ACTUATOS 7 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Actúatos 7 mg/ml Syrup

Dry extract ofHedera helix L. (ivy)

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

Follow exactly the administration instructions of the medicine 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Actúatos and what is it used for
2. What you need to know before taking Actúatos
3. How to take Actúatos
4. Possible side effects
5. Storage of Actúatos
6. Contents of the pack and further information

1. What is Actúatos and what is it used for

Actúatos 7 mg/ml syrup is a herbal medicine used as an expectorant for productive cough in adults, adolescents, and children over 2 years of age.

2. What you need to know before taking Actúatos

Do not take Actúatos:

• If you are allergic to ivy (Hedera helix L.), to plants of the Araliaceae family, or to any of the other components of this medicine (listed in section 6).

• Do not administer to children under 2 years of age, as there is a risk that expectorants may worsen respiratory symptoms.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medicine.

You should consult your doctor or pharmacist in cases of dyspnea (difficulty breathing), fever, or purulent sputum.

Cautions are recommended in patients with gastritis or gastric ulcer.

In case of worsening of symptoms or if no improvement occurs after 7 days of starting treatment, it should be discontinued and a doctor should be consulted.

Children

In the case of persistent or recurrent cough in children between 2 and 4 years of age, a medical diagnosis is required before starting treatment.

Taking Actúatos with other medicines

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

Pregnancy, breastfeeding, and fertility:

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

Pregnancy and breastfeeding:

The safety of this medicine during pregnancy and breastfeeding has not been established, and therefore, its use is not recommended in these circumstances.

Fertility

No data are available on fertility.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Actúatos contains sorbitol.

This medicine contains 385 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

3. How to take Actúatos

Follow exactly the administration instructions of this medicine 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:

Adolescents and adults: 5 ml of syrup, 2 or 3 times a day (equivalent to 70-105 mg daily of dry extract of ivy leaf).

Children between 6 and 11 years of age: 5 ml of syrup 2 times a day (equivalent to 70 mg daily of dry extract of ivy leaf).

Children from 2 to 5 years: 2.5 ml of syrup 2 times a day (equivalent to 35 mg daily of dry extract of ivy leaf).

Children under 2 years: Actúatos should not be administered to children under 2 years of age.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

This medicine is taken orally. Shake the bottle well before use.

To ensure that you always take the recommended dose, you should use the measuring cup included, which is graduated up to 10 ml.

You should consult a doctor if it worsens or does not improve after a week of treatment

If you take more Actúatos than you should

Overdose may cause nausea, vomiting, diarrhea, and agitation.

In case you have taken more Actúatos than you should, or 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 amount ingested.

If you forget to take Actúatos

Do not take a double dose to make up for forgotten doses. If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Frequency not known: gastrointestinal reactions such as nausea, vomiting, and diarrhea, and allergic reactions such as hives, skin rashes, difficulty breathing, and anaphylactic reaction have been reported.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Actúatos

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack, after "EXP". The expiry date is the last day of the month indicated.

Once the pack is opened, it expires after 12 months. Remember to record the opening date on the medicine pack.

Medicines should not be disposed of via wastewater or household waste. Place the packs and any unused medicines in the Sigre Point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packs and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Actúatos 7 mg/ml syrup:

The active ingredient is: dry extract of Hedera helix leaf.

1 ml of Actúatos contains 7 mg of dry extract of Hedera helix L.,leaf (leaves of ivy) (4-8:1), extraction solvent: ethanol 30% m/m

The other ingredients are: non-crystallizable liquid sorbitol (E-420), xanthan gum, potassium sorbate, citric acid, purified water, simethicone, and cherry flavor. See section 2 "Actúatos contains sorbitol".

Appearance of the product and contents of the pack:

The medicine is presented in 150 ml amber PET bottles, with a child-resistant polypropylene closure. It includes a polypropylene measuring cup, colorless and graduated in 2.5, 5, and 10 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adventia Pharma, S.L.

Calle Viera y Clavijo, 30, 2º

35002 Las Palmas de Gran Canaria (Spain)

Manufacturer:

Kern Pharma S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Actúa Pharma, S.L.

Calle Viera y Clavijo, 30, 2º

35002 Las Palmas de Gran Canaria (Spain)

Date of the last revision of this package leaflet: June 2025

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/