KALOBA FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

KALOBA

film-coated tablets

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

1. What KALOBA tablets are and what they are used for

KALOBA tablets are film-coated tablets containing 20 mg of dried (liquid) extract of the root of Pelargonium sidoidesDC (1:8-10) EPs® 7630. Extraction agent: Ethanol 11% (m/m).

Therapeutic indications:

KALOBA tablets are a traditional herbal medicinal product for the relief of common cold, based on traditional use.

This medication is indicated for adults, adolescents, and children over 6 years of age.

It belongs to the pharmacotherapeutic group of cold medications.

2. What you need to know before taking KALOBA tablets

Do not take KALOBAtablets

• If you are allergic (hypersensitive) to the extract of Pelargonium sidoides or any of the ingredients of KALOBA tablets (see section 6).
• You should not take KALOBA film-coated tablets if you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take KALOBA tablets.

If symptoms do not improve or worsen after 1 week of treatment, or if you have a fever for several days, liver dysfunction of different origin, difficulty breathing, or bloody sputum, discontinue treatment and consult your doctor immediately.

Children

This medication should not be administered to children under 6 years of age.

Use of KALOBA tablets with other medications

No interactions with other medications are known.

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 film-coated tablets should not be taken during pregnancy and breastfeeding, as there is insufficient data on the use of this medication in these circumstances.

Driving and using machines

It is unlikely that KALOBA tablets will affect your ability to drive or operate machinery.

KALOBAtablets contain Lactose monohydrate.

If your doctor has informed you that you have an intolerance to some sugars, contact your doctor before taking this medication. Each tablet contains 20 mg of lactose monohydrate.

3. How to take KALOBA tablets

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

KALOBA tablets are an oral preparation.

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

• Adults and adolescents over 12 years: 1 tablet, 3 times a day (breakfast, lunch, and dinner).
• Children from 6 to 12 years: 1 tablet, 2 times a day (breakfast and dinner).

The tablets should be swallowed with liquid (preferably a glass of water). Do not take the tablets while lying down.

How long should you take KALOBA tablets

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

If you take more KALOBA tablets than you should

No symptoms of overdose are known to date.

If you forget to take KALOBA tablets

Do not take a double dose to make up for forgotten doses, but continue treatment with KALOBA film-coated tablets 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 tablets.

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 Surveillance 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 tablets

Keep this medication out of sight and reach of children.

Do not use KALOBA tablets after the expiration date stated on the box and blister after Cad.:. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of KALOBA film-coated tablets:

The active ingredient is 20 mg of dried (liquid) extract of the root of Pelargonium sidoidesDC (1:8-10) (EPs® 7630). The extraction agent is ethanol 11% (m/m).

The other ingredients (excipients) are: microcrystalline cellulose; sodium croscarmellose; hypromellose; red iron oxide E 172; lactose monohydrate; macrogol 1500; magnesium stearate; maltodextrin; α-octadecyl-ω-hydroxypoly(oxyethylene)-5; anhydrous colloidal silica; precipitated silica; dimethicone; sorbic acid; talc.

Appearance of the product and package contents

KALOBA film-coated tablets are packaged in blisters and can be found in boxes of 21, 42, and 63 tablets. 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 more 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: May 2025.

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.es/.