Kaloba gotas orales leaflet – Spain

How to use Kaloba gotas orales

Introduction

Leaflet: information for the patient

KALOBA® oral drops
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 oral dropsand what it is used for

2. What you need to know before starting to takeKALOBA oral drops

3. How to takeKALOBA oral drops

4. Possible side effects

5. Storage ofKALOBA oral drops

6. Contents of the pack and additional information

1. What is KALOBA oral drops and what is it used for

KALOBA oral drops is a liquid extract solution of the root ofPelargonium sidoidesDC (1:8-10) (EPs® 7630) (extraction agent: Ethanol 11% (m/m)) taken in drops.

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

2. What you need to know before starting to take KALOBA oral drops

Do not take KALOBA oral drops:

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

- If you have severe liver disease, since there is not enough experience in these areas.

Areas.

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

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
This medication is not suitable for use in children under 6 years.

Use of KALOBA oral drops with other medications
No interactions with other medications are known to date.

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 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.

Important for women:

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

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

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

In the recommended dosage for children aged 6 to 12 years, this amount corresponds to 84 mg of alcohol per dose of 20 drops (1 ml), which is equivalent to 1.8 ml of beer and 0.7 ml of wine.

This statement is intended to inform parents and children that the product contains a low level of alcohol.

In the dosage for adults, adolescents, and children over 12 years, this amount corresponds to 125 mg of alcohol per dose of 30 drops (1.5 ml), which is equivalent to 2.7 ml of beer or 1.1 ml of wine.

This medication is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol.

3. How to take KALOBA oral drops

KALOBA oral drops is a liquid preparation for oral use.

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, adolescents, and children over 12 years: 30 drops 3 times a day

b) Children from 6 to 12 years: 20 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 upright and, if necessary, give a slight tap on the base of the bottle.

For how long should you take KALOBA oral drops

The recommended duration of treatment is 7 days. You can continue treatment for 2-3 days to prevent relapses. Treatment should not exceed 2 weeks at most.

If you take more KALOBA oral drops than you should

No cases of overdose have been reported to date.

If you forgot to take KALOBA oral drops

Do not take a double dose to compensate for the missed doses, but continue treatment with KALOBA oral drops 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.

4. Possible Adverse Effects

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 oral drops:

Uncommon effects(affect more than 1 in 1000 people treated but less than 1 in 100):

Abdominal problems such as stomach pain, burning, nausea, or diarrhea may occur.

Rare effects(affect more than 1 in 10,000 people treated but less than 1 in 1000):

Mild bleeding of the gums or nose may occur.
On rare occasions, allergic reactions (e.g., skin rash, urticaria, skin itching, and mucous membrane itching) may occur. These reactions may also occur with the first dose.

Very rare cases(affect 1 in 10,000 people or fewer treated): serious hypersensitivity reactions with facial swelling, difficulty breathing, and blood pressure drop may occur.

Unknown frequency: Different types of liver dysfunction; the causal relationship between this observation and the product's use has not been demonstrated.

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 Medicinal Products for Human Use. http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of KALOBA oral drops

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

Do not use KALOBA oral drops 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.
Store your medication in a cool place below 30°C.

Dispose of the containers six months after the opening date.

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 oral drops is a natural product, small variations in color and taste may occur.

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

6. Contents of the packaging and additional information

Composition of KALOBA oral drops:
The active ingredient is a liquid extract ofPelargonium sidoidesDC (EPs® 7630).

Each 10 g (= 9.75 ml) of oral drops contains as active ingredient 8.0 g of liquid extract of the root ofPelargonium sidoides(EPs® 7630), obtained with ethanol 11% (m/m) with a plant dry matter / extract ratio (1:8-10).
The other components are:
Etanol 12% (v/v) corresponding to 84 mg per ml of solution
Glycerol 174 mg per ml of solution

Appearance of the product and contents of the packaging

The product is a transparent solution that is packaged in brown glass bottles, with a dropper and screw-top cap.

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

Holder of the marketing authorization and responsible 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 review 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/