ViscoteÍna 50 mg/ml soluciÓn oral

PATIENT INFORMATION LEAFLET

Viscoteína 50 mg/ml oral solution

Carbocisteine

Read this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• 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 after 5 days, or if you experience: fever, skin eruptions, persistent headache or sore throat, consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

1.What Viscoteína is and for what it is used

2.Before taking Viscoteína

3.How to take Viscoteína

4.Possible adverse effects

5.Storage of Viscoteína

6.Additional information

Viscoteína belongs to a group of medications called mucolítics, and is used to liquefy excessive and/or thick bronchial secretions, making their elimination easier.

Do not take Viscoteína:

• If you are allergic (hypersensitive) to carbocisteine and its derivatives, or to any of the other components of Viscoteína.
• If you have a stomach or duodenal ulcer.
• This medication should not be administered to children under 2 years old.
• If you are asthmatic or have severe respiratory insufficiency.

Be especially careful with Viscoteína:

• If you have severe liver or kidney insufficiency.
• In elderly patients, who are especially sensitive to the adverse effects of carbocisteine.
• During the first few days, it is normal for expectoration to increase, but if symptoms persist for more than 5 days or worsen, you should consult your doctor.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Consult your doctor before taking Viscoteína if you are taking cough medications or those that reduce bronchial secretions.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

This medication should not be taken during pregnancy or breastfeeding.

Driving and operating machines

No interference with driving and/or operating machines has been described when taking Viscoteína.

Important information about some of the components of Viscoteína

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 1.5 g of saccharose per 5 ml.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219) and propyl parahydroxybenzoate, sodium salt (E-217).

Patients on low-sodium diets should note that this medication contains 34.75 mg of sodium per dose of 5 ml and 104.24 mg of sodium per dose of 15 ml.

Consult your doctor or pharmacist if you have any doubts.

This medication is administered orally, either undiluted or diluted in water or another liquid, and preferably before meals. The normal dose is:

• Adults and children over 12 years old: 15 ml (750 mg of carbocisteine) three times a day.
• Children 5 to 12 years old: 5 ml (250 mg of carbocisteine) three times a day.
• Children 2 to 5 years old: 2.5 ml (125 mg of carbocisteine) three times a day.

It is recommended to drink plenty of liquid during the day.

Instructions for correct administration of the preparation

To ensure correct dosing and given its use in pediatrics, it is recommended to perform the dosing using the dosing cup included in the presentation, which has the following measurements marked: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Place the dosing cup on a flat surface and at eye level. Fill it with the solution up to the line indicating your dose.

After use, wash the dosing cup with water.

If symptoms worsen or persist after 5 days, or if you experience: fever, skin eruptions, persistent headache, or sore throat, you should consult a doctor.

If you take more Viscoteína than you should:

Accidental ingestion of very high doses may cause hypersensitivity reactions, nausea, vomiting, diarrhea, headaches, gastrointestinal bleeding, etc.

If you have taken more Viscoteína than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 0420, indicating the medication and the amount ingested.

If you forgot to take Viscoteína:

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Viscoteína may have adverse effects, although not everyone will experience them.

The observed adverse effects are described below according to their frequency of presentation: Very frequent (affects more than 1 in 10 patients), Frequent (affects between 1 and 10 in 100 patients), Infrequent (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).

Frequent Adverse Effects (affects between 1 and 10 in 100 patients):

Discomforts in the digestive system (gastric discomfort, nausea, diarrhea) may occur, especially at high doses, which usually disappear with a reduction in the administered dose.

Rare Adverse Effects(affects between 1 and 10 in 10,000 patients):

Allergic reactions (hypersensitivity reactions), accompanied by urticaria (hives and itching), headache, skin eruptions.

Very Rare Adverse Effects (affects less than 1 in 10,000 patients):

Bronchial spasm (sudden sensation of difficulty breathing, as occurs in asthma). In these cases, it is recommended to discontinue treatment and consult a doctor.

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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Viscoteína after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Viscoteína Composition:

• The active principle is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
• The other components are:sucrose, sodium saccharin, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), caramel colorant (E-150), caramel flavor, sodium hydroxide for pH adjustment, purified water.

Product Appearance and Packaging Contents:

Viscoteína is an oral solution for administration that is presented in a glass bottle with a polypropylene/polycarbonate high-density (PP/HDPE) cap with a child-resistant closure, containing 200 ml of oral solution and a dosing cup.

The dosing cup has the following marked 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

Responsible for Manufacturing:

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea,Edificio 901

48160 Derio (Bizkaia)

Spain

This leaflet was approved in: February 2025

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/