Dasergin

Package Leaflet: Information for the Patient

Dasergin, 5 mg, Film-Coated Tablets

Desloratadine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in the Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Dasergin and What is it Used for
• 2. Important Information Before Taking Dasergin
• 3. How to Take Dasergin
• 4. Possible Side Effects
• 5. How to Store Dasergin
• 6. Contents of the Pack and Other Information

1. What is Dasergin and What is it Used for

What is Dasergin

Dasergin Contains Desloratadine, Which is an Antihistamine.

How Dasergin Works

Dasergin is an Anti-Allergic Medication that Does not Cause Drowsiness. It Helps Control Allergic Reactions and Their Symptoms.

When to Use Dasergin

Dasergin Relieves Symptoms Associated with Allergic Rhinitis (Hay Fever or Allergy to Dust Mites) in Adults and Adolescents Aged 12 Years and Older. Symptoms Include: Sneezing, Runny or Itchy Nose, Itchy Palate, and Itchy, Red, or Teary Eyes. Dasergin is also Used to Relieve Symptoms of Urticaria (a Skin Condition Caused by Allergy). Symptoms of this Condition Include: Itchy Skin and Hives. Relief of these Symptoms Lasts Throughout the Day, Allowing for a Return to Normal Daily Activities and Normal Sleep. If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor.

2. Important Information Before Taking Dasergin

When Not to Take Dasergin

• 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 Dasergin, Discuss with Your Doctor or Pharmacist:

• 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.

Dasergin 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.

Taking Dasergin with Food, Drink, and Alcohol

Dasergin can be Taken with or Without Food. Be Cautious When Taking Dasergin with Alcohol.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication. Dasergin is Not Recommended During Pregnancy or Breastfeeding. Fertility. There is No Available Data on the Effect on Male and Female Fertility.

Driving and Using Machines

It is Not Expected that this Medication, When Taken as Recommended, Will Affect Your Ability to Drive or Operate Machinery. Although Drowsiness is Unlikely, it is Recommended to Avoid Activities that Require Concentration, such as Driving or Operating Machinery, Until You Know How You React to this Medication.

Dasergin Contains Lactose and Sodium

If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication. The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Dasergin

Always Take this Medication Exactly as Described in the Package Leaflet. If You are Unsure, Consult Your Doctor or Pharmacist.

Adults and Adolescents Aged 12 Years and Older

The Recommended Dose is One Tablet Once a Day, Swallowed with Water, Taken with or Without Food. This Medication is for Oral Use. Swallow the Tablet Whole. The Duration of Treatment with Dasergin 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 May 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-Term Use. For Urticaria, the Duration of Treatment May Vary. Follow Your Doctor's Advice. If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor. Do Not Take Dasergin for More than 10 Days Without Consulting a Doctor.

Taking More than the Recommended Dose of Dasergin

Take Dasergin Only as Prescribed. In Case of Accidental Overdose, Serious Side Effects are Unlikely to Occur. However, if You Take More than the Recommended Dose of Dasergin, Inform Your Doctor or Pharmacist Immediately.

Missing a Dose of Dasergin

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 Further Questions on the Use of this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Dasergin can Cause Side Effects, Although not Everybody Gets Them. After Desloratadine was Introduced, Very Rare Cases of Severe Allergic Reactions (Difficulty Breathing, Wheezing, Itching, Hives, and Swelling) Have Been Reported. If You Experience any of these Severe Side Effects, Stop Taking the Medication and Consult a Doctor Immediately. In Clinical Studies in Adults, Side Effects were Almost the Same as those 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 Studies with Desloratadine:

• Fatigue,
• Dry Mouth,
• Headache.

Adults

After Desloratadine was Introduced, the Following Side Effects Have Been Reported:

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

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

• Unusual Weakness,
• Jaundice and/or Yellowing of the Eyes,
• Increased Sensitivity of the Skin to Sunlight, Even on Cloudy Days and to UV (Ultraviolet) Radiation, for Example, UV Radiation from a Sunbed,
• Changes in Heart Rhythm,
• Abnormal Behavior,
• Aggressive Behavior,
• Increased Appetite,
• Weight Gain.

Children

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

• Slow Heartbeat,
• Change in Heart Rhythm,
• Abnormal Behavior,
• Aggressive Behavior.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in the Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. 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 Dasergin

Keep the Medication Out of Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Packaging (Box and Blister) After: EXP. The Expiration Date Refers to the Last Day of the Specified Month. Store in the Original Packaging to Protect from Moisture. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Dasergin Contains

• The Active Substance is Desloratadine. Each Film-Coated Tablet Contains 5 mg of Desloratadine.
• The Other Ingredients are: Microcrystalline Cellulose, Hypromellose, Hydrochloric Acid (for pH Adjustment), Sodium Hydroxide (for pH Adjustment), Corn Starch, Lactose Monohydrate, and Talc in the Tablet Core, and Hypromellose, Macrogol 400, Lactose Monohydrate, Titanium Dioxide (E171), and Indigo Carmine (E132) in the Tablet Coating (See Section 2, "Dasergin Contains Lactose and Sodium").

What Dasergin Looks Like and Contents of the Pack

Light Blue, Round, Film-Coated Tablets with a Diameter of 6.5 mm and a Thickness of 2.3-3.5 mm. Dasergin is Available in Cardboard Boxes Containing Blisters of 10 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For More Detailed Information on the Names of Medicinal Products in Other EU Member States, Contact the Local Representative of the Marketing Authorization Holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500

Date of Last Revision of the Leaflet: