Cetirizine Zentiva

048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets

Patient Information Leaflet

Cetirizina Zentiva 10 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT CETIRIZINE ZENTIVA IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is the active substance in Cetirizine Zentiva.
Cetirizine Zentiva is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizine Zentiva is indicated for the relief of

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING CETIRIZINE ZENTIVA

Do not take Cetirizine Zentiva if

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Zentiva.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets
If you have problems urinating (such as spinal cord disorders or prostate or bladder problems), consult your doctor.
If you are an epileptic patient or at risk of seizures, you must consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille, corresponding to one glass of wine) and cetirizine used at recommended doses.
However, there are no available data on the safety of concomitant use of high doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Zentiva together with alcohol.
If you have scheduled allergy tests, ask your doctor whether you should stop taking Cetirizine Zentiva several days before the tests. This medicine may affect test results.
Children
Do not give this medicine to children under 6 years of age, because the tablet formulation does not allow the necessary dose adjustment.
Other medicines and Cetirizine Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are sensitive, you may notice that the concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.
Cetirizine Zentiva with food and drinks
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Cetirizine Zentiva should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus. However, the medicine may be administered if necessary and after medical advice.
Cetirizine passes into breast milk. The risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Zentiva during breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or driving ability after taking Cetirizine Zentiva at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizine Zentiva, especially if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizine Zentiva contains monohydrate lactose.
048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets
Cetirizine Zentiva contains monohydrate lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE CETIRIZINE ZENTIVA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets with a glass of liquid. The tablets may be divided into two equal doses.

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg once daily as 1 tablet.

Children aged 6 to 12 years
The recommended dose is 5 mg twice daily, as half a tablet twice daily.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you suffer from severe renal disease, inform your doctor or pharmacist, as they may adjust the dose accordingly.
If your child suffers from renal disease, contact your doctor or pharmacist, as they may adjust the dose according to your child’s needs.

If you feel that the effect of Cetirizine Zentiva is too weak or too strong, inform your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your symptoms. Please consult your doctor or pharmacist for advice.

If you take more Cetirizine Zentiva than you should
If you think you have taken too much Cetirizine Zentiva, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the undesirable effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heartbeat, tremors, and urinary retention.

If you forget to take Cetirizine Zentiva
Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizine Zentiva
If you stop treatment with Cetirizine Zentiva, itching (intense prickling sensation) and/or urticaria may rarely return.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Cetirizine Zentiva can cause adverse effects, although not everyone experiences them.
The following adverse effects are rare or very rare, but you must stop taking the medicine and contact your doctor immediately if you notice them.

• Allergic reactions, including anaphylactic shock (a severe, life-threatening allergic reaction) and angioedema (a severe allergic reaction causing swelling of the face and throat).

These reactions may start immediately after the first dose of the medicine or may begin later.
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Agitation.
• Paraesthesia (abnormal sensation on the skin).
• Abdominal pain.
• Itching (skin pruritus), rash.
• Asthenia (extreme tiredness), malaise.

Rare (may affect up to 1 in 1,000 people)

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

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

• Thrombocytopenia (low platelet levels in the blood).
• Tic (repetitive spasm).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste).
• Blurred vision, accommodation disorders (difficulty focusing), oculorotation (eyes with uncontrollable circular movements).
• Fixed drug eruption.
• Abnormal urination (bedwetting, pain and/or difficulty passing urine).

048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets
Not known (frequency cannot be estimated from the available data)

• Increased appetite.
• Suicidal ideation (recurrent thoughts about self-harm or suicide).
• Nightmares.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or moving).
• Urinary retention (inability to completely empty the bladder).
• Itching (intense pruritus) and/or urticaria upon discontinuation.
• Joint pain.
• Skin rash with pus-filled blisters.
• Hepatitis (liver inflammation).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETIRIZINE ZENTIVA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Cetirizina Zentiva contains

• The active substance of Cetirizina Zentiva is cetirizine hydrochloride. One film-coated tablet contains 10 mg of cetirizine hydrochloride.
• The excipients are monohydrate lactose, maize starch, povidone 30, magnesium stearate, hypromellose 2910/5 (E464), macrogol 6000, talc, titanium dioxide (E171), simeticone emulsion SE 4.

Description of the appearance of Cetirizina Zentiva and contents of the pack
White or almost white, oblong, film-coated tablets, with a break line on one side.
Packs containing 7, 10, 15, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
048 – C1B/2018/990
Cetirizina Zentiva 10 mg film-coated tablets
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale Bodio 37/b – 20158 Milano
Manufacturer
Zentiva, k.s.
U kabelovny 130,
102 37 Praha 10 - Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets
For non-prescription package
PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizina Zentiva 10 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

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

1. WHAT CETIRIZINE ZENTIVA IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is the active substance in Cetirizine Zentiva.
Cetirizine Zentiva is an antiallergic medicinal product.
In adults and children aged 6 years and older, Cetirizine Zentiva is indicated for the relief of

