Zirtec decongestant antihistamine

PACKAGE LEAFLET

For medicinal products subject to medical prescription

Package leaflet: information for the patient

Zirtec Decongestant Antihistamine 5 mg + 120 mg prolonged-release tablets

cetirizine dihydrochloride + pseudoephedrine hydrochloride
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 any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zirtec Decongestant Antihistamine is and what it is used for

Zirtec Decongestant Antihistamine prolonged-release tablets contain two active substances:
cetirizine dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body
during an allergic or inflammatory reaction) and pseudoephedrine hydrochloride (a vasoconstrictor that
decongests the nasal mucosa).
Zirtec Decongestant Antihistamine is used to relieve symptoms of acute inflammation of the nasal mucosa (acute rhinitis), such as nasal congestion, runny nose, nasal and/or ocular itching, and tearing.

2. What you should know before taking Zirtec Decongestant Antihistamine

Do not take Zirtec Decongestant Antihistamine

• if you are allergic to cetirizine, pseudoephedrine, ephedrine, piperazines, or any of the other ingredients of this medicine (listed in section 6);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication, or if you have serious problems with the coronary arteries supplying the heart (severe coronary artery disease);
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or from kidney failure/severe kidney problems (severe renal insufficiency);
• if your thyroid gland is overactive and the condition is not under control (uncontrolled hyperthyroidism);
• if you have serious heart rhythm disorders (severe arrhythmia);
• if you have a tumor called pheochromocytoma;
• if you have increased pressure inside the eye (elevated intraocular pressure or glaucoma);
• if you have difficulty urinating (urinary retention);
• if you have had a cerebrovascular disorder called stroke;
• if you are at risk of developing a brain hemorrhage (hemorrhagic stroke);
• if you are taking dihydroergotamine;
• if you are being treated with certain antidepressants called monoamine oxidase inhibitors (MAOIs), or have taken them within the last two weeks (see "Other medicines and Zirtec Decongestant Antihistamine");
• if you are pregnant;
• if you are breastfeeding;
• in children under 12 years of age.

Warnings and precautions
Take Zirtec Decongestant Antihistamine only for short-term treatment (see section 3).
Talk to your doctor or pharmacist before taking Zirtec Decongestant Antihistamine if:

• you have diabetes;
• your thyroid gland is overactive (hyperthyroidism);
• you have high blood pressure;
• you have a fast heartbeat (tachycardia) or an irregular heartbeat (cardiac arrhythmia);
• you have heart disease due to insufficient blood supply from the coronary arteries (ischemic heart disease);
• you have a medical condition in which the action of the medicine may cause problems, in patients predisposed to urinary retention (e.g. spinal cord injury, prostatic hyperplasia, prostate hypertrophy, or bladder outflow obstruction), as Zirtec Decongestant Antihistamine may increase the risk of urinary retention;
• your liver and/or kidneys do not function properly (moderate hepatic or renal insufficiency);
• you have an enlarged prostate (prostatic hypertrophy) or problems urinating;
• you are at risk of hypercoagulation, such as in inflammatory bowel disease;
• you are over 65 years old.

Caution is required when using Zirtec Decongestant Antihistamine if you are taking medicines that could predispose to hemorrhagic stroke, such as other nasal decongestants; medicines that reduce blood vessel dilation (vasoconstrictors); and other medicines that could alter the effect of Zirtec Decongestant Antihistamine (see "Other medicines and Zirtec Decongestant Antihistamine").
With Zirtec Decongestant Antihistamine, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, stop using Zirtec Decongestant Antihistamine and contact your doctor or seek immediate medical attention. See section 4.
With Zirtec Decongestant Antihistamine, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, stop taking Zirtec Decongestant Antihistamine and contact your doctor or seek immediate medical care immediately (see section 4).
If you develop fever and the appearance of numerous small blisters, stop treatment with Zirtec Decongestant Antihistamine and contact your doctor.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may lead to reduced blood supply to the brain. Stop immediately using Zirtec Decongestant Antihistamine and seek immediate medical assistance if you develop symptoms that could indicate PRES or RCVS (see section 4, “Possible side effects” for symptoms).
If you are scheduled for an allergy test, inform your doctor, as you must stop taking Zirtec Decongestant Antihistamine several days before the test. This medicine may alter the results of allergy testing.

