Package Insert: Patient Information

Xazal 5 mg Film-Coated Tablets

For adults and children aged 6 years and above

Levocetirizine dihydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to 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 package insert. See section 4.

Contents of the pack and additional information

The active ingredient of Xazal is levocetirizine dihydrochloride. Xazal is an antihistamine medication.

For the treatment of signs of disease (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis);

Urticaria.

Do not take Xazal

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of Xazal (listed in section 6).
• If you have a severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Xazal.

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 Xazal may worsen the seizures.

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

Children

Xazal is not recommended for children under 6 years old as the coated tablets do not allow for dose adjustment.

Other medications and Xazal

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Xazal with food, drinks, and alcohol

Caution is advised if Xazal is taken with alcohol or other agents that act on the brain. In sensitive patients, taking Xazal with alcohol or other agents that act on the brain may cause additional decrease in attention capacity and performance.

Xazal can be taken both on an empty stomach and with 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 Xazal may experience drowsiness/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, and driving ability were detected after taking levocetirizine at the recommended dose.

Xazal contains lactose

If your doctor has told you 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 for adults and children aged 6 years and above 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 kidney disease requiring dialysis should not take Xazal.

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 and above

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

Use in children

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

How and when to take Xazal?

Only for oral use

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

How long should your treatment with Xazal 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 Xazal than you should

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

In case of overdose or accidental ingestion of Xazal, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 620 420.

If you forget to take Xazal

If you have forgotten to take Xazal, or if you take a dose lower than prescribed by your doctor, do not take a double dose to compensate for the missed doses. Continue taking your normal dose when it is due.

If you interrupt treatment with Xazal

Stopping treatment should not have negative effects. However, it is rare for intense itching to appear when stopping Xazal, 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 questions 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.

Rare: may affect up to 1 in 100 patients

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 (skin swelling, redness, and itching), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurring thoughts or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching when treatment is interrupted.

Stop taking Xazal at the first signs of hypersensitivity reaction and immediately inform your doctor. 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 for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Xazal

• 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, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance of the product and contents of the package

The film-coated tablets are white or off-white, oval-shaped, and have the mark “Y” engraved on one of their faces.

They are packaged in blisters of 1, 2, 4, 5, 7, 10, 2x10, 10x10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90, and 100 tablets. Not all package sizes may be marketed.

Marketing Authorization Holder

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n,

Edificio Bronce, 5th Floor

28020 Madrid.

Responsible for manufacturing

Aesica Pharmaceuticals S.r.l

Via Praglia 15, I-10044 Pianezza (TO)

Italy