ACTITHIOL MUCOLITIC INFANTILE 20 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Actithiol Mucolytic Infant 20 mg/ml Oral Solution

carbocisteine

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Actithiol Mucolytic Infant is and what it is used for.
2. What you need to know before taking Actithiol Mucolytic Infant.
3. How to take Actithiol Mucolytic Infant.
4. Possible side effects.
5. Storage of Actithiol Mucolytic Infant.
6. Package Contents and Additional Information.

1. What Actithiol Mucolytic Infant is and what it is used for

Actithiol Mucolytic Infant contains carbocisteine. Carbocisteine is a mucolytic that fluidifies 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.

2. What you need to know before taking Actithiol Mucolytic Infant

Do not take Actithiol Mucolytic Infant

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

Actithiol Mucolytic Infant is contraindicated in children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before taking Actithiol Mucolytic Infant.

• It is not recommended to take it at the same time as a medicine that inhibits the cough reflex or dries up bronchial secretions (e.g., atropinic medications).
• Administer with caution in elderly patients who are particularly 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 Mucolytic Infant with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

It is not recommended to take this medicine with drugs that inhibit the cough reflex or substances that inhibit bronchial secretions (e.g., atropinic medications), as it may cause retention of these bronchial secretions and make their expectoration difficult.

Taking Actithiol Mucolytic Infant with Food and Drinks

See section 3 for instructions on how to take Actithiol Mucolytic Infant.

Pregnancy and Breastfeeding

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.

It is not recommended to use this medicine in pregnant or breastfeeding women.

Driving and Using Machines

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

Actithiol Mucolytic Infant contains tartrazine (E-102), methyl parahydroxybenzoate (E-219), and sodium.

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

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-219).

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

3. How to Take Actithiol Mucolytic Infant

Follow the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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 measuring cup of oral solution (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 measuring cup of oral solution (600 mg of carbocisteine).

It is recommended to take this medicine before meals.

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

Do not take more doses than recommended.

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

Your doctor will indicate the duration of your treatment with Actithiol Mucolytic Infant.

If you think the effect of Actithiol Mucolytic Infant is too strong or too weak, tell your doctor or pharmacist.

If You Take More Actithiol Mucolytic Infant Than You Should

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

If You Forget to Take Actithiol Mucolytic Infant

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

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

4. Possible Side Effects

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

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

Gastrointestinal disorders (gastric discomfort, diarrhea, nausea, vomiting, and very rarely gastrointestinal bleeding), headache, dizziness, skin rash, and very rarely difficulty breathing, with or without wheezing (bronchospasm), may also appear.

In these cases, it is recommended to discontinue treatment.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package 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 help provide more information on the safety of this medicine.

5. Storage of Actithiol Mucolytic Infant

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Actithiol Mucolytic Infant 20 mg/ml Oral Solution

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

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

Appearance of the Product and Package Contents

Actithiol Mucolytic Infant is presented in 200 ml bottles, with a measuring cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca

Barcelona (Spain)

Date of the Last Revision of this Package Leaflet:September 2023

Additional Information for the Patient

Some colds and flu can be accompanied by an accumulation of mucus in the respiratory tract. Sometimes, 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 mucus, to expel phlegm and clear the airways.

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 necessary cough 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