Jovesto
Poland
Table of Contents
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 of the same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- 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. The medicine may harm other people, even if their symptoms are identical.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet:
- What Jovesto is and what it is used for
- Important information before taking Jovesto
- How to take Jovesto
- Possible side effects
- How to store Jovesto
- 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.
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 (an allergic skin disorder), 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 to take Jovesto, consult your doctor, pharmacist, or nurse:
- if the patient has a history or family history of seizures;
- if the patient has kidney function disorders.
Children and adolescents
Jovesto must not be used in children under 12 years of age.
Jovesto and other medicines
No interactions between Jovesto and other medicines are known.
You should 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
Jovesto may be taken with or without food.
Caution should be exercised if consuming alcohol while taking Jovesto.
Pregnancy, breastfeeding, and 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 during pregnancy and breastfeeding is not recommended.
Fertility
There are no available data on the effects on fertility in men and women.
Driving and operating machinery
This medicine, when taken at the recommended doses, should not affect the ability to drive or operate machinery. Although most people do not experience drowsiness after taking it, activities requiring attention, such as driving or operating machinery, should be avoided until the patient knows how their body reacts to the medicine.
3. How to take Jovesto
Jovesto should always be taken as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily.
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 less 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 most days for at least 4 days per week and for more than 4 consecutive weeks), the doctor may recommend longer-term treatment.
- In patients with urticaria, the duration of treatment may vary. Always follow your doctor's instructions exactly.
Taking more Jovesto than recommended
Always take the dose of Jovesto prescribed by your doctor. Severe 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 everyone gets them.
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 should be discontinued and
immediate medical help must be sought.
In clinical trials in adults, side effects after 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 reported adverse effect.
The following adverse effects have been reported during clinical trials with desloratadine.
Common (may affect fewer than 1 in 10 people):
- fatigue,
- dry mouth,
- headache.
Adults
After desloratadine was marketed, 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,
- restlessness with increased body movements,
- liver inflammation,
- abnormal liver function test results.
Frequency not known (cannot be estimated from 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 not known (cannot be estimated from 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, patients should inform their 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 this medicine.
5. How to store the medicine Jovesto
Keep the medicine out of 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 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 required. Following this advice helps protect the environment.
6. Contents of the pack and other information
What Jovesto contains
- The active substance in this medicine is desloratadine. Each coated tablet contains 5 mg of desloratadine.
- Other ingredients 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, lake (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 the 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: 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 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.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation Number in the Netherlands, country of export: RVG 109201
Parallel Import Authorisation Number: 158/22