Package leaflet: Information for the patient

Alerdes, 5 mg, film-coated tablets
Desloratadinum
Please read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if you feel worse, contact your doctor.

Table of contents

What Alerdes is and what it is used for
Important information before taking Alerdes
How to take Alerdes
Possible side effects
How to store Alerdes
Contents of the pack and other information

1. What Alerdes is and what it is used for

What Alerdes is
Alerdes contains desloratadine, which is an antihistamine medicine.
How Alerdes works
Alerdes is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Alerdes should be used
Alerdes relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, for example, hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, nasal itching or nasal discharge, itching of the palate, as well as itching, redness or watering of the eyes.
Alerdes is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief of these symptoms lasts throughout the day, helping patients return to normal daily activities and achieve normal sleep.
If there is no improvement after 3 days or if you feel worse, contact your doctor.

2. Information before using Alerdes

When not to use Alerdes

if the patient is allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting Alerdes, discuss this with your doctor or pharmacist:

if the patient has kidney function disorders,
if the patient has a personal or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Alerdes and other medicines
No interactions between Alerdes and other medicines are known.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Alerdes with food, drink and alcohol
Alerdes can be taken with or without food.
Caution should be exercised when taking Alerdes with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of Alerdes is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
This medicine, when used at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the individual response to this medicine is known.
Alerdes contains lactose
Alerdes contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Alerdes

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily, taken with water, with or without food.
This medicine is intended for oral use.
The tablet should be swallowed whole.
If there is no improvement after 3 days, or if the patient feels worse, a doctor should be consulted.
Do not use Alerdes for longer than 10 days without consulting a doctor.
Taking more Alerdes than recommended
Alerdes should only be taken as described in the patient information leaflet or as directed by a doctor. Serious adverse effects are not expected after accidental overdose. However, if a dose higher than recommended has been taken, contact a doctor or pharmacist.
If you forget to take Alerdes
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Alerdes
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Since the introduction of desloratadine to the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe adverse effects occur, treatment should be discontinued immediately and medical advice should be sought without delay.

In clinical trials involving adult patients, adverse effects were almost the same as those observed with placebo tablets (tablets without active substance). However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, headache was the most commonly reported adverse effect.

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

Common: may occur in up to 1 in 10 patients

fatigue,
dry mouth,
headache.

Adults
After the introduction of desloratadine to the market, the following adverse effects have been reported:

Very rare: may occur in up to 1 in 10,000 patients

severe allergic reactions,
rapid heartbeat,
vomiting,
dizziness,
muscle pain,
restlessness with excessive motor activity,
rash,
abdominal pain,
gastrointestinal upset,
somnolence (drowsiness),
hallucinations,
hepatitis,
palpitations or irregular heartbeat,
nausea,
diarrhoea,
insomnia,
seizures,
abnormal liver function test results.

Frequency unknown: cannot be estimated from the available data

unusual weakness,
yellowing of the skin and/or eyes,
increased skin sensitivity to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation from sunbeds,
change in heartbeat rhythm,
unusual behaviour,
aggressive behaviour,
weight gain,
increased appetite.

Children
Frequency unknown: cannot be estimated from the available data

slow heartbeat,
unusual behaviour,
aggressive behaviour,
change in heartbeat rhythm,
weight gain,
increased appetite.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
Adverse effects can also be reported to the responsible entity. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Alerdes

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Alerdes contains

The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
Other ingredients are: Core: anhydrous lactose, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, low-substituted hydroxypropyl cellulose, magnesium stearate, colloidal anhydrous silica. Coating: hypromellose 6 mPa·s, titanium dioxide (E 171), talc, indigo carmine (E 132), lacquer, polyethylene glycol 6000.

What Alerdes looks like and contents of the pack
Alerdes 5 mg coated tablets are blue, round, and biconvex.
The pack contains 10 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain