Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.
Kevenix, 5 mg, orally disintegrating tablets
Desloratadinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Kevenix is and what it is used for

What Kevenix is
Kevenix contains desloratadine, which is an antihistamine medicine.
How Kevenix works
Kevenix is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Kevenix should be used
Kevenix 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, runny or itchy nose, itchy palate, as well as itchy, red or watery eyes.
Kevenix 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 their normal daily activities and sleep normally.
If there is no improvement or if the patient feels worse, consult a doctor.

2. Important information before using Kevenix

When not to use Kevenix

if the patient is allergic to desloratadine or to any of the other ingredients of the medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting to use Kevenix, consult your doctor or pharmacist:

if the patient has kidney function disorders,
if the patient has a history or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Kevenix and other medicines
No interactions between Kevenix 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.
Kevenix with food, drink and alcohol
Kevenix does not need to be taken with water or any other liquid. Additionally, Kevenix may be taken with or without food. Caution should be exercised when taking Kevenix 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 her doctor or pharmacist before using this medicine.
The use of Kevenix is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and using machines
It is not expected that Kevenix, when used at the recommended dose, affects the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the patient knows how this medicine affects them.
Kevenix orally disintegrating tablets contain aspartame (E 951)
The medicine contains 3 mg of aspartame in each 5 mg dose. Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Kevenix orally disintegrating tablets contain sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, meaning the medicine is considered "sodium-free".

3. How to take Kevenix

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is:

Adults and adolescents (aged 12 years and older): one 5 mg orodispersible tablet of Kevenix once daily, taken with or without food. The dose should be taken immediately after opening the blister.

This medicine is intended for oral use.
Before administration, carefully open the blister and remove the orodispersible tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or other liquids are not required to swallow the dose. The dose should be taken immediately after opening the blister.
The duration of treatment with Kevenix will be determined by your doctor, depending on the type of allergic rhinitis diagnosed in the patient.
If the patient has intermittent allergic rhinitis (symptoms occurring fewer than 4 days per week or for fewer than 4 weeks), your doctor will recommend a treatment regimen based on the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occurring on 4 or more days per week and for more than 4 weeks), your doctor may recommend long-term treatment.
In the case of urticaria, the duration of treatment may vary between individual patients. Therefore, the patient should follow the doctor's instructions.
Taking more Kevenix than recommended
Kevenix should only be taken as prescribed. Accidental overdose is not expected to cause severe adverse effects.
However, if you have taken more than the recommended dose of Kevenix, inform your doctor or pharmacist immediately.
Missing a dose of Kevenix
If you miss a dose at the scheduled time, take it as soon as possible and then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Kevenix
If you have any further questions about 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 everybody will experience them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported since desloratadine has been placed on the market. If any of these severe adverse reactions occur, you must stop taking the medicine immediately and consult a doctor without delay.

In adults, adverse reactions were almost the same as 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 affect up to 1 in 10 patients

fatigue
dry mouth
headache

The following adverse reactions have been reported since desloratadine has been placed on the market:

Very rare: may affect up to 1 in 10,000 patients

severe allergic reactions
rapid heartbeat
vomiting
dizziness
muscle pain
restlessness with increased motor activity
rash
abdominal pain
stomach upset
somnolence (drowsiness)
hallucinations
hepatitis
palpitations and irregular heartbeat
nausea
diarrhoea
insomnia
seizures
abnormal liver function test results

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

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

Additional adverse reactions in children and adolescents

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

slow heartbeat
unusual behaviour
changes in heart rhythm
aggressive behaviour

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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

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

5. How to store Kevenix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Store in the original packaging. Protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Kevenix contains

The active substance is desloratadine 5 mg.
The other ingredients are: potassium polyacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavour (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray dried), potassium hydroxide (for pH adjustment).

What Kevenix looks like and contents of the pack
Kevenix 5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges, embossed with the number "5".
Kevenix is packed in packs containing 30 orodispersible tablets.
For further information, please contact the responsible party
or parallel importer.
Responsible party in Finland, country of export:
SanoSwiss UAB
Lvovo 25-701
LT-09320 Vilnius
Lithuania
Manufacturer:
Genepharm S.A.
18 km Marathon Avenue
15351 Pallini
Greece
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Parallel importer:
BIJON medica, UAB
Jonavos str. 16A
LT-44269 Kaunas
Lithuania
Repackaged in:
UAB “Entafarma”
Klonėnų vs. 1
LT-19156 Širvintos district
Lithuania
Marketing authorisation number in Finland, country of export: 29582
Parallel import authorisation number: 173/22