TESLOR

Package leaflet: Information for the patient

Teslor, 5 mg, coated tablets
Desloratadinum
Please read carefully all the information in this leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Teslor is and what it is 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 pack and other information

1. What Teslor is and what it is used for

Teslor is an antihistamine medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Teslor relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, watery or itchy nose, itching of the palate, as well as itchy, red or watery eyes.
Teslor is also used to relieve symptoms associated with urticaria (skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief of these symptoms lasts throughout the day, helping the patient return to normal daily activities and sleep.
If there is no improvement or if the patient feels worse, 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, consult a doctor or pharmacist:

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

Children and adolescents
This medicine must not be given to children under 12 years of age.

Teslor and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
No interactions between Teslor and other medicines are known.

Taking Teslor with food, drink and alcohol
Teslor may be taken with or without food.
Caution is advised when taking Teslor with alcohol.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Teslor is not recommended during pregnancy or breastfeeding.

Fertility
There is no available data on the effect of Teslor on fertility in men and women.

Driving and using machines
This medicine, when taken at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to refrain from activities requiring mental concentration, such as driving or operating machinery, until the individual's response to this medicine has been established.

3. How to take Teslor

This medicine should always be taken according to the instructions given by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Adults and adolescents (aged 12 years and older):
• The recommended dose is one tablet once daily, 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 treating physician after establishing the type of allergic rhinitis present in the patient.
If the patient suffers from intermittent allergic rhinitis (symptoms occurring for less than 4 days per week or for less than 4 weeks), the treating physician will recommend a treatment regimen based on the previous course of the disease.
If the patient suffers from persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks), the treating physician may recommend longer-term use of the medicine.
In the case of urticaria, the duration of treatment may vary between individual patients. Therefore, the patient should follow the treating physician's instructions.

Taking more than the recommended dose of Teslor
Teslor should be taken according to the doctor's instructions. Serious adverse effects are unlikely following accidental overdose. However, if more than the recommended dose of Teslor has been taken, contact your doctor or pharmacist.

Missing a dose of Teslor
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.

After desloratadine was introduced into clinical use, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria and swelling) have been reported. If any of these severe adverse reactions occur, treatment should be discontinued immediately and you should consult a doctor without delay.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo tablet (a tablet without active substance). However, fatigue, dry mouth and headache were reported more frequently than with the placebo tablet. In adolescents, headache was the most commonly reported adverse reaction.

The following adverse reactions have been reported during clinical trials with desloratadine:

Common: may occur in at least 1 in 10 patients

• fatigue;
• dry mouth;
• headache.

Adults

After desloratadine was placed on the market, the following adverse reactions have been reported:

Very rare: may occur in less than 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;
• stomach discomfort;
• diarrhoea;
• dizziness;
• drowsiness;
• insomnia;
• muscle pain;
• hallucinations;
• convulsions;
• restlessness with excessive motor activity;
• hepatitis;
• abnormal liver function test results.

Frequency unknown: frequency cannot be estimated from available data

• unusual weakness;
• yellowing of the skin and/or eyes (jaundice);
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds;
• changes in heartbeat rhythm;
• unusual behaviour;
• aggressive behaviour;
• weight gain;
• increased appetite.

Children

Frequency unknown: frequency cannot be estimated from available data

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

Reporting of adverse reactions

If you experience any adverse reactions, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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]. Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Teslor

Keep this medicine 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 stated month.
LOT is the batch number.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such actions help protect the environment.

6. Contents of the pack and other information

What Teslor contains

• The active substance is desloratadine 5 mg.
• The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, magnesium stearate, and anhydrous colloidal silicon dioxide. Additionally, the tablet coating Opadry Blue 03A30735 consists of: hypromellose 6cP, titanium dioxide (E 171), microcrystalline cellulose, stearic acid, and indigo carmine (E 132).

What Teslor looks like and contents of the pack
Teslor 5 mg are blue, round, film-coated tablets, convex on both sides.
The medicine is packed in blisters of 10 film-coated tablets.
Pack sizes contain 10 or 30 film-coated tablets.
Marketing Authorisation 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