Jovesto

Patient Information Leaflet

Jovesto, 0.5 mg/ml, oral solution
Desloratadinum
Please read the entire leaflet before using this medicine, as it contains important information
for the patient.
Keep this leaflet for future reference.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm other people, even if their symptoms are identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.
Table of contents:

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

1. What Jovesto is and what it is used for

What Jovesto is
Jovesto contains desloratadine, which is an antihistamine medicine.
How Jovesto works
Jovesto is an antiallergic medicine that does not cause drowsiness. It helps relieve allergic reactions and their symptoms.
When Jovesto should be used
Jovesto relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged at least 1 year. Symptoms include sneezing, watery nasal discharge, nasal itching, itching of the palate, and itching, redness, or watering of the eyes.
Jovesto is also used to relieve symptoms of urticaria (an allergic skin condition), such as itchy rash.
Symptom relief lasts for 24 hours, allowing return to normal daily activities and undisturbed sleep.

2. Important information before using Jovesto

When not to use Jovesto
if the patient is allergic to desloratadine, loratadine, or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Jovesto, consult your doctor, pharmacist, or
nurse:
if the patient has a history or family history of seizures
if the patient has impaired kidney function.

Use in children
This medicine should not be used in children under 1 year of age.

Jovesto with other medicines
No interactions between Jovesto and other medicines are known.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Jovesto with food, drink, and alcohol
This medicine may be taken with or without food.
Exercise caution when consuming alcohol during treatment with Jovesto.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of Jovesto is not recommended during pregnancy and breastfeeding.

Fertility
There are no available data on the effects on fertility in women and men.

Driving and operating machinery
When used at recommended doses, this medicine should not affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is not recommended to engage in activities requiring alertness, such as driving or operating machinery, until the patient knows how their body reacts to the medicine.

Jovesto contains sorbitol, propylene glycol, and sodium
This medicine contains up to 97.5 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If the patient (including a child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking this medicine (or giving it to a child).
This medicine contains 102.30 mg of propylene glycol in each ml of oral solution.
This medicine contains 3.85 mg of sodium (the main component of table salt) in each ml of oral solution.
This corresponds to 0.19% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Jovesto

Jovesto must always be taken according to the doctor's or pharmacist's instructions. If in doubt, consult a doctor or pharmacist.

Children

• Children aged 1 to 5 years: The recommended dose is 2.5 ml (½ measuring spoon of 5 ml capacity) of oral solution once daily.
• Children aged 6 to 11 years: The recommended dose is 5 ml (1 measuring spoon of 5 ml capacity) of oral solution once daily.

Adults and adolescents (aged at least 12 years):
The recommended dose is 10 ml (2 measuring spoons of 5 ml capacity) of oral solution once daily.
If an oral syringe is included in the package, it should be used to measure the correct dose of the medicine.
The medicine is intended for oral use.
Swallow the recommended amount of the medicine and then drink a small amount of water. Jovesto may be taken with or without food.

How to measure the dose of the medicine
The medicine package includes a measuring spoon marked with volumes of 2.5 ml and 5 ml, or an oral syringe with 0.5 ml graduations.
To measure the dose using the syringe:

• Unscrew the cap and place it in a safe place.
• Immerse the tip of the syringe into the oral solution.
• Pull back the plunger to draw up the required dose of the medicine.
• Remove the syringe and close the bottle.

If air bubbles are visible inside the syringe after drawing up the solution, turn the syringe with the tip pointing upwards. The air will rise to the top.
Pull back the plunger slightly, then gently press it to remove the air bubbles.
The presence of a few small bubbles is not a problem.
If in doubt about how to measure the dose, consult a doctor or pharmacist.

Administering the medicine from the syringe

• Ensure the child remains in a stable, upright position.
• Gently insert the tip of the syringe into the child's mouth, directing it towards the cheek.
• Slowly press the plunger of the syringe. Do not empty it quickly. The medicine will flow into the child's mouth.
• Allow the child to swallow the medicine calmly.

The doctor will determine the duration of treatment depending on the type of allergic rhinitis diagnosed in the patient and will inform how long Jovesto should be used.

• If the patient has intermittent allergic rhinitis (when symptoms occur less than 4 days per week or for less than 4 weeks), the doctor will recommend a treatment approach based on the previous course of the disease.
• If the patient has persistent allergic rhinitis (when symptoms occur at least 4 days per week and last longer than 4 weeks), the doctor may recommend longer-term treatment.
• In patients with urticaria, the duration of treatment may vary. Strictly follow the doctor's instructions.

Taking more than the recommended dose of Jovesto
Always take the dose of Jovesto prescribed by the doctor. After accidental overdose, severe disturbances should not occur. However, if more than the recommended dose of Jovesto is taken, contact a doctor, pharmacist, or nurse immediately.

Missing a dose of Jovesto
If a patient forgets to take the medicine at the usual time, it should be taken as soon as possible, then continue with the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Jovesto
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Since desloratadine has been marketed, very rare cases of severe allergic reactions
(having difficulty breathing, wheezing, itching, hives, and swelling) have been reported.
If any of these adverse reactions occur in a patient, treatment must be discontinued and immediate medical help must be sought.

In clinical trials, adverse reactions to Jovesto in most children and adults were almost the same as those observed with placebo (a solution containing no active substance).
Common adverse reactions in children under 2 years of age were: diarrhoea, fever, and insomnia, whereas adults reported fatigue, dry mouth, and headache more frequently than with placebo.

During clinical trials with desloratadine, the following adverse reactions were reported:

Children
Common in children under 2 years of age (may occur in fewer than 1 in 10 people)

• diarrhoea
• fever
• insomnia

Adults
Common (may occur in fewer than 1 in 10 people)

• fatigue
• dry mouth
• headache

After desloratadine was marketed, the following adverse reactions have been reported:

Adults
Very rare (may occur in fewer than 1 in 10,000 people)

• severe allergic reactions
• rash
• very strong or irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• indigestion
• diarrhoea
• dizziness
• somnolence (sleepiness)
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• motor restlessness with increased body movements
• hepatitis
• abnormal liver function test results

Frequency not known (frequency cannot be estimated from available data)

• unusual behaviour
• aggressive behaviour
• unusual weakness
• yellowing of the skin and (or) eyes
• increased skin sensitivity to sunlight (even on cloudy days) and to UV radiation (e.g. in a solarium)
• changes in heart rhythm
• weight gain
• increased appetite
• low mood
• dry eyes

Children
Frequency not known (frequency cannot be estimated from available data)

• unusual behaviour
• aggressive behaviour
• slow heartbeat
• changes in heart rhythm
• weight gain
• increased appetite

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301 / fax: +48 22 49 21 309 / website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to the further monitoring of the medicine's safety.

5. How to store Jovesto

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage.
Shelf life after first opening the bottle: 2 months.
Do not use this medicine if you notice any changes in the appearance of the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Jovesto contains
The active substance is desloratadine. Each ml of oral solution contains 0.5 mg of desloratadine.
The other ingredients are: sorbitol liquid, non-crystallizing (E 420), propylene glycol, citric acid monohydrate, sodium citrate, hypromellose 2910, sucralose, disodium edetate, Tutti frutti flavour, purified water.

What Jovesto looks like and contents of the pack
A clear, colourless solution.
It is available in amber glass bottles (type III) with a polypropylene screw cap, a multilayer polyethylene liner, and child-resistant closure, placed in a cardboard box.
Each package includes either an oral dosing spoon marked with "CE 0373" and volume markings at 2.5 ml and 5 ml, or an oral syringe with a capacity of 5 ml marked "CE 0373", graduated every 0.5 ml.
Pack sizes:
60 ml or 150 ml of oral solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Balkanpharma Troyan AD
1 Krayrechna Str.
Troyan 5600, Bulgaria

For more detailed information about the medicine and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00