Desloratadine Sopharma

B. PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: information for the patient

Desloratadine Sopharma, 0.5 mg/ml, oral solution

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 you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any doubts.
• 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.
• If you experience any side effects, you should tell your doctor, pharmacist, or nurse. This also applies to any possible side effects not listed 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 Sopharma is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Desloratadine Sopharma

Desloratadine Sopharma relieves 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, adolescents, and children over 1 year of age. These symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes.
Desloratadine Sopharma is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
The 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 use Desloratadine Sopharma:

Warnings and precautions

Before taking Desloratadine Sopharma, you should consult a doctor, pharmacist, or nurse:

Use in children and adolescents

Do not give this medicine to children under 1 year of age.

Desloratadine Sopharma and other medicines

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

Desloratadine Sopharma with food, drink, and alcohol

Desloratadine Sopharma can be taken with or without food.
You should be cautious when taking Desloratadine Sopharma with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult a doctor or pharmacist before taking this medicine.
It is not recommended to take Desloratadine Sopharma if you are pregnant or breastfeeding.
Fertility
There is no available data 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 operating machinery, until you know how you react to this medicinal product.

Desloratadine Sopharma contains sorbitol and propylene glycol

This medicine contains 375 mg of sorbitol per 2.5 ml, which corresponds to 150 mg/ml. Patients with hereditary fructose intolerance should not take this medicinal product.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder where the person cannot break down fructose, you should talk to your doctor before taking this medicine.
This medicine contains approximately 127 mg of propylene glycol per 2.5 ml, which corresponds to 50.67 mg/ml.

3. How to take Desloratadine Sopharma

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Use in children

Children from 1 to 5 years of age:
The recommended dose is 2.5 ml of oral solution once a day.
Children from 6 to 11 years of age:
The recommended dose is 5 ml of oral solution once a day.
To administer the correct volume of oral solution, you should use the measuring syringe provided with the packaging.

Adults and adolescents over 12 years of age:

The recommended dose is 10 ml of oral solution once a day.
To administer the correct volume of oral solution, you should use the measuring cup or the measuring syringe provided with the packaging.
This medicine is intended for oral use.
The dose of oral solution should be swallowed and followed by water. The medicine can be taken with or without food.
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 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 persistent allergic rhinitis (symptoms occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend longer treatment with the medicine.
In the case of urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking a higher dose of Desloratadine Sopharma than recommended

Desloratadine Sopharma should only be taken as prescribed. If you accidentally take more than the recommended dose, you should tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Desloratadine Sopharma

If you miss a dose, you should take it as soon as possible and then continue with the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Desloratadine Sopharma

If you have any further questions about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Desloratadine Sopharma can cause side effects, although not everybody gets them.
After the marketing of desloratadine, 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 consult your doctor immediately.
In clinical trials, most children and adults experienced side effects with desloratadine that were almost the same as with a placebo or a tablet that does not contain the active substance.
However, in children under 2 years of age, common side effects were diarrhea, fever, and insomnia, while in adult patients, fatigue, dry mouth, and headache were observed more frequently than with a placebo.
The following side effects have been reported in clinical trials with desloratadine:
Children
Common (may affect up to 1 in 10 children):

• diarrhea
• fever
• insomnia

Adults
Common (may affect up to 1 in 10 people):

• fatigue
• dry mouth
• headache

After the marketing of desloratadine, the following side effects have been reported:
Adults
Very rare (may affect up to 1 in 10,000 people):

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness with excessive motor activity
• rash
• abdominal pain
• nausea
• drowsiness
• hallucinations
• hepatitis
• palpitations or irregular heartbeat
• nausea
• diarrhea
• insomnia
• seizures
• abnormal liver function test results Unknown (frequency cannot be estimated from the available data):
• unusual weakness
• jaundice
• increased sensitivity of the skin to sunlight and UV radiation (even in cloudy weather), for example, in a solarium.
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• low mood
• dry eyes

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

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

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 listed in this leaflet. You can also report side effects directly to the Department of Post-Marketing Surveillance 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, e-mail: [email protected]. You can also report side effects 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle (after EXP).
The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
The medicine does not require special precautions for storage temperature.
Store in the original packaging to protect from light.
Shelf life after first opening the bottle: 6 months.
Do not use this medicine if you notice any changes in the appearance of the solution.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Desloratadine Sopharma contains

• The active substance is desloratadine. 1 ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients are: liquid sorbitol, non-crystallizing (E420), propylene glycol (E1520), sucralose (E955), hypromellose 15 cP, sodium citrate, sour cherry flavor (D-limonene, benzaldehyde, alpha-terpineol, 2-phenylethanol, triacetin, propylene glycol), citric acid monohydrate, disodium edetate, and purified water.

What Desloratadine Sopharma looks like and contents of the packaging

Desloratadine Sopharma is a clear, colorless liquid with a cherry flavor.
Desloratadine Sopharma is available in 120 ml bottles with a dark brown glass (type III) or PET, equipped with a ring that allows detection of tampering with the packaging and a LDPE liner, with a child-resistant closure.
A measuring cup (allowing measurement of 2.5 ml, 5 ml, 10 ml, 15 ml, and 20 ml or 2.5 ml, 3 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml, and 20 ml) and a measuring syringe (allowing measurement of 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, and 5 ml) are provided with the packaging to administer the medicinal product.

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
Date of revision of the leaflet:11.08.2023