Iovesto
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Package Leaflet: Information for the Patient
Jovesto, 5 mg, Film-Coated Tablets
Desloratadine
Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
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.
Package Leaflet Contents:
- 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. Package Contents and Other Information
1. What is Jovesto and What is it Used for
What is Jovesto
Jovesto Contains Desloratadine, Which is an Antihistamine Medication.
How Jovesto Works
Jovesto is an Anti-Allergic Medication that Does not Cause Drowsiness. It Helps to Relieve Allergic Reactions and their Symptoms.
When to Use Jovesto
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.
2. Important Information Before Taking Jovesto
When Not to Take Jovesto
If You are Allergic to Desloratadine, Loratadine, or any of the Other Ingredients of this Medication (Listed in Section 6).
Warnings and Precautions
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.
Children and Adolescents
Do not Give this Medication to Children Under 12 Years of Age.
Jovesto and Other Medications
No Interactions with Other Medications are Known. Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Plan to Take.
Jovesto with Food, Drink, and Alcohol
You Can Take Jovesto with or Without Food. Be Cautious When Consuming Alcohol While Taking Jovesto.
Pregnancy, Breastfeeding, and Fertility
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.
Fertility
No Data are Available on the Effects of Jovesto on Fertility in Men and Women.
Driving and Using Machines
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.
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 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.
- If You Have Seasonal Allergic Rhinitis (Where Symptoms Occur Less Than 4 Days a Week or for Less Than 4 Weeks), Your Doctor Will Recommend Treatment Based on Your Medical History.
- If You Have Perennial Allergic Rhinitis (Where Symptoms Occur for More Than 4 Days a Week and Last More Than 4 Weeks), Your Doctor May Recommend Longer-Term Treatment.
- For Patients with Urticaria, the Duration of Treatment May Vary. Follow Your Doctor's Instructions Closely.
Taking More Jovesto Than Recommended
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.
Missing a Dose of Jovesto
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.
Stopping Jovesto Treatment
If You Have any Further Questions on the Use of this Medication, Ask Your Doctor, Pharmacist, or Nurse.
4. Possible Side Effects
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)
- Fatigue
- Dry Mouth
- Headache
Very Rare(May Occur in Less Than 1 in 10,000 People)
- Severe Allergic Reactions
- Rash
- Very Strong or Irregular Heartbeat
- Fast Heartbeat
- Abdominal Pain
- Nausea
- Vomiting
- Indigestion
- Diarrhea
- Dizziness
- Drowsiness
- Difficulty Sleeping
- Muscle Pain
- Hallucinations
- Seizures
- Restlessness with Increased Body Movements
- Hepatitis
- Abnormal Liver Function Test Results
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 on Cloudy Days) and to UV Radiation (e.g., in a Solarium)
- Changes in Heartbeat
- Weight Gain
- Increased Appetite
Children
Frequency Not Known(Frequency Cannot be Estimated from the Available Data)
- Abnormal Behavior
- Aggressive Behavior
- Slow Heartbeat
- Changes in Heartbeat
- Weight Gain
- Increased Appetite
Reporting Side Effects
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.
5. How to Store Jovesto
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.
6. Package Contents 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; Coating: Opadry Blue 03B50689 [Hypromellose, Titanium Dioxide (E171), Macrogol 400, Indigo Carmine (E132), Lac].
What Jovesto Looks Like and Contents of the Package
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 and Manufacturer
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.
For More Information on this Medication and its Names in the Member States of the European Economic Area, Please Contact:
Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, Tel. 22 209 70 00, Logo Sandoz
Date of Last Revision of the Package Leaflet:
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterLek Pharmaceuticals d.d. Lek Pharmaceuticals d.d. LEK S.A. Salutas Pharma GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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