INISTON MUCOSIDAD 20mg/ml ORAL SOLUTION MINT FLAVOR

2. What you need to know before taking Inistón Mucosidad

Do not take Inistón Mucosidad:

• if you are allergic to guaifenesin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Inistón Mucosidad:

• if you have had a cough for more than 7 days or if your cough is recurrent or accompanied by fever, rash, or persistent headache
• if you have a persistent cough that may be caused by asthma
• if you have a cough that produces a large amount of mucus (phlegm)
• if you have severe liver or kidney problems
• if you consume alcohol

Interference with diagnostic tests

If you are going to have a urine test, it is important that you inform your doctor or nurse that you are taking or have recently taken this medication, as it may affect the results of some tests.

Children:

Administration of this medication is not indicated in children under 12 years of age.

Other medications and Iniston Mucosidad

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

It is not recommended to take this medication with other cough medications intended to suppress coughing (antitussives or cough suppressants), as they may interfere with the action of this medication.

Taking Inistón Mucosidad with food and drinks

You can take this medication with or without food or drink.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should not be used during pregnancy unless advised by a doctor.

• Do not take this medication if you are breastfeeding before consulting your doctor or pharmacist.

Driving and using machines

Inistón Mucosidad is not expected to affect your ability to drive or use machines. However, if you do not feel well, do not drive or use machinery.

Inistón Mucosidad contains

• This medication contains 381 mg of alcohol (ethanol) in each 10 ml dose, which is equivalent to 38.1 mg/ml. The amount in 10 ml of this medication is equivalent to 9.5 ml of beer or 3.8 ml of wine. The small amount of alcohol in this medication will not produce noticeable effects.
• Red Ponceau 4R (E-124), a red colorant. May cause allergic reactions.
• This medication contains less than 1 mmol (23 mg) of sodium per 10 ml dose; it is essentially "sodium-free".
• This medication contains 10 mg of sodium benzoate per 10 ml dose.
• This medication contains 2003.5 mg of propylene glycol in each 10 ml dose. If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. If you have liver or kidney failure, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

Macrogol glycerol hydroxystearate-40. May cause stomach upset and diarrhea.

3. How to take Inistón Mucosidad

Follow the administration instructions for this medication described in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• This solution is for oral use only.
• Do not use more than the established dose:

If you take more Inistón Mucosidad than you should

If you take too much medication, contact a doctor or go to your nearest Health Center, taking this leaflet and the medication packaging with you.

If you take too much medication, you may develop kidney stones.

Symptoms may include:

• Stomach upset, nausea, and drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

If you forget to take Inistón Mucosidad

You should take this medication only when you need it, carefully following the dosing instructions. If you forget to take a dose, take the next dose when it is due. Do not take a double dose to make up for forgotten doses. Do not take more than 4 doses (40 ml) in 24 hours.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking this medication and consult your doctor immediately:

Allergic reactions, including skin rashes (which can be severe, including blisters, abrasion, and skin peeling) and itching

Difficulty breathing, swelling of the face, neck, tongue, or throat (anaphylactic reaction).

Mild side effects that may occur (frequency not known):

Nausea and vomiting

Stomach pain and diarrhea

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Inistón Mucosidad

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

Do not store above 25°C.

Keep in the original packaging to protect from light. Do not use if the bottle is broken when purchased.

Do not use this medication after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

After opening the package, use only within the next 4 weeks.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Inistón Mucosidad

The active ingredient is Guaifenesin. Each ml of oral solution contains 20 mg of guaifenesin (each 10 ml of oral solution contains 200 mg of guaifenesin).

The other components (excipients) are: xanthan gum, sodium chloride, sodium saccharin, ammonium glycyrrhizate, citric acid, sodium citrate, macrogol glycerol hydroxystearate-40, levomenthol, raspberry flavor (including ethanol), glycerol, macrogol 1500, propylene glycol (E1520), ethanol, purified water, sodium benzoate (E211), Ponceau 4R (E124), caramel (E150.

For more information on any of the excipients, see section 2.

Appearance of the product and package contents

Inistón Mucosidad is a clear red slightly opalescent solution for oral use only. It is packaged in 150 ml amber glass bottles with a child-resistant plastic cap. A 10 ml graduated dosing cup is included for administering the medication.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-MADRID

Manufacturer:

Delpharm Orleans,

5 avenue de Concyr,

Orleans Cedex 2, 45071

France.

O

Kenvue Belgium NV,

Michel De Braeystraat 52

2000 Antwerpen

Belgium.

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium/Luxembourg:Bronchosedal Mucus Menthol 20 mg/ml syrup

Ireland:Benylin Phlegm Cough Menthol 100 mg/5ml Oral Solution

Italy:Actigrip Tosse Mucolitico “Gusto Mentolo 20 mg/ml, Soluzione Orale”

Spain:Iniston Mucosidad 20 mg/ml Solución Oral Sabor Menta

United Kingdom (Northern Ireland):Benylin Mucus Cough Menthol flavour 100mg/5ml oral solution

Date of the last revision of this leaflet: December 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es