Deslodina

Package Leaflet: Information for the Patient

Deslodyna, 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 Them, 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 Deslodyna and What is it Used For
• 2. Important Information Before Taking Deslodyna
• 3. How to Take Deslodyna
• 4. Possible Side Effects
• 5. How to Store Deslodyna
• 6. Package Contents and Other Information

1. What is Deslodyna and What is it Used For

Deslodyna Contains Desloratadine, Which is an Antihistamine.
Deslodyna is an Anti-Allergic Medication That Does Not Cause Drowsiness. It Helps Control Allergic Reactions and Their Symptoms.
Deslodyna Relieves Symptoms Associated with Allergic Rhinitis (Inflammation of the Nasal Mucous Membranes Caused by Allergies, Such as Hay Fever or Allergies to Dust Mites) in Adults and Adolescents Aged 12 Years and Older. Symptoms Include: Sneezing, Runny Nose or Itching, Itching of the Palate, and Itching, Redness, or Tearfulness of the Eyes.
Deslodyna is Also Used to Relieve Symptoms Associated with Urticaria (Skin Changes Caused by Allergies). Symptoms of this Condition Include: Itching of the Skin and Urticaria.
Relief of These Symptoms Lasts All Day, Making it Easier to Perform Daily Activities and Allowing for Normal Sleep.

2. Important Information Before Taking Deslodyna

When Not to Take Deslodyna:

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

Warnings and Precautions

Before Taking Deslodyna, Discuss the Following with Your Doctor or Pharmacist:

• If You Have Kidney Function Disorders,
• 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.

Deslodyna and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking, or Have Recently Taken, and Any Medications You Plan to Take.
There are No Known Interactions Between Deslodyna and Other Medications.

Deslodyna with Food, Drink, and Alcohol

Deslodyna Can be Taken with or Without Food.
Be Cautious When Taking Deslodyna with Alcohol.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, Think You May be Pregnant, or Plan to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication.
Deslodyna is Not Recommended During Pregnancy or Breastfeeding.
There is No Available Data on the Effect on Fertility in Men and Women.

Driving and Using Machines

It is Not Expected That this Medication, When Taken as Recommended, Will Affect Your Ability to Drive or Use Machines. However, Since Most People Do Not Experience Drowsiness, it is Recommended to Avoid Activities That Require Concentration, Such as Driving or Using Machines, Until You Know How You React to this Medication.

Deslodyna Contains Isomalt

If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.

3. How to Take Deslodyna

Always Take this Medication 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, Taken with or Without Food.
The Medication is Intended for Oral Use. Swallow the Tablet Whole with a Glass of Water.
The Duration of Treatment with Deslodyna Will be Determined by Your Doctor, Depending on the Type of Allergic Rhinitis You Have.
If You Have Seasonal Allergic Rhinitis (Symptoms 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 Last 4 or More Days a Week and More Than 4 Weeks), Your Doctor May Recommend Longer Treatment with Deslodyna.
In Urticaria, the Duration of Treatment May Vary from Patient to Patient, So Follow Your Doctor's Recommendations.

Overdose of Deslodyna

Take Deslodyna as Recommended by Your Doctor. If You Accidentally Take More Than the Recommended Dose, it is Unlikely to Cause Serious Disorders. However, if You Take More Than the Recommended Dose of Deslodyna, Tell Your Doctor, Pharmacist, or Nurse Immediately.

Missing a Dose of Deslodyna

If You Miss a Dose, Take it as Soon as Possible, and 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, Deslodyna Can Cause Side Effects, Although Not Everybody Gets Them.
After Desloratadine Was Introduced to the Market, Very Rare Cases of Severe Allergic Reactions (Difficulty Breathing, Wheezing, Itching, Urticaria, and Swelling) and Rash Have Been Reported.
If You Experience Any of These Severe Side Effects, Stop Taking the Medication and See a Doctor Immediately.
In Clinical Trials in Adult Patients, Side Effects Were Almost the Same as Those Experienced with a Placebo. However, Fatigue, Dry Mouth, and Headache Were Reported More Frequently Than with a Placebo. In Adolescents, the Most Commonly Reported Side Effect Was Headache.
The Following Side Effects Have Been Reported in Clinical Trials with Desloratadine:

• Fatigue
• Dry Mouth
• Headache

After Desloratadine Was Introduced to the Market, the Following Side Effects Have Been Reported:

• Severe Allergic Reactions
• Rapid Heartbeat
• Vomiting
• Dizziness
• Muscle Pain
• Restlessness and Excessive Activity
• Rash
• Abdominal Pain
• Upset Stomach
• Drowsiness
• Hallucinations
• Hepatitis
• Pounding and Irregular Heartbeat
• Nausea
• Diarrhea
• Insomnia
• Seizures
• Abnormal Liver Function Test Results

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

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

Children

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

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse.
Side Effects Can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 22 49 21 309, E-mail: [email protected].
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of this Medication.

5. How to Store Deslodyna

Keep the Medication Out of Sight and Reach of Children.
Do Not Store Above 30°C.
Store in the Original Package to Protect from Moisture.
Do Not Use this Medication After the Expiry Date Stated on the Carton and Blister. The Expiry Date is the Last Day of the Month Stated.
Do Not Use this Medication if You Notice a Change in the Appearance of the Tablets.
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. Package Contents and Other Information

What Deslodyna Contains

• The Active Substance is Desloratadine. Each Tablet Contains 5 mg of Desloratadine.
• The Other Ingredients (Excipients) are: Tablet Core: Isomalt (E 953), Corn Starch, Microcrystalline Cellulose, Heavy Magnesium Oxide, Hydroxypropyl Cellulose; Crospovidone (Type A), Magnesium Stearate; Tablet Coating: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc, Indigo Carmine (E 132).

What Deslodyna Looks Like and Contents of the Package

Deslodyna 5 mg, Film-Coated Tablets are Blue, Round, Biconvex, Film-Coated Tablets with a Diameter of Approximately 6.5 mm.
Deslodyna is Packaged in Blisters Contained in a Carton, Which Contains 10 or 30 Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal Product Information

Tel.: (22) 742 00 22
E-mail: [email protected]
Date of Approval of the Package Leaflet:27.07.2017