Package Leaflet: Information for the Patient

Cetirizine Normon 10mg Film-Coated Tablets

cetirizine dihydrochloride

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Cetirizine Normon

3. How to take Cetirizine Normon

4. Possible side effects

5. Storage of Cetirizine Normon

6. Contents of the pack and additional information

The active ingredient of Cetirizina Normon is cetirizine dihydrochloride.

Cetirizina Normon is an antihistamine medication.

Cetirizina Normon is indicated in adults and children aged 6 years and above for:

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

Do not use Cetirizina NORMON

-if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min);

• if you are allergic to cetirizine dihydrochloride, to any of the other components of this medication (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active principles of other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cetirizina NORMON

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

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

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

No clinically significant interactionshave been observedbetween alcohol (with a blood level of 0.5per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, there are no available safety data when taking together higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid the joint consumption of alcohol during treatment.

If you are scheduled to undergo an allergy test, consult your doctor if you should interrupt the intake of Cetirizina 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 old, as this formulation does not allow for the necessary dose adjustment.

Other medications and Cetirizina NORMON

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

Taking Cetirizina NORMON with food, drinks, and alcohol

Food does not affect the absorption of Cetirizina NORMON.

Pregnancy and breastfeeding

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

Cetirizina NORMON should be avoided in pregnant women. Accidental use of the medication in pregnant women should not produce anyharmfuleffects 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 infants cannot be ruled out. Therefore, do not take Cetirizina NORMON during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina NORMON produces attention alterations, reaction ability decrease, and driving ability impairment at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You must closely observe your response to the 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.

The tablets must be swallowed with a glass of liquid.

The tablet can be split into 2 equal doses.

Adults and adolescents over 12 years old:

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

Children between 6 and 12 years old:

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

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

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to 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.

Treatment duration:

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 Cetirizina Normon than you should

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

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, discomfort, dilated pupils, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forgot to take Cetirizina Normon

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Cetirizina Normon

In rare cases, 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.

Like all medicines, Cetirizina Normon may cause side effects, although not everyone will experience them.

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

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

These reactions can start soon after taking the medicine for the first time, or they can start later.

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

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

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

• Restlessness
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itching on the skin), 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 (heart beats too quickly)
• 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 in blood)
• Tics (spasms)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), nystagmus (uncontrolled circular eye movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug-induced rash
• Difficulty or inability to urinate (bedwetting, pain, and/or difficulty urinating)

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

• Increased appetite
• Thoughts of suicide (recurring thoughts or obsession with suicide), nightmares
• Amnesia, memory deterioration
• Dizziness (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria after stopping treatment
• Joint pain
• Rash with blisters containing pus

- Hepatitis (inflammation of the liver)

Reporting side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

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

Do not store at a temperature above30°C.

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

Cetirizina Normon Composition

• The active ingredient of Cetirizina Normon is cetirizine dihydrochloride. A coated tablet contains 10mg of cetirizine dihydrochloride.
• The other components are microcrystalline cellulose, macrogol 6000, magnesium stearate, hypromellose, talc, pregelatinized cornstarch, and titanium dioxide (E-171).

Product Appearance and Packaging Content

Coated tablets with a film coating, white or almost white in color, round, biconvex, marked with C/T on one face and anonymous on the other, and scored on one face.

Package with 20tablets.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos- Madrid (SPAIN)

Last Review Date of this Leaflet:January 2023

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