DESLORATADINE EG STADA

Package leaflet: Information for the patient

DESLORATADINE EG STADA 5 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What DESLORATADINE EG STADA is and what it is used for
2. What you need to know before taking DESLORATADINE EG STADA
3. How to take DESLORATADINE EG STADA
4. Possible side effects
5. How to store DESLORATADINE EG STADA
6. Contents of the pack and other information

1. What DESLORATADINA EG STADA is and what it is used for

What DESLORATADINA EG STADA is
DESLORATADINA EG STADA contains desloratadine, which is an antihistamine.
How DESLORATADINA EG STADA works
DESLORATADINA EG STADA is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When DESLORATADINA EG STADA should be used
DESLORATADINA EG STADA relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
DESLORATADINA EG STADA is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improving your sleep.

2. What you need to know before taking DESLORATADINE EG STADA

DO NOT take DESLORATADINE EG STADA

• if you are allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking DESLORATADINE EG STADA

• if you have reduced kidney function.
• if you or a family member has a history of seizures.

Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and DESLORATADINE EG STADA
No interactions between DESLORATADINE EG STADA and other medicines are known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
DESLORATADINE EG STADA with food, drinks and alcohol
DESLORATADINE EG STADA can be taken with or without food.
Use caution when taking DESLORATADINE EG STADA with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of DESLORATADINE EG STADA during pregnancy or breastfeeding is not recommended.
Fertility
There are no data available on male and female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how you respond to this medicine.
DESLORATADINE EG STADA contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take DESLORATADINE EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily with water, with or without food.
Method of administration
This medicine is for oral use.
Swallow the tablet whole.
Duration of treatment
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take DESLORATADINE EG STADA. If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will prescribe a treatment regimen based on an assessment of your medical history. If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may prescribe a longer-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow your doctor's instructions.
If you take more DESLORATADINE EG STADA than you should
Take DESLORATADINE EG STADA only as prescribed. No serious problems are expected following accidental overdose. However, if you take more DESLORATADINE EG STADA than prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take DESLORATADINE EG STADA
If you forget to take your dose at the prescribed time, take it as soon as possible and then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
During post-marketing surveillance of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine and contact your doctor immediately.

In clinical studies in adults, side effects were similar to those observed with an inactive tablet (placebo). However, fatigue, dry mouth, and headache were reported more frequently than with an inactive tablet (placebo). In adolescents, headache was the most commonly reported side effect.

In clinical studies with desloratadine, the following side effects were reported as:
Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the post-marketing use of desloratadine, the following side effects have been reported as:
Very rare: may affect up to 1 in 10,000 people

• severe allergic reactions
• skin rash
• pounding or irregular heartbeat
• rapid heartbeat
• stomach ache
• feeling unwell (nausea)
• vomiting
• stomach discomfort
• diarrhoea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• restlessness with increased body movement
• liver inflammation
• abnormal liver function tests

Not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased skin sensitivity to sunlight, even on cloudy days, and to UV light, for example from UV lamps in sunbeds
• changes in heart rhythm
• abnormal behaviour
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children
Not known: frequency cannot be estimated from the available data

• slowed heartbeat
• changes in heart rhythm
• abnormal behaviour
• aggression

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DESLORATADINE EG STADA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, on the blister and on the single-dose divisible blister after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DESLORATADINA EG STADA contains
The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
The other components are:
Tablet core: dibasic calcium phosphate dihydrate, microcrystalline cellulose (E460(i)), maize starch,
talc (E553B), zinc stearate.
Tablet coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol 400 (E1521), indigo carmine aluminium lake (E132).
Description of the appearance of DESLORATADINA EG STADA and contents of the pack
DESLORATADINA EG STADA 5 mg film-coated tablets appear as film-coated tablets, light blue to blue in colour, round, biconvex, with "5" printed on one side and smooth on the other side, and with a diameter of approximately 6 mm.
Blister and unit-dose divisible blister in OPA-Al-PVC-Al.
[Blister] and [Unit-dose divisible blister]
20 film-coated tablets
20x1 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano - Italy
Manufacturers
STADA M&D S.R.L. Strada Trascăului, No. 10, Turda 401135, Cluj - Romania
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel – Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
DE Desloratadin STADA 5 mg Filmtabletten
IT DESLORATADINA EG STADA
The latest approved version of the package leaflet for this medicinal product is available by scanning the QR code on the outer packaging with a smartphone/device. The same information is available at the following URL: