BISOLVON MUCOLITIC INFANTILE 0.8 mg/ml SYRUP

Introduction

PATIENT INFORMATION LEAFLET

BISOLVON MUCOLYTIC INFANT 0.8 MG/ML SYRUP

Bromhexine hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If you experience 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 condition worsens or does not improve after 5 days of treatment.

Contents of the leaflet

1. What BISOLVON MUCOLYTIC INFANT is and what it is used for
2. What you need to know before taking BISOLVON MUCOLYTIC INFANT
3. How to take BISOLVON MUCOLYTIC INFANT
4. Possible side effects
5. Storage of BISOLVON MUCOLYTIC INFANT
6. Package contents and additional information

1. What BISOLVON MUCOLYTIC INFANT is and what it is used for

Bromhexine, the active ingredient of this medicine, belongs to the so-called mucolytics that act by decreasing the viscosity of mucous secretions, fluidizing them and facilitating their elimination.

This medicine is indicated to reduce the viscosity of mucus and phlegm, facilitating their expulsion, in colds and flu for children from 2 to 12 years old.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

2. What you need to know before taking BISOLVON MUCOLYTIC INFANT

During the first days of treatment, as the secretions become more fluid, you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.

Do not take BISOLVON MUCOLYTIC INFANT:

• if you are allergic to bromhexine or any of the other components of this medicine (listed in section 6).
• Children under 2 years of age cannot take this medicine.

Warnings and precautions

There have been reports of severe skin reactions associated with the administration of bromhexine hydrochloride. If you experience a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using BISOLVON MUCOLYTIC and consult your doctor immediately.

You should consult your doctor before taking this medicine if you have:

• Severe liver disease
• Severe kidney disease
• If you are asthmatic or have a history of asthma, suffer from any severe respiratory disease or have difficulty coughing
• If you have diseases that predispose you to suffer from digestive bleeding, such as stomach or duodenal ulcers.

Children

Children under 2 yearsof age cannot take this medicine; it is contraindicated in them.

In children from 2 to 6 years old, it should be taken under medical supervision.

Other medicines and BISOLVON MUCOLYTIC INFANT

Taking Bisolvon Mucolytic Infant with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Do not administer concurrently with antitussive medicines (for cough), as it may cause an accumulation of fluidized mucus, or with those that decrease bronchial secretions because they may counteract the effects of bromhexine. No negative interactions have been reported with antibiotics.

Taking BISOLVON MUCOLYTIC INFANT with food and drinks

Taking this medicine with food and drinks does not affect the efficacy of the treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No studies have been conducted on the effects of Bisolvon Mucolytic Infant on human fertility.

This medicine should not be used during pregnancy or breastfeeding.

Driving and using machines

During treatment with this medicine, dizziness may occur on some occasions; if you feel dizzy, do not drive or operate machines.

BISOLVON MUCOLYTIC INFANT contains Maltitol liquid

This medicine contains maltitol liquid. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

BISOLVON MUCOLYTIC INFANT contains benzoic acid

This medicine contains 1.27 mg of benzoic acid per ml. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

BISOLVON MUCOLYTIC INFANT contains propylene glycol

This medicine contains 4.725 mg of propylene glycol per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

3. How to take BISOLVON MUCOLYTIC INFANT

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Children from 6 to 12 years old: 5 ml per dose, 3 times a day. Do not exceed the dose of 15 ml per day.

Children from 2 to 6 years old: 2.5 ml per dose, 3 times a day. Do not exceed the dose of 7.5 ml per day. In this population, consult your doctor before taking this medicine.

Children under 2 years old: Bisolvon Mucolytic Infant is contraindicated in children under 2 years old.

For adolescents over 12 years old, other pharmaceutical forms more suitable for this age group are available.

How to take:

This medicine is taken orally.

Measure the dose with the dosing cup included.

It is recommended to drink a glass of water or any other liquid after each dose and to drink plenty of liquid throughout the day.

If you worsen, symptoms persist, or new ones appear after 5 daysof treatment, or if you experience:

fever, skin rashes, persistent headache, or sore throat, consult your doctor.

If you take more BISOLVON MUCOLYTIC INFANT than you should

If you have taken more BISOLVON MUCOLYTIC INFANT than you should, you may experience vomiting, diarrhea, nausea, and abdominal pain. Consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 915.620.420, indicating the medicine and the amount taken.

If you forget to take BISOLVON MUCOLYTIC INFANT

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Uncommon side effects that may affect up to 1 in 100 people: vomiting, diarrhea, nausea, pain in the upper abdomen.

Rare side effects (may affect 1 in 1,000 people):

1. Hypersensitivity reactions

1. Bronchospasm (closure of airways in the lungs) or exanthema, urticaria.

Frequency not known (cannot be estimated from the available data):

• Anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus.

• Dizziness and headache

• Heartburn

• Increased levels of transaminases (liver enzymes)

• Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of BISOLVON MUCOLYTIC INFANT

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine after 6 months of opening the packaging for the first time.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in 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.

6. Package contents and additional information

Composition of BISOLVON MUCOLYTIC INFANT

• Each ml of syrup contains 0.8 milligrams of bromhexine hydrochloride.

• The other components (excipients) are maltitol liquid (E-965), sucralose, benzoic acid (E-210), hydroxyethylcellulose, strawberry flavor, cherry flavor, and purified water.

Appearance of the product and package contents

BISOLVON MUCOLYTIC INFANT is a colorless or almost colorless syrup with a strawberry flavor.

It is presented in a glass bottle containing 100 ml of syrup and includes a dosing cup with graduations.

Marketing authorization holder and manufacturer

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

Delpharm Reims S.A.S.

10 rue Colonel Charbonneaux

51100 Reims

France

Date of the last revision of this leaflet:August 2021

Additional information for the patient

Some colds and flu can be accompanied by an accumulation of mucus in the respiratory tract. On occasion, this mucus becomes thick and adheres to the walls of these airways.

This explains that in these processes, coughing occurs as a defense mechanism of the body itself against the appearance of mucosity, to expel phlegm and clear the airways.

Bromhexine fluidizes the adhered mucus, detaching it. At the end of the cold or flu, there is a decrease in mucosity and, therefore, in the cough needed to eliminate it.

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