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Patient Information Leaflet

Desloratadine Normon 5 mg Film-Coated Tablets

desloratadine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not give it 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 leaflet. See section 4.

Desloratadina Normon tablets are an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina Normon tablets relieve 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 Normon tablets are 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 Normon

- If you are allergic (hypersensitive) to desloratadine or to any of the other components of this medication (including those listed in section 6) or to loratadine.

Desloratadina Normon is indicated for adults and adolescents (12 years of age and older).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Normon

- If you have impaired renal function.

- If you have a personal or family history of seizures.

Use in children and adolescents

Do not administer this medication to children under 12 years of age.

Desloratadina Normon use with other medications

No known interactions of Desloratadina Normon with other medications.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Desloratadina Normon use with food and beverages

Desloratadina Normon can be taken regardless of meals.

Be careful when taking desloratadine with alcohol.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, it is not recommended to take Desloratadina Normon.

Fertility

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Desloratadina Normon contains lactose

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

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

Adults and adolescents 12 years of age and older:

The recommended dose is one tablet once a daywith water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

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

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 Normon than you should

Take Desloratadina Normon only as your doctor has instructed. An accidental overdose is not expected to cause serious problems.However, if you take more Desloratadina Normon than you were told, tell your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Desloratadina Normon

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

If you interrupt treatment with Desloratadina Normon

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medicines, Desloratadina Normon may cause side effects, although not everyone will experience them.

During the marketing of desloratadina, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been communicated.If you experience any of these severe side effects, stop taking this medication and seek immediate medical attention.

In clinical trials in adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadina, the following side effects were reported:

Frequent: the following may affect up to 1 in 10 people

• Fatigue
• Dry mouth
• Headache

Adults

During the marketing of desloratadina, the following side effects were reported:

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

• Severe allergic reactions
• Fast heart rate
• Vomiting
• Dizziness
• Muscle pain
• Restlessness with increased body movement
• Skin rash
• Stomach pain
• Upset stomach
• Drowsiness
• Hallucinations
• Liver inflammation
• Strong or irregular heartbeats
• Nausea (urge to vomit)
• Diarrhea
• Difficulty sleeping
• Seizures
• Abnormal liver function test results

Unknown frequency: the frequency cannot be estimated from available data

• Unusual weakness
• Yellowing of the skin and/or eyes
• Increased skin sensitivity to the sun, even on cloudy days, and to ultraviolet light, for example, from a tanning bed
• Abnormal heart rhythm
• 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
• Abnormal heart rhythm
• Abnormal behavior
• Aggression

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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, https://www.notificaRAM.es.By reporting side 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 use Desloratadina Normon after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Desloratadina Normon

- The active ingredient is desloratadine 5 mg.

- The other components of the tablet are: lactose, microcrystalline cellulose, calcium hydrogen phosphate, low-substitution hydroxypropyl cellulose, magnesium stearate, colloidal silica, hypromellose, macrogol 6000, talc, titanium dioxide (E-171), and indigo carmine lake (E132).

Appearance of the product and contents of the packaging

Coated tablets, round, biconvex, blue in color, and printed with a “D” on one side.

They are presented in packs of 20 tablets.

Titular of the marketing authorization and responsible manufacturer

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: June 2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/75840/P_75840.html