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

Desloratadine
Jovesto and Desloratadine Sandoz 5 mg are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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 relieve the allergic reaction and its symptoms.

When to use Jovesto

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

2. Important information before taking Jovesto

When not to use Jovesto

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

Warnings and precautions

Before taking Jovesto, discuss it with your doctor, pharmacist, or nurse:

• if you have a history of seizures or a family history of seizures;
• if you have kidney problems.

Children and adolescents

Do not use Jovesto in children under 12 years of age.

Jovesto and other medicines

No interactions with other medicines are known.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Jovesto with food, drink, and alcohol

You can take Jovesto with or without food.
Be careful when drinking alcohol while taking Jovesto.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Jovesto 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 taken as recommended, is unlikely to affect your ability to drive or use machines. However, it is recommended not to 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

Always take Jovesto exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily.
Swallow the tablet whole with water, with or without food.
The medicine is for oral use.
Your doctor will determine the duration of treatment depending on the type of allergic rhinitis you have and will inform you how long to take Jovesto.

• If you have intermittent allergic rhinitis(in which symptoms occur less than 4 days a week or for less than 4 weeks), your doctor will recommend treatment based on the history of the disease.
• If you have persistent allergic rhinitis(in which symptoms occur for more than 4 days a week and last more than 4 weeks), your doctor may recommend longer treatment.
• In patients with urticaria, the treatment duration may vary. Follow your doctor's instructions carefully.

Taking too much Jovesto

Always take the recommended dose of Jovesto. If you accidentally take more than the recommended dose, contact your doctor, pharmacist, or nurse immediately.

Missing a dose of Jovesto

If you forget to take a tablet at the usual time, take it as soon as possible and then continue with your normal dosing schedule. Do not take a double dose to make up for a forgotten dose.

Stopping Jovesto treatment

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Common(may affect up to 1 in 10 people)

• fatigue,
• dry mouth,
• headache.

After desloratadine was made available, the following side effects were reported.

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

• severe allergic reactions,
• rash,
• very strong or irregular heartbeat,
• fast 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
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight (even in cloudy weather) 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 not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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

Keep this medicine out of the sight and reach of children.
Do not use Jovesto after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage precautions.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 imprint "5" on one side.
The tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
The packs contain 30, 60, and 90 film-coated tablets.
For more detailed information, contact the Marketing Authorization Holder or the 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.
Domaniewska 50C
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:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands, country of export, authorization number: RVG 109201

Parallel import authorization number: 158/22 Date of approval of the leaflet: 06.04.2022

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