Iovesto

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Jovesto(Desloratadine Sandoz 5 mg), 5 mg, film-coated tablets
Desloratadinum
Jovesto and Desloratadine Sandoz 5 mg are different trade names for the same medicine.
You should read the contents of the leaflet before taking the medicine,
as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 pack and other information

1. What is Jovesto and what is it used for

What is Jovesto

Jovesto contains desloratadine, which is an antihistamine.

How Jovesto works

Jovesto is an anti-allergic medicine that does not cause drowsiness. It helps to alleviate the allergic reaction and its symptoms.

When to use Jovesto

Jovesto alleviates the symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, e.g., hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. The symptoms include sneezing, runny nose or itchy nose, itchy palate, and itchy, red, or teary eyes.
Jovesto is also used to alleviate the symptoms of urticaria (a skin disorder caused by an allergy), such as itchy hives.
The alleviation of symptoms lasts throughout the day, allowing for a return to normal daily activities and proper sleep.

2. Important information before taking Jovesto

When not to use Jovesto

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

Warnings and precautions

Before taking Jovesto, you should discuss it with your 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.

Children and adolescents

The medicine should not be used in children under 12 years of age.

Jovesto and other medicines

No interactions with other medicines are known.
You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Jovesto with food, drink, and alcohol

Jovesto can be taken with or without food.
You should be cautious when consuming alcohol while taking Jovesto.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Jovesto should not be used during pregnancy and breastfeeding.

Fertility

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

Driving and using machines

This medicine, when used as recommended, is unlikely to affect your ability to drive or use machines. However, you should not engage in activities that require attention, such as driving or using machines, until you know how your body reacts to the medicine.

3. How to take Jovesto

You should always take Jovesto exactly as your doctor or pharmacist has told you. If you are unsure, you should ask your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily.
The tablets should be swallowed whole with water, with or without food.
The medicine is intended for oral use.
Your doctor will determine the duration of treatmentbased on the type of allergic rhinitis diagnosed and inform you 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 history of the disease.
• 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 treatment duration may vary. You should strictly follow the doctor's recommendations.

Taking a higher dose of Jovesto than recommended

You should always take the dose of Jovesto prescribed by your doctor. In case of accidental overdose, no serious disorders should occur. However, if you take more Jovesto than recommended, you should contact your doctor, pharmacist, or nurse immediately.

Missing a dose of Jovesto

If you forget to take a tablet at the usual time, you should take it as soon as possible and then continue with the recommended dose. Do not take a double dose to make up for the missed dose.

Stopping Jovesto treatment

If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Jovesto can cause side effects, although not everybody gets them.
After the marketing of desloratadine, very rare cases of severe allergic reactions(with difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these side effects, you should stop taking the medicine and seek medical help immediately.
In clinical trials in adults, the side effects of Jovesto were almost the same as those of placebo (tablets without an active substance), although fatigue, dry mouth, and headache were reported more frequently.
In adolescents, the most common side effect was headache.
The following side effects have been reported during clinical trials with desloratadine.

Frequent(may affect up to 1 in 10 people)

• fatigue
• dry mouth
• headache

Adults
After the marketing of desloratadine, the following side effects have been reported.

Very rare(may affect up to 1 in 10,000 people)

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

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

• abnormal behavior
• aggressive behavior
• abnormal weakness
• jaundice
• 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

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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jovesto

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if you notice any changes in the appearance of the tablet.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Jovesto contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are:

tablet core: corn starch, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, hydrogenated vegetable oil (type 1);
coating: Opadry Blue 03B50689 [hypromellose, titanium dioxide (E 171), macrogol 400, indigo carmine, lake (E 132)].

What Jovesto looks like and contents of the pack

Jovesto film-coated tablets are light blue, round, biconvex (with a diameter of 6.5 ± 0.1 mm), with the engraving "5" on one side.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
The packs contain 10, 30, 60, and 90 film-coated tablets.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V., Veluwezoom 22, 1327 AH Almere, Netherlands

Manufacturer:

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
S.C. Sandoz, S.R.L., Livezeni Street no 7A, Targu Mures, Romania

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Netherlands marketing authorization number, the country of export:RVG 109201

Parallel import authorization number: 395/22 Date of leaflet approval: 26.10.2022

[Information about the trademark]