Kaloba syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
KALOBA® syrup Pelargonium sidoides extract
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for use of this medicine as described in this leaflet or as given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 syrup is and what it is used for
- What you need to know before taking KALOBA syrup
- How to take KALOBA syrup
- Possible adverse effects
- Storage of KALOBA syrup
- Contents of the pack and other information
1. What KALOBA syrup is and what it is used for
KALOBA syrup is a syrup containing an extract of the root of Pelargonium sidoides DC (1:8-10) (EPs® 7630), dried. Extraction agent: Ethanol 11% (m/m).Therapeutic indications: KALOBA syrup 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 medications. This medicine is indicated for adults, adolescents, and children from 3 years of age.
2. What you need to know before starting KALOBA syrup
Do not take KALOBA syrup:
- If you are allergic (hypersensitive) to Pelargonium sidoides extract or to any of the ingredients of KALOBA syrup (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 syrup.
If symptoms do not improve or worsen after 1 week of treatment, or if fever, liver dysfunction of different origin, difficulty breathing, or bloody sputum occur, consult your doctor immediately.
Children There is insufficient information available regarding use in children; therefore, this medicine must not be used in children under 3 years of age.
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 recently taken, or might need to take any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
KALOBA syrup must not be taken during pregnancy or breastfeeding due to insufficient data on the use of this medicine under these circumstances.
Driving and operating machinery It is unlikely that KALOBA syrup will affect your ability to drive or operate machinery.
3. How to take KALOBA syrup
KALOBA syrup is a liquid preparation for oral use (syrup). Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If your doctor has not prescribed otherwise, the daily dose is as follows:
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Adults and adolescents over 12 years of age: take 7.5 ml of syrup 3 times a day
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Children from 6 to 12 years of age: take 5 ml of syrup 3 times a day
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Children from 3 to 5 years of age: take 2.5 ml of syrup 3 times a day
Take the syrup in the morning, at midday, and in the evening.
A dosing cap is provided for administering KALOBA syrup. The dosing cap has different calibration marks. Open the bottle and slowly fill the dosing cap up to the prescribed millilitre (ml) level. Then administer the syrup directly from the dosing cap into the mouth. Ensure that children are in an appropriate position for swallowing to avoid choking. Wash the dosing cap with water after each use and dry it.
If you prefer to use a spoon, use the dosing cap to measure the prescribed amount and then pour it into the spoon.
Close the bottle with the screw cap after each use.
How long should you take KALOBA syrup
The recommended duration of treatment is 7 days. The treatment may be continued for an additional 2–3 days to prevent relapse. The treatment should not exceed a maximum of 2 weeks.
If you take more KALOBA syrup than you should
There have been no reported cases of overdose to date.
If you forget to take KALOBA syrup
Do not take a double dose to make up for a missed dose, but continue treatment with KALOBA syrup as indicated in this leaflet or prescribed by your doctor.
If you have any questions 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 will experience them.
The following list of adverse effects includes all reactions that have occurred during treatment with KALOBA syrup:
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 diarrhea 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 1 or fewer in 10,000 people treated): serious hypersensitivity reactions may occur, including facial swelling, difficulty breathing, and drop in blood pressure. |
Frequency unknown: Hepatic dysfunction of various origins; a causal relationship between this observation and 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 can 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 syrup
Keep this medicine out of the sight and reach of children. Do not use KALOBA syrup after the expiry date which is stated on the carton and label after Exp.: The expiry date refers to the last day of the month indicated.
No special storage conditions are required. Discard the container six months after opening.
After a long period of time from manufacture, liquid herbal extracts may become cloudy, although this has no effect on the product's efficacy. Since KALOBA syrup 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 you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of KALOBA syrup: The active substance is an extract of Pelargonium sidoides DC (EPs® 7630), dried.
1 ml (1.06 g) of syrup contains 2.67 mg of extract (as dry extract) from the root of Pelargonium sidoides DC and/or Pelargonium reniforme Curt (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 pack
KALOBA syrup is a viscous, brownish-orange syrup. It is available in 100 ml containers.
Marketing Authorization Holder and Manufacturer:
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Straße 4
76227 Karlsruhe / Germany
You may request information regarding this medicinal product 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 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.gob.es/