Package Insert: Information for the User

Desloratadina Viso Pharmaceutical 5 mg Tablets EFG

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, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given 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 they are not listed in this package insert. See section 4.

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What is Desloratadina Viso Farmacéutica

Desloratadina Viso contains desloratadine which is an antihistamine.

How Desloratadina Viso Farmacéutica works

Desloratadina Viso Farmacéutica is an antiallergic medication that does not cause drowsiness.

It helps to control the allergic reaction and its symptoms.

When to use Desloratadina Viso Farmacéutica

Desloratadina Viso Farmacéutica relieves symptoms associated withallergic 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 Viso Farmacéutica is also used to relieve symptoms associated withurticaria(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 Viso Farmacéutica

Warnings and precautions

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

Use in children and adolescents

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

Other medications and Desloratadina Viso Farmacéutica

No known interactions of Desloratadina Viso Farmacéutica with other medications. Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Taking Desloratadina Viso Farmacéutica with food, drinks and alcohol

Desloratadina Viso Farmacéutica can be taken with or without food. Be cautious when taking Desloratadina 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 Viso Farmacéutica if you are pregnant or breastfeeding your baby.

Fertility

No data is available on male and female fertility.

Driving and operating machines

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machines. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of alertness, such as driving a car or operating machines, until you have determined your own response to the medication.

Desloratadina Viso Farmacéutica contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him 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 administered orally.

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 Viso Farmacéutica.

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 or 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 Viso Farmacéutica than you should

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

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 forget to take Desloratadina Viso Farmacéutica

If you forget 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 dose.

If you interrupt treatment with Desloratadina Viso Farmacéutica

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 desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, hives, and swelling of the face, tongue, or throat) 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, 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.

During clinical trials with desloratadine, the following side effects were reported:

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following side effects were reported:

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

• severe allergic reactions
• rapid heartbeats
• vomiting
• dizziness
• muscle pain
• agitation with increased body movement
• skin rash
• stomach pain
• upset stomach
• drowsiness
• hallucinations
• inflammation of the liver
• strong or irregular heartbeats
• nausea (gagging)
• diarrhea
• difficulty sleeping
• seizures
• alteration in liver function tests

Unknown frequency: the frequency cannot be estimated from available data

• unusual weakness
• yellow skin and eyes
• increased skin sensitivity to the sun, even on cloudy days, and to ultraviolet light, for example, from a tanning bed
• change in heart rhythm
• abnormal behavior
• aggression
• increased appetite

Children

Unknown frequency: the frequency cannot be estimated from available data

• slow heart rate
• change in heart rhythm

• abnormal behavior
• aggression
• depressed mood
• dry eyes

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 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 on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina Viso Farmacéutica

The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine. The other components of the tablet are microcrystalline cellulose, lactose monohydrate, cornstarch, anhydrous colloidal silica, and magnesium stearate

Appearance of the product and contents of the package

Desloratadina Viso Farmacéutica is presented in white to light pink, circular, biconvex tablets marked with ‘L5’ on one face and smooth on the other face.

Desloratadina Viso Farmacéutica is presented in blisters in packages of 7, 10, 14, 15, 20, 28, 30, 50, or 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH,

Industriestr. 31, 82194 Gröbenzell,

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o

Fibichova 143, 56617 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:Viso Farmacéutica, S.L.U.,

c/ Retama, 7, 7th floor

28045 Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last reviewed date of the prospectus: January 2018

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