Leaflet: information for the user

Actithiol Mucolítico infantil 20 mg/ml oral solution

carbocisteína

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Actithiol Mucolítico infantil contains carbocisteine. Carbocisteine is a mucolytic that liquefies and reduces the viscosity of mucus to facilitate its elimination.

It is indicated for the relief of excess mucus and phlegm, facilitating its expulsion, in acute processes of the respiratory tract.

Do not take Actithiol Mucolítico infantil

• If you are allergic to carbocisteine, any related compound, or any of the other components of this medication (listed in section 6).
• If you have a gastric or duodenal ulcer.
• If you have asthma or other severe respiratory insufficiency.

Actithiol Mucolítico infantil is contraindicated in children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actithiol Mucolítico infantil.

• Do not take this medication at the same time as a medication that inhibits the cough reflex or dries up bronchial secretions (for example, "atropinic" medications).
• Administer with caution in elderly patients who are especially sensitive to the adverse effects of carbocisteine and in cases of severe hepatic and/or renal insufficiency.
• During the first few days, it is normal for expectoration to increase, but if symptoms persist for more than 5 days or worsen, you should consult your doctor.
• If you have hypothyroidism.

Taking Actithiol Mucolítico infantil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take this medication with medications that inhibit the cough reflex or substances that inhibit bronchial secretions (for example, "atropinic" medications), as it may cause retention of these bronchial secretions and make it difficult to expectorate.

Taking Actithiol Mucolítico infantil with food and drinks

See section 3 for instructions on how to take Actithiol Mucolítico infantil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for use in pregnant women or breastfeeding women.

Driving and operating machinery

The administration of this medication should be taken into account, due to the possible adverse effects observed (headache, dizziness).

Actithiol Mucolítico infantil contains tartrazine (E-102), parahydroxybenzoate sodium methanol (E-219), and sodium.

This medication may cause allergic reactions because it contains tartrazine (E-102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate sodium methanol (E-219).

This medication contains 41.6 mg of sodium (main component of table salt/for cooking) in each 10 ml. This is equivalent to 2.1% of the maximum daily sodium intake recommended for an adult.

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

Remember to take your medication.

Use in children

The recommended dose for children between 2 and 5 years of age is:

1 dose of 5 ml from the measuring cup orally, 3 times a day. The daily dose is 3 doses of 5 ml from the oral solution measuring cup (300 mg of carbocisteine).

The recommended dose for children between 5 and 12 years of age is:

1 dose of 10 ml from the measuring cup orally, 3 times a day. The daily dose is 3 doses of 10 ml from the oral solution measuring cup (600 mg of carbocisteine).

It is recommended to take this medication before meals.

It is advised to use the measuring cup included in the package for a correct dosing.

Do not take more doses than recommended.

Your doctor may increase the dose based on the clinical case.

Your doctor will indicate the duration of your treatment with Actithiol Mucolítico infantil.

If you estimate that the action of Actithiol Mucolítico infantil is too strong or too weak, inform your doctor or pharmacist.

If you take more Actithiol Mucolítico infantil than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the dose ingested.

If you forgot to take Actithiol Mucolítico infantil

If you forget to take a dose, take it as soon as you can.

Do not take a double dose to compensate for the missed dose.

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

In some cases, mild allergic reactions such as rash, itching, or swelling may occur.

Gastrointestinal disturbances (gastric discomfort, diarrhea, nausea, vomiting, and very rarely gastrointestinal bleeding), headache, dizziness, skin eruptions, and, very rarely, difficulty breathing accompanied or not by wheezing (bronchospasm) may also appear.

In these cases, treatment should be discontinued.

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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actithiol Mucolítico infantil 20 mg/ml oral solution

The active ingredient is carbocisteine. Each ml of oral solution contains 20 mg of carbocisteine.

The other components are: sodium caramellose, sodium hydroxide, methyl parahydroxybenzoate (E-219), sucralose, disodium phosphate, citric acid, vanilla flavor, tartrazine (E-102) and purified water.

Appearance of the product and contents of the packaging

Actithiol Mucolítico infantil is presented in 200 ml bottles, with a dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca

Barcelona (Spain)

Last review date of this leaflet:September 2023

Additional information for the patient

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

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 tracts.

Carbocisteine fluidifies the adhered mucus, detaching it. At the end of the cold or flu process, 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