Desloratadine Pensa 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Pensa 5 mg film-coated tablets EFG

Read the entire 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Desloratadine Pensa is and what it is used for

What Desloratadine Pensa is

Desloratadine Pensa contains desloratadine, which is an antihistamine.

How Desloratadine Pensa works

Desloratadine Pensa is an antiallergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When Desloratadine Pensa should be used

Desloratadine Pensa 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, itchy palate, and itchy, red or watery eyes.

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

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 Pensa

Do not take Desloratadine Pensa

• 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 Pensa:

? If you have impaired kidney function.

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

Children and adolescents

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

Taking Desloratadine Pensa with other medicines

There are no known interactions between Desloratadine Pensa and other medicines.

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

Taking Desloratadine Pensa with food, drinks, and alcohol

Desloratadine Pensa can be taken regardless of meals.

Be cautious when taking Desloratadine Pensa 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 Pensa if you are pregnant or breastfeeding.

Fertility

There are no data available regarding 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 your individual response to the medicine.

3. How to take Desloratadine Pensa

Follow exactly the instructions for use of 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 for oral use.

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 Pensa.

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 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 therefore you should follow your doctor's instructions.

If you take more Desloratadine Pensa than you should

Take Desloratadine Pensa only as directed by your doctor. 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Pensa

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 forgotten doses.

If you stop taking Desloratadine Pensa

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

During the marketing of Desloratadine Pensa, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported.

If you experience any of these serious adverse effects, stop taking this medicine and contact your doctor immediately.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadine, the following adverse effects were reported as:

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of Desloratadine Pensa, the following adverse effects were reported as:

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

• serious allergic reactions
• skin rash
• strong or irregular heartbeats
• rapid heartbeats
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhoea
• dizziness
• somnolence
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• liver inflammation
• abnormal liver function tests

Frequency not known: cannot be estimated from the available data

• unusual weakness
• yellowish discoloration of the skin and/or 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
• depressed mood
• dry eyes

Children

Frequency not known: cannot be estimated from the available data

• slow heartbeat
• change in the way the heart beats
• abnormal behaviour
• aggression

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for 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 Pensa

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions; store in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

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

Film coating: Opadry Blue 03A30735, which consists of: hypromellose 6 cP, titanium dioxide (E171), microcrystalline cellulose, stearic acid, indigotin, indigo carmine (E132).

Nature of the product and pack contents

Film-coated blue tablets, round, biconvex, with a diameter of 6.5 mm and a thickness of 3.2 mm.

Desloratadine Pensa 5 mg film-coated tablets are available in packs of 20 tablets made of PVC/PE/PVDC – Aluminium or PVC/PCTFE (Aclar) – Aluminium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Date of the last revision of this leaflet: May 2022

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