CETIRIZINE NORMON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cetirizine Normon 10mg film-coated tablets EFG

cetirizine dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

The active ingredient of Cetirizine Normon is cetirizine dihydrochloride.

Cetirizine Normon is an antiallergic medication.

Cetirizine Normon is indicated in adults and children from 6 years of age for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of urticaria.

2. What you need to know before taking Cetirizine Normon

Do not take Cetirizine Normon

• if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min);
• if you are allergic to cetirizine dihydrochloride, to any of the other ingredients of this medication (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances to other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cetirizine Normon.

If you have kidney insufficiency, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

If you have problems urinating (such as spinal cord or prostate and bladder problems), please consult your doctor.

If you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, safety data are not available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid concurrent consumption of alcohol during treatment.

If you are scheduled to undergo an allergy test, consult your doctor if you should stop taking Cetirizine Normon a few days before the test. This medication may affect the results of your allergy tests.

Children

Do not administer this medication to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

Other medications and Cetirizine Normon

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

Taking Cetirizine Normon with food, drinks, and alcohol

Food does not affect the absorption of Cetirizine Normon.

Pregnancy and breastfeeding

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

The use of Cetirizine Normon should be avoided in pregnant women. Accidental use of the medication in pregnant women should not produce any harmful effects on the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Normon during breastfeeding, unless you consult your doctor.

Driving and using machines

Clinical studies have not shown evidence that Cetirizine Normon produces alterations in attention, decreased reaction capacity, and ability to drive at the recommended dose.

If you plan to drive, perform potentially hazardous activities, or use machinery, do not exceed the recommended dose. You should closely observe your response to the medication.

3. How to take Cetirizine Normon

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into 2 equal doses.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once a day as 1 tablet.

Children between 6 and 12 years:

5 mg twice a day, as half a tablet twice a day.

Other pharmaceutical forms of this active substance may be more suitable for children: ask your doctor or pharmacist.

Patients with renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg once a day.

If you suffer from severe kidney disease, please contact your doctor or pharmacist, who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor or pharmacist, who may adjust the dose according to your child's needs.

If you notice that the effect of cetirizine is too weak or too strong, consult your doctor.

Duration of treatment:

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

If you take more Cetirizine Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Normon

Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizine Normon

Rarely, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking cetirizine.

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

4. Possible side effects

Like all medications, Cetirizine Normon can cause side effects, although not everyone experiences them.

The following side effects are rare or very rare, but you should stop taking the medication and tell your doctor immediately if you notice any of them:

Allergic reactions, including severe reactions and angioedema (severe allergic reaction that causes swelling of the face or throat).

These reactions can start soon after taking the medication for the first time or may start later.

Common side effects(may affect up to 1 in 10 patients)

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

Uncommon side effects(may affect up to 1 in 100 patients)

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itching), rash
• Asthenia (extreme fatigue), malaise

Rare side effects(may affect up to 1 in 1,000 patients)

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (rapid heart rate)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

Very rare side effects(may affect up to 1 in 10,000 patients)

• Thrombocytopenia (low platelet count)
• Tics (involuntary muscle contractions)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), ocular gyration (uncontrolled eye movements)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Urinary retention (inability to fully empty the bladder)

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Increased appetite
• Suicidal thoughts (recurring or obsessive thoughts of suicide), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to fully empty the bladder)
• Pruritus (intense itching) and/or urticaria after stopping treatment
• Joint pain
• Blistering rash

• Hepatitis (inflammation of the liver)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cetirizine Normon

Keep out of the reach and sight of children.

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

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Cetirizine Normon

• The active ingredient of Cetirizine Normon is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are microcrystalline cellulose, macrogol 6000, magnesium stearate, hypromellose, talc, pregelatinized corn starch, titanium dioxide (E-171).

Appearance of the product and package contents

White or almost white, round, biconvex film-coated tablets, marked with C/T on one face and blank on the other, and scored on one face.

Package with 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 package leaflet:January 2023

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67862/P_67862.html