Kaloba oral drops
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What KALOBA oral drops is and what it is used for
- 2. What you need to know before starting to take KALOBA oral drops
- 3. How to take KALOBA oral drops
- 4. Possible adverse effects
- 5. Storage of KALOBA oral drops
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
KALOBA® oral drops Pelargonium sidoides extract
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet
- What KALOBA oral drops are and what they are used for
- What you need to know before taking KALOBA oral drops
- How to take KALOBA oral drops
- Possible adverse effects
- How to store KALOBA oral drops
- Contents of the pack and other information
1. What KALOBA oral drops is and what it is used for
KALOBA oral drops is a liquid extract solution from the root of Pelargonium sidoides DC (1:8-10) (EPs® 7630) (extraction agent: Ethanol 11% (m/m)), taken as drops.
Therapeutic indications: KALOBA oral drops is a traditional herbal medicinal product for the relief of the common cold, based on traditional use. It belongs to the pharmacotherapeutic group of cold preparations. This medicine is indicated for adults, adolescents, and children from 3 years of age.
2. What you need to know before starting to take KALOBA oral drops
Do not take KALOBA oral drops:
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If you are allergic (hypersensitive) to Pelargonium sidoides extract or to any of the ingredients of
KALOBA oral drops (see section 6). -
If you have severe liver disease, as there is insufficient experience in such cases.
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, or if fever develops, liver dysfunction of any cause occurs, breathing becomes difficult, or bloody sputum appears, consult your doctor immediately.
Children
This medicine is not suitable for use in children under 3 years of age.
Use of KALOBA oral drops with other medicines
No interactions with other medicines are currently known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
KALOBA oral drops should not be taken during pregnancy and breastfeeding due to insufficient data on the use of this medicine under these circumstances.
Important for women: |
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. |
Driving and use of machines It is unlikely that KALOBA oral drops will affect your ability to drive or operate machinery.
KALOBA oral drops contains 12% (v/v) ethanol (alcohol)
This medicine contains 125 mg of alcohol (ethanol) per single dose of 30 drops for adults, equivalent to 1.5 ml of KALOBA oral drops.
The amount of alcohol (ethanol) in 30 drops of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol contained in this medicine does not produce any noticeable effect.
3. How to take KALOBA oral drops
KALOBA oral drops is a liquid preparation for oral use. Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
If your doctor has not prescribed otherwise, the daily dose is as follows:
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Adults, adolescents and children over 12 years: 30 drops three times a day
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Children from 6 to 12 years: 20 drops three times a day
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Children from 3 to 5 years: 10 drops three times a day
Take the drops with some liquid in the morning, at midday and in the evening.
To facilitate the release of the drops, hold the bottle vertically and, if necessary, give a light tap on the bottom of the bottle.
How long to take KALOBA oral drops
The recommended duration of treatment is 7 days. Treatment may be continued for 2–3 additional days to prevent relapses. The treatment should not exceed a maximum of 2 weeks.
If you take more KALOBA oral drops than you should
There are no known cases of overdose to date.
If you forget to take KALOBA oral drops
Do not take a double dose to make up for 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 medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone experiences them.
The following list of adverse effects includes all reactions that have occurred during treatment with KALOBA oral drops:
Uncommon side effects (affect more than 1 in 1,000 people treated but less than 1 in 100): Gastrointestinal problems such as stomach pain, burning sensation, nausea, or diarrhoea may occur. |
Rare side effects (affect more than 1 in 10,000 people treated but less than 1 in 1,000):
|
Very rare cases (affect one or fewer than one in 10,000 people treated): serious hypersensitivity reactions may occur, including facial swelling, difficulty breathing, and drop in blood pressure. |
Frequency not known: Hepatic dysfunction of various origins; a causal relationship between this observation and the use of the product has not been established. |
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of KALOBA oral drops
Keep this medicine out of the sight and reach of children. Do not use KALOBA oral drops after the expiry date stated on the carton and label following Exp.: The expiry date refers to the last day of the month indicated. Store your medicine in a cool place below 30°C. Discard the container six months after opening.
After a long period of time from manufacture, liquid herbal extracts may become cloudy, although this does not affect the product's effectiveness. Since KALOBA oral drops is a natural product, slight variations in colour and taste may occur.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of KALOBA oral drops: The active substance is a liquid extract of Pelargonium sidoides DC (EPs® 7630).
Each 10 g (= 9.75 ml) of oral drops contains as the active substance 8.0 g of liquid extract from the root of Pelargonium sidoides (EPs® 7630), obtained using 11% ethanol (m/m) with a dry plant material to extract ratio of 1:8–10.
Contains 12% ethanol (v/v), equivalent to 84 mg per ml of solution.
The other component is: Glycerol 85%.
Appearance of the product and contents of the pack
The product is a clear solution packed in brown glass bottles with a dropper dispenser and screw cap.
KALOBA oral drops are available in bottles containing 20, 50 and 100 ml of solution. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Straße 4
76227 Karlsruhe / Germany
Information about this medicinal product is available upon request from 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 most recent revision of this leaflet: October 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/