Viscoteina 50 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Viscoteína 50 mg/ml oral solution
Carbocisteína
Read the entire leaflet carefully because it contains important information for you.
This medicine can be purchased without a prescription. However, to obtain the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If symptoms worsen or persist beyond 5 days, or if you develop: fever, skin rash, persistent headache, or sore throat, you should consult a doctor.
- If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Viscoteína is and what it is used for
- Before taking Viscoteína
- How to take Viscoteína
- Possible side effects
- How to store Viscoteína
- Further information
1. What Viscoteína is and what it is used for
Viscoteína belongs to a group of medicines called mucolytics, and is used to liquefy excessive and/or thick bronchial secretions, facilitating their removal.
2. Before taking Viscoteïna
Do not take Viscoteïna:
- If you are allergic (hypersensitive) to carbocisteine and its derivatives, or to any of the other components of Viscoteïna.
- If you have a stomach or duodenal ulcer.
- This medicine should not be given to children under 2 years of age.
- If you have asthma or severe respiratory insufficiency.
Take special care with Viscoteïna:
- If you have severe liver or kidney impairment.
- In elderly patients, who are particularly sensitive to the adverse effects of carbocisteine.
- During the first few days it is normal for expectoration to increase; however, if symptoms persist for more than 5 days or worsen, you must consult your doctor.
Use of other medicines:
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Consult your doctor before taking Viscoteïna if you are taking cough suppressants or medicines that reduce bronchial secretions.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
This medicine should not be taken during pregnancy or breastfeeding.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
Driving and use of machines
No interference with driving or operating machinery has been reported when taking Viscoteïna.
Important information about some of the components of Viscoteïna
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 1.5 g of sucrose per 5 ml.
It may cause allergic reactions (possibly delayed), as it contains methylparahydroxybenzoate, sodium salt (E-219) and propylparahydroxybenzoate, sodium salt (E-217).
Patients on low-sodium diets should be aware that this medicine contains 34.75 mg of sodium per 5 ml dose and 104.24 mg of sodium per 15 ml dose.
3. How to take Viscoteína
Consult your doctor or pharmacist if you have any doubts.
This medicine is administered orally, either alone or diluted in water or another liquid, preferably before meals. The usual dosage is:
- Adults and children over 12 years: 15 ml (750 mg carbocisteine) three times daily.
- Children from 5 to 12 years: 5 ml (250 mg carbocisteine) three times daily.
- Children from 2 to 5 years: 2.5 ml (125 mg carbocisteine) three times daily.
It is recommended to drink plenty of fluids throughout the day.
Instructions for correct administration of the preparation
To ensure accurate dosing, and given its use in pediatric patients, it is recommended to measure the dose using the dosing cup supplied with the product, which is marked with the following measurements: 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml.
Place the dosing cup on a flat surface at eye level. Fill it with the solution up to the line indicating your prescribed dose.
After use, wash the dosing cup with water.
If symptoms worsen or persist beyond 5 days, or if fever, skin rashes, persistent headache or sore throat occur, you must consult a doctor.
If you have taken more Viscoteína than you should:
Accidental ingestion of very high doses may cause hypersensitivity reactions, nausea, vomiting, diarrhea, headache, gastrointestinal bleeding, etc.
If you have taken more Viscoteína than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 0420, indicating the medicine and the amount ingested.
If you forget to take Viscoteína:
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Viscoteína may cause adverse effects, although not everyone experiences them.
The adverse effects observed are described below according to their frequency of occurrence: Very common (affects more than 1 in 10 patients), Common (affects between 1 and 10 in 100 patients), Uncommon (affects between 1 and 10 in 1,000 patients), Rare (affects between 1 and 10 in 10,000 patients), Very rare (affects less than 1 in 10,000 patients).
Common adverse effects (affects between 1 and 10 in 100 patients):
Gastrointestinal disturbances (gastric discomfort, nausea, diarrhea) may occur, especially at high doses, which usually resolve with dose reduction.
Rare adverse effects (affects between 1 and 10 in 10,000 patients):
Hypersensitivity reactions (allergic reactions), accompanied by urticaria (appearance of hives and itching), headache, skin rashes.
Very rare adverse effects (affects less than 1 in 10,000 patients):
Bronchospasm (sudden sensation of difficulty breathing, as occurs in asthma). In such cases, it is recommended to discontinue treatment and consult a doctor.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Viscoteína
Keep out of the reach and sight of children.
Store below 30°C.
Do not use Viscoteína after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.
6. Additional Information
Composition of Viscoteína:
- The active substance is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
- The other components are: sucrose, sodium saccharin, methylparahydroxybenzoate, sodium salt (E-219), propylparahydroxybenzoate, sodium salt (E-217), caramel colorant (E-150), caramel flavor, sodium hydroxide for pH adjustment, purified water.
Appearance of the product and contents of the container:
Viscoteína is an oral solution supplied in a glass bottle with a polypropylene/polyethylene high-density (PP/HDPE) cap equipped with a child-resistant closure (Child-proof), containing 200 ml of oral solution and a dosing cup.
The dosing cup is marked with the following measurements: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.
Marketing Authorization Holder:
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer:
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain
This leaflet was last approved in: February 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/