Package Insert: Information for the Patient

Desloratadina Combix 5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should 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 or pharmacist, even if they are not listed in this package insert. See section 4.

Desloratadina Combix is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina Combixrelieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy). These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Combix 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 continue your daily activities and normal sleep periods.

Do not take Desloratadina Combix

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

Desloratadina Combix is indicated for adults and adolescents (12 years of age and older)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Combix:

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

Taking Desloratadina Combix with other medicines

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

No known interactions of desloratadine with other medicines.

Taking Desloratadina Combix with food and drinks

Desloratadina Combix can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you are pregnant or breastfeeding, it is not recommended to take Desloratadina Combix.

Driving and operating machinery

At the recommended dose, Desloratadina Combix is not expected to cause drowsiness or impair your ability to pay attention. However, very rarely some people may experience drowsiness, which may affect your ability to drive or use machines.

Desloratadina Combix contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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.

The recommended dose is:

Adults and adolescents (12 years of age and older): take one tablet once a day. Swallow the tablet whole with water, with or without food.

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

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for 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 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 Desloratadina Combix than you should

Take Desloratadina Combix 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 or pharmacist 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 Combix

If you forgot to take your dose at the usual 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 the missed doses.

If you interrupt treatment with Desloratadina Combix

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

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruption have been communicated. Very rarely, palpitations, rapid heartbeats, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and liver function test alterations have also been reported.

In adults, the adverse 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.

Adults

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

• Abnormal behavior
• Aggression
• Weight gain
• Increased appetite
• Depressed mood
• Dry eyes

Children

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

• Slow heart rate
• Change in heart rhythm
• Abnormal behavior
• Aggression
• Weight gain
• Increased appetite
• Depressed mood
• Dry eyes

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

If you notice any change in the appearance of Desloratadina Combix, inform your pharmacist.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at 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 ofDesloratadina Combix

• The active ingredient is desloratadine 5 mg.

The other components are Potassium polacrilex, anhydrous citric acid (E330), gelatin, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, mannitol (E421), lactose monohydrate, magnesium stearate, sodium stearyl fumarate, hypromellose (E464), talc (E553b), triacetin (E1518), potassium sorbate (E202),and titanium dioxide (E171) and indigo carmine lake.

Appearance of the product and content of the packaging

Blue film-coated tablets, round, marked on one side with “5”and smooth on the other.

Aluminum-Aluminum blisters with desiccant and OPA/Aluminum/PVC/Aluminum blisters.

Packages of 20 tablets.

Holder of the marketing authorization

Combix, S.L.U. Laboratories

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: July 2022

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