Desloratadine Almus 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Almus 5 mg film-coated tablets EFG

Read the entire 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, pharmacist or nurse.

• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents :

1. What Desloratadine Almus is and what it is 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 other information

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

What Desloratadine Almus is

Desloratadine Almus contains desloratadine, which is an antihistamine.

How Desloratadine Almus works

Desloratadine Almus is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When Desloratadine Almus should be used

Desloratadine Almus relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example 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 Almus is 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 starting to take Desloratadine Almus

Do not take Desloratadine Almus

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse 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 need to take any other medicines.

Taking Desloratadine Almus with food and drink

Desloratadine Almus 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Fertility

No data are available regarding male and female fertility.

Driving and using machines

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

Desloratadine Almus tablets contain isomalt. 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 Desloratadine Almus

Follow exactly the instructions for use of this medicine as given 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 Desloratadine Almus.

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

If you have persistent allergic rhinitis (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 Almus than you should

Take Desloratadine Almus only as directed by your doctor. 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Desloratadine Almus

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

During the marketing of Desloratadine Almus, very rare cases of severe 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 see your doctor without delay.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient.

In adolescents, headache was the most frequently reported adverse reaction.

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

Common: these may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following adverse effects have been reported:

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

? severe allergic reactions ? skin rash ? strong or irregular heartbeat

? rapid heartbeat ? stomach pain ? feeling sick (nausea)

? vomiting ? upset stomach ? diarrhoea

? dizziness ? somnolence ? difficulty sleeping

? muscle pain ? hallucinations ? seizures

? agitation with increased ? liver inflammation ? changes in liver function tests

body movement

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 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

5. Storage of Desloratadine Almus

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

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

Do not use this medicine after the expiry date: EXP, shown on the packaging and blister. The expiry date refers to the last day of the month indicated.

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. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, 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 Almus

The active substance is desloratadine.

Each tablet contains 5 mg of desloratadine.

The other components are:

Tablet core:

Isomalt (isomaltitol) (E-953)

Pregelatinized corn starch

Microcrystalline cellulose

Light magnesium oxide

Hydroxypropylcellulose

Crospovidone (Type A)

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E-171)

Macrogol/PEG 3350

Talc

FD&C Blue #2 / Indigo carmine aluminum lake (E-132)

Appearance of the medicinal product and contents of the pack

Desloratadine Almus 5 mg film-coated tablets EFG are blue, oblong, biconvex film-coated tablets with an approximate diameter of 6.5 mm.

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.

Only some 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

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara, 123 51

Greece

Date of latest revision of this leaflet: July 2022

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