Leaflet: information for the user

Aralevo 5 mg Film-coated Tablets EFG

Levocetirizine dihydrochloride

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What Aralevo is and what it is used for

2. What you need to know before you start taking Aralevo

3. How to take Aralevo

4. Possible side effects

5. Storage of Aralevo

6. Contents of the pack and additional information

This medication is an antihistamine used for the treatment of allergies. The active ingredient of Aralevo is levocetirizine dihydrochloride.

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

Chronic idiopathic urticaria.

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 a severe impairment of renal function (severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Be especially careful with Aralevo

• Aralevo is not recommended for use in children under 6 years old since the film-coated tablets do not allow for dose adjustment.

Use of other medications

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

Taking Aralevo with food and beverages

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

In sensitive patients, the simultaneous intake of cetirizine or levocetirizine and alcohol or other agents acting at the central nervous system level may have effects on the central nervous system, although the racemic cetirizine has shown that it does not potentiate the effect of alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

Some patients treated with Aralevo may experience drowsiness, fatigue and exhaustion. If you are going to drive, perform potentially hazardous activities or use machinery, it is recommended that you wait and observe your response to the medication. Nevertheless, in special tests performed on healthy individuals, no alterations in attention, reaction time and ability to drive 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 indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

The usual dose for adults and children aged 6 years and above is one tablet per day.

Patients with renal insufficiency should receive a lower dose according to the severity of their renal disease.

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

Patients with both liver and renal insufficiency should take a lower dose according to the severity of their renal 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 either 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 dose lower than prescribed by your doctor, do not take a double dose to compensate for the missed doses, simply wait until the next scheduled dose time and take the normal dose prescribed by your doctor.

If you interrupt treatment with Aralevo

Stopping treatment with Aralevo before the scheduled time should not have any adverse effects, in the sense that the symptoms of the disease should reappear progressively with a severity not greater than the severity before starting treatment with Aralevo.

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

Like all medications, Aralevo may produce adverse effects, although not all people will experience them.

Currently, the estimated frequency is subdivided into:

Very frequent at least 1 in 10 patients

Frequent at least 1 in 100 patients

Uncommon at least 1 in 1000 patients

Rare at least 1 in 10,000 patients

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

Frequency unknown: cannot be estimated from available data.

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

Less frequent adverse effects, such as exhaustion and abdominal pain, have been observed.

Frequency unknown:ocular crisis(uncontrolled circular eye movements).

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

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

No special conservation conditions are required.

Keep out of reach and sight of children.

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

Do not use Aralevo if visible signs of deterioration are observed.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medicines. In this way, you will help protect the environment.

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 Opadry white.

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara). Spain.

This leaflet was revised in July 2018