Teslor

Leaflet included in the packaging: patient information

Teslor, 0.5 mg/ml, oral solution

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 for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any undesirable symptoms occur, including any undesirable symptoms not mentioned in this leaflet, you should inform your 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 helps control 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 allergy to dust mites))
in adults, adolescents, and children over 1 year of age. The symptoms include: sneezing, runny nose or itching of the nose, 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, you 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 1 year of age.

Teslor and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is taking or has recently taken, as well as about medicines that the patient plans to take.
There are no known interactions between Teslor and other medicines.

Teslor with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Fertility

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

Driving and using machines

It is not expected that this medicine will affect the ability to drive or use machines.
Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects them.

Teslor contains sorbitol, propylene glycol

Sorbitol

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

Propylene glycol

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

3. How to take Teslor

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

Children

Children from 1 to 5 years of age:
the recommended dose is 2.5 ml (½ measuring spoon of 5 ml) of oral solution once a day.
Children from 6 to 11 years of age:
The recommended dose is 5 ml (one measuring spoon of 5 ml) of oral solution once a day.

Adults and adolescents over 12 years of age:

The recommended dose is 10 ml (two measuring spoons of 5 ml) of oral solution once a day.
If a measuring spoon or oral syringe is provided with the bottle of oral solution, it can be used to measure the correct amount of oral solution.
This medicine is intended for oral use.
The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food.
The duration of treatment with Teslor will be determined by the doctor based on the type of allergic rhinitis that 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 only be taken as directed. There should not be any serious disorders after accidental overdose of the medicine. However, if a higher dose of Teslor than recommended is taken, you should consult a doctor or pharmacist.

Missing a dose of Teslor

If a dose of the medicine is missed, it should be taken as soon as possible, and then the regular dosing schedule should be resumed.
A double dose should not be taken to make up for the missed dose.

Stopping the use of Teslor

If there are any further doubts about the use of this medicine, you 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 angioedema) have been reported. If any of these severe side effects occur, you should stop taking the medicine and consult a doctor immediately.
In clinical trials, most children and adults experienced side effects that were almost the same as those after taking a placebo or a tablet that did not contain the active substance. However, in children under 2 years of age, common side effects were diarrhea, fever, and insomnia, while in adult patients, fatigue, dry mouth, and headache were reported more frequently than after taking a placebo.
The following side effects have been reported in clinical trials of desloratadine:
Children
Common:may occur in up to 1 in 10 children

• diarrhea;
• fever;
• insomnia.

Adults
Common:may occur in up to 1 in 10 patients

• fatigue;
• dry mouth;
• headache.

After the marketing of desloratadine, the following side effects have been reported:
Adults
Very rare:may occur in up to 1 in 10,000 patients

• severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and angioedema);
• 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 in cloudy weather, and to UV radiation (ultraviolet), for example, to UV radiation 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;
• unusual behavior;
• aggressive behavior;
• changes in heart rhythm;
• weight gain;
• increased appetite.

Reporting side effects

If any side effects occur, including any side effects not mentioned in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 helps 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.
This medicine should not be used after the expiry date stated on the packaging and bottle after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature.
Store in the original packaging.
Teslor should not be used if a change in the appearance of the oral solution is observed.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your 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 0.5 mg in 1 ml.
• The other ingredients are: sodium citrate, liquid sorbitol, sucralose, anhydrous citric acid, propylene glycol, hypromellose, Tutti Frutti flavor, and purified water.

What Teslor looks like and what the packaging contains

Teslor, oral solution is available in bottles with a child-resistant closure.
A measuring spoon or oral syringe is provided with the 60 ml and 150 ml packs.
The oral syringe allows for the measurement of a dose of 2.5 and 5 ml.
The measuring spoon allows for the measurement of a dose of 2.5 and 5 ml.
The medicine is available in bottles of 60 ml and 150 ml.

Marketing authorization holder and manufacturer

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

• 95-200 Pabianice, Poland (logo)

Date of the last update of the leaflet: