Desloratadine Alter 5 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Desloratadine Alter 5 mg orodispersible tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Desloratadine Alter is a non-sedating antiallergic medicine. It helps control allergic reactions and their symptoms.

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.

Desloratadine is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rash (hives).

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 Alter

Do not take Desloratadine Alter

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadine Alter:

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

Children and adolescents

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

Other medicines and Desloratadine Alter

There are no known interactions between Desloratadine and other medicines.

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

Taking Desloratadine Alter with food, drinks and alcohol

It is not necessary to take Desloratadine Alter with food or drinks.

It can also be taken regardless of meals. Be cautious when taking Desloratadine Alter 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 that you take Desloratadine Alter.

There are no data available regarding male and female fertility.

Driving and using machines

At the recommended dose, Desloratadine Alter 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 your individual response to the medicine.

Desloratadine Alter contains aspartame

This medicine may be harmful to people with phenylketonuria, as it contains aspartame, which is a source of phenylalanine.

3. How to take Desloratadine Alter

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

Use in adults and adolescents aged 12 years and older

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

This medicine is for oral use.

Before use, carefully open the blister pack and remove the orodispersible tablet without breaking it. Place it in your mouth, where it will disintegrate immediately. No water or other liquid is needed to swallow the dose.

Take the tablet immediately after removing it from the blister pack.

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

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 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 Desloratadine Alter than you should

Take desloratadine only as directed by your doctor. An accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Alter

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

4. Possible adverse effects

Like all medicines, Desloratadina Alter may cause adverse effects, although not everybody gets them.

During the marketing of Desloratadina Alter, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and seek medical attention right away.

In clinical trials with Desloratadina, the following adverse effects were reported as:

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

• fatigue
• dry mouth
• headache

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

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

• serious allergic reactions
• skin rash
• strong or irregular heartbeat
• rapid heartbeat
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhea
• dizziness
• somnolence
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movements
• liver inflammation
• abnormalities in liver function tests

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

• unusual weakness
• yellowing 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
• changes 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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Alter

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

Do not use this medicine after the expiry date which is stated on the packaging and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the package and other information

Composition of Desloratadine Alter

• The active substance is desloratadine 5 mg.
• The other components are microcrystalline cellulose, pregelatinized corn starch, polyvinyl alcohol-polyethylene glycol copolymer, butyl methacrylate copolymer, red iron oxide, talc, mannitol, crospovidone, aspartame (E951), calcium stearate and strawberry flavor.

Appearance of the product and contents of the pack

Desloratadine Alter 5 mg is presented as orodispersible tablets, i.e., tablets that dissolve in the mouth. They are mottled light red, flat-surfaced, round tablets.

The tablets are packaged in Poliamide/Aluminum/PVC blisters and another made of Aluminum.

Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter
C/ Mateo Inurria, 30
28036 Madrid

Date of the most recent review of this leaflet: October 2023

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