Kaloba jarabe

Leaflet: information for the patient

KALOBA® syrup
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 contained in this leaflet or those given 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 get worse or do not improve after 7 days.

1. What isKALOBA syrupand what it is used for

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

3. How to takeKALOBA syrup

4. Possible side effects

5. Storage ofKALOBA syrup

6. Contents of the pack and additional information

KALOBA syrup is a syrup of extract from the root ofPelargonium sidoidesDC (1:8-10) (EPs® 7630), dried. Solvent: Ethanol 11% (m/m).

Therapeutic indications:
KALOBA syrup is a traditional herbal medicine for the relief of the common cold based on traditional use.
It belongs to the pharmacotherapeutic group of cold medicines.
This medicine is indicated for adults, adolescents, and children aged 6 years and above.

Do not take KALOBA syrup:

- If you are allergic (hypersensitive) to the extract ofPelargonium sidoidesor to any of the ingredients of KALOBA syrup (see section 6).

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

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

If symptoms do not improve or worsen after 1 week of treatment, in case of appearance of fever, liver dysfunction of different origin, difficult breathing or bloody sputum, consult your doctor immediately.

Children
There is not enough information available about treatment in children, therefore this medicine should not be used in children under 6 years.

Use of KALOBA syrup with other medicines
No interactions with other medicines are known to date.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Driving and operating machines
It is unlikely that KALOBA syrup will affect your ability to drive or use machinery.

KALOBA syrup is a liquid preparation for oral use (syrup).

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

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

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

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

A measuring cap is provided for the administration of KALOBA syrup. The measuring cap has different calibration marks. Open the bottle and fill the measuring cap slowly until the desired milliliters (ml) are reached according to the prescription. Administer the syrup directly from the measuring cap to the mouth. Ensure that children are in an appropriate position for ingestion to prevent choking. Wash the measuring cap with water after each use and dry it.

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

Close the bottle with the screw-top cap after each use.

For how long should KALOBA syrup be taken

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 syrup than you should

No cases of overdosing have been reported to date.

If you forgot to take KALOBA syrup

Do not take a double dose to compensate for the missed doses, but continue treatment with KALOBA syrup 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 everyone will experience them.

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

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 syrup after the expiration date that appears on the box and on the label after Cad.: The expiration date is the last day of the month indicated.

No special storage conditions are required.

Dispose of the containers six months after opening.

After a long period of time since its manufacture, liquid plant extracts may become turbid, 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.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

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

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

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

Appearance of the product and contents of the packaging

KALOBA syrup is a thick, orange-brown syrup. It is available in 100 ml containers.

Holder of the marketing authorization and responsible for manufacturing:

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 holder of the marketing authorization:

SCHWABE FARMA IBÉRICA, S.A.U.
Avenida de la Industria, 4. Building 2, staircase 1, 2nd floor.

28108 Alcobendas, Madrid

Date of the last review of this leaflet: May 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.gob.es/