
Ask a doctor about a prescription for Iovesto
Desloratadine
Keep this Package Leaflet, You May Need to Read it Again. If You Have any Further Questions, Ask Your Doctor, Pharmacist, or Nurse. This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same. If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.
Jovesto Contains Desloratadine, Which is an Antihistamine Medication.
Jovesto is an Anti-Allergic Medication that Does not Cause Drowsiness. It Helps to Relieve Allergic Reactions and their Symptoms.
Jovesto Relieves Symptoms of Allergic Rhinitis (Hay Fever or House Dust Mite Allergy) in Adults and Adolescents Aged 12 Years and Older. Symptoms Include Sneezing, Runny or Itchy Nose, Itchy Palate, and Itchy, Red, or Tearful Eyes. Jovesto is also Used to Relieve Symptoms of Urticaria (Hives), Such as Itchy Rash. The Relief of Symptoms Lasts Throughout the Day, Allowing for Normal Daily Activities and Undisturbed Sleep.
If You are Allergic to Desloratadine, Loratadine, or any of the Other Ingredients of this Medication (Listed in Section 6).
Before Taking Jovesto, Discuss with Your Doctor, Pharmacist, or Nurse: If You Have a History of Seizures or a Family History of Seizures, If You Have Kidney Problems.
Do not Give this Medication to Children Under 12 Years of Age.
No Interactions with Other Medications are Known. Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Plan to Take.
You Can Take Jovesto with or Without Food. Be Cautious When Consuming Alcohol While Taking Jovesto.
If You are Pregnant, Breastfeeding, or Think You May be Pregnant, Consult Your Doctor or Pharmacist Before Taking this Medication. It is not Recommended to Take Jovesto During Pregnancy and Breastfeeding.
No Data are Available on the Effects of Jovesto on Fertility in Men and Women.
This Medication, When Taken as Directed, Should not Affect Your Ability to Drive or Operate Machinery. However, Do not Engage in Activities that Require Attention Until You Know How Jovesto Affects You.
Always Take Jovesto Exactly as Your Doctor or Pharmacist has Told You. If You are not Sure, Ask Your Doctor or Pharmacist.
The Recommended Dose is One Tablet Once a Day. Swallow the Tablet Whole with Water, with or Without Food. The Medication is for Oral Use. Your Doctor Will Determine the Duration of Treatment Based on the Type of Allergic Rhinitis You Have and Inform You How Long to Take Jovesto.
Always Take the Recommended Dose of Jovesto as Prescribed by Your Doctor. If You Accidentally Take More Than the Recommended Dose, You Should not Experience Serious Problems. However, If You Take More Jovesto Than Recommended, Contact Your Doctor, Pharmacist, or Nurse Immediately.
If You Forget to Take a Tablet at the Usual Time, Take it as Soon as Possible, Then Continue with Your Regular Schedule. Do not Take a Double Dose to Make Up for a Forgotten Dose.
If You Have any Further Questions on the Use of this Medication, Ask Your Doctor, Pharmacist, or Nurse.
Like all Medications, 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, Stop Taking Jovesto and Seek Medical Attention Immediately. In Clinical Studies in Adults, the Side Effects of Jovesto Were Almost the Same as those of a Placebo (a Tablet Without the Active Substance), Although Fatigue, Dry Mouth, and Headache Were Reported More Often. In Adolescents, Headache Was the Most Common Side Effect. During Clinical Studies with Desloratadine, the Following Side Effects Were Reported.
Adults
After the Marketing of Desloratadine, the Following Side Effects Have Been Reported.
Frequent(May Occur in Less Than 1 in 10 People)
Very Rare(May Occur in Less Than 1 in 10,000 People)
Frequency Not Known(Frequency Cannot be Estimated from the Available Data)
Children
Frequency Not Known(Frequency Cannot be Estimated from the Available Data)
If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.
Keep this Medication Out of the Sight and Reach of Children. Do not Use this Medication After the Expiry Date Stated on the Carton and Blister After EXP. The Expiry Date Refers to the Last Day of that Month. Store in the Original Package. Do not Use this Medication if You Notice any Change in the Appearance of the Tablet. Medications Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Required. This Will Help Protect the Environment.
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; Coating: Opadry Blue 03B50689 [Hypromellose, Titanium Dioxide (E171), Macrogol 400, Indigo Carmine (E132), Lac].
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 Blisters of OPA/Aluminum/PVC/Aluminum or PVC/Aclar/Aluminum, in a Carton. The Packages Contain 10, 10x1, 30, 30x1, 60, and 90 Film-Coated Tablets.
Marketing Authorization Holder: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria. Manufacturers: Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia; Lek S.A., ul. Podlipie 16, 95-010 Stryków; Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia.
Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, Tel. 22 209 70 00, Logo Sandoz
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