Zirtec: detailed information

PACKAGE LEAFLET

For medicinal products subject to medical prescription

PACKAGE LEAFLET: INFORMATION FOR THE USER**

Zirtec 10 mg film-coated tablets

Cetirizine dihydrochloride
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Zirtec is and what it is used for
What you need to know before taking Zirtec
How to take Zirtec
Possible side effects
How to store Zirtec
Contents of the pack and other information

1. What Zirtec is and what it is used for

Cetirizine dihydrochloride is the active substance in Zirtec.
Zirtec is an antiallergic medicinal product.
In adults and children from 6 years of age, Zirtec 10 mg film-coated tablets are indicated:

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria.

2. What you need to know before taking Zirtec

Do not take Zirtec

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zirtec.
If you have kidney impairment, consult your doctor; a lower dose may be required. Your doctor will determine the appropriate dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰ (g/l), corresponding to one glass of wine) and cetirizine administered at recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol.
Therefore, as with all antihistamines, it is recommended to avoid concomitant intake of Zirtec with alcohol.
If you are scheduled for an allergy test, ask your doctor whether you should stop taking Zirtec for a few days before the test. This medicine may alter the results of allergy testing.

Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.

Other medicines and Zirtec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Zirtec with food and drinks
Food does not affect the absorption of Zirtec.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Zirtec should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce harmful effects on the fetus; however, the medicine should be taken only if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you should not take Zirtec while breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or ability to drive vehicles after taking Zirtec at the recommended dose.
However, you should carefully assess your response to the medicine after taking Zirtec if you intend to drive, engage in potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Zirtec film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Zirtec

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

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg (1 tablet) once daily.
Other formulations of this medicine may be more suitable for children; please consult your doctor or
pharmacist.

Use in children aged between 6 and 12 years
The recommended dose is 5 mg (half a tablet) twice daily.
Other formulations of this medicine may be more suitable for children; please consult your doctor or
pharmacist.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you have severe kidney disease, contact your doctor, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor, who may adjust the dose according to the child's needs.

If you feel that the effect of Zirtec 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 condition, and is determined
by your doctor.

If you take more Zirtec than you should
If you think you have taken an overdose of Zirtec, 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 (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).

If you forget to take Zirtec
Do not take a double dose to make up for the missed dose.

If you stop taking Zirtec
If you stop treatment with Zirtec, itching (intense pruritus) and/or urticaria may rarely reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
contact your doctor immediately if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or later on.

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

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhoea, nausea, dry mouth
Fatigue

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

Agitation
Paresthesia (abnormal skin sensation)
Abdominal pain
Pruritus (itchy skin), rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

Allergic reactions, some of which are severe (very rare)
Depression, hallucinations, aggression, confusion, insomnia
Seizures
Tachycardia (rapid heartbeat)
Abnormal liver function
Urticaria
Edema (swelling)
Weight gain

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (allergic reaction to the medicine)
Abnormal urinary elimination (involuntary emptying of the bladder during sleep, pain and/or difficulty urinating)

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

Increased appetite
Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
Amnesia (memory loss), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Pruritus (intense itching) and/or urticaria following discontinuation of treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalized acute exanthematous pustulosis (skin eruption with pus-filled blisters)
Hepatitis (liver inflammation)

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

5. How to store Zirtec

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Zirtec contains

The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other components are: microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silicon dioxide, magnesium stearate, Opadry Y-1-7000 (hypromellose (E464), titanium dioxide (E171), polyethylene glycol 400).

Description of the appearance of Zirtec and pack sizes
Film-coated tablet, white, oblong, with a score line and the logo Y-Y.
Pack sizes: 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UCB Pharma S.p.A., Via Varesina, 162 - 20156 Milano (Italy)

Manufacturers:
Aesica Pharmaceuticals S.r.l., Via Praglia, 15 - I-10044 Pianezza (TO) (Italy)
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6, Hungary
UCB Pharma GmbH, Alfred-Nobel-Straße 10, 40789 Monheim, Germany
UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, The Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria: Zyrtec 10 mg – Filmtabletten
Belgium: Zyrtec
Bulgaria: Zyrtec
Cyprus: Zyrtec
Czech Republic: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Germany: Zyrtec
Greece: Ziptek
Hungary: Zyrtec 10 mg filmtabletta
Ireland: Zirtek tablets
Italy: Zirtec 10 mg film-coated tablets
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Malta: Zyrtec
The Netherlands: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Portugal: Zyrtec
Slovakia: Zyrtec
Slovenia: Zyrtec 10 mg filmsko obložene tablete
Spain: Zyrtec 10 mg comprimidos recubiertos con película
United Kingdom (Northern Ireland): Zirtek allergy tablets

PATIENT INFORMATION LEAFLET

For over-the-counter medicines

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Zirtec 10 mg film-coated tablets

Cetirizine dihydrochloride
Please read this entire leaflet carefully before taking this medicine, as 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.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

What Zirtec is and what it is used for
What you need to know before taking Zirtec
How to take Zirtec
Possible side effects
How to store Zirtec
Contents of the pack and other information

1. What Zirtec is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Zirtec.
Zirtec is an antiallergic medicinal product.
In adults and children aged 6 years and older, Zirtec 10 mg film-coated tablets are indicated:

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria.

2. What you need to know before taking Zirtec

Do not take Zirtec

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zirtec.
If you have kidney impairment, consult your doctor; if necessary, you should take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have problems urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are a patient with epilepsy or at risk of seizures, you should 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 the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Zirtec together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Zirtec for a few days before the test. This medicine may alter the results of allergy testing.

Children
Do not give this medicine to children under 6 years of age, because the tablet formulation does not allow for the necessary dose adjustments.

Other medicines and Zirtec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Zirtec with food and drinks
Food does not significantly affect the absorption of Zirtec.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Zirtec 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 taken only if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you should not take Zirtec while breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles after taking Zirtec at the recommended dose.
However, you should carefully observe your individual response to the medicine after taking Zirtec, especially if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Zirtec film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Zirtec

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The tablets should be taken with a glass of liquid.
The tablet may be divided into two equal parts.

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

Use in children aged 6 to 12 years
The recommended dose is 5 mg (half a tablet) twice daily.

If you feel that the effect of Zirtec 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. Ask your doctor or pharmacist for advice.

If you take more Zirtec than you should
If you think you have taken an overdose of Zirtec, inform your doctor.
The doctor will decide what measures to take, if necessary.
After an overdose, the undesirable effects listed below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupil dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors and urinary retention (difficulty completely emptying the bladder).

If you forget to take Zirtec
Do not take a double dose to make up for the missed dose.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
inform your doctor immediately if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or later on.

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

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhea, nausea, dry mouth
Fatigue

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

Agitation
Paresthesia (abnormal skin sensation)
Abdominal pain
Itching (itchy skin), skin rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

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

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (taste disturbance)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (drug allergy)
Abnormal urination (involuntary bladder emptying during night sleep, pain and/or difficulty urinating)

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

Increased appetite
Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
Amnesia (memory loss), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Itching (intense pruritus) and/or urticaria following discontinuation of treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalized exanthematous pustulosis (skin eruption with pus-filled blisters)
Hepatitis (liver inflammation)

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

5. How to store Zirtec

6. Package contents and other information

What Zirtec contains

The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are: microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silica, magnesium stearate, Opadry Y-1-7000 (hypromellose (E464), titanium dioxide (E171), macrogol 400).

Description of the appearance of Zirtec and package contents
White, oblong, film-coated tablet with a score line and the logo Y-Y.
Packaged in packs containing 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UCB Pharma S.p.A., Via Varesina 162, 20156 - Milan (Italy)

Manufacturers:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I - 10044 Pianezza (TO), Italy
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6., Hungary
UCB Pharma GmbH, Alfred-Nobel-Straße 10, 40789 Monheim, Germany
UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, The Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zirtec 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
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, consult 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, as 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:

What Zirtec is and what it is used for
What you need to know before taking Zirtec
How to take Zirtec
Possible side effects
How to store Zirtec
Contents of the pack and other information

1. What Zirtec is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Zirtec. Zirtec is an antiallergic medicine.
In adults and pediatric patients aged 2 years and older, Zirtec 10 mg/ml oral drops, solution is indicated:

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria.

2. What you need to know before taking Zirtec

Do not take Zirtec

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (active substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zirtec.
If you have kidney impairment, consult your doctor; if necessary, you should take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should 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 the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Zirtec together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Zirtec a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and Zirtec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Zirtec with food and drinks
Food does not affect the absorption of Zirtec.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Zirtec 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 only be taken if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you should not take Zirtec while breastfeeding unless advised by your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles after taking Zirtec at the recommended dose.
However, you should carefully observe your response to the medicine after taking Zirtec if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Zirtec oral drops, solution contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), and sodium
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
This medicine contains 350 mg of propylene glycol (E1520) per ml.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Zirtec

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The drops should be dispensed into a spoon or diluted in water and taken orally.
If using dilution, especially when administering to children, consider that the volume of water to which the drops are added should be proportionate to the amount of liquid the
patient is able to swallow. The diluted solution must be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the flow of drops stops and the correct amount has not been dispensed, return the bottle to the upright position, then turn it upside down again and continue counting the drops.

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg (20 drops) once daily.

Use in children aged 6 to 12 years
The recommended dose is 5 mg (10 drops) twice daily.

Use in children aged 2 to 6 years
The recommended dose is 2.5 mg (5 drops) twice daily.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (10 drops) once daily.
If you have severe renal disease, contact your doctor, who may adjust the dose accordingly.
If your child has renal disease, contact your doctor, who will adjust the dose according to the child's needs.

If you feel that the effect of Zirtec 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 and will be determined by your doctor.

If you take more Zirtec than you should
If you think you have taken an overdose of Zirtec, inform your doctor.
Your doctor will decide which measures to take, if necessary.
After an overdose, the following adverse effects may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors and urinary retention (difficulty completely emptying the bladder).

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

If you stop taking Zirtec
If you stop treatment with Zirtec, itching (intense prickling) and/or urticaria may rarely reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
contact your doctor immediately if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or at a later time.

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

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhoea, nausea, dry mouth
Fatigue

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

Agitation
Paraesthesia (abnormal skin sensation)
Abdominal pain
Itching (itchy skin), skin rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

Allergic reactions, some of which are severe (very rare)
Depression, hallucinations, aggression, confusion, insomnia
Seizures
Tachycardia (increased heart rate)
Abnormal liver function
Urticaria (hives)
Oedema (swelling)
Weight gain

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (drug allergy)
Abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty in urinating)

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

Increased appetite
Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
Amnesia (memory loss), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Itching (intense pricking sensation) and/or urticaria following discontinuation of treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalised exanthematous pustulosis (skin eruption with pus-filled blisters)
Hepatitis (inflammation of the liver)

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

5. How to store Zirtec

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month.
Do not use more than 3 months after first opening the bottle.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Zirtec contains

The active substance is cetirizine dihydrochloride. 1 ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
The other components are: glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.

Description of the appearance of Zirtec and contents of the pack
Zirtec is supplied as a clear, colourless liquid.
Packaged in bottles containing volumes of 10, 15 or 20 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
UCB Pharma S.p.A., Via Varesina 162, 20156 - Milano (Italy)
Manufacturers
Aesica Pharmaceuticals S.r.l., Via Praglia 15, 10044 Pianezza (TO), Italy
Nextpharma SAS, 17 Route de Meulan, 78520 Limay, France
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6., Hungary
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Zyrtec 10 mg/ml - Tropfen
Belgium: Zyrtec
Bulgaria: Zyrtec
Czech Republic: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Greece: Ziptek
Hungary: Zyrtec 10 mg/ml belsőleges oldatos cseppek
Ireland: Zirtek oral drops 10mg/ml
Italy: Zirtec 10 mg/ml gocce orali soluzione
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Romania: Zyrtec
Slovakia: Zyrtec
Spain: Zyrtec 10 mg/ml gotas orales en solución

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zirtec 1 mg/ml oral solution

Cetirizine dihydrochloride
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 others, even if their symptoms are the same as yours, as it could 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

What Zirtec is and what it is used for
What you need to know before taking Zirtec
How to take Zirtec
Possible side effects
How to store Zirtec
Contents of the pack and other information

1. What Zirtec is and what it is used for

Cetirizine dihydrochloride is the active substance in Zirtec.
Zirtec is an antiallergic medicinal product.
In adults and children from 2 years of age, Zirtec 1 mg/ml oral solution is indicated:

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria.

2. What you should know before taking Zirtec

Do not take Zirtec

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine dihydrochloride or to any of the other ingredients (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zirtec.
If you are a patient with renal impairment, consult your doctor; if necessary, you should take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Zirtec together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Zirtec for a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and Zirtec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Zirtec with food and drinks
Food does not affect the absorption of Zirtec.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Zirtec should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not cause harmful effects on the fetus; however, the medicine should be taken only if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Zirtec during breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or ability to drive vehicles after taking Zirtec at the recommended dose.
You should carefully observe your response to the medicine after taking Zirtec if you intend to drive, engage in potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Zirtec oral solution contains sorbitol (E 420), methyl p-hydroxybenzoate (E 218), propyl
p-hydroxybenzoate (E 216), propylene glycol (E 1520), and sodium.
This medicine contains 1575 mg of sorbitol (E 420) per 5 ml, equivalent to 315 mg/ml.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains methyl p-hydroxybenzoate (E 218) and propyl p-hydroxybenzoate (E 216), which may cause allergic reactions (including delayed reactions).
This medicine contains 250 mg of propylene glycol (E 1520) per 5 ml, equivalent to 50 mg/ml.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Zirtec

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The solution can be taken undiluted.
Adults and adolescents from 12 years of age
The recommended dose is 10 mg once daily as 10 ml of oral solution (two full measuring cups).
Use in children aged 6 to 12 years
The recommended dose is 5 mg twice daily as 5 ml (one full measuring cup) twice daily.
Use in children aged 2 to 6 years
The recommended dose is 2.5 mg twice daily as 2.5 ml of oral solution (half a measuring cup)
twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you have severe kidney disease, contact your doctor, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor, who may adjust the dose according to
the child's needs.
If you feel that the effect of Zirtec 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 and is determined
by your doctor.
If you take more Zirtec than you should
If you think you have taken an overdose of Zirtec, inform your doctor.
Your doctor will decide which 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 (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors and urinary retention (difficulty completely emptying the bladder).
If you forget to take Zirtec
Do not take a double dose to make up for the missed dose.
If you stop taking Zirtec
If you stop treatment with Zirtec, itching (intense prickling sensation) and/or urticaria may rarely reappear.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or later.

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

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhea, nausea, dry mouth
Fatigue

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

Agitation
Paresthesia (abnormal skin sensation)
Abdominal pain
Itching (itchy skin), skin rash
Asthenia (extreme fatigue), malaise (feeling unwell)

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

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

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (allergy to the medicine)
Abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty in urinating)

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

Increased appetite
Suicidal ideation (suicidal thoughts or concerns), nightmares
Amnesia (memory loss), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Itching (intense pricking sensation) and/or urticaria following discontinuation of treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalized acute exanthematous pustulosis (skin rash with pus-filled blisters)
Hepatitis (inflammation of the liver)

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

5. How to store Zirtec

6. Package contents and other information

What Zirtec contains

The active substance is cetirizine dihydrochloride. 10 ml (equivalent to 2 full measuring cups) contain 10 mg of cetirizine dihydrochloride.
The other components are: sorbitol (E 420), glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), banana flavour 54.330/A (Firmenich), sodium acetate, glacial acetic acid, purified water.
10 ml of Zirtec oral solution (2 full measuring cups) contain 3.15 g of glucose equivalents (sorbitol).

Description of the appearance of Zirtec and contents of the pack
Clear, colourless liquid with a slightly sweet taste and banana flavour.
Pack containing a bottle with volumes of 60, 75, 100, 150 or 200 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UCB Pharma S.p.A., Via Varesina 162, 20156 Milan (Italy)
Manufacturers
Aesica Pharmaceuticals S.r.l., Via Praglia 15, 10044 Pianezza (TO), Italy
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki, Poland
UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria: Zyrtec 1 mg/ml oral solution
Belgium: Zyrtec
Cyprus: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Ireland: Zirtek oral solution 1mg/ml
Italy: Zirtec 1mg/ml oral solution
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Malta: Zyrtec
Netherlands: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Portugal: Zyrtec
Slovenia: Zyrtec 1 mg/ml oral solution
Spain: Zyrtec 1 mg/ml oral solution
United Kingdom (Northern Ireland): Zirtek allergy solution