LEVOCETIRIZINE NORMON 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Levocetirizine Normon 5 mg film-coated tablets EFG

For adults and children from 6 years of age

Levocetirizine dihydrochloride

Read the entire leaflet carefully before starting to take this medication, 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 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 side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Levocetirizine Normon and what is it used for
2. What you need to know before taking Levocetirizine Normon
3. How to take Levocetirizine Normon
4. Possible side effects
5. Storage of Levocetirizine Normon
6. Package contents and additional information

1. What is Levocetirizine Normon and what is it used for

The active substance of Levocetirizine Normon is levocetirizine dihydrochloride. Levocetirizine Normon is an antiallergic medication.

It is used to treat the symptoms associated with:

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

2. What you need to know before taking Levocetirizine Normon

Do not take Levocetirizine 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 severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Normon.

If you have any condition that prevents you from emptying your urinary 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 taking Levocetirizine Normon may worsen seizures.

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

Children

Levocetirizine Normon is not recommended for children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Other medications and Levocetirizine Normon

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

Taking Levocetirizine Normon with food, drinks, and alcohol

Caution is advised if you take Levocetirizine Normon and alcohol or other central nervous system depressants at the same time.

In sensitive patients, taking Levocetirizine Normon with alcohol or other central nervous system depressants may cause additional decreased attention and reduced performance.

Levocetirizine Normon can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Some patients treated with Levocetirizine Normon 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 conducted in healthy individuals, no alterations in attention, reaction time, or driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizine Normon contains lactose

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 Levocetirizine Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

Renal and hepatic impairment

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

Patients with severe kidney disease that requires dialysis should not take Levocetirizine Normon.

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

Patients with both hepatic and renal impairment should take a lower dose based on the severity of their kidney disease, and in children, the dose should also be chosen based on body weight; the dose will be determined by your doctor.

Patients 65 years of age and older

In elderly patients, no dose adjustment is necessary if kidney function is normal.

Use in children

Levocetirizine Normon is not recommended for children under 6 years of age.

For oral use only.

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

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

If you take more Levocetirizine 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. Telephone 915 620 420.

If you forget to take Levocetirizine Normon

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

If you stop taking Levocetirizine Normon

Stopping treatment should not have negative effects. However, rarely, intense itching (pruritus) may occur when stopping Levocetirizine Normon, even if these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require restarting treatment. The symptoms usually disappear when treatment is restarted.

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

4. Possible side effects

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

Common: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from available data

Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), seizures, tingling, dizziness, syncope, tremor, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness, and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching (pruritus) when stopping treatment.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levocetirizine Normon

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Levocetirizine Normon 5 mg:

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

Appearance of the product and package contents

Levocetirizine Normon 5 mg is presented in the form of white or almost white, round, biconvex film-coated tablets that are packaged in containers of 20 tablets.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

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

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

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and updated information about this medication 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