Package Insert: Information for the Patient

Levocetirizine Normon 5 mg Film-Coated Tablets EFG

For adults and children aged 6 years and above

Levocetirizine dihydrochloride

Read this package insert carefully before starting to take this medication, 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 medication has been prescribed to you alone, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Levocetirizina Normon is levocetirizine dihydrochloride. Levocetirizina Normon is an antihistamine medication.

It is used for the treatment of the symptoms associated with:

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

Do not take Levocetirizina Normon

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of this medication (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 Levocetirizina Normon.

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 have a risk of seizures, please consult your doctor as the use of Levocetirizina Normon may worsen the seizures.

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

Children

Levocetirizina Normon is not recommended for children under 6 years old as the film-coated tablets do not allow for dose adjustment.

Other medications and Levocetirizina Normon

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

Taking Levocetirizina Normon with food, drinks, and alcohol

Caution is advised if Levocetirizina Normon is taken and at the same time alcohol or other agents that act on the brain are consumed.

In sensitive patients, the simultaneous intake of Levocetirizina Normon with alcohol or other agents that act on the brain may cause additional decreased attention capacity and decreased performance.

Levocetirizina Normon 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 Levocetirizina Normon may experience drowsiness/drowsiness, fatigue, and exhaustion. If you are going to drive, perform potentially hazardous activities, or operate 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 capacity, and driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizina Normon contains lactose

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 this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Consult your doctor or pharmacist again in case of doubt.

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 Levocetirizina Normon.

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

Patients with both renal and hepatic 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

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

For oral use only.

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

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

If you take more Levocetirizina Normon 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 915 620 420.

If you forget to take Levocetirizina Normon

If you have forgotten to take Levocetirizina Normon, 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 withLevocetirizina Normon

Stopping treatment should not have negative effects. However, rarely, intense itching may occur when stopping Levocetirizina Normon, 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.

Infrequent: 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 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 Levocetirizina Normon at the first signs of hypersensitivity reaction and inform your doctor immediately. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), hoarseness, sudden drop in blood pressure that may 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging 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 point of your pharmacy. If in doubt, 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 LevocetirizineNormon 5 mg:

• The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other components are microcrystalline cellulose, lactose monohydrate, hydroxypropylmethylcellulose with low substitution, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), talc, and macrogol 6000.

Appearance of the product and contents of the packaging

Levocetirizine Normon 5 mg is presented in the form of film-coated tablets, white or almost white in color, round, biconvex, and printed, which are presented in packs of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:November 2023.

Other sources of information

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/73181/P_73181.html