Leaflet: information for the user

Levocetirizine Aurovitas Spain 5 mg film-coated tablets EFG

For adults and children aged 6 years and above

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. See section 4.

6. Contents of the pack and additional information

The active ingredient of Levocetirizina Aurovitas Spain is dihydrochloride of levocetirizine. Levocetirizina Aurovitas Spain is an antiallergic medication for the treatment of disease signs (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis).
• Urticaria.

Do not take Levocetirizina Aurovitas Spain

• If you are allergic to dihydrochloride levocetirizine, cetirizine, hydroxyzine, or any of the other components of this medication (listed in section 6).
• If you have severe kidney impairment (severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levocetirizina Aurovitas Spain.

If you have any condition that prevents you from emptying your bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you are epileptic or at risk of seizures, please consult your doctor as the use of levocetirizine may worsen the seizures.

If you are to undergo an allergy test, ask your doctor if you need to stop taking levocetirizine several days beforehand. This medication may affect the results of the allergy test.

Children

Levocetirizina Aurovitas Spain is not recommended for children under 6 years old as the current formulation in coated tablets does not allow for dose adjustment in children.

Other medications and Levocetirizina Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Levocetirizina Aurovitas Spain with food, drinks, and alcohol

Caution is recommended if levocetirizine is taken and at the same time alcohol or other agents acting on the brain are consumed. In sensitive patients, the simultaneous intake of levocetirizine with alcohol or other agents acting on the brain may cause additional decreased attention capacity and decreased performance.

Levocetirizine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Some patients treated with levocetirizine may experience drowsiness, fatigue, and exhaustion.Be careful if you are going to drive or operate machinery until you know how this medication affects you.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.

Levocetirizina Aurovitas Spain contains lactose

Levocetirizina Aurovitas Spain 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 of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults and children over 6 years old is one tablet per day.

Special dosing instructions for specific populations:

Renal and hepatic insufficiency

Patients with renal insufficiency should receive a lower dose according to the severity of their renal disease and, in children, the dose will also be chosen based on their body weight; the dose will be determined by your doctor.

Patients with severe renal insufficiency should not take levocetirizine.

Patients with only hepatic insufficiency should take the normal prescribed dose. Patients with both hepatic 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 their body weight; the dose to be taken will be determined by your doctor.

Patients aged 65 years or older

No dose adjustment is necessary in elderly patients with normal renal function.

Use in children

Levocetirizine Aurovitas Spain is not recommended in children under 6 years old.

How and when to take Levocetirizine Aurovitas Spain?

For oral use only.

The tablets should be swallowed whole with water and can be taken with or without food.

How long should your treatment with Levocetirizine Aurovitas Spain last?

The duration of treatment depends on the type, duration, and course of symptoms and will be determined by your doctor.

If you take more Levocetirizine Aurovitas Spain than you should

If you take more levocetirizine than you should, in adults it may cause drowsiness.In children, it may initially cause agitation and restlessness followed by drowsiness.

If you think you have taken an overdose of levocetirizine, please inform your doctor (or pharmacist); he will decide what actions should be taken or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levocetirizine Aurovitas Spain

If you forget to take levocetirizine or if you take a lower dose than prescribed by your doctor, do not take a double dose to compensate for the missed doses. Take your next dose when it is due.

If you interrupt treatment with Levocetirizine Aurovitas Spain

Stopping treatment should not have negative effects. However, rarely, intense itching may appear when stopping levocetirizine, even if these symptoms were not present at the start of treatment. Symptoms may disappear spontaneously. In some cases, symptoms may be intense and require restarting treatment. Symptoms usually disappear when treatment is restarted.

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

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

Frequent:may affect up to 1 in 10 people.

Dry mouth, headache, fatigue, and drowsiness.

Infrequent:may affect up to 1 in 100 people.

Exhaustion and abdominal pain.

Unknown frequency:cannot be estimated from available data.

Other adverse effects that have been described include palpitations, increased heart rate (tachycardia), seizures, paresthesia, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision,ocular crisis(uncontrolled circular movements of the eyes),pain or difficulty urinating, inability to urinate, edema, pruritus (itching), urticaria (hives, redness, and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Intense pruritus (itching) when treatment is interrupted.

Stop taking levocetirizine and immediately inform your doctor if you experience the first signs of hypersensitivity reaction. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Levocetirizina Aurovitas Spain

• The active ingredient is levocetirizine. Each film-coated tablet contains 5 mg of dihydrochloride of levocetirizine (which corresponds to 4.2 mg of levocetirizine).
• The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate (core), hypromellose (E464), titanium dioxide (E171), and polyethylene glycol (coating).

Appearance of the product and content of the container

Levocetirizine film-coated tablets are oval and biconvex, white or off-white in color, with the mark “L9CZ” on one face and “5” on the other.

It is available in blisters of 1, 2, 4, 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112, and 120 tablets and single-dose blisters containing 30x1 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain Levocetirizina Aurovitas Spain 5 mg film-coated tablets EFG

Portugal Levocetirizina Actavis

Last review date of this leaflet: August 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/)