JUANOLTUS EXPECTORANT SYRUP

Patient Information Leaflet

Introduction

Patient Information Leaflet

Juanoltus Expectorant Syrup

Extract of Hedera helix L

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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 any 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 you worsen or do not improve after 7 days.

Contents of this leaflet

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

1. What Juanoltus is and what it is 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 leaf, to plants from 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 general risk in this patient group that respiratory symptoms may worsen due to the action of secretolytic medicines (disease signs may deteriorate).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Juanoltus.

You should consult your doctor or pharmacist immediately if you experience dyspnea (difficulty breathing), fever, or purulent sputum.

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

Children

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

Other medicines and Juanoltus

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

No interactions between Juanoltus and other medicines or other types of interactions 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 might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Due to insufficient safety data, the use of Juanoltus during pregnancy is not recommended.

Breastfeeding

Due to insufficient safety data, the use of Juanoltus during breastfeeding is not recommended.

Fertility

No data are available regarding fertility.

Driving and using machines

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

Juanoltus contains maltitol and glucose (provided by raspberry flavoring)

This medicine contains liquid maltitol (E-965). If your doctor has diagnosed you with intolerance to certain sugars, consult him before taking this medicine.

This medicine contains glucose. If your doctor has diagnosed you with intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

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

3. How to take Juanoltus

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 ivy leaf extract per day).

Children from 6 to 11 years

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

Children from 2 to 5 years

2.5 ml of Juanoltus, twice a day (35 mg of dry ivy leaf extract 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 starting to take Juanoltus).

Patients with kidney or liver problems

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

Instructions for use

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

To ensure the correct dose (accurate administration of the recommended amount of syrup), an oral dosing syringe is included.

How to use the dosing syringe:

The dosing syringe has a printed measurement scale to draw up the recommended amount of syrup for each dose.

2. Insert the syringe into the opening of the open bottle. Gently push until firmly in place. The plunger must be inside the syringe.

3. Carefully turn the bottle upside down and gently pull the plunger to draw the liquid up to the selected dosage mark.

4. Turn the bottle upright and remove the syringe with a gentle twist. Close the bottle after taking the dose.

5. The syrup can be taken by emptying the syringe directly into the mouth or by using a spoon.

6. After taking the dose, clean the individual parts of the syringe and dry them.

Duration of use

Consult a doctor if symptoms worsen or do not improve after one week of treatment.

If you take more Juanoltus than you should

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

If you take more Juanoltus than you should, speak to your doctor, who will determine 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• Gastrointestinal reactions (nausea, vomiting, diarrhoea), allergic reactions such as urticaria, skin rashes, dyspnoea (difficulty breathing), and anaphylactic reactions may occur, although the frequency of occurrence of these is unknown (cannot be estimated from the available data).

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of 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 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 must not be used more than 6 months after first opening the bottle. Remember to record the date of opening on the medicine container.

Once opened, no special storage conditions are required. Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Contents of Juanoltus

The active substance is dried ivy extract (Hedera helix L.).

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

The other components are:

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

Appearance of Juanoltus and contents of the pack

Juanoltus is a yellowish-brown opalescent liquid with a fruity odour, supplied 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 homogeneous.

Marketing Authorisation Holder

ANGELINI PHARMA ESPAÑA, S.L.
c/ Antonio Machado, 78-80
3rd floor, module A-Edificio Australia
08840 Viladecans, Barcelona (Spain)

Manufacturer

Krewel Meuselbach GmbH
Krewelstr. 2
53783 Eitorf
Germany

This leaflet was last reviewed in: July 2025

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