Teslor

Leaflet included in the packaging: patient information

Teslor, 5 mg, film-coated tablets

Desloratadine

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Teslor and what is it used for
• 2. Important information before taking Teslor
• 3. How to take Teslor
• 4. Possible side effects
• 5. How to store Teslor
• 6. Contents of the packaging and other information

1. What is Teslor and what is it used for

Teslor is an antiallergic medicine that does not cause drowsiness. It facilitates the control of allergic reactions and their symptoms.
Teslor alleviates symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older.
The symptoms include: sneezing, runny discharge or nasal itching, itching of the palate and itching, redness or tearing of the eyes.
Teslor is also used to alleviate symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: skin itching and urticaria.
The alleviation of these symptoms lasts throughout the day, making it easier to return to normal, daily activities and normal sleep.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Teslor

When not to take Teslor

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

Warnings and precautions

Before starting to take Teslor, the patient should consult a doctor or pharmacist:

• if the patient has kidney function disorders;
• if the patient has a history of seizures or a family history of seizures.

Children and adolescents

This medicine should not be given to children under 12 years of age.

Teslor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no known interactions between Teslor and other medicines.

Taking Teslor with food, drink, and alcohol

Teslor can be taken with or without food.
Care should be taken when taking Teslor with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Teslor is not recommended during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or use machines. However, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects the patient.

3. How to take Teslor

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.

• Adults and adolescents (12 years and older):
• The recommended dose is one tablet once a day, taken with water, with or without food. This medicine is intended for oral use. The tablet should be swallowed whole.

The duration of treatment with Teslor will be determined by the doctor, depending on the type of allergic rhinitis the patient has.
If the patient has intermittent allergic rhinitis (symptoms occur for less than 4 days a week or for less than 4 weeks), the doctor will recommend a treatment schedule based on the patient's medical history.
If the patient has persistent allergic rhinitis (symptoms occur for 4 or more days a week and for more than 4 weeks), the doctor may recommend longer use of the medicine.
In the case of urticaria, the duration of treatment may vary from patient to patient. Therefore, the patient should follow the doctor's recommendations.

Taking a higher dose of Teslor than recommended

Teslor should be taken as directed by a doctor. There should be no serious disorders after accidental overdose of the medicine. However, if a higher dose of Teslor than recommended is taken, the patient should consult a doctor or pharmacist.

Missing a dose of Teslor

If a dose is missed, it should be taken as soon as possible, and then the patient should return to their regular dosing schedule.
A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Teslor can cause side effects, although not everybody gets them.
After the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) have been reported. If any of these severe side effects occur, the patient should stop taking the medicine and consult a doctor immediately.
In clinical trials in adults, side effects were almost the same as 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 of desloratadine:

• Frequent:may occur in up to 1 in 10 patients
• fatigue;
• dry mouth;
• headache.

Adults
After the marketing of desloratadine, the following side effects have been reported:

• Very rare:may occur in up to 1 in 10,000 patients
• severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling);
• rash;
• palpitations and irregular heartbeat;
• rapid heartbeat;
• abdominal pain;
• nausea (vomiting);
• vomiting;
• upset stomach;
• diarrhea;
• dizziness;
• drowsiness;
• insomnia;
• muscle pain;
• hallucinations;
• seizures;
• restlessness with excessive motor activity;
• hepatitis;
• abnormal liver function test results.

Frequency not known:frequency cannot be estimated from the available data

• unusual weakness;
• jaundice of the skin and/or eyes;
• increased skin sensitivity to sunlight, even on cloudy days, and to UV radiation (e.g., in a solarium);
• changes in heart rhythm;
• unusual behavior;
• aggressive behavior;
• weight gain;
• increased appetite.

Children
Frequency not known(frequency cannot be estimated from the available data):

• slow heartbeat;
• changes in heart rhythm;
• unusual behavior;
• aggressive behavior;
• weight gain;
• increased appetite.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration 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, 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 the medicine.

5. How to store Teslor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
Lot means batch number.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Teslor contains

• The active substance of the medicine is desloratadine in a dose of 5 mg.
• The other ingredients are: microcrystalline cellulose, maize starch, magnesium stearate, and anhydrous colloidal silica. Additionally, the tablet coating Opadry Blue03A30735consists of: hypromellose 6cP, titanium dioxide (E 171), microcrystalline cellulose, stearyl alcohol, and indigo carmine (E 132).

What Teslor looks like and what the packaging contains

Teslor, 5 mg, are blue, round, and biconvex film-coated tablets.
The medicine is packaged in blisters of 10 film-coated tablets.
The packaging contains 10 or 30 film-coated tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151

• 95-200 Pabianice, Poland (logo)

Manufacturer

Genepharm S.A.
18km Marathon Avenue
15351 Pallini
Greece

Date of last revision of the leaflet: