Iovesto

Package Leaflet: Information for the Patient

Jovesto, 0.5 mg/ml, Oral Solution

Desloratadine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medication has been prescribed specifically for you. Do not pass it on to others.
The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
See section 4.

Table of Contents of the Leaflet:

• 1. What is Jovesto and What is it Used For
• 2. Important Information Before Taking Jovesto
• 3. How to Take Jovesto
• 4. Possible Side Effects
• 5. How to Store Jovesto
• 6. Contents of the Package and Other Information

1. What is Jovesto and What is it Used For

What is Jovesto

Jovesto contains desloratadine, which is an antihistamine medication.

How Jovesto Works

Jovesto is an anti-allergic medication that does not cause drowsiness. It helps to alleviate allergic reactions and their symptoms.

When to Use Jovesto

Jovesto alleviates symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, e.g., hay fever or dust mite allergy) in adults, adolescents, and children aged 1 year and older. The symptoms include sneezing, runny nose or nasal congestion, itchy nose, itchy palate, and itchy, red, or watery eyes.
Jovesto is also used to alleviate symptoms of urticaria (a skin disorder caused by allergy), such as itchy hives.
The alleviation of symptoms lasts throughout the day, allowing for normal daily activities and proper sleep.

2. Important Information Before Taking Jovesto

When Not to Take Jovesto

if the patient is allergic to desloratadine, loratadine, or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting to take Jovesto, the patient should discuss it with their doctor, pharmacist, or nurse:
if the patient has a history of seizures or a family history of seizures
if the patient has kidney function disorders.

Use in Children

The medication should not be used in children under 1 year of age.

Jovesto and Other Medications

No interactions between Jovesto and other medications are known.
The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

Jovesto with Food, Drink, and Alcohol

The medication can be taken with or without food.
Care should be taken when consuming alcohol while taking Jovesto.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Jovesto is not recommended during pregnancy and breastfeeding.

Fertility

There is no available data on the effect on fertility in women and men.

Driving and Operating Machines

This medication, when taken in the recommended doses, should not affect the ability to drive or operate machines. Although most people do not experience drowsiness, it is not recommended to engage in activities that require attention, such as driving or operating machines, until the patient knows how their body reacts to the medication.

Jovesto Contains Sorbitol, Propylene Glycol, and Sodium

This medication contains up to 97.5 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medication (or giving it to their child).
This medication contains 102.30 mg of propylene glycol in each ml of oral solution.
This medication contains 3.85 mg of sodium (the main component of common salt) in each ml of oral solution.
This corresponds to 0.19% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Take Jovesto

Jovesto should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

Children

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

Adults and Adolescents (aged 12 and over):
The recommended dose is 10 ml (2 measuring spoons of 5 ml) of oral solution once a day.
If a measuring cup is provided with the package, it should be used to measure the correct dose of the medication.
The medication is intended for oral use.
The patient should swallow the recommended amount of medication and then drink a small amount of water. The medication can be taken with or without food.

How to Measure the Dose of Jovesto

A measuring spoon with marked volumes of 2.5 ml and 5 ml or an oral syringe with a scale of 0.5 ml is provided with the medication package.
To measure the dose with an oral syringe:

• unscrew the cap and put it in a safe place
• immerse the tip of the syringe in the oral solution
• pull the syringe plunger to draw the required dose of the medication
• remove the syringe and close the bottle.

If air bubbles are visible inside the syringe after drawing the solution, turn the syringe upside down. The air will move upwards.
Pull the plunger and then gently press it to remove the air bubbles.
A small amount of remaining air bubbles should not be a problem.
In case of doubts about how to measure the dose, the patient should consult their doctor or pharmacist.

Administering Jovesto with a Syringe

• Make sure 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 syringe plunger. Do not empty it quickly. The medication will flow into the child's mouth.
• Allow the child to swallow the medication calmly.

The doctor will determine the duration of treatmentbased on the type of allergic rhinitis diagnosed in the patient and inform them how long to take Jovesto.

• If the patient has intermittent allergic rhinitis(in which symptoms occur less than 4 days a week or for less than 4 weeks), the doctor will recommend treatment based on the patient's history.
• If the patient has persistent allergic rhinitis(in which symptoms occur at least 4 days a week and last more than 4 weeks), the doctor may recommend longer treatment.
• In patients with urticaria, the duration of treatment may vary. The patient should strictly follow the doctor's recommendations.

Overdose of Jovesto

The patient should always take the dose of Jovesto prescribed by their doctor. In case of accidental overdose, no severe disorders should occur. However, if a higher dose of Jovesto is taken, the patient should immediately consult their doctor, pharmacist, or nurse.

Missing a Dose of Jovesto

If the patient forgets to take the medication at the usual time, they should do so as soon as possible and then return to the recommended dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Jovesto

In case of any further doubts about taking this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Jovesto can cause side effects, although not everybody gets them.
After the introduction of desloratadine to the market, very rare cases of severe allergic reactions(with difficulty breathing, wheezing, itching, hives, and swelling) have been reported.
If the patient experiences any of these unwanted reactions, they should stop taking the medication and seek medical help immediately.
In clinical trials, most children and adults experienced side effects of Jovesto that were almost the same as those after taking a placebo (a solution that does not contain the active substance).
Common side effects in children under 2 years of age were: diarrhea, fever, and insomnia, while adults more often reported than after taking a placebo: fatigue, dry mouth, and headache.
During clinical trials with desloratadine, the following side effects were reported:

• Children

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

• diarrhea
• fever
• insomnia

Adults

Common(may occur in less than 1 in 10 people)

• fatigue
• dry mouth
• headache

After the introduction of desloratadine to the market, the following side effects have been reported:

• Adults

Very Rare(may occur in less than 1 in 10,000 people)

• severe allergic reactions
• rash
• very strong or irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• indigestion
• diarrhea
• dizziness
• drowsiness
• difficulty falling asleep
• muscle pain
• hallucinations
• seizures
• restlessness with increased body movements
• hepatitis
• abnormal liver function test results

Frequency Not Known(frequency cannot be estimated from the available data)

• abnormal behavior
• aggressive behavior
• abnormal weakness
• yellowing of the skin and (or) eyes
• increased sensitivity of the skin 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 the available data)

• abnormal behavior
• aggressive behavior
• slow heartbeat
• changes in heart rhythm
• weight gain
• increased appetite

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Jovesto

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medication.
Shelf life after opening the bottle: 2 months.
Do not use this medication if any changes in the appearance of the solution are observed.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Jovesto Contains

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

What Jovesto Looks Like and What the Package Contains

Clear, colorless solution.
Available in orange glass bottles (type III) with a polypropylene cap with a multi-layered polyethylene liner and a child-resistant closure, placed in a cardboard box.
A measuring spoon marked "CE 0373" with volumes of 2.5 ml and 5 ml or an oral syringe with a capacity of 5 ml marked "CE 0373" with a scale of 0.5 ml is provided with all packages.
Package sizes:
60 ml or 150 ml of oral solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
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
Balkanpharma Troyan AD
1 Krayrechna Str.
Troyan 5600, Bulgaria

For More Information on the Medication and its Names in the Member States of the European Economic Area, Please Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz Logo
Date of Last Revision of the Leaflet:06/2022