Actithiol Mucolytic Pediatric 20 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Actithiol Mucolytic paediatric 20 mg/ml oral solution

carbocysteine

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Actithiol Mucolytic paediatric is and what it is used for.
2. What you need to know before taking Actithiol Mucolytic paediatric.
3. How to take Actithiol Mucolytic paediatric.
4. Possible adverse effects.
5. How to store Actithiol Mucolytic paediatric.
6. Contents of the pack and other information.

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

Actithiol Mucolytic Pediatric contains carbocisteine. Carbocisteine is a mucolytic agent that liquefies and reduces the viscosity of mucus, facilitating its removal.

It is indicated for the relief of excess mucus and phlegm, aiding in their expulsion during acute respiratory tract conditions.

2. What you need to know before starting to take Actithiol Mucolytic Pediatric

Do not take Actithiol Mucolytic Pediatric

• If you are allergic to carbocysteine, to related compounds, or to any of the other ingredients of this medicine (listed in section 6).
• If you have gastroduodenal ulcer.
• If you have asthma or another severe respiratory insufficiency.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Actithiol Mucolytic Pediatric.

• It is not recommended to take this medicine simultaneously with drugs that suppress the cough reflex or dry bronchial secretions (e.g., medications known as “anticholinergics” or “atropine-like” drugs).
• Use with caution in elderly patients who may be particularly sensitive to the adverse effects of carbocysteine, and in cases of severe hepatic and/or renal insufficiency.
• During the first few days, an increase in sputum production is normal; however, if symptoms persist for more than 5 days or worsen, you should consult your doctor.
• If you have hypothyroidism.

Taking Actithiol Mucolytic Pediatric with other medicines

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

It is not recommended to take this medicine with drugs that suppress the cough reflex or substances that inhibit bronchial secretions (e.g., medications known as “anticholinergics” or “atropine-like” drugs), as this may lead to retention of bronchial secretions and hinder expectoration.

Taking Actithiol Mucolytic Pediatric with food and drinks

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

Pregnancy and breastfeeding

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

The use of this medicine is not recommended in pregnant or breastfeeding women.

Driving and using machines

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

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

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

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

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

3. How to take Actithiol Mucolytic Pediatric

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in children

Recommended dose for children aged 2 to 5 years:

One 5 ml dose from the dosing cup administered orally, three times daily. The daily dose is 3 doses of 5 ml from the dosing cup of oral solution (300 mg of carbocisteine).

Recommended dose for children aged 5 to 12 years:

One 10 ml dose from the dosing cup administered orally, three times daily. The daily dose is 3 doses of 10 ml from the dosing cup of oral solution (600 mg of carbocisteine).

It is recommended to take this medicine before meals.

It is advisable to use the dosing cup provided in the package for accurate dosing.

Do not take more than the recommended dose.

Your doctor may increase the dose depending on the clinical condition.

Your doctor will advise you on the duration of your treatment with Actithiol Mucolytic Pediatric.

If you feel that the effect of Actithiol Mucolytic Pediatric is too strong or too weak, inform your doctor or pharmacist.

If you take more Actithiol Mucolytic Pediatric than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the dose ingested.

If you forget to take Actithiol Mucolytic Pediatric

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 missed dose.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

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

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

In such cases, discontinuation of treatment is recommended.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Actithiol Pediatric Mucolytic

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

Do not store above 25 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Package contents and additional information

Composition of Actithiol Mucolytic Pediatric 20 mg/ml oral solution

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

The other components are: sodium carmellose, sodium hydroxide, sodium 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 container

Actithiol Mucolytic Pediatric is supplied in 200 ml bottles, with a dosing 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 latest revision of this leaflet: September 2023

Additional information for the patient

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

This explains why coughing occurs during these conditions—as the body's own defense mechanism against mucus buildup, in order to expel phlegm and clear the airways.

Carbocisteine fluidifies the adherent mucus, loosening it. At the end of the cold or flu episode, mucus production decreases and, consequently, so does the cough needed to eliminate it.

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