JUANOLTUS EXPECTORANT SYRUP

Introduction

Package Leaflet: Information for the User

Juanoltus Expectorant Syrup

Extract of Hedera helix L

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

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

1. What is Juanoltus and what is it used for

Juanoltus 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 Juanoltus

Do not take Juanoltus

• If you are allergic to ivy leaves, to plants of the Araliaceae family, or to any of the other components of this medicine (listed in section 6).
• Do not administer this medicine to children under 2 years of age, as there is a risk, in general, in this patient group, that respiratory symptoms may worsen due to the action of secretolytic medicines (disease signs may worsen).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Juanoltus.

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

If you have stomach problems such as gastritis or gastric ulcers, you should consult your doctor before taking Juanoltus.

Children

In children from 2 to 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Other Medicines and Juanoltus

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

No interactions of Juanoltus with other medicines or other forms of interaction have been reported.

Taking Juanoltus with Food, Drinks, and Alcohol

No special precautions are required.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Due to the lack of sufficient data on safety, the use of Juanoltus is not recommended during pregnancy.

Breastfeeding

Due to the lack of sufficient data on safety, the use of Juanoltus is not recommended during breastfeeding.

Fertility

No data are available on fertility.

Driving and Using Machines

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

Juanoltus contains Maltitol and Glucose

This medicine contains liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause tooth decay.

This medicine contains less than 23 mg of sodium (1 mmol) per dose (5 ml); it is essentially "sodium-free".

3. How to Take Juanoltus

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

The recommended dose is:

Adolescents, Adults, and Elderly

5 ml of Juanoltus, three times a day (105 mg of dry extract of ivy leaves per day).

Children from 6 to 11 years

5 ml of Juanoltus, twice a day (70 mg of dry extract of ivy leaves per day).

Children from 2 to 5 years

2.5 ml of Juanoltus, twice a day (35 mg of dry extract of ivy leaves per day).

Children under 2 years

Do not administer this medicine to children under 2 years of age (see section 2. What you need to know before taking Juanoltus).

Patients with Kidney or Liver Problems

There are no special administration instructions for patients with kidney or liver problems due to the lack of data.

Instructions for Use

Juanoltus is taken orally. Shake the bottle well before use.

To take the correct dose (ensure the intake of the recommended amount of syrup), a dosing syringe is included.

How to use the dosing syringe:

The dosing syringe has a measurement scale printed on it, to extract the recommended amount of syrup for each intake.

1. Place the syringe in the opening of the open bottle. Push gently until it is fixed. The plunger should be inside the syringe.
2. Turn the bottle carefully upside down and extract the liquid gently by pulling the plunger to the selected dosing mark.
3. Invert the bottle and extract the syringe with a gentle rotation. Close the bottle after taking the dose.
4. The syrup can be taken by emptying the syringe directly into the mouth or using a spoon.
5. After taking the dose, clean the individual parts of the syringe and dry them.

Duration of Use

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

If you take more Juanoltus than you should

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

If you take more Juanoltus than you should, talk to your doctor, who will decide what measures are necessary.

If you forget to take Juanoltus

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

If you have any further questions on 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.

• May occur

gastrointestinal reactions (nausea, vomiting, diarrhea), allergic reactions such as hives, skin rashes, dyspnea (difficulty breathing), anaphylactic reactions, although the frequency of occurrence of these is unknown (cannot be estimated from the available data).

If you experience any of the above-mentioned side effects, consult your doctor or pharmacist.

If you notice symptoms of allergy (hypersensitivity), stop taking the medicine and consult your doctor.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this 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 Juanoltus

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Juanoltus should not be used for more than 6 months after the first opening of the bottle. Remember to note the opening date on the medicine packaging.

Once opened, it does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Contents of Juanoltus

The active substance is dry extract of ivy (Hedera helixL.)

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

The other ingredients are:

liquid maltitol (E-965), potassium sorbate, xanthan gum, anhydrous citric acid, cherry flavor, raspberry flavor (containing glucose and sodium), purified water.

Appearance of Juanoltus and Contents of the Pack

Juanoltus is a yellowish-brown opalescent liquid with a fruity odor, presented in 100 ml amber glass bottles. A dosing syringe is included.

Turbidity may appear in the solution. In this case, shake the bottle well until it is homogeneous.

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

This leaflet was last revised in:July 2025

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