Levocetirizine Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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 you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Levocetirizine Normon is and what it is used for
2. What you need to know before taking Levocetirizine Normon
3. How to take Levocetirizine Normon
4. Possible side effects
5. How to store Levocetirizine Normon
6. Contents of the pack and other information

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

The active substance of Levocetirizine Normon is levocetirizine dihydrochloride. Levocetirizine Normon is an antiallergy medicine.

It is used to treat the signs of disease (symptoms) associated with:

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

2. What you need to know before starting Levocetirizine Normon

Do not take Levocetirizine Normon

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney disease requiring dialysis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levocetirizine Normon.

If you have any condition that impairs your ability to empty your urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Levocetirizine Normon may worsen seizures.

If you are scheduled to undergo allergy testing, ask your doctor whether you should stop taking Levocetirizine Normon several days in advance. This medicine may affect the results of allergy testing.

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 medicines and Levocetirizine Normon

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Taking Levocetirizine Normon with food, drinks, and alcohol

Caution is advised when taking Levocetirizine Normon together with alcohol or other agents acting on the brain.

In sensitive patients, taking Levocetirizine Normon simultaneously with alcohol or other central nervous system-acting agents may cause additional reduction in attention capacity and reduced performance.

Levocetirizine Normon can be taken either on an empty stomach or with food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Some patients treated with Levocetirizine Normon may experience drowsiness/sedation, fatigue, and exhaustion. If you intend to drive, perform potentially hazardous activities, or operate machinery, you are advised to wait and observe your response to the medication. However, in special studies conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills was detected after taking levocetirizine at the recommended dose.

Levocetirizine Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Levocetirizine Normon

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children aged 6 years and older is one tablet daily.

Special dosage instructions for specific populations:

Renal and hepatic impairment

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

Patients with severe kidney disease requiring dialysis must not take Levocetirizine Normon.

Patients with hepatic impairment alone should take the standard prescribed dose.

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

Patients aged 65 years and older

In elderly patients, dose adjustment is not necessary if renal function is normal.

Use in children

The use of Levocetirizine Normon is not recommended in children under 6 years of age.

For oral use only.

The tablets should be swallowed whole with water and may be taken either on an empty stomach or with 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 forget 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 missed doses. Continue taking your normal dose at the next scheduled time.

If you stop taking Levocetirizine Normon

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

Frequent: may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and somnolence.

Uncommon: may affect up to 1 in 100 patients
Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from available data
Other adverse effects reported include palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, syncope, tremor, dysgeusia (disturbance of taste sensation), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness, and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Pruritus (intense itching) upon discontinuation of treatment.

At the first signs of hypersensitivity reaction, stop taking Levocetirizine Normon 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 whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, which can be fatal.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Normon

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other 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 components are microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), talc and macrogol 6000.

Nature of the product and pack contents

Levocetirizine Normon 5 mg is presented as white or almost white, round, biconvex, film-coated tablets with printed markings, available in packs of 20 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: November 2023.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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