Package leaflet: Information for the patient

AlergoTeva, 5 mg, coated tablets
Desloratadine
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents

What AlergoTeva is and what it is used for
Important information before taking AlergoTeva
How to take AlergoTeva
Possible side effects
How to store AlergoTeva
Contents of the pack and other information

1. What AlergoTeva is and what it is used for

What AlergoTeva is
AlergoTeva contains the active substance desloratadine, which has antihistaminic properties.
How AlergoTeva works
AlergoTeva is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When AlergoTeva should be used
AlergoTeva relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents 12 years of age and older. These symptoms include: sneezing, watery or itchy nose, itching of the palate, and itchy, red, or watery eyes.
AlergoTeva is also used to relieve symptoms of urticaria (a skin condition caused by allergy). Symptoms of this condition include: itchy skin and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep normally.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using AlergoTeva

When not to use 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, consult your doctor, pharmacist, or nurse:

if the patient has kidney function disorders;
if the patient has a personal or family 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 between AlergoTeva and other medicines are known.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
AlergoTeva with food, drink and alcohol
AlergoTeva can be taken with or without food.
Caution should be exercised when taking AlergoTeva with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The use of AlergoTeva is not recommended 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 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 alertness, such as driving or operating machinery, until the patient knows how they react to this medicine.

3. How to use AlergoTeva

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, 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.
Your doctor or pharmacist will determine the duration of treatment with AlergoTeva based on the type of allergic rhinitis affecting the patient.
If the patient has intermittent allergic rhinitis (symptoms occurring for fewer than 4 days per week or for fewer than 4 weeks), your doctor or pharmacist will recommend a treatment regimen considering the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks), your doctor or pharmacist may recommend longer-term use of the medicine.
In urticaria, the duration of treatment may vary among individual patients, so the patient should follow the doctor's or pharmacist's advice.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Do not take AlergoTeva for longer than 10 days unless otherwise directed by a doctor.
Taking more AlergoTeva than recommended
AlergoTeva should be taken as directed by your doctor or pharmacist. Serious adverse effects are not expected after accidental overdose. However, if you take more than the recommended dose of AlergoTeva, inform your doctor, pharmacist, or nurse immediately.
If you forget to take AlergoTeva
If you miss a dose at the scheduled time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping AlergoTeva
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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, discontinue use of the medicine immediately and consult a doctor without delay.

In clinical trials involving adult patients, adverse reactions were almost the same as those observed with placebo tablets (tablets without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, the most commonly reported adverse reaction was headache.

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

Common (may occur in up to 1 in 10 patients):

fatigue
dry mouth
headache

After desloratadine was introduced to the market, the following adverse reactions have been reported:

Very rare (may occur in up to 1 in 10,000 patients):

severe allergic reactions
rash
palpitations or irregular
rapid heartbeat
abdominal pain
vomiting
stomach discomfort
nausea
dizziness
somnolence
diarrhoea
muscle pain
hallucinations
insomnia
restlessness
hepatitis
convulsions
hyperkinesia
abnormal liver function test results

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

unusual weakness
jaundice (yellowing of the skin and/or eyes)
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
low mood
dry eyes

Additional adverse reactions occurring in children:

Unknown (frequency cannot be estimated from the available data):

slow heartbeat
change in heart rhythm
unusual behaviour
aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Adverse reactions can also be reported to the marketing authorization holder.

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

5. How to store AlergoTeva

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.
No special storage conditions are required for this medicine.
Inform your pharmacist if you notice any change in the appearance of the tablet.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What AlergoTeva contains

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

What AlergoTeva looks like and contents of the pack
Blue, round, film-coated tablets, 6 mm in diameter, biconvex, marked with an embossed "LT" on one side.
AlergoTeva 5 mg, film-coated tablets are packed in blisters containing: 7 or 10 tablets.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
For further information about the medicinal product and its names in the European Economic Area member states, please contact the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.