BISOLVON MUCOLITIC 1.6 mg/ml SYRUP

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

BISOLVON MUCOLYTIC 1.6 MG/ML SYRUP

Bromhexine hydrochloride

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

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

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Contents of the package leaflet

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

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

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

This medication is indicated to reduce the viscosity of mucus and phlegm, making it easier to expel them, in colds and flu.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment.

2. What you need to know before taking BISOLVON MUCOLYTIC

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

Do not take BISOLVON MUCOLYTIC:

• if you are allergic to bromhexine or any of the other components of this medication (listed in section 6).
• Do not use in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisolvon Mucolytic.

There have been reports of severe skin reactions associated with the administration of bromhexine hydrochloride. If you experience a skin rash (including lesions on 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 medication if you have:

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

Children and adolescents

Do not administer this medication to children under 12 yearswithout consulting a doctor. Children under 2 yearscannot take this medication; it is contraindicated in them.

Other medications and BISOLVON MUCOLYTIC

Taking Bisolvon Mucolytic with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication. Do not administer concurrently with antitussive medications (for cough) or those that decrease bronchial secretions, as this may cause an accumulation of fluidized mucus. No negative interactions have been reported with antibiotics.

Taking BISOLVON MUCOLYTIC with food and beverages

Taking this medication with food and beverages 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 medication.

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

This medication should not be used during pregnancy or breastfeeding.

Driving and using machines

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

BISOLVON MUCOLYTIC contains liquid maltitol

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

It may produce a mild laxative effect because it contains 2.5 g of liquid maltitol per 5 ml.

Caloric value: 2.3 kcal/g of maltitol/isomaltose.

BISOLVON MUCOLYTIC contains benzoic acid

This medication 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 of age).

3. How to take BISOLVON MUCOLYTIC

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

The recommended dose is:

Adults and children over 12 years: administer 10 ml (16 mg) per dose, 3 times a day. Do not exceed the dose of 30 ml per day (48 mg).

Use in children and adolescents: children between 2 and 12 years of age should not take this medication without consulting a doctor.

How to take:

This medication 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 symptoms persist after 5 daysof treatment, or if you experience: fever, skin rash, persistent headache, or sore throat, consult your doctor.

If you take more BISOLVON MUCOLYTIC than you should:

If you have taken more Bisolvon Mucolytic than you should, the side effects may intensify, especially those related to the stomach and intestines. Consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

If you forget to take BISOLVON MUCOLYTIC

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

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

4. Possible side effects

Like all medications, BISOLVON MUCOLYTIC may cause side effects, although not everyone may experience them.

• Uncommon side effects (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):
• Hypersensitivity reactions
• Bronchospasm (closure of airways in the lungs)
• Exanthema, urticaria.
• Frequency not known (cannot be estimated from 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 skin 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of BISOLVON MUCOLYTIC

No special storage conditions are required.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication after 12 months of opening the packaging for the first time.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of BISOLVON MUCOLYTIC

• Each ml of syrup contains 1.6 milligrams of bromhexine hydrochloride as the active ingredient
• The other components (excipients) are: liquid maltitol (E965), benzoic acid (E-210), sucralose, cherry flavor, chocolate flavor, levomenthol, and purified water.

Appearance of the product and package contents

BISOLVON MUCOLYTIC is a nearly colorless syrup with a fruity odor.

It is presented in a brown glass bottle containing 200 ml of syrup and includes a dosing cup.

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 package leaflet:August 2021

Additional information for the patient

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

This explains why, 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 necessary cough to eliminate it.

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