Desloratadina kern pharma 0,5 mg/ml solucion oral efg

Label: Information for the User

Desloratadina Kern Pharma 0.5 mg/ml Oral Solution EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Desloratadina oral solution is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy). These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina oral solution is also used to relieve symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

Do not take Desloratadina Kern Pharma

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

Desloratadina Kern Pharma is indicated for children aged 1 to 11 years, adolescents (from 12 years of age), and adults, including the elderly.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Desloratadina Kern Pharma:

• if you have impaired renal function.
• if you have a personal or family history of seizures.

Use of Desloratadina Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

No known interactions exist between desloratadine and other medications.

Use of Desloratadina Kern Pharma with food, drinks, and alcohol

Desloratadine can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, it is not recommended to take desloratadine oral solution.

Driving and operating machinery

At the recommended dose, desloratadine is not expected to cause drowsiness or impair your ability to pay attention. However, very rarely, some people may experience drowsiness, which can affect your ability to drive or operate machinery.

Desloratadina Kern Pharma oral solution contains sorbitol.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Desloratadina Kern Pharma oral solution contains propylene glycol.

This medication contains 200 mg of propylene glycol in each ml of product.

The concurrent administration with any alcohol dehydrogenase substrate such as ethanol may cause severe adverse reactions in newborns.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Children aged 1 to 5 years: take 2.5 ml of oral solution once a day.

Children aged 6 to 11 years: take 5 ml of oral solution once a day.

Adults and adolescents (12 years of age and older): take 10 ml of oral solution once a day.

Plastic bottle with dosing syringe: Use the dosing syringe contained in the package with the oral solution bottle to take the correct amount of oral solution.

Glass bottle with measuring cup: Use the measuring cup contained in the package with the oral solution bottle to take the correct amount of oral solution.

Swallow the oral solution dose, and then drink a little water. You can take this medication with or without food.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take Desloratadina Kern Pharma oral solution.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment plan based on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, and you should follow your doctor's instructions.

If you take more Desloratadina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desloratadina Kern Pharma

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Desloratadina Kern Pharma

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Desloratadina Kern Pharma may produce adverse effects, although not all people will experience them.

In most children and adults, the adverse effects with oral desloratadina were approximately the same as with a solution or a tablet that does not contain an active ingredient. However, frequent adverse effects in children under 2 years of age were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain an active ingredient.

During the marketing of desloratadina in oral solution, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruption have been reported. Very rare cases of palpitations, rapid heartbeats, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, convulsions, agitation with increased body movement, liver inflammation, and alteration in liver function tests have also been reported.

Adults

Unknown frequency: the frequency cannot be estimated from available data

- Abnormal behavior

- Aggression

- Weight gain

- Increased appetite

- Depressed mood

- Dry eyes

Children

Unknown frequency: the frequency cannot be estimated from available data

• Slow heart rate- Changes in heart rhythm
• Abnormal behavior- Aggression

- Depressed mood

- Dry eyes

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not freeze. Store in the original packaging.

Once opened, the contents of the bottle must be used within 6 months.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any change in the appearance of the oral solution.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

Composition of Desloratadina Kern Pharma

• The active ingredient is Desloratadina. Each ml of oral solution contains 0.5 mg of desloratadina.
• The other components of the oral solution are: sorbitol (E420), propylene glycol (E1520), sodium saccharin (E954), sodium citrate (E331), citric acid (E330), raspberry flavor andpurified water.

Appearance of the product and contents of the packaging

Desloratadina Kern Pharma is presented in an amber-colored plastic bottle containing 120 ml of oral solution, accompanied by a dosing syringe and closed with a child-resistant polypropylene cap.

Desloratadina Kern Pharma is presented in an amber-colored glass bottle containing 120 ml of oral solution, accompanied by a dosing cup and closed with a metal cap.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa -Barcelona

Date of the last review of this leaflet: June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/