Iniston Mucosidad 20 mg/ml oral solution, peppermint flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Inistón Mucosidad 20 mg/ml oral solution, peppermint flavour

Guaifenesin

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

Follow exactly the instructions for use provided 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 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 your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

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 adverse effects
5. How to store Inistón Mucosidad
6. Contents of the pack and other information

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

Inistón Mucosidad contains guaifenesin, which is a type of medicine called an expectorant.

It helps relieve chesty cough (productive cough) by reducing phlegm (mucus), facilitating expectoration, and making the cough more productive. This medicine is indicated for adults and adolescents aged 12 years and older.

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

2. What you need to know before starting to take Inistón Mucosidad

Do not take Inistón Mucosidad:

• if you are allergic to guaifenesin or to any of the other components of this medicine (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 due to have urine tests, it is important to inform your doctor or nurse that you are taking or have recently taken this medicine, as it may affect the results of certain tests.

Children:

This medicine is not indicated for use in children under 12 years of age.

Other medicines and Inistón Mucosidad

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.

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

Taking Inistón Mucosidad with food and drink

You may take this medicine with or without food or drink.

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 using this medicine. This medicine should not be used during pregnancy unless directed by a doctor.

• Do not take this medicine while breastfeeding without first consulting your doctor or pharmacist.

Driving and using machines

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 medicine contains 381 mg of alcohol (ethanol) in each 10 ml dose, equivalent to 38.1 mg/ml. The amount in 10 ml of this medicine is equivalent to 9.5 ml of beer or 3.8 ml of wine. The small amount of alcohol in this medicine will not produce noticeable effects.
• Ponceau 4R (E-124), a red dye. May cause allergic reactions.
• This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose; thus, it is essentially “sodium-free”.
• This medicine contains 10 mg of sodium benzoate per 10 ml dose.
• This medicine contains 2003.5 mg of propylene glycol in each 10 ml dose. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. If you have hepatic or renal impairment, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional monitoring while you are taking this medicine.

Macrogol glycerol hydroxystearate-40. May cause stomach discomfort and diarrhoea.

3. How to take Inistón Mucosidad

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

• This solution is for oral use only
• Do not exceed the dose stated 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, taking this leaflet and the medicine package with you.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91.5620420, indicating the medicine and the amount ingested.

If you forget to take Inistón Mucosidad

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

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

Allergic reactions including skin rash (which may be severe, including blistering, erosion and peeling of the skin) and itching

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

Mild-intensity effects that may occur (Frequency not known):

Nausea and vomiting

Stomach pain and diarrhoea

Reporting of adverse effects

If you experience any kind 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 Inistón Mucosidad

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

Do not store above 25°C.

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

Do not use this medicine after the expiry date stated on the bottle and on the carton after EXP. The expiry date refers to the last day of the month indicated.

After opening the container, use within 4 weeks only.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Collection Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inistón Mucosidad

The active substance 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 glycyrrhizinate, citric acid, sodium citrate, macrogol glycerol hydroxystearate-40, levomenthol, raspberry flavour (containing ethanol), glycerol, macrogol 1500, propylene glycol (E1520), ethanol, purified water, sodium benzoate (E211), Ponceau 4R (E124), caramel (E150).

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

Nature of the product and contents of the container

Inistón Mucosidad is a slightly opalescent light red solution for oral use only. It is supplied in 150 ml amber glass bottles with a plastic child-resistant closure. A 10 mL dosing cup is included for administering the medicine.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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.

Or

Kenvue Belgium NV,

Michel De Braeystraat 52

2000 Antwerpen

Belgium.

This medicinal product is authorised 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 siroop

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 Oral Solution, Mint Flavour

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

Date of the most recent review of this leaflet: December 2021

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