Leaflet: information for the patient

Desloratadine Almus 5 mg film-coated tablets EFG

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, pharmacist or nurse.

• This medicine has been prescribed for you only, and you must 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Desloratadine Almus

3.How to take Desloratadine Almus

4.Possible side effects

5Storage of Desloratadine Almus

6.Contents of the pack and additional information

What is Desloratadina Almus

Desloratadina Almus contains desloratadine, which is an antihistamine.

How Desloratadina Almus works

Desloratadina Almus is an antiallergic medication that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.

When to use Desloratadina Almus

Desloratadina 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 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Almus is also used to relieve symptoms associated with urticaria (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 to continue your daily activities and normal sleep periods.

Do not take Desloratadina Almus

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Desloratadina Almus:

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

Children and adolescents

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

Taking Desloratadina Almus with other medications

No known interactions have been reported for Desloratadina Almus with other medications.

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

Taking Desloratadina Almus with food and drinks

Desloratadina 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

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 alert mental, such as driving a car or operating machinery, until you have determined your own response to the medication.

Desloratadina Almus tablets contain isomalt. 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 day with 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 Almus.

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 Almus than you should

Take Desloratadina Almus only as your doctor has instructed. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Almus

If you forgot to take your dose at the scheduled time, take it as soon as possible and 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 Almus

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

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

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

In clinical trials in adults, the side effects were approximately the same as those 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 as:

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 as:

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

?severe allergic reactions?skin eruption?strong or irregular heartbeats

?rapid heartbeats?stomach pain?nausea (vomiting)

?vomiting?stomach upset?diarrhea

?dizziness?drowsiness?difficulty sleeping

?muscle pain?hallucinations?convulsions

?agitation with increased?inflammation of the stomach?alteration in movement

corporal functionhepatic function

Unknown frequency: the frequency cannot be estimated from the available data

?unusual weakness

?yellowing of the skin and/or eyes

?increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a sunbed.

?change in the way the heart beats

?abnormal behavior

?aggression

?weight gain, increased appetite

?depressed mood

? dry eyes

Nochildren

Unknown frequency: the frequency cannot be estimated from the available data

?slow heart rate?change in the way the heart beats

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano. Website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not store at a temperature above30°C. Store in the original packaging to protect it from humidity.

Do not use this medication after the expiration date: CAD that appears on the packaging and blister. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Desloratadina Almus

The active ingredient is desloratadine.

Each tablet contains 5 mg of desloratadine.

The other components are:

Tablet core:

Isomalta (isomaltitol) (E-953)

Pre-gelatinized cornstarch

Microcrystalline cellulose

Heavy magnesium oxide

Hydroxypropyl cellulose

Crospovidone (Type A)

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E-171)

Macrogol/PEG 3350

Talc

FD&C Blue #2/Aluminum lake carmine of indigo (E-132)

Appearance of the product and content of the container

Desloratadina Almus 5 mg film-coated tablet is a blue-colored, oblong, biconvex tablet with an approximate diameter of 6.5mm.

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

Containers of 7, 10, 15, 20, 21, 28, 30, 50, 90, or 100 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara, 123 51

Greece

Last review date of this leaflet: July 2022

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