Desloratadine +pharma

Package Leaflet: Information for the Patient

Desloratadine +pharma, 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 or Pharmacist.
• This Medication Has Been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same.
• If You Experience Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Desloratadine +pharma and What is it Used For
• 2. Important Information Before Taking Desloratadine +pharma
• 3. How to Take Desloratadine +pharma
• 4. Possible Side Effects
• 5. How to Store Desloratadine +pharma
• 6. Package Contents and Other Information

1. What is Desloratadine +pharma and What is it Used For

Desloratadine +pharma Contains Desloratadine, Which is an Antihistamine.
Desloratadine +pharma is an Anti-Allergic Medication that Does Not Cause Drowsiness. It Helps Control
Allergic Reactions and Their Symptoms.
Desloratadine +pharma Relieves Symptoms Associated with Allergic Rhinitis
(Inflammation of the Nasal Passages Caused by Allergies, Such as Hay Fever or Allergies to Dust Mites) in Adults and Adolescents Aged 12 Years and Older. These Symptoms Include:
Sneezing, Itching or Discharge from the Nose, Itching of the Palate, and Itching, Redness or Tearfulness of the Eyes.
Desloratadine +pharma is Also Used to Relieve Symptoms Associated with Urticaria
(A Skin Condition Caused by Allergies). These Symptoms Include: Itching of the Skin and Urticaria.
The Relief of These Symptoms Lasts Throughout the Day, Making it Easier to Return to Normal Daily Activities and Normal Sleep.

2. Important Information Before Taking Desloratadine +pharma

When Not to Take Desloratadine +pharma

• If You are Allergic to Desloratadine, to Any of the Other Ingredients of this Medication (Listed in Section 6), or to Loratadine.

Warnings and Precautions

Before Taking Desloratadine +pharma, Discuss it with Your Doctor, Pharmacist, or Nurse:

• If You Have Kidney Problems
• If You Have a History of Seizures or a Family History of Seizures.

Children and Adolescents

Do Not Give this Medication to Children Under 12 Years of Age.

Desloratadine +pharma and Other Medications

No Interactions Have Been Reported Between Desloratadine +pharma and Other Medications.
Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.

Desloratadine +pharma with Food, Drink, and Alcohol

Desloratadine +pharma Can Be Taken with or Without Food.
Be Cautious When Taking Desloratadine +pharma with Alcohol.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication.
Desloratadine +pharma Should Not be Used During Pregnancy or Breastfeeding.
There is No Available Data on the Effect on Fertility in Men and Women.

Driving and Operating Machinery

Desloratadine +pharma is Not Expected to Affect the Ability to Drive or Operate Machinery at the Recommended Dose. However, it is Recommended to Avoid Activities that Require Concentration, Such as Driving or Operating Machinery, Until You Know How You React to this Medication.

3. How to Take Desloratadine +pharma

Always Take this Medication Exactly as Your Doctor 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.

Method of Administration

Swallow the Tablet Whole with Water, with or Without Food.

Duration of Treatment

The Duration of Treatment with Desloratadine +pharma Will be Determined by Your Doctor, Depending on the Type of Allergic Rhinitis You Have.
If You Have Seasonal Allergic Rhinitis (Symptoms that Last Less than 4 Days a Week or Less than 4 Weeks), Your Doctor Will Recommend a Treatment Schedule Based on Your Medical History.
If You Have Chronic Allergic Rhinitis (Symptoms that Last 4 or More Days a Week and More than 4 Weeks), Your Doctor May Recommend Long-Term Use of the Medication.
In the Case of Urticaria, the Duration of Treatment May Vary from Patient to Patient, So You Should Follow Your Doctor's Recommendations.

Taking More Than the Recommended Dose of Desloratadine +pharma

Desloratadine +pharma Should Only be Taken as Prescribed.
No Serious Problems are Expected if You Accidentally Take More Than the Recommended Dose. However, if You Take More Than the Recommended Dose of Desloratadine +pharma, Contact Your Doctor, Pharmacist, or Nurse Immediately.

