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PATIENT INFORMATION LEAFLET

Desloratadina Qualigen 5 mg Film-Coated Tablets

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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

6. Contents of the pack and additional information

What is Desloratadina Qualigen

It is a medication that contains desloratadine, which is an antihistamine.

How Desloratadina Qualigen works

Desloratadina Qualigen tablets 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 Qualigen tablets are 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 Qualigen

• SIf you are allergic to desloratadineor to any of the other components of this medication (including those listed in section 6) or to loratadine.
• Desloratadina Qualigen contains soy lecithin (E-322). Do not use in case of an allergy to peanuts or soy.

Warnings and precautions

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

- If you have impaired renal function.

- If you have a personal or family history of seizures.

Use in children and adolescents

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

Taking Desloratadina Qualigen with other medications

No known interactions of Desloratadina Qualigen with other medications.

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

Taking Desloratadina Qualigen with food, drinks, and alcohol

Desloratadina Qualigen can be taken regardless of meals.

Be careful when taking Desloratadina Qualigen with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding or think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not recommend taking Desloratadina Qualigen tablets if you are pregnant or breastfeeding.

Driving and operating machinery

At the recommended dose, this medication 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 that require a state of mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Desloratadina Qualigen contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Adults and adolescents 12 years of age and older

The recommended dose is one tablet once a day.

Swallow the tablet whole with water, with or without food.

This medication is for oral use.

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

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 Qualigen than you should

Take Desloratadina Qualigen tablets only as your doctor has instructed. An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadina Qualigen than you were told, inform your doctor, pharmacist, or nurse immediately.

If you forget to take Desloratadina Qualigen

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 the missed dose.

If you interrupt treatment with Desloratadina Qualigen

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

Like all medicines, Desloratadina Qualigen tablets may cause side effects, although not everyone will experience them.

During the marketing of Desloratadina Qualigen, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been communicated.

If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.

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 frequently reported adverse reaction.

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

Frequent: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of Desloratadina Qualigen, the following side effects were reported:

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

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, from a sunbed
• change in the way the heart beats
• weight gain, increased appetite
• abnormal behavior
• aggression
• change in the way the heart beats
• depressed mood
• dry eyes

Children

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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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.

Store in the original packaging.

Do not use Desloratadina Qualigen after the expiration date that appears on the packaging and blister after “CAD”. 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina Qualigen

• The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.

• The other components of the tablets (excipients) are:

Tablet core: disodium hydrogen phosphate, cornstarch, microcrystalline cellulose (E-460i), lactose monohydrate, pregelatinized cornstarch, anhydrous colloidal silica (E-551), hydrogenated cottonseed oil, magnesium stearate (E-470b).

• Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soy lecithin (E-322), xanthan gum (E-415),indigo carmine (E-132).

Appearance of the product and content of the container

Desloratadina Qualigen 5 mg is presented in the form of coated tablets. The tablets are round, biconvex, and blue.

Desloratadina Qualigen 5 mg coated tablets are presented in containers of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, or 100 tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 SANT JOAN DESPÍ (Barcelona) Spain

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 SANT JOAN DESPÍ (Barcelona) Spain

Last review date of this leaflet:June 2022

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