Desloratadine Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Normon 5 mg film-coated tablets EFG

desloratadine

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

• Keep this leaflet, 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Desloratadine Normon is and what it is used for
2. What you need to know before taking Desloratadine Normon
3. How to take Desloratadine Normon
4. Possible adverse effects
5. How to store Desloratadine Normon
6. Contents of the pack and other information

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

Desloratadine Normon tablets are an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadine 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 or itchy nose, itching of the palate, and eye itching, redness, or watering.

Desloratadine Normon tablets are also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep periods.

2. What you need to know before taking Desloratadine Normon

Do not take Desloratadine Normon

• If you are allergic (hypersensitive) to desloratadine or to any of the other components of this medicine (listed in section 6) or to loratadine.

Desloratadine 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 Desloratadine Normon

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

Use in children and adolescents

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

Taking Desloratadine Normon with other medicines

There are no known interactions between Desloratadine Normon and other medicines.

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

Taking Desloratadine Normon with food and drink

Desloratadine Normon can be taken regardless of meals.

Be cautious when taking desloratadine with alcohol.

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breastfeeding a baby, it is not recommended to take Desloratadine Normon.

Fertility

There are no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how you personally respond to this medicine.

Desloratadine Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Desloratadina Normon

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

Adults and adolescents aged 12 years and older:

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

This medicine 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 how long you should take Desloratadina Normon.

If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on the assessment of your medical history.

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

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

If you take more Desloratadina Normon than you should

Take Desloratadina Normon only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more Desloratadina Normon than prescribed, tell your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Desloratadina Normon

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

If you stop taking Desloratadina Normon

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

4. Possible adverse effects

Like all medicines, Desloratadine Normon may cause adverse effects, although not everyone will experience them.

During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and contact your doctor without delay.

In clinical trials in adults, adverse 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 desloratadine, the following adverse effects were reported as:

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

• Fatigue
• Dry mouth
• Headache

Adults

During the marketing of desloratadine, the following adverse effects were reported as:

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

• Serious allergic reactions
• Rapid heartbeat
• Vomiting
• Dizziness
• Muscle pain
• Restlessness with increased body movement
• Skin rash
• Stomach pain
• Upset stomach
• Somnolence
• Hallucinations
• Liver inflammation
• Strong or irregular heartbeat
• Nausea
• Diarrhea
• Difficulty sleeping
• Seizures
• Abnormal liver function tests

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

• Unusual weakness
• Yellowish discoloration of the skin and/or eyes
• Increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example ultraviolet light from a sunbed
• Change in heart rhythm
• Abnormal behaviour
• Aggression
• Weight gain, increased appetite
• Depressed mood
• Dry eyes

Children

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

• Slow heartbeat
• Change in heart rhythm
• Abnormal behaviour
• Aggression

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Normon

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

Do not use Desloratadine Normon after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Do not use this medicine if you notice any changes in the appearance of the tablets.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Normon

• The active substance is desloratadine 5 mg.
• The other components of the tablet are: lactose, microcrystalline cellulose, calcium hydrogen phosphate, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal silica, hypromellose, macrogol 6000, talc, titanium dioxide (E-171), and indigo carmine lake (E132).

Appearance of the medicinal product and contents of the pack

Film-coated, round, biconvex blue tablets, printed on one side with a "D".

Presented in packs of 20 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: June 2022

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

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