DESLORATADINE Viso Farmacéutica 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Desloratadine Viso Farmacéutica 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Desloratadine Viso Farmacéutica and what is it used for
2. What you need to know before you take Desloratadine Viso Farmacéutica
3. How to take Desloratadine Viso Farmacéutica
4. Possible side effects
5. Storage of Desloratadine Viso Farmacéutica
6. Contents of the pack and further information

1. What is Desloratadine Viso Farmacéutica and what is it used for

What is Desloratadine Viso Farmacéutica

Desloratadine Viso contains desloratadine, which is an antihistamine.

How Desloratadine Viso Farmacéutica works

Desloratadine Viso Farmacéutica is an anti-allergic medicine that does not cause drowsiness.

It helps to control the allergic reaction and its symptoms.

When to use Desloratadine Viso Farmacéutica

Desloratadine Viso Farmacéutica relieves the symptoms associated with allergic rhinitis(inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) 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 Viso Farmacéutica is also used to relieve the symptoms associated with urticaria(a skin disease caused by an allergy). These symptoms include itching and skin rash.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

2. What you need to know before you take Desloratadine Viso Farmacéutica

Do not take Desloratadine Viso Farmacéutica

• if you are allergic to desloratadine or 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 taking Desloratadine Viso Farmacéutica:

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

Use in children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and Desloratadine Viso Farmacéutica

There are no known interactions between Desloratadine Viso Farmacéutica and other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Desloratadine Viso Farmacéutica with food, drinks, and alcohol

Desloratadine Viso Farmacéutica can be taken with or without food. Be cautious when taking Desloratadine with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Desloratadine Viso Farmacéutica if you are pregnant or breastfeeding.

Fertility

There is no available data on male and female fertility.

Driving and using machines

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

Desloratadine Viso Farmacéutica contains lactose

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

3. How to take Desloratadine Viso Farmacéutica

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents from 12 years of age

The recommended dose is one tablet once a day with water, with or without food.

This medicine is administered orally.

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 Viso Farmacéutica.

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 schedule based on the assessment of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week or for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from one patient to another, and therefore, you should follow your doctor's instructions.

If you take more Desloratadine Viso Farmacéutica than you should

Take Desloratadine Viso Farmacéutica only as your doctor has told you. It is not expected that an accidental overdose will cause serious problems. However, if you take more desloratadine than you should, tell your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Viso Farmacéutica

If you forget to take your dose at the scheduled time, take it as soon as possible, and then continue with the usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadine Viso Farmacéutica

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rash, and swelling of the face, tongue, or throat) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

In clinical trials in adults, the side effects were approximately the same as with a tablet that does not contain the active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

The following side effects have been reported in clinical trials with desloratadine:

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

The following side effects have been reported during the marketing of desloratadine:

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

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• agitation with increased body movement
• skin rash
• stomach pain
• upset stomach
• drowsiness
• hallucinations
• liver inflammation
• strong or irregular heartbeat
• nausea
• diarrhea
• difficulty sleeping
• seizures
• abnormal liver function tests

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

• unusual weakness
• yellowing of the skin and 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

Children

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

• slow heartbeat
• change in the way the heart beats

• abnormal behavior
• aggression
• depressed mood
• dry eyes

Reporting of side effects

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

5. Storage of Desloratadine Viso Farmacéutica

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Viso Farmacéutica

The active substance is desloratadine. Each tablet contains 5 mg of desloratadine. The other ingredients of the tablet are microcrystalline cellulose, lactose monohydrate, corn starch, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenmark Arzneimittel GmbH,

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:Viso Farmacéutica, Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:January 2018

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/