Teslor

Package leaflet: Information for the patient

Teslor, 0.5 mg/ml, oral solution
Desloratadinum
Please read carefully the entire 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, please 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 someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

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 antiallergic 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, adolescents, and children above 1 year of age. These symptoms include: sneezing, watery or itchy nose, itching of the palate, and itching, redness or watering of the eyes.
Teslor is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and enabling normal 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 of seizures or a family history of seizures.

Children and adolescents
This medicine should not be given to children during the first year of life.

Teslor and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No interactions between Teslor and other medicines are known.

Teslor, food, drink and alcohol
Teslor may be taken with or without food.
Caution should be exercised when taking Teslor with alcohol.

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

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

Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects 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 the medicine is known.

Teslor contains sorbitol and propylene glycol

Sorbitol
The medicine contains 150 mg of sorbitol in each 1 ml of syrup.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—has been diagnosed in the patient, the patient should consult a doctor before taking the medicine or giving it to a child.

Propylene glycol
The medicine contains 150 mg of propylene glycol in each 1 ml of syrup.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Teslor

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Children

Children aged 1 to 5 years:
The recommended dose is 2.5 ml (½ measuring spoon with a capacity of 5 ml) of oral solution once daily.

Children aged 6 to 11 years:
The recommended dose is 5 ml (one 5 ml measuring spoon) of oral solution once daily.

Adults and adolescents aged 12 years and older:
The recommended dose is 10 ml (two 5 ml measuring spoons) of oral solution once daily.

If an oral syringe is supplied with the bottle of oral solution, it may be used interchangeably to measure the appropriate volume of oral solution.

This medicine is intended for oral use.
The dose of oral solution should be swallowed and followed with water. The medicine may be taken with or without food.

The duration of treatment with Teslor will be determined by the attending physician after establishing the type of allergic rhinitis present in the patient.

If the patient suffers from intermittent allergic rhinitis (symptoms occur for less than 4 days per week or for less than 4 weeks), the attending physician will recommend a treatment regimen based on the previous course of the disease.

If the patient suffers from persistent allergic rhinitis (symptoms occur for 4 or more days per week and for more than 4 weeks), the attending physician may recommend prolonged use of the medicine.

In cases of urticaria, the duration of treatment may vary between individual patients. Therefore, the patient should follow the instructions of the attending physician.

Taking more Teslor than recommended

Teslor should only be taken as prescribed. Severe adverse effects are unlikely to occur after accidental overdose. However, if a dose higher than recommended is taken, contact a 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.

Stopping Teslor treatment

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe adverse reactions occur, treatment should be discontinued and medical advice should be sought immediately.

In clinical trials, adverse reactions in most children and adults were almost the same as those observed after administration of a solution or tablet not containing active substance. However, in children under 2 years of age, common adverse reactions included diarrhoea, fever, and insomnia, whereas in adult patients fatigue, dry mouth, and headache were reported more frequently than with placebo tablet.

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

Children
Common: may occur in less than 1 in 10 children

• diarrhoea;
• fever;
• insomnia.

Adults
Common: may occur in less than 1 in 10 patients

• fatigue;
• dry mouth;
• headache.

Since desloratadine has been marketed, the following adverse reactions have been reported:

Adults
Very rare: may occur in less than 1 in 10,000 patients

• severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling);
• rash;
• palpitations and irregular heartbeat;
• rapid heartbeat;
• abdominal pain;
• nausea (feeling sick);
• vomiting;
• gastrointestinal discomfort;
• diarrhoea;
• dizziness;
• somnolence (drowsiness);
• insomnia;
• muscle pain;
• hallucinations;
• seizures;
• restlessness with increased motor activity;
• hepatitis;
• abnormal liver function tests.

Frequency not known: 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 in sunbeds;
• changes in heart rhythm;
• unusual behaviour;
• aggressive behaviour;
• weight gain;
• increased appetite.

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

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

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can also 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 may also be reported to the marketing authorization holder.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Teslor

Keep Teslor out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements for this medicinal product.
Store in the original immediate packaging.
Do not use Teslor if you notice any change in the appearance of the oral solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Teslor contains

• The active substance is desloratadine at a dose of 0.5 mg in 1 ml.
• The other ingredients are: sodium citrate, liquid sorbitol, sucralose, anhydrous citric acid, propylene glycol, hypromellose, Tutti Frutti flavouring, liquid, and purified water.

What Teslor looks like and contents of the pack
Teslor oral solution is available in bottles closed with a screw cap with child-resistant closure.
A measuring spoon or an oral syringe is supplied with 60 ml and 150 ml pack sizes.
The oral syringe allows measuring doses of 2.5 ml and 5 ml.
The measuring spoon allows measuring doses of 2.5 ml and 5 ml.
The medicine is available in 60 ml and 150 ml bottles.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95 - 200 Pabianice
Poland
(logo)