Leaflet: information for the user

Inistón Mucosidad 20mg/ml oral solution, peppermint flavor

Guaifenesina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

1.What Inistón Mucosidad is and what it is used for

2.What you need to know before taking Inistón Mucosidad

3.How to take Inistón Mucosidad

4.Possible side effects

5.Storage of Inistón Mucosidad

6.Contents of the pack and additional informationl

InistónMucosidadcontains guaifenesin, which is a type of medication called an expectorant.

It helps to relieve chest cough (productive cough) by reducing phlegm (mucus), facilitating expectoration and making the cough more productive. The medication is indicated for adults and adolescents 12 years of age and older.

You should consult your doctor if it worsens or does not improve after 7 days.

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 expels 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 to undergo urine analysis, it is essential to 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:

The administration of this medication is not indicated in children under 12 years.

Other medications and Iniston Mucosidad

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

This medication should not be taken with other cough medications intended to suppress coughing (antitussives or cough suppressants), as they may interfere with the action of this medication.

Administration of Inistón Mucosidad with food and beverages

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

Pregnancy and lactation

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

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

Driving and operating machinery

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

Inistón Mucosidad contains

• This medication contains 381 mg of alcohol (ethanol) in each 10 ml dose, 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), red dye. 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 each 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 insufficiency, 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 discomfort and diarrhea

Follow exactly the administration instructions for this medication described in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

- This solution is only for oral use

- Do not use more than the established dose below:

If you take more Inistón Mucosidad than you should

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

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

Symptoms may include:

- Stomach discomfort, nausea, and drowsiness.

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

If you forgot to take Inistón Mucosidad

You should take this medicine only when needed, following carefully the dosage instructions. If you forget to take a dose, take the next dose when due. Do not take a double dose to compensate for missed doses. Do not take more than 4 doses (40 ml) in 24 hours.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Allergic reactions including skin eruptions (which may be severe, including the appearance of blisters, abrasions, and skin peeling) and itching

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

Mild effects that may occur (Unknown frequency):

Nausea and vomiting

Stomach pain and diarrhea

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 Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light. Do not use if the bottle is broken when purchasing.

Do not use this medication after the expiration date that appears on the bottle and in the box after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Inistón Mucosidad

The active ingredient is Guaifenesin. Each ml of oral solution contains 20 mg of guaifenesin (each 10ml of oral solution contains 200mg 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 (includes 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 contents of the package

Inistón Mucosidadis a clear reddish-colored, slightly opalescent solution for oral use only. It is packaged in 150 ml amber glass bottles with a plastic cap with a child-resistant safety system. A 10 mL 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

Johnson & Johnson Consumer NV/SA,

Michel De Braeystraat 52

2000 Antwerpen

Bélgica.

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

Bélgica/Luxemburgo:Bronchosedal Mucus Menthol 20 mg/ml siroop

Irlanda:Benylin PhlegmCough Menthol 100 mg/5ml Oral Solution

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

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

Reino Unido (Irlanda del Norte):Benylin Mucus Cough Menthol flavour 100mg/5ml oral solution

Last review date of this leaflet: December 2021

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