Kevenix

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Kevenix, 5 mg, Oral Disintegrating Tablets

Desloratadine

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Kevenix and what is it used for

What is Kevenix

Kevenix contains desloratadine, which is an antihistamine.

How Kevenix works

Kevenix is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Kevenix

Kevenix relieves the 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 and adolescents aged 12 years and older. The symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Kevenix is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms include: skin itching and urticaria. The 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 if you feel worse, you should consult a doctor.

2. Before you take Kevenix

When not to take Kevenix

• if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions

Before taking Kevenix, you should discuss it with your doctor or pharmacist:

• if you have kidney problems,
• if you have a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Kevenix with other medicines

No interactions with other medicines are known. However, tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about medicines you plan to take.

Kevenix with food, drink, and alcohol

Taking Kevenix does not require drinking water or any other liquid. Additionally, Kevenix can be taken with or without food. You should be cautious when taking Kevenix with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Kevenix during pregnancy or breastfeeding. FertilityThere are no available data on the effect on fertility in males and females.

Driving and using machines

It is unlikely that Kevenix, when taken as recommended, will affect your 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 you know how this medicine affects you.

Kevenix oral 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 to people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Kevenix oral disintegrating tablets contain sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per oral disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Kevenix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is:

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

This medicine is for oral use only. Before taking, carefully open the blister and remove the oral disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed 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 you have. If you have seasonal allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your medical history. If you have perennial allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term use of the medicine. For urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Take more Kevenix than you should

Kevenix should be taken only as prescribed. In case of accidental overdose, no serious disorders should occur. However, if you take more Kevenix than you should, tell your doctor or pharmacist immediately.

Forget to take Kevenix

If you forget to take a dose at the right time, take it as soon as you remember, and then continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

Stop taking Kevenix

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After desloratadine was marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) were reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately. In adults, side effects were almost the same as after taking a placebo. However, fatigue, dry mouth, and headache were reported more often than after taking a placebo. In adolescents, the most commonly reported side effect was headache. The following side effects were reported in clinical trials with desloratadine:

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

The following side effects were reported after desloratadine was marketed.

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

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness with excessive physical activity
• rash
• abdominal pain
• upset stomach
• drowsiness
• hallucinations
• hepatitis
• palpitations and irregular heartbeat
• nausea
• diarrhea
• insomnia
• seizures
• abnormal liver function tests

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

• unusual weakness
• increased skin sensitivity to the sun, even in cloudy weather, and to UV radiation (e.g., in a solarium)
• unusual behavior
• changes in heart rhythm
• weight gain, increased appetite
• yellowing of the skin and/or eyes
• aggressive behavior

Additional side effects in children and adolescents

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

• slow heartbeat
• unusual behavior
• changes in heart rhythm
• aggressive behavior

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kevenix

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. Do not use this medicine if you notice any visible signs of deterioration. Store in the original package. Protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Kevenix contains

• The active substance is desloratadine in a dose of 5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (to adjust pH).

What Kevenix looks like and contents of the pack

Kevenix 5 mg oral disintegrating tablets are brick-red, round, flat tablets with beveled edges, with the engraving "5". Kevenix is packaged in packs containing 30 oral disintegrating tablets.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Finland, the 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, Netherlands, Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany, Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Parallel importer:

BIJON medica, UAB, Jonavos str. 16A, LT-44269 Kaunas, Lithuania

Repackaged by:

UAB “Entafarma”, Klonėnų vs. 1, LT-19156 Širvintų r. sav., Lithuania, Marketing authorization number in Finland, the country of export: 29582

Parallel import authorization number: 173/22 Date of approval of the leaflet: 20.04.2022