Desloratadine Sopharma

B. INFORMATION LEAFLET INCLUDED IN THE PACKAGING

Information leaflet included in the packaging: information for the patient

Desloratadine Sopharma, 5 mg, film-coated tablets

Desloratadine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, you should consult a doctor or pharmacist. This also applies to any possible side effects not mentioned in this leaflet. See section 4.

Table of contents of the leaflet

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

1. What is Desloratadine Sopharma and what is it used for

What is Desloratadine Sopharma

Desloratadine Sopharma contains desloratadine - a substance with antihistamine action.

How Desloratadine Sopharma works

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

When to use Desloratadine Sopharma

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, e.g. hay fever or allergy to dust mites) in adults, adolescents, and children aged 12 and above. These symptoms include: sneezing, runny nose or nasal itching, itching of the palate, and itching, redness, or tearing of the eyes. Desloratadine is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Desloratadine Sopharma

When not to take Desloratadine Sopharma:

• 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 this medicine, you should consult a doctor or pharmacist:

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

Children and adolescents

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

Desloratadine Sopharma and other medicines

No interactions of desloratadine with other medicines are known. You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.

Desloratadine Sopharma with food, drink, and alcohol

Desloratadine tablets can be taken with or without food. You should be cautious when taking the medicine and consuming alcohol at the same time.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you think you may be pregnant or plan to become pregnant before taking this medicine, you should consult a doctor or pharmacist. Desloratadine is not recommended during pregnancy or breastfeeding. There are no available data on the effect of Desloratadine Sopharma on fertility in women and men.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended that you do not perform activities that require concentration, such as driving or using machines, until you know how you react to this medicinal product.

Desloratadine Sopharma contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. Desloratadine Sopharma contains sodiumin an amount of less than 1 mmol (23 mg) per dose, so it is essentially sodium-free.

3. How to take Desloratadine Sopharma

The medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

Use in adults and adolescents aged 12 and above:

The recommended daily dose is one tablet taken with water, with or without food. The medicine is intended for oral use. The tablet should be swallowed whole. The duration of treatment with Desloratadine Sopharma will be determined by your doctor, depending on the type of allergic rhinitis you have. If you have intermittent allergic rhinitis (symptoms that occur for less than four days a week or for less than four weeks), your doctor will recommend a treatment schedule based on your medical history. If you have persistent allergic rhinitis (symptoms that occur for four or more days a week and for more than four weeks), your doctor may recommend longer treatment with the medicine. The duration of treatment for urticaria may vary from person to person. Therefore, you should follow your doctor's recommendations.

Taking a higher dose of Desloratadine Sopharma than recommended

Desloratadine Sopharma should only be taken as directed. If you accidentally take more of the medicine than recommended, you should not experience serious problems. However, if you take a higher dose of Desloratadine Sopharma than recommended, you should immediately tell your doctor, pharmacist, or nurse.

Missing a dose of Desloratadine Sopharma

If you miss a dose, you should take it as soon as possible, and then return to the recommended dosing schedule. You should not take a double dose to make up for a missed dose. If you have any further doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After the introduction of desloratadine to the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, swelling) have been reported. If you experience any of these serious side effects, you should stop taking the medicine and immediately consult a doctor. In clinical trials, side effects in adults were almost the same as after taking placebo tablets. However, fatigue, dry mouth, and headache were observed more often than after taking a placebo tablet. In adolescents, the most commonly reported side effect was headache. In clinical trials of desloratadine, the following side effects were reported:

• fatigue
• dryness of the mouth
• headache

Adults

After the introduction of desloratadine to the market, the following side effects have been reported:

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• rash
• abdominal pain
• nausea
• drowsiness
• palpitations or irregular heartbeat
• nausea
• diarrhea
• insomnia
• seizures
• abnormal liver function test results

With unknown frequency (frequency cannot be estimated from the available data):

• muscle pain
• restlessness with excessive motor activity
• hallucinations
• hepatitis
• unusual weakness
• jaundice
• increased sensitivity of the skin to sunlight and UV radiation
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• low mood
• dry eyes

Children

With unknown frequency (frequency cannot be estimated from the available data):

• slow heartbeat
• changes in heart rhythm
• aggression
• abnormal behavior

Reporting side effects

If you experience any side effects, you should tell your doctor, pharmacist, or nurse. This also applies to any possible side effects not mentioned in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desloratadine Sopharma

The medicine should be stored out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton - after "EXP". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. 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 Desloratadine Sopharma contains

• The active substance of the medicine is desloratadine. One film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, corn starch, hypromellose 15 cP, talc, sodium stearyl fumarate, anhydrous colloidal silica.

Tablet coating: hypromellose 6 cP, lactose monohydrate, titanium dioxide (E171), macrogol 3350, indigo carmine (E132), quinoline yellow (E104), lacquer.

What Desloratadine Sopharma looks like and what the pack contains

Desloratadine Sopharma 5 mg is light blue, round, biconvex film-coated tablets with a diameter of 6 mm. Desloratadine Sopharma 5 mg, film-coated tablets are available in blisters of PVC/PCTFE/Aluminum in packs of 7, 10, 14, 28, 30, 56, or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o. Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

Sopharma AD 16 Iliensko Shosse Str. 1220 Sofia Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Десл5 mg филмирани таблетки Estonia: Desloratadine Sopharma Latvia: Desloratadine Sopharma 5 mg apvalkotās tabletes Lithuania: Desloratadine Sopharma 5 mg plėvele dengtos tabletės Poland: Desloratadine Sopharma Date of last revision of the leaflet:25.10.2024