Leaflet: information for the patient

KALOBA?

film-coated tablets

Extract ofPelargonium sidoides

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

1. What isKALOBA tabletsand what it is used for

2. What you need to know before starting to takeKALOBA tablets

3. How to takeKALOBA tablets

4. Possible side effects

5. Storage ofKALOBA tablets

6. Contents of the pack and additional information

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

Therapeutic indications:

KALOBAtablets are a plant-based traditional medicine for the relief of common cold, based on traditional use.

This medicine is indicated in adults, adolescents and children over 6 years old.

It belongs to the pharmacotherapeutic group of medicines for the common cold.

Do not take KALOBAtablets:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take KALOBAtablets.

If symptoms do not improve or worsen after 1 week of treatment or if you have 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 old.

Use of KALOBA tablets with other medications

No interactions with other medications are known.

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

Pregnancy and breastfeeding

KALOBA coated tablets should not be taken during pregnancy and breastfeeding due to insufficient data on the use of this medication in these circumstances.

Driving and operating machinery

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 any sugar, contact your doctor before taking this medication. Each tablet contains 20 mg of lactose monohydrate.

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

KALOBA tabletsare 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 from6 to12 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 in a lying position.

For 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 at most.

If you take more KALOBA tablets than you should

No symptoms of overdose have been reported to date.

If you forgot to take KALOBA tablets

Do not take a double dose to compensate for the missed doses, but continue treatment with KALOBA tablets as indicated in this leaflet or prescribed by your doctor.

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

Like all medications, this medication may have adverse effects, although not all people will experience them.

The following list of adverse effects includes all reactions that have occurred during treatment with KALOBA tablets.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the medication that you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition ofKALOBA coated tablets:

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

The other components (excipients) are:

Maltodextrin, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, precipitated silica, magnesium stearate, hypromellose 5 mPas, polyethylene glycol (macrogol 1500), iron (III) oxide (E 172), iron (III) oxide (E172), titanium dioxide E171, talc, simethicone, methylcellulose, sorbic acid.

Appearance of the product and contents of the packaging

KALOBA coated tablets, are presented packaged in blisters and may be found in boxes of 21, 42 and 63 tablets. Not all presentations may be marketed.

Holder of the authorization and responsible for manufacturing

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Straße 4

76227 Karlsruhe / Germany

Further information about this medication can be requested 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

Last review date of this leaflet: April 2018

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