Desloratadine Genoptim

Package Leaflet: Information for the User

Desloratadine Genoptim, 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, as you may Need to Read it Again.
• Ask your Doctor or Pharmacist if you have any Further Questions.
• 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 any of the Side Effects get Serious, or if you Notice any Side Effects not Listed in this Package Leaflet, Tell your Doctor or Pharmacist.

Package Leaflet Contents:

• 1. What is Desloratadine Genoptim and what is it Used for
• 2. Important Information Before Taking Desloratadine Genoptim
• 3. How to Take Desloratadine Genoptim
• 4. Possible Side Effects
• 5. How to Store Desloratadine Genoptim
• 6. Package Contents and other Information

1. What is Desloratadine Genoptim and what is it Used for

Desloratadine Genoptim is an Antihistamine that does not Cause Drowsiness. It Helps to
Control Allergic Reactions and their Symptoms.
Desloratadine Genoptim Relieves Symptoms Associated with Allergic Rhinitis (Hay Fever or
House Dust Mite Allergy), Including Sneezing, Runny or Itchy Nose, Itchy Palate, Itchy, Red or
Tearful Eyes.
Desloratadine Genoptim is also Used to Relieve Symptoms of Urticaria (a Skin Condition
Caused by an Allergy). Symptoms of this Condition Include Itchy Skin and Hives.
The Relief of these Symptoms Lasts all Day, Making it Easier to Carry out Normal Daily
Activities and have a Normal Night's Sleep.
Desloratadine Genoptim is Indicated for Use in Adults and Adolescents (12 years and Older).

2. Important Information Before Taking Desloratadine Genoptim

When not to Take Desloratadine Genoptim

• 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

• If you have Kidney Problems;
• If you have a History of Seizures or a Family History of Seizures.

If any of these Apply to you, or if you are not Sure, you should Consult your Doctor before
Taking Desloratadine Genoptim.

Other Medications and Desloratadine Genoptim

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.
No Interactions with other Medications are Known for Desloratadine Genoptim.

Desloratadine Genoptim with Food and Drink

Desloratadine Genoptim can be Taken with or without Food.

Pregnancy and Breastfeeding

If you are Pregnant, Breastfeeding, or Think you may be Pregnant, or are Planning to become
Pregnant, ask your Doctor or Pharmacist for Advice before Taking this Medication.

Driving and Using Machines

Desloratadine does not Affect the Ability to Drive or Use Machines, or has a Negligible Effect.
It is not Expected that Desloratadine Genoptim will Cause Drowsiness when Taken at the
Recommended Dose. However, very Rarely, some People may Experience Drowsiness, which
may Affect their Ability to Drive or Use Machines.

Desloratadine Genoptim Contains Lactose

If you have been Told by your Doctor that you have an Intolerance to some Sugars, you should
Consult your Doctor before Taking this Medication.

3. How to Take Desloratadine Genoptim

Always Take this Medication Exactly as your Doctor has Told you. If you are not Sure, ask your
Doctor or Pharmacist.
The Usual Dose is:
Use in Children: The Efficacy and Safety of Desloratadine Genoptim in Children below 12 years
of Age have not been Established. No Data are Available.
Adults and Adolescents (12 years and Older): one Tablet once a Day. The Tablet should be
Swallowed Whole with Water, with or without Food.
The Duration of Treatment with Desloratadine Genoptim will be Determined by your Doctor, who
will Assess the Type of Allergic Rhinitis you are Suffering from.
If you have Intermittent Allergic Rhinitis (Symptoms that Occur for less than 4 Days a Week or for
less than 4 Weeks), your Doctor will Recommend a Treatment Plan Based on your Medical
History. If you have Persistent Allergic Rhinitis (Symptoms that Occur for 4 Days or more per
Week and for more than 4 Weeks), your Doctor will Recommend Long-Term Use of the
Medication.
In the Case of Urticaria, the Duration of Treatment may Vary from Patient to Patient. For this
Reason, you should Follow your Doctor's Advice.

Taking more than the Recommended Dose of Desloratadine Genoptim

Desloratadine Genoptim should be Taken only as Directed. No Serious Problems are Expected
if you Accidentally Take more than the Recommended Dose. However, if you Take more than the
Recommended Dose, you should Consult your Doctor or Pharmacist.

Forgetting to Take a Dose of Desloratadine Genoptim

If you Miss a Dose, Take it as soon as you Remember, and then Continue with your Regular
Dosing 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 or Pharmacist.

4. Possible Side Effects

Like all Medications, Desloratadine Genoptim can Cause Side Effects, although not Everybody
gets them.
In Adult Patients, 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 Marketing of Desloratadine Genoptim, very Rare Cases of Severe Allergic Reactions
(Difficulty Breathing, Wheezing, Itching, Hives, Swelling) and Rash have been Reported. Very
Rare Cases of the Following have also been Reported: Rapid Heartbeat, Abdominal Pain, Nausea
(Feeling Sick), Vomiting, Upset Stomach, Diarrhea, Dizziness, Drowsiness, Sleeplessness, Muscle
Pain, Hallucinations, Seizures, Restlessness with Excessive Physical Activity, Hepatitis, and
Abnormal Liver Function Tests.
The Following Side Effects have been Reported, but their Frequency is not Known (Frequency
not Known): Abnormal Behavior, Aggressive Behavior, and Changes in Heart Rate, Weight Gain,
Increased Appetite, Low Mood, and Dry Eyes.
If you get any Side Effects, Talk to your Doctor or Pharmacist. This includes any Possible Side
Effects not Listed in this Package Leaflet.

Reporting Side Effects

If you get any Side Effects, Talk to your Doctor or Pharmacist. This includes any Possible Side
Effects not Listed in this Package Leaflet. You can also Report Side Effects Directly to the
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and
Biocides, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49
21 309, website: https://smz.ezdrowie.gov.pl. By Reporting Side Effects, you can Help Provide more
Information on the Safety of this Medication.

5. How to Store Desloratadine Genoptim

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.
The Expiry Date Stated is the Last Day of the Month.
Store in the Original Package to Protect from Light and Moisture.
Do not Use the Medication if the Tablets Appear to have Changed.
Medicines should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how
to Dispose of Medicines no Longer Required. These Measures will Help Protect the Environment.

6. Package Contents and other Information

What Desloratadine Genoptim Contains

• The Active Substance is Desloratadine 5 mg
• The other Ingredients are: Lactose Anhydrous, Microcrystalline Cellulose, Calcium Hydrogen
  Phosphate Anhydrous, Hypromellose, Magnesium Stearate, Silicon Dioxide, Titanium Dioxide (E
  171), Talc, Indigo Carmine (E 132), Lacquer, and Macrogol 6000.

What Desloratadine Genoptim Looks like and Contents of the Package

Blue, Round, Biconvex Film-Coated Tablets with "D" Engraved on one Side.
Desloratadine Genoptim, 5 mg, Film-Coated Tablets are Packaged in Blisters of 10, 20, 30, 50, or 100
Tablets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Synoptis Pharma Sp.z o.o
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer:
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6
ES – 28760 Tres Cantos, Madrid
Spain

This Medicinal Product is Authorized in the Member States of the European Economic Area

Under the Following Names:

Portugal: Desloratadina NORMON 5 mg Comprimidos Revestidos por Película
Bulgaria: Desloratadine IBERMEDGEN 5 mg Филмирани Таблетки
Germany: Desloratadin IBERMEDGEN 5 mg Filmtabletten
Poland: Desloratadine Genoptim
Romania: Desloratadină IBERMEDGEN 5 mg Comprimate Filmate
Spain: Desloratadina TARBIS 5 mg Comprimidos Recubiertos con Película EFG
Date of Last Revision of the Package Leaflet:July 2022