DESLORATADINE ALMUS 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Desloratadine Almus 5 mg film-coated tablets EFG

Read this 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 further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Desloratadine Almus and what is it used for
2. What you need to know before taking Desloratadine Almus
3. How to take Desloratadine Almus
4. Possible side effects

5 Storage of Desloratadine Almus

1. Contents of the pack and further information

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

What is Desloratadine Almus

Desloratadine Almus contains desloratadine, which is an antihistamine.

How Desloratadine Almus works

Desloratadine Almus is an anti-allergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to use Desloratadine Almus

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

Desloratadine Almus is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

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

2. What you need to know before taking Desloratadine Almus

Do not take Desloratadine Almus

• if you are allergic to the active substance or 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 Almus:

• if you have impaired kidney 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.

Taking Desloratadine Almus with other medicines

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

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

Taking Desloratadine Almus with food and drinks

Desloratadine Almus can be taken with or without food.

Be careful when taking desloratadine with alcohol.

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 medicine.

It is not recommended to take Desloratadine Almus if you are pregnant or breastfeeding.

Fertility

There are no data available 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 engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Desloratadine Almus tablets contain isomalt. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Desloratadine Almus

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 Desloratadine Almus.

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

If your allergic rhinitis is persistent (symptoms present for 4 or more days a 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 you should follow your doctor's instructions.

If you take more Desloratadine Almus than you should

Take Desloratadine Almus only as your doctor has told you. An accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Desloratadine Almus

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

If you stop taking Desloratadine Almus

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of Desloratadine Almus, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rashes, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

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 commonly reported adverse reaction.

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

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

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

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

severe allergic reactions, skin rash, irregular or strong heartbeats, fast heart rate, stomach pain, nausea, vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, changes 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, e.g., from a sunbed, changes in heart rhythm, abnormal behavior, aggression, weight gain, increased appetite, depressed mood, dry eyes

Children

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

slow heart rate, changes in heart rhythm

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Almus

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

Do not store above 30°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date: EXP that appears on the packaging and blister. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Almus

The active substance is desloratadine.

Each tablet contains 5 mg of desloratadine.

The other ingredients are:

Core of the tablet:

Isomalt (isomaltitol) (E-953)

Pregelatinized corn starch

Microcrystalline cellulose

Heavy magnesium oxide

Hydroxypropylcellulose

Crospovidone (Type A)

Magnesium stearate

Coating of the tablet:

Polyvinyl alcohol

Titanium dioxide (E-171)

Macrogol/PEG 3350

Talc

FD&C Blue #2/ Aluminum Lake Carmine Indigo (E-132)

Appearance of the product and contents of the pack

Desloratadine Almus 5 mg film-coated tablets EFG are blue, oblong, biconvex, and approximately 6.5mm in diameter.

Desloratadine Almus 5 mg film-coated tablets EFG are packaged in Polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC)/Aluminum blisters.

Pack sizes: 7, 10, 15, 20, 21, 28, 30, 50, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara, 123 51

Greece

Date of the last revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/