Desloratadine Viso Farmacéutica 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desloratadine Viso Farmacéutica 5 mg 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What Desloratadine Viso Farmacéutica is

Desloratadine Viso contains desloratadine, which is an antihistamine.

How Desloratadine Viso Farmacéutica works

Desloratadine Viso Farmacéutica is a non-sedating antiallergic medicine.

It helps control the allergic reaction and its symptoms.

When Desloratadine Viso Farmacéutica should be used

Desloratadine Viso Farmacéutica 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 aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.

Desloratadine Viso Farmacéutica is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rash.

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep patterns.

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

Do not take Desloratadine Viso Farmacéutica

• 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

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

Taking Desloratadine Viso Farmacéutica with food, drinks and alcohol

Desloratadine Viso Farmacéutica can be taken with or without food. Exercise caution when taking Desloratadine with alcohol.

Pregnancy, breastfeeding and fertility

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

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

Fertility

There are no data available 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 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 have determined how the medicine affects you.

Desloratadine Viso Farmacéutica contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Desloratadine Viso Farmacéutica

Follow exactly the instructions for administering 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 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 you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If you have persistent allergic rhinitis (symptoms present for 4 or more days per week or 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 Viso Farmacéutica than you should

Take Desloratadine Viso Farmacéutica only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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, then continue with your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Desloratadine Viso Farmacéutica

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may 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 of the face, tongue, or throat) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and seek medical attention without delay.

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 frequently reported adverse reaction.

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

• serious allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness with increased body movement
• skin rash
• stomach pain
• upset stomach
• somnolence
• 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 sunlight, even on cloudy days, and to ultraviolet light, for example ultraviolet light from a sunbed
• change in the way the heart beats
• abnormal behaviour
• 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 behaviour
• aggression
• depressed mood
• dry eyes

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of 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 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 outer packaging and blister after 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 empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Viso Farmacéutica

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

Appearance of the product and contents of the container

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

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH,

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o

Fibichova 143

56617 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder: Viso Farmacéutica, Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the most recent review of the leaflet: January 2018

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