Missing a Dose of Desloratadine +pharma

If You Miss a Dose, Take it as Soon as Possible, Then Continue with Your Regular Dosing Schedule. Do Not Take a Double Dose to Make Up for a Missed Dose.
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, Desloratadine +pharma Can Cause Side Effects, Although Not Everybody Gets Them.
In Clinical Studies in Adults, Side Effects Were Almost the Same as Those Seen with a Dummy Tablet. However, Fatigue, Dry Mouth, and Headache Were Reported More Frequently than with a Dummy Tablet. In Adolescents, the Most Commonly Reported Side Effect Was Headache.
After the Medication Was Marked, Very Rarely, Serious Allergic Reactions (Difficulty Breathing, Wheezing, Itching, Urticaria, and Swelling) Were Reported. If You Experience Any of These Side Effects, Stop Taking the Medication and See Your Doctor Immediately.
The Following Side Effects Have Been Reported in Clinical Studies:

• Frequent: May Occur in Up to 1 in 10 Patients
• Fatigue
• Dry Mouth
• Headache

Adults

After the Medication Was Marked, the Following Side Effects Have Been Reported:
Very Rare: May Occur in Up to 1 in 10,000 Patients

• Severe Allergic Reactions
• Fast Heartbeat
• Vomiting
• Dizziness
• Muscle Pain
• Restlessness with Excessive Motor Activity
• Rash
• Abdominal Pain
• Upset Stomach
• Drowsiness
• Hallucinations
• Hepatitis
• Palpitations and Irregular Heartbeat
• Nausea
• Diarrhea
• Insomnia
• Seizures
• Abnormal Liver Function Tests

Frequency Not Known: Frequency Cannot be Estimated from the Available Data

• Unusual Weakness
• Increased Sensitivity of the Skin to Sunlight, Even on Cloudy Days, and to UV Radiation, Such as UV Radiation in a Solarium
• Changes in Heart Rate
• Yellowing of the Skin and/or Eyes
• Abnormal Behavior
• Aggressive Behavior
• Weight Gain, Increased Appetite
• Low Mood
• Dry Eyes

Children

Frequency Not Known: Frequency Cannot be Estimated from the Available Data

• Slow Heartbeat
• Changes in Heart Rate
• Abnormal Behavior
• Aggressive Behavior

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Adverse Reaction Monitoring 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
Side Effects Can Also be Reported 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 Desloratadine +pharma

Keep the Medication Out of Sight and Reach of Children.
Store in the Original Package to Protect from Moisture and Light.
Do Not Use the Medication if You Notice Any Change in the Appearance of the Tablets.
Do Not Use the Medication After the Expiration Date Stated on the Carton and Blister After: "Expiration Date" or "EXP". The Expiration Date is the Last Day of the Specified Month.
Do Not Throw Away Medications via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications That are No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Desloratadine +pharma Contains

• Active Substanceis Desloratadine in a 5 mg Dose.
• Other Ingredients are: Microcrystalline Cellulose, Mannitol, Magnesium Stearate, Hypromellose 6 cPs, Hydroxypropyl Cellulose, Titanium Dioxide (E 171), Indigo Carmine (E 132), Lacquer.

What Desloratadine +pharma Looks Like and What the Package Contains

Desloratadine +pharma is a Light Blue, Round, Biconvex, Film-Coated Tablet.
Desloratadine +pharma is Available in Packages (Blisters) of 10, 15, or 30 Film-Coated Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

+pharma Arzneimittel GmbH
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Iberfar - Indústria Farmacêutica, S.A.
Estrada Consiglieri Pedroso, n. 123
Queluz de Baixo
Barcarena, 2734-501
Portugal
Genericon Pharma Gesellschaft m.b.H.
Hafnerstraße 211
8054 Graz
Austria
To Obtain Detailed Information on the Medication and its Names in the Member States of the European Economic Area, Contact the Representative of the Marketing Authorization Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
Tel: +48 12 262 32 36
Date of Last Revision of the Package Leaflet:October 2024