Alergoteva

Package Leaflet: Information for the Patient

AlergoTeva, 5 mg, Film-Coated Tablets

Desloratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is AlergoTeva and what is it used for

What is AlergoTeva

AlergoTeva contains the active substance desloratadine, which has antihistamine properties.

How AlergoTeva works

AlergoTeva is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to take AlergoTeva

AlergoTeva relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. AlergoTeva is also used to relieve symptoms associated with urticaria (hives). These symptoms include itchy skin and hives. Relief of these symptoms persists 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 after 3 days, they should consult their doctor.

2. Important information before taking AlergoTeva

When not to take AlergoTeva

• 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 taking AlergoTeva, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has kidney problems;
• if the patient has a history of seizures.

Children and adolescents

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

AlergoTeva and other medicines

No interactions with other medicines are known. The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

AlergoTeva with food, drink, and alcohol

AlergoTeva can be taken with or without food. The patient should be cautious when taking AlergoTeva with alcohol.

Pregnancy, breastfeeding, and fertility

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

Fertility

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

Driving and using machines

It is unlikely 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.

3. How to take AlergoTeva

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their 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 for oral use. The tablet should be swallowed whole. The doctor or pharmacist will determine the duration of treatment with AlergoTeva based on the type of allergic rhinitis the patient has. If the patient has intermittent allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), the doctor or pharmacist will recommend a treatment schedule based on the patient's medical history. If the patient has persistent allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), the doctor or pharmacist may recommend longer use of the medicine. In urticaria, the duration of treatment may vary from patient to patient, so the patient should follow the doctor's or pharmacist's advice. If there is no improvement or the patient feels worse after 3 days, they should consult their doctor. The patient should not take AlergoTeva for more than 10 days unless their doctor advises otherwise.

Taking a higher dose of AlergoTeva than recommended

AlergoTeva should be taken as directed by the doctor or pharmacist. If the patient accidentally takes more than the recommended dose, they should inform their doctor, pharmacist, or nurse immediately.

Missing a dose of AlergoTeva

If the patient misses a dose, they should take it as soon as possible and then continue with their regular dosing schedule. The patient should not take a double dose to make up for a missed dose.

Stopping treatment with AlergoTeva

If the patient has any further questions about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, AlergoTeva can cause side effects, although not everybody gets them. After desloratadine was made available, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) were reported. If any of these severe side effects occur, the patient should stop taking the medicine and consult their doctor immediately. In clinical studies, side effects in adults were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more often than with a placebo. In adolescents, the most commonly reported side effect was headache. The following side effects were reported in clinical studies with desloratadine: Frequent(may affect up to 1 in 10 people): fatigue, dry mouth, headache. The following side effects were reported after desloratadine was made available: Very rare(may affect up to 1 in 10,000 people): severe allergic reactions, rash, palpitations or irregular heartbeat, fast heartbeat, abdominal pain, vomiting, stomach upset, nausea, dizziness, drowsiness, diarrhea, muscle pain, hallucinations, insomnia, restlessness with increased physical activity, hepatitis, seizures, abnormal liver function test results. Frequency not known(frequency cannot be estimated from the available data): unusual weakness, yellowing of the skin and/or eyes, increased sensitivity of the skin to sun, even in cloudy weather, and to UV (ultraviolet) radiation, such as UV radiation in a solarium, changes in heartbeat, unusual behavior, aggressive behavior, weight gain, increased appetite, low mood, dry eyes. Additional side effects reported in children: Unknown(frequency cannot be estimated from the available data): slow heartbeat, changes in heartbeat, unusual behavior, aggressive behavior.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store AlergoTeva

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. If the patient notices any change in the appearance of the tablet, they should inform their pharmacist. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What AlergoTeva contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are: tablet core: microcrystalline cellulose, maize starch, mannitol, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine (E132), lactose.

What AlergoTeva looks like and contents of the pack

Blue, round, film-coated tablets, 6 mm in diameter, biconvex, with "LT" embossed on one side. AlergoTeva 5 mg, film-coated tablets are packaged in blisters containing 7 or 10 tablets.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw

Manufacturer

Actavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

To obtain more detailed information on the medicine and its authorized names in the Member States of the European Economic Area, the marketing authorization holder should be contacted:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.

Date of last revision of the leaflet: August 2022