Leaflet: information for the user

Juanoltus Expectorant syrup

Extract ofHedera helix L

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

1. What Juanoltus is and for what it is used

2. What you need to know before starting to take Juanoltus

3. How to take Juanoltus

4. Possible adverse effects

5. Storage of Juanoltus

6. Contents of the package and additional information

Juanoltus is a plant-based medication used as an expectorant for productive cough in adults, adolescents, and children over 2 years old.

Do not take Juanoltus

• If you are allergic to ivy leaf, to plants of the Araliaceae family or to any of the other components of this medication (listed in section 6).
• Do not administer this medication to children under 2 years old as there is a risk, in general, in this group of patients, of worsening respiratory symptomsdue to the action of secretolytic medications (the signs of the disease may worsen).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Juanoltus.

Seek immediate medical attention in cases of dyspnea (difficulty breathing), fever or purulent sputum.

If you have stomach problems such as gastritis or gastric ulcer, 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 medications and Juanoltus

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

No interactions of Juanoltus with other medications 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 intend to become pregnant, consult your doctor before using this medication.

Pregnancy

Lack of sufficient data on safety, the use of Juanoltus during pregnancy is not recommended.

Breastfeeding

Lack of sufficient data on safety, the use of Juanoltus during breastfeeding is not recommended.

Fertility

No data are available on fertility.

Driving and operating machines

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

Juanoltus contains maltitol

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication 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).

Childrenfrom 6 to 11 years

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

Children from 2 to 5 years

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

Children under 2 years

Do not administer this medication to children under 2 years (see section 2. What you need to know before starting to take Juanoltus).

Patients with kidney or liver problems

No special administration instructions are available for patients with kidney or liver problems due to lack of data.

Usage instructions

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

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

How to use the dosing syringe:

The dosing syringe has an imprinted measurement scale, to extract the recommended amount of syrup for each dose.

1.2.3.4.

1. Place the syringe in the open bottle hole. Gently push until it is fixed. The plunger must be inside the syringe.
2. Turn the bottle carefully upside down and extract the liquid gently pulling the plunger to the selected dosage 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 you worsen or do not improve after a 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 forgot to take Juanoltus

Do not take a double dose to compensate for the missed doses.

If you have more questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

• They may cause

Gastrointestinal reactions (nausea, vomiting, diarrhea), allergic reactions such as urticaria, skin eruptions, dyspnea (difficulty breathing), anaphylactic reactions, although the frequency of these is unknown (cannot be estimated from the data obtained).

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

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

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

Once opened, it does not require special conservation conditionsMedicines should not be thrown down the drains or in the trash. Dispose of the packaging and the medication you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication you no longer need. In this way, you will help protect the environment.

Contents of Juanoltus

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

1 ml of syrup contains 7 mg of dry extract ofHedera helixL. 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 flavor, raspberry flavor, purified water.

Appearance of Juanoltus and contents of the packaging

Juanoltus is an opalescent liquid of brown-yellow color with a fruity odor that is presented in amber-colored glass bottles of100 ml. A dosing syringe is included.

The solution may appear turbid. In this case, shake the bottle well until homogenization.

Holder of the marketing authorization

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: December 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/