Package Insert: Information for the Patient

Cetirizine Zentiva 10 mg Film-Coated Tablets EFG

dihydrochloride of cetirizine

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Cetirizina Zentiva is cetirizine dihydrochloride.

Cetirizina Zentiva is an antihistamine medication.

Cetirizina Zentiva is indicated in adults and children aged 6 years and above for the relief of:

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

Do not take Cetirizina Zentiva if:

• You have terminal renal disease (severe kidney failure requiring dialysis),
• 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 drugs).

Warnings and precautions

Consult your doctor or pharmacist before takingCetirizina Zentiva.

If you are a patient with kidney failure, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

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

If you are an epileptic patient or a patient at risk of seizures, 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 recommended doses. However, there are no available data on the safety of taking high doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid consuming Cetirizina Zentiva with alcohol during treatment.

If you have been scheduled for an allergy test, ask your doctor if you should stop taking Cetirizina Zentiva for a few days before the test. This medication may affect the results of 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 Zentiva

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

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants can affect your attention and ability to react.

Taking Cetirizina Zentiva with food, drinks, and alcohol

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

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

Cetirizina Zentiva should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harm to the fetus. However, the medication should only be administered if necessary and under medical advice.

Cetirizine is excreted in breast milk.The risk of secondary effects in infants cannot be ruled out.Therefore, do not take Cetirizina Zentiva during breastfeeding, unless you have consulted your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina Zentiva produces attention impairments, reaction time decreases, and the ability to drive, after taking Cetirizina Zentiva at the recommended dose.

You should closely observe your response to the medication after taking Cetirizina Zentiva. Do not exceed the recommended dose if you intend to drive, perform potentially hazardous activities, or use machinery.

Cetirizina Zentiva contains Lactose monohydrate

Cetirizina Zentiva contains lactose monohydrate. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

The tablets should be swallowed with a glass of liquid. The tablet can be divided into equal doses.

The recommended doses are as follows.

Adults and adolescents over 12 years

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

Children between 6 and 12 years

The recommended dose is 5 mg twice a day, as half a tablet twice a day.

Patients with renal insufficiency

Patients with moderate renal insufficiency are recommended to take 5 mg once a day.

If you have severe kidney disease, contact your doctor or pharmacist as they may adjust your dose accordingly.

If your child has severe kidney disease, contact your doctor or pharmacist as they may adjust your child's dose according to your child's needs.

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

Treatment duration

The duration of treatment will depend on the type, duration, and course of your symptoms and will be determined by your doctor.Please seek advice from your doctor or pharmacist.

If you take more Cetirizina Zentiva than you should

Inform your doctor if you think you have taken an overdose of Cetirizina Zentiva.

Your doctor will then decide what measures should be taken.

You can also call the Toxicology Information Service, phone: 91 562 04 20 indicating the medicine and the amount taken.

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupil, itching, restlessness, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention.

If you forget to take Cetirizina Zentiva

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

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

If you interrupt treatment with Cetirizina Zentiva

In rare cases, pruritus (intense itching) and/or urticaria may recur if you stop taking Cetirizina Zentiva.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects are rare or very rare, but you must stop taking the medicine and consult your doctor immediately if you notice them.

• Allergic reactions, including anaphylactic shock (severe potentially fatal allergic reaction) and angioedema (severe allergic reaction causing facial or throat inflammation).

These reactions may start soon after the first dose, or they may start later.

Frequent (may affect 1 in 10 people)

• Drowsiness (lack of sleep).
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

Not frequent (may affect 1 in 100 people)

• Agitation.
• Paresthesias (abnormal skin sensations).
• Abdominal pain.
• Pruritus (intense itching), rash.
• Asthenia (extreme fatigue), malaise.
• Diarrhea.

Rare (may affect 1 in 1,000 people)

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

Very rare (may affect 1 in 10,000 people)

• Thrombocytopenia (low platelet count).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (taste alteration).
• Blurred vision, accommodation disorder (difficulty focusing), nystagmus (uncontrolled eye movements).
• Fixed drug eruption.
• Abnormal urination (bedwetting, pain, and/or difficulty urinating).

Frequency not known (frequency cannot be estimated from available data)

• Increased appetite.
• Suicidal thoughts (recurring thoughts or concern about suicide).
• Nightmares.
• Amnesia, memory lapses.
• Dizziness (sensation of rotation or movement).
• Urinary retention (inability to completely empty the bladder).
• Pruritus (intense itching) and/or urticaria after treatment suspension.
• Rash with pus-filled blisters.
• Joint pain.
• Hepatitis (liver inflammation).

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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 at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

What Cetirizina Zentiva contains

• The active ingredient of Cetirizina Zentiva is cetirizine dihydrochloride. A coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are lactose monohydrate, cornstarch, povidone 30, magnesium stearate, titanium dioxide (E 171), hypromellose 2910/5 (E 464), macrogol 6000, talc, and simethicone emulsion SE 4.

What Cetirizina Zentiva looks like and the contents of the pack

Coated tablets with a white to off-white film coating, oblong with a notch in the middle on one side.

Pack with 7, 10, 15, 20, 30, 50 or 100 coated tablets.

All pack sizes may not be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

or

Winthrop Arzneimittel GmbH

Brünigstrasse 50

65926 Frankfurt am Main

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2023

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