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

2. WHAT YOU NEED TO KNOW BEFORE TAKING CETIRIZINE ZENTIVA

Do not take Cetirizina Zentiva if

• you have severe kidney disease (severe renal failure with creatinine clearance less than 10 ml/min);

048 – C1B/2018/990
Cetirizina Zentiva 10 mg film-coated tablets

• you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6) or to hydroxyzine or piperazine derivatives (active substances of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Zentiva.
If you have kidney impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you have problems with urination (such as spinal cord disorders or prostate, bladder problems), consult your doctor.
If you are an epileptic patient or at risk of seizures, you must consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses.
However, there are no available data on safety when high doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid concomitant intake of Cetirizina Zentiva and alcohol.
If you have scheduled allergy tests, ask your doctor whether you should stop taking Cetirizina Zentiva several days before the tests. This medicine may affect test results.
Children
Do not give this medicine to children under 6 years of age, because the tablet formulation does not allow the necessary dose adjustment.
Other medicines and Cetirizina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are sensitive, you may notice that the concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.
Cetirizina Zentiva with food and drink
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cetirizina Zentiva should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus. However, the medicine should be administered only if necessary and after medical advice.
Cetirizine passes into breast milk. The risk of adverse effects in breastfed infants cannot be excluded. Therefore, you must not take Cetirizina Zentiva while breastfeeding unless you have consulted your doctor.
048 – C1B/2018/990
Cetirizina Zentiva 10 mg film-coated tablets
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive following the intake of Cetirizina Zentiva at the recommended dose.
You must carefully observe your response to the medicine after taking Cetirizina Zentiva if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizina Zentiva contains monohydrate lactose.
Cetirizina Zentiva contains monohydrate lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE CETIRIZINE ZENTIVA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablets may be divided into two equal doses.

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg once daily as 1 tablet.

Children aged 6 to 12 years
The recommended dose is 5 mg twice daily, as half a tablet twice daily.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you suffer from severe renal disease, inform your doctor or pharmacist, as they may adjust the dose accordingly.
If your child suffers from renal disease, contact your doctor or pharmacist, as they may adjust the dose according to your child's needs.

If you feel that the effect of Cetirizine Zentiva is too weak or too strong, inform your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your symptoms. Please consult your doctor or pharmacist for advice.

If you take more Cetirizine Zentiva than you should
If you think you have taken an excessive dose of Cetirizine Zentiva, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the adverse effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rhythm, tremors and urinary retention.
048 – C1B/2018/990
Cetirizine Zentiva 10 mg film-coated tablets

If you forget to take Cetirizine Zentiva
Do not take a double dose to make up for a forgotten dose.

If you stop taking Cetirizine Zentiva
If you stop treatment with Cetirizine Zentiva, itching (intense pruritus) and/or urticaria may rarely return.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions are rare or very rare, but you must stop taking the medicine and speak to your doctor immediately if you notice them:

• Allergic reactions, including anaphylactic shock (a severe, life-threatening allergic reaction) and angioedema (a severe allergic reaction causing swelling of the face and throat).

These reactions may start immediately after the first dose of the medicine or may develop later.

Common (may affect up to 1 in 10 people)

• Drowsiness.
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dryness of the oral cavity.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Agitation.
• Paresthesia (abnormal sensation on the skin).
• Abdominal pain.
• Itching (skin pruritus), rash.
• Asthenia (extreme fatigue), malaise.

Rare (may affect up to 1 in 1,000 people)

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

Very rare (may affect up to 1 in 10,000 people)
048 – C1B/2018/990
Cetirizina Zentiva 10 mg film-coated tablets

• Thrombocytopenia (low platelet levels in the blood).
• Tic (repetitive spasm).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (taste disturbance).
• Blurred vision, accommodation disorders (difficulty focusing), oculogyration (eyes with uncontrolled circular movements).
• Fixed drug eruption.
• Abnormal urination (bedwetting, pain and/or difficulty passing urine).

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

• Increased appetite.
• Suicidal ideation (recurring thoughts of self-harm or suicide).
• Nightmare.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the bladder of urine).
• Itching (intense pruritus) and/or urticaria upon discontinuation.
• Skin rash with pustule-containing blisters.
• Joint pain.
• Hepatitis (liver inflammation).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETIRIZINE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Cetirizina Zentiva contains

• The active substance in Cetirizina Zentiva is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The excipients are monohydrate lactose, maize starch, povidone 30, magnesium stearate, hypromellose 2910/5 (E464), macrogol 6000, talc, titanium dioxide (E 171), simethicone emulsion SE 4.

Description of the appearance of Cetirizina Zentiva and the contents of the pack
048 – C1B/2018/990
Cetirizina Zentiva 10 mg film-coated tablets
Film-coated tablets, white, round, with a break line on one side and marked with the code AG on the other.
Pack sizes of 7, 10, 15, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale Bodio 37/b – 20158 Milan, Italy
Manufacturer
Zentiva, k.s.
U kabelovny 130,
102 37 Praha 10 - Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the European Economic Area Member States under the following names: