Jovesto

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Jovesto (Desloratadine Sandoz 5 mg), 5 mg, film-coated tablets
Desloratadinum
Jovesto and Desloratadine Sandoz 5 mg are different brand names of the same medicine.
Read the leaflet carefully before using the medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• 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. 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 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 and adolescents aged 12 years and older. Symptoms include sneezing, watery nasal discharge or nasal itching, itching of the palate, as well as itching, redness, or watering of the eyes.
Jovesto is also used to relieve symptoms of urticaria (a skin condition caused by allergy), such as itchy rash.
Symptom relief lasts throughout the day, 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 ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Jovesto, consult a doctor, pharmacist, or
nurse:

• if the patient has a personal or family history of seizures,
• if the patient has impaired kidney function.

Children and adolescents
Jovesto must not be used in children under 12 years of age.
Interaction of Jovesto with other medicines
No interactions between Jovesto and other medicines are known.
Inform your doctor or pharmacist about all medicines currently used, recently taken, or which the patient intends to use.
Jovesto, food, drink, and alcohol
Jovesto can be taken with or without food.
Caution is advised when consuming alcohol during treatment with Jovesto.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Jovesto is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect 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 perform activities requiring attention, such as driving or operating machinery, until the patient's individual response to the medicine is known.

3. How to take Jovesto

Jovesto should always be taken according to the doctor's or pharmacist's instructions. If in doubt, consult 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.
This medicine is for oral use.
Your doctor will determine the duration of treatment depending on the type of allergic rhinitis diagnosed in the patient and will inform you how long you should continue taking Jovesto.

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

Taking more Jovesto than recommended
Always take the dose of Jovesto prescribed by your doctor. Serious adverse effects are not expected after accidental overdose. However, if you take more Jovesto than recommended, contact your doctor, pharmacist, or nurse immediately.
If you forget to take Jovesto
If you forget to take a tablet at your usual time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Jovesto
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (with difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these adverse reactions occur in a patient, treatment should be discontinued immediately and medical help must be sought without delay.

In clinical trials in adults, side effects following administration of Jovesto were almost the same as with placebo (tablets containing no active substance), although fatigue, dry mouth, and headache were reported more frequently.
In adolescents, headache was the most commonly occurring adverse effect.

The following adverse effects have been reported during clinical trials with desloratadine.

Common (may affect fewer than 1 in 10 people)

• feeling tired
• dry mouth
• headache

Adults
After desloratadine was introduced to the market, the following adverse effects have been reported.

Very rare (may affect 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
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• movement restlessness with increased body movements
• hepatitis (inflammation of the liver)
• abnormal liver function test results

Frequency unknown (cannot be estimated from the available data)

• unusual behaviour
• aggressive behaviour
• unusual 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 heartbeat
• increased body weight
• increased appetite

Children
Frequency unknown (cannot be estimated from the available data)

• unusual behaviour
• aggressive behaviour
• slow heartbeat
• changes in heartbeat
• increased body weight
• increased appetite

Reporting of adverse effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store the medicine Jovesto

Keep the medicine 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 stated month.
No special storage instructions apply.
Do not use this medicine if you notice any changes in the appearance of the tablet.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Jovesto contains

• The active substance is desloratadine. Each coated tablet contains 5 mg of desloratadine.
• Other components of the medicine are:

Tablet core: maize starch, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, hydrogenated vegetable oil (type 1);
Coating: Opadry Blue 03B50689 [hypromellose, titanium dioxide (E 171), polyethylene glycol 400, indigo carmine, lac (E 132)].

What Jovesto looks like and contents of the pack

Jovesto coated tablets are light blue, round, biconvex (with a diameter of 6.5 ± 0.1 mm), with an imprint "5" on one side.

The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, and placed in a cardboard box.
Pack sizes contain 10, 30, 60, and 90 coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Sandoz B.V., Veluwezoom 22, 1327 AH Almere, the 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, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in the Netherlands, country of export: RVG 109201
Parallel Import Authorisation Number: 395/22