Desloratadine Sandoz 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Desloratadine Sandoz 5 mg Film-coated 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What is Desloratadine Sandoz

Desloratadine Sandoz contains desloratadine, which is an antihistamine.

How Desloratadine Sandoz works

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

When to use Desloratadine Sandoz

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, e.g., hay fever or 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 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 normal sleep periods.

2. What you need to know before taking Desloratadine Sandoz

Do not take Desloratadine Sandoz

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Desloratadine Sandoz:

• 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.

Other medicines and Desloratadine Sandoz

There are no known interactions between desloratadine and other medicines.

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

Taking Desloratadine Sandoz with food, drinks, and alcohol

Desloratadine Sandoz can be taken with or without food.

Use caution when taking Desloratadine Sandoz with alcohol.

Pregnancy, breast-feeding, and fertility

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

Desloratadine is not recommended if you are pregnant or breastfeeding.

Fertility

There are no data available regarding male or 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 perform activities requiring mental alertness, such as driving a car or operating machinery, until you know how the medicine affects you.

3. How to take Desloratadine Sandoz

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 Sandoz film-coated tablets.

• 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 Desloratadine Sandoz than you should

Take desloratadine 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 or pharmacist or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Sandoz

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 forgotten doses.

If you stop treatment with Desloratadine Sandoz

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

4. Possible adverse effects

Like all medicines, this medicine can 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 and seek immediate medical attention.

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 common side effect.

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

Common: 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: may affect up to 1 in 10,000 people

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

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

• behavioural changes,
• aggression,
• depressed mood,
• dry eyes,
• unusual weakness,
• yellowing of the skin and 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,
• weight gain,
• increased appetite.

Children

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

• behavioural changes,
• aggression,
• slow heart rate,
• change in heart rhythm,
• weight gain,
• increased appetite.

Reporting of adverse effects

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

5. Storage of Desloratadine Sandoz

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

Do not use this medicine after the expiry date stated on the carton and bottle after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Sandoz

• The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other components are:

Core: maize starch, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, hydrogenated vegetable oil (type 1).

Coating: Opadry blue 03B50689 containing: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Desloratadine Sandoz 5 mg film-coated tablets are light blue, round, biconvex tablets, marked with the number “5” on one side. Diameter: 6.50 ± 0.10 mm.

Desloratadine Sandoz 5 mg film-coated tablets are packed in OPA/ALU/PVC/ALU blisters or in PVC/Aclar/ALU blisters.

Unit dose packs:

Desloratadine Sandoz 5 mg is available in: 1x1, 2x1, 3x1, 5x1, 7x1, 10x1, 14x1, 15x1, 20x1, 21x1, 30x1, 50x1, 90x1 and 100x1 film-coated tablets.

Multi-unit packs:

Desloratadine Sandoz 5 mg is available in: 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Lek Pharmaceuticals d.d.
Verovskova 57, SI-1526
Ljubljana, Slovenia

or

Salutas Pharma GmbH
Otto-von-Guericke-Allee 5
39179 Barleben
Germany

or

Lek S.A.
Ul. Domaniewska 50C
02-672 Warsawa
Poland

or

Lek Pharmaceuticals d.d.
Trimlini 2 D
9220 Lendava
Slovenia

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria: Desloratadin Sandoz 5 mg filmtabletten
Belgium: Desloratadin Sandoz 5 mg filmomhulde tabletten
Denmark: Desloratadine Sandoz
Finland: Desloratadine Sandoz 5 mg kalvopäällysteinen tabletti
France: Desloratadine Sandoz 5 mg comprimé pelliculé
Italy: DESLORATADINA SANDOZ 5 mg compresse rivestite con film
Netherlands: Desloratadine Sandoz 5 mg filmomhulde tabletten
Portugal: Desloratadina Sandoz 5 mg comprimido revestido por película
Sweden: Desloratadine Sandoz 5 mg filmdragerade tabletter

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

Detailed 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.