PATIENT INFORMATION LEAFLET

BISOLVON MUCOLYTIC 1.6 MG/ML SYRUP

Bromhexine hydrochloride

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.
• For advice on any aspect of your dose, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.
• You must consult a doctor if you get worse or do not improve after 5 days.

The bromhexine, active ingredient of this medication, belongs to the so-called mucolytics that act by reducing the viscosity of mucous secretions, liquefying them and facilitating their elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating their expulsion, in colds and flu.

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

During the first days of treatment, as the secretions liquefy, you may notice an increase in mucus and phlegm, which will decrease over the course of the treatment.

Do not take BISOLVON MUCOLÍTICO:

- 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 old.

Warnings and precautions

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

Severe skin reactions have been reported associated with the administration of bromhexine hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Bisolvon Mucolítico 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, have a severe respiratory disease, or have difficulty coughing
• If you have diseases that predispose you to gastrointestinal bleeding, such as stomach or duodenal ulcers.

Children and adolescents

Do not administer this medication to childrenunder 12 years oldwithout consulting your doctor. Childrenunder 2 years oldcannot take this medication, it is contraindicated in them.

Other medications and BISOLVON MUCOLÍTICO

Taking Bisolvon Mucolítico 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 cough suppressants or medications that reduce bronchial secretions, as it may cause an accumulation of liquefied mucus. No negative interactions have been reported with antibiotics.

Taking BISOLVON MUCOLÍTICO with food and drinks

The taking of this medication 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 medication.

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

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

During treatment with this medication, dizziness may occur in some cases, so if you feel dizzy, do not drive or operate machinery.

BISOLVON MUCOLÍTICO contains maltitol liquid

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

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

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

BISOLVON MUCOLÍTICO contains benzoic acid

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

Use in children and adolescents: children between 2 and 12 years old cannot take this medication without consulting a doctor.

How to take:

This medication is taken orally

Measure the dose with the dosing cup provided.

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

• If symptoms persist after5 daysof treatment, or if any of the following occur: fever, skin rash, persistent headache or sore throat, consult a doctor.

If you take more BISOLVON MUCOLÍTICO than you should:

If you have taken more Bisolvón Mucolítico than you should, the adverse effects may intensify, especially those related to the stomach and intestines.Consult a doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

If you forgot to take BISOLVON MUCOLÍTICO

Do not take a double dose to make up for the missed dose.

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

Like all medications, BISOLVON MUCOLÍTICO can produce adverse effects, although not all people will experience them.

• Adverse effects that are infrequent (may affect up to 1 in 100 people):
• Vomiting, diarrhea, nausea, pain in the upper part of the abdomen,
• Adverse effects that are rare (may affect 1 in 1,000 people):
• Allergic reactions
• Asthma 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 (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling) and pruritus.
• Dizziness and headache
• Stomach burning
• Increased levels of transaminases (liver enzymes)
• Severe skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute pustular exanthema).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keepthis medicationout of the sight andreach of children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of BISOLVON MUCOLÍTICO

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

Appearance of the product and contents of the packaging

BISOLVON MUCOLÍTICO is a nearly colourless syrup with a fruity odour.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Group Sanofi

Responsible for manufacturing:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

Last review date of this leaflet:August 2021

Additional information for the patient

Some colds and flu may be accompanied by the accumulation of mucus in the respiratory tract. In some cases, this mucus becomes thick and adheres to the walls of the tract.

This explains why in these processes, coughing occurs as a defense mechanism of the body against the appearance of mucus, to expel phlegm and clear the respiratory tract.

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

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.