on the base of the bottle.

How long should you take KALOBA oral drops

The recommended treatment duration is 7 days.It 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 oral drops than you should

No cases of overdose are known to date.

If you forget to take KALOBA oral drops

Do not take a double dose to make up for forgotten doses, but continue the treatment with KALOBA oral drops 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 all people experience them.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System. 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 Oral Drops

Keep this medication out of sight and reach of children.Do not use KALOBA oral drops after the expiration date stated on the carton and label after Exp.: The expiration date is the last day of the month indicated.Store your medication in a cool place below 30°C.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 oral drops are a natural product, small variations in color and taste may occur.Medications should not be thrown away through wastewater or household waste. 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 oral drops:The active ingredient is a liquid extract of Pelargonium sidoidesDC (EPs® 7630).

Each 10 g (= 9.75 ml) of oral drops contains as the active ingredient 8.0 g of liquid extract of the root of Pelargonium sidoides(EPs® 7630), obtained with ethanol 11% (m/m) with a plant dry extract ratio (1:8-10).

It contains ethanol 12% (v/v) which corresponds to 84 mg per ml of solution.

The other component is: Glycerol 85%.

Appearance of the Product and Package Contents

The product is a clear solution that is packaged in brown glass bottles with a dropper and screw cap.

KALOBA oral drops may be found in bottles of 20, 50, and 100 ml of solution. Not all presentations may be marketed.

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. building 2, staircase 1, 2nd floor.

28108 Alcobendas, Madrid

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

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