ARALEVO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aralevo 5 mg Film-Coated Tablets EFG

Levocetirizine Dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Aralevo and what is it used for
2. What you need to know before taking Aralevo
3. How to take Aralevo
4. Possible side effects
5. Storage of Aralevo
6. Package Contents and Additional Information

1. What is Aralevo and what is it used for

This medication is an antihistamine used to treat allergies. The active ingredient in Aralevo is levocetirizine dihydrochloride.

For the treatment of disease signs (symptoms) associated with allergic conditions such as:

Chronic urticaria of unknown origin (chronic idiopathic urticaria).

2. What you need to know before taking Aralevo

Do not take Aralevo

• If you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine or to any of the other components of Aralevo (see "Composition of Aralevo").
• If you have severe kidney impairment (severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Be cautious with Aralevo

• Aralevo is not recommended for use in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Aralevo with food and drinks

Caution is recommended if you take Aralevo at the same time as alcohol.

In sensitive patients, taking cetirizine or levocetirizine and alcohol or other central-acting agents may have effects on the central nervous system, although the cetirizine racemate has shown that it does not potentiate the effect of alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Tell your doctor if you are pregnant, trying to become pregnant, or are breastfeeding.

Driving and using machines

Some patients treated with Aralevo may experience drowsiness, fatigue, and exhaustion. If you are going to drive, perform potentially hazardous activities, or use machinery, you are advised to wait and observe your response to the medication. However, in special tests performed on healthy individuals, no alterations in attention, reaction capacity, or driving ability were detected after taking levocetirizine at the recommended dose.

Important information about some of the components of Aralevo

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Aralevo

Follow the administration instructions for Aralevo exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

The normal dose for adults and children over 6 years is one tablet per day.

Patients with kidney impairment should receive a lower dose according to the severity of their kidney disease.

Patients with only liver impairment should take the prescribed normal dose.

Patients with liver and kidney impairment should take a lower dose based on the severity of their kidney disease, and in children, the dose will be based on body weight; your doctor will determine the dose to be taken.

Aralevo is not recommended for use in children under 6 years of age.

The tablets should be swallowed whole with water and can be taken on an empty stomach or with food.

If you take more Aralevo than you should

A significant overdose may cause drowsiness in adults. In children, it may initially cause agitation and restlessness followed by drowsiness.

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 medication and the amount ingested).

If you forget to take Aralevo

If you have forgotten to take Aralevo, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses; simply wait until the next scheduled dose and take the normal dose prescribed by your doctor.

If you stop treatment with Aralevo

Stopping treatment with Aralevo before it is due should not have harmful effects, in the sense that the symptoms of the disease should gradually reappear with no greater severity than before starting treatment with Aralevo.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Aralevo can cause side effects, although not everyone will experience them.

The estimated frequency is currently subdivided into:

Very common: at least 1 in 10 patients

Common: at least 1 in 100 patients

Uncommon: at least 1 in 1,000 patients

Rare: at least 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients, including isolated cases

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

Frequent side effects, mostly mild to moderate, have been reported, such as dry mouth, headache, fatigue, and drowsiness.

Uncommon side effects, such as exhaustion and abdominal pain, have been observed.

Frequency not known: oculogyric crisis (uncontrolled circular movements of the eyes).

Other side effects have also been reported, such as palpitations, convulsions, visual disturbances, edema, pruritus (itching), skin rash, urticaria (swelling, redness, and itching of the skin), shortness of breath, weight gain, muscle pain, aggressive or agitated behavior, hepatitis, abnormal liver function, and nausea.

At the first signs of a hypersensitivity reaction, stop taking Aralevo and see your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing along with hives (angioedema), sudden decrease in blood pressure that can lead to collapse or shock, which can be fatal.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Aralevo

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Aralevo after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Aralevo if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aralevo

• The active ingredient is levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.

• The other components are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, and white Opadry.

Appearance of the product and package contents

The film-coated tablets are white, round, and scored.

They are packaged in 2x10 blister packs and in bottles of 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara), Spain.

This package leaflet was last revised in July 2018