Children
Do not give this medicine to children under 12 years of age.

Other medicines and Zirtec Decongestant Antihistamine
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking:

• medicines used for depression known as monoamine oxidase inhibitors (MAOIs) (see "Do not take Zirtec Decongestant Antihistamine") or tricyclic antidepressants;
• medicines that reduce nasal congestion (decongestants, such as phenylpropanolamine, phenylephrine, ephedrine);
• medicines that stimulate the nervous system, including appetite suppressants and stimulants such as amphetamines;
• alcohol or other substances that depress the nervous system;
• medicines used for high blood pressure (antihypertensives), such as beta-blockers, methyldopa, guanethidine, and reserpine;
• medicines used to support heart function, called cardiac glycosides (e.g., digoxin or digitoxin);
• medicines such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine that cause constriction of blood vessels;
• non-steroidal anti-inflammatory drugs (NSAIDs);
• ritonavir (a medicine for HIV virus);
• linezolid (an antibiotic);
• medicines used to reduce stomach acidity: antacids and proton pump inhibitors;
• kaolin, a substance used as an excipient in many medicines.

If you are due to undergo surgery requiring certain types of anesthesia, inform your doctor that you are taking Zirtec Decongestant Antihistamine.

Zirtec Decongestant Antihistamine with food, drinks, and alcohol
Zirtec Decongestant Antihistamine can be taken with or without food.
Consumption of alcohol may enhance the central nervous system depressant effects of Zirtec Decongestant Antihistamine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Zirtec Decongestant Antihistamine must not be taken during pregnancy or breastfeeding.

Driving and using machines
At recommended doses, Zirtec Decongestant Antihistamine usually does not cause drowsiness. However, in rare cases, Zirtec Decongestant Antihistamine may reduce alertness, especially if you have consumed alcoholic beverages or other medicines that depress the central nervous system. If you experience drowsiness or dizziness, do not drive or operate machinery.
For individuals engaged in sports: using Zirtec Decongestant Antihistamine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Zirtec Decongestant Antihistamine contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Zirtec Decongestant Antihistamine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. How to take Zirtec Decongestant Antihistamine

Take Zirtec Decongestant Antihistamine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: one tablet twice daily (one in the morning and one in the evening).

Patients with liver problems
The recommended dose is one tablet once daily.

Patients with kidney problems
The dose must be determined by the doctor according to renal function.

The tablets must be swallowed whole with some liquid and must not be broken, chewed, or crushed.

The duration of treatment should not exceed the duration of symptoms of acute rhinitis and in any case should not exceed 7 days. After 7 days, consult your doctor or pharmacist, as treatment should continue with a medicine containing cetirizine only.

Use in children and adolescents
Children aged 12 years and older: 1 tablet twice daily (one in the morning and one in the evening).
Zirtec Decongestant Antihistamine must not be used in children under 12 years of age.

If you take more Zirtec Decongestant Antihistamine than you should
If you have taken an excessive dose of Zirtec Decongestant Antihistamine, go immediately to the nearest emergency room.

Overdose may cause the following symptoms: diarrhoea, dizziness, fatigue, headache, malaise, dilated pupils, urinary retention, increased and/or irregular heart rate, high blood pressure, or signs of central nervous system depression (loss of alertness up to complete unconsciousness, bluish discoloration of mucous membranes, periods of breathing arrest, cardiocirculatory collapse) or central nervous system excitation (insomnia, hallucinations, tremors, epileptic seizures), which may even be fatal.

If you forget to take Zirtec Decongestant Antihistamine
If you have forgotten to take the tablet, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose. Subsequent doses should be taken every 12 hours.

If you stop taking Zirtec Decongestant Antihistamine
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zirtec Decongestant Antihistamine may cause side effects, although not
all people experience them.
Stop immediately treatment with Zirtec Decongestant Antihistamine and contact your
doctor urgently if you develop symptoms that could be signs of reversible posterior encephalopathy
syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision.

You may experience the following side effects:
Common (may affect up to 1 in 10 people):
fast heartbeat, dry mouth, nausea, weakness (asthenia), dizziness, drowsiness, headache,
vertigo, nervousness, insomnia;
Uncommon (may affect up to 1 in 100 people):
agitation, anxiety;
Rare (may affect up to 1 in 1,000 people):
heart rhythm disorders, hypersensitivity reactions (including anaphylactic shock), seizures, tremor,
hallucinations, pallor, high blood pressure, vomiting, liver function abnormalities, urinary problems, dry
skin, skin rash, excessive sweating, urticaria;
Very rare (may affect up to 1 in 10,000 people):
drug-induced fixed eruption, angioedema (a severe allergic reaction causing swelling of the face or
throat), circulatory collapse, inflammation of the colon due to insufficient blood supply (ischaemic colitis),
cerebrovascular event (stroke), psychosis, taste disturbances;
Not known (frequency cannot be estimated from the available data):
serious conditions affecting the brain's blood vessels known as reversible posterior encephalopathy
syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion,
depression, tics, a state of excitement and euphoria, suicidal thoughts, paraesthesia, restlessness,
involuntary muscle contractions causing parts of the body to assume abnormal and often painful postures or
movements (dystonia), movement disorders (dyskinesia), memory loss (amnesia), memory impairment,
syncope, accommodation disorder (eye disorder), blurred vision and difficulty focusing, prolonged abnormal
pupil dilation, eye pain, visual impairment, abnormal intolerance to visual perception of light, reduced blood
flow to the optic nerve (ischaemic optic neuropathy), uncontrolled circular eye movements (oculogyric crisis),
palpitations, heart attack (myocardial infarction), low blood pressure, difficulty breathing (dyspnoea), diarrhoea,
abdominal discomfort, involuntary loss of urine, difficulty urinating (urinary retention), erectile dysfunction,
swelling due to fluid accumulation, malaise, severe skin reactions characterized by fever and numerous small
superficial pustules surrounded by large red areas, itching*, joint pain (arthralgia), muscle pain (myalgia).
Isolated cases of liver inflammation (hepatitis) have been reported when cetirizine is administered alone.
* Itching may also occur after discontinuation of the medicine.
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 adverse
reactions reporting system. By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store Zirtec Decongestant Antihistamine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zirtec Decongestant Antihistamine contains
The active substances are:

• cetirizine dihydrochloride 5 mg (equivalent to 4.21 mg of cetirizine)
• pseudoephedrine hydrochloride 120 mg (equivalent to 98.316 mg of pseudoephedrine)

The tablet core contains: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, sodium croscarmellose.
The coating contains:
Opadry Y-1-7000 consisting of:

• Hypromellose (E 464)
• Titanium dioxide (E 171)
• Polyethylene glycol 400

Description of the appearance of Zirtec Decongestant Antihistamine and package contents
The combination of cetirizine and pseudoephedrine is available as prolonged-release tablets, white to off-white, round and biconvex in shape.
Prolonged-release tablets of Zirtec Decongestant Antihistamine are packaged in PVC-Al blisters and available in pack sizes of 6 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma S.p.A.
Via Varesina 162
20156 Milan
Italy
Manufacturer
Aesica Pharmaceuticals S.r.l.
Via Praglia 15
10044 Pianezza (TO)

PATIENT INFORMATION LEAFLET

For over-the-counter medicines

Package leaflet: information for the patient

Zirtec Decongestant Antihistamine 5 mg + 120 mg prolonged-release tablets

cetirizine dihydrochloride + pseudoephedrine hydrochloride
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.

• 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 your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Zirtec Decongestant Antihistamine is and what it is used for

Zirtec Decongestant Antihistamine prolonged-release tablets contain two active substances:
cetirizine dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body during an allergic or inflammatory reaction) and pseudoephedrine hydrochloride (a vasoconstrictor that decongests the nasal mucosa).
Zirtec Decongestant Antihistamine is used to relieve symptoms of acute inflammation of the nasal mucosa (acute rhinitis), such as nasal congestion, runny nose, nasal and/or ocular itching, and tearing.

2. What you need to know before taking Zirtec Decongestant Antihistamine

Do not take Zirtec Decongestant Antihistamine

• if you are allergic to cetirizine, pseudoephedrine, ephedrine, piperazines, or any of the other ingredients of this medicine (listed in section 6);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication, or have severe problems with the coronary arteries supplying the heart (severe coronary artery disease);
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or renal failure/severe kidney problems (severe renal insufficiency);
• if your thyroid gland is overactive and the condition is not under control (uncontrolled hyperthyroidism);
• if you have severe heart rhythm disorders (severe arrhythmia);
• if you have a tumor called pheochromocytoma;
• if you have high pressure inside the eye (elevated intraocular pressure or glaucoma);
• if you have difficulty urinating (urinary retention);
• if you have had a brain blood vessel disorder called stroke;
• if you are at risk of developing cerebral hemorrhage (hemorrhagic stroke);
• if you are taking dihydroergotamine;
• if you are being treated with certain antidepressants called monoamine oxidase inhibitors (MAOIs), or have taken them within the last two weeks (see "Other medicines and Zirtec Decongestant Antihistamine");
• if you are pregnant;
• if you are breastfeeding;
• in children under 12 years of age.

Warnings and precautions
Take Zirtec Decongestant Antihistamine only for short-term treatment (see section 3).
Talk to your doctor or pharmacist before taking Zirtec Decongestant Antihistamine if:

• you have diabetes;
• your thyroid gland is overactive (hyperthyroidism);
• you have high blood pressure;
• you have a fast heartbeat (tachycardia) or an irregular heartbeat (cardiac arrhythmia);
• you have heart disease due to insufficient blood supply from the coronary arteries (ischemic heart disease);
• you have a medical condition in which the medicine's activity could cause problems, in patients predisposed to urinary retention (e.g. spinal cord injury, benign prostatic hyperplasia, prostatic hypertrophy, or bladder outflow obstruction), as Zirtec Decongestant Antihistamine may increase the risk of urinary retention;
• your liver and/or kidneys do not function properly (moderate hepatic or renal insufficiency);
• you have an enlarged prostate (prostatic hypertrophy) or have difficulty urinating;
• you are at risk of hypercoagulability, as in inflammatory bowel disease;
• you are over 65 years of age.

Caution is required when using Zirtec Decongestant Antihistamine if you are taking medicines that could predispose to hemorrhagic stroke, such as other nasal decongestants; medicines that reduce blood vessel dilation (vasoconstrictors); and other medicines that could alter the effect of Zirtec Decongestant Antihistamine (see "Other medicines and Zirtec Decongestant Antihistamine").
With Zirtec Decongestant Antihistamine, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, stop using Zirtec Decongestant Antihistamine and contact your doctor or seek immediate medical help. See section 4.
With Zirtec Decongestant Antihistamine, a reduction in blood flow to the optic nerve may occur. If sudden vision loss occurs, stop taking Zirtec Decongestant Antihistamine and contact your doctor or seek immediate medical attention (see section 4).
If you develop fever and numerous small blisters, stop treatment with Zirtec Decongestant Antihistamine and contact your doctor.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may lead to reduced blood supply to the brain. Stop immediately using Zirtec Decongestant Antihistamine and seek immediate medical assistance if you develop symptoms that could indicate PRES or RCVS (see section 4 “Possible side effects” for symptoms).
If you are scheduled for an allergy test, inform your doctor, as you must stop taking Zirtec Decongestant Antihistamine several days before the test. This medicine may alter the results of allergy testing.

Children
Do not give this medicine to children under 12 years of age.

Other medicines and Zirtec Decongestant Antihistamine
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that you inform your doctor or pharmacist if you are taking:

• medicines used for depression known as monoamine oxidase inhibitors (MAOIs) (see “Do not take Zirtec Decongestant Antihistamine”) or tricyclic antidepressants;
• medicines that reduce nasal congestion (decongestants, such as phenylpropanolamine, phenylephrine, ephedrine);
• medicines that stimulate the nervous system, including appetite suppressants and stimulants such as amphetamines;
• alcohol or other substances that depress the nervous system;
• medicines used for high blood pressure (antihypertensives), such as beta-blockers, methyldopa, guanethidine, and reserpine;
• medicines used to support heart function, called cardiac glycosides (e.g., digoxin or digitoxin);
• medicines such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine that cause constriction of blood vessels;
• non-steroidal anti-inflammatory drugs (NSAIDs);
• ritonavir (a medicine for HIV virus);
• linezolid (an antibiotic);
• medicines used to reduce stomach acidity: antacids and proton pump inhibitors;
• kaolin, a substance used as an excipient in many medicines.

If you are scheduled for surgery requiring certain types of anesthesia, inform your doctor that you are taking Zirtec Decongestant Antihistamine.

Zirtec Decongestant Antihistamine with food, drinks, and alcohol
Zirtec Decongestant Antihistamine can be taken with or without food.
Consumption of alcohol may enhance the central nervous system depressant effects of Zirtec Decongestant Antihistamine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Zirtec Decongestant Antihistamine must not be taken during pregnancy or breastfeeding.

Driving and using machines
At recommended doses, Zirtec Decongestant Antihistamine usually does not cause drowsiness. However, in rare cases, Zirtec Decongestant Antihistamine may reduce alertness, especially when combined with alcoholic beverages or other medicines that depress the central nervous system. If you experience drowsiness or dizziness, do not drive or operate machinery.
For individuals engaged in sports: using Zirtec Decongestant Antihistamine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Zirtec Decongestant Antihistamine contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Zirtec Decongestant Antihistamine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. How to take Zirtec Decongestant Antihistamine

Take Zirtec Decongestant Antihistamine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: one tablet twice daily (one in the morning and one in the evening).

Patients with liver problems
The recommended dose is one tablet once daily.

Patients with kidney problems
The dose must be determined by the doctor according to renal function.

The tablets must be swallowed whole with some liquid and must not be broken, chewed or crushed.

The duration of treatment should not exceed the duration of acute rhinitis symptoms and in any case should not exceed 7 days. After 7 days, consult your doctor or pharmacist, as treatment should continue with a medicine containing cetirizine only.

Use in children and adolescents
Children aged 12 years and older: 1 tablet twice daily (one in the morning and one in the evening).
Zirtec Decongestant Antihistamine must not be used in children under 12 years of age.

If you take more Zirtec Decongestant Antihistamine than you should
If you have taken an excessive dose of Zirtec Decongestant Antihistamine, go immediately to the nearest emergency department.
Overdose may cause the following symptoms: diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, urinary retention, increased and/or irregular heartbeat, high blood pressure, or signs of central nervous system depression (loss of alertness up to complete unconsciousness, bluish discoloration of mucous membranes, periods of respiratory arrest, cardiocirculatory collapse) and/or central nervous system excitation (insomnia, hallucinations, tremors, epileptic seizures), which may even be fatal.

If you forget to take Zirtec Decongestant Antihistamine
If you forget to take a tablet, take it as soon as you remember. Do not take a double dose to make up for the missed dose. Subsequent doses should be taken every 12 hours.

If you stop treatment with Zirtec Decongestant Antihistamine
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zirtec Decongestant Antihistamine may cause side effects, although not everyone experiences them.
Stop treatment with Zirtec Decongestant Antihistamine immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision.

You may experience the following side effects:
Common (may affect up to 1 in 10 people):
fast heartbeat, dry mouth, nausea, weakness (asthenia), dizziness, drowsiness, headache, vertigo, nervousness, insomnia;
Uncommon (may affect up to 1 in 100 people):
agitation, anxiety;
Rare (may affect up to 1 in 1,000 people):
heart rhythm disorders, hypersensitivity reactions (including anaphylactic shock), seizures, tremor, hallucinations, pallor, high blood pressure, vomiting, altered liver function, difficulty urinating, dry skin, skin rash, excessive sweating, urticaria;
Very rare (may affect up to 1 in 10,000 people):
drug-induced fixed eruption, angioedema (a severe allergic reaction causing swelling of the face or throat), circulatory collapse, inflammation of the colon due to insufficient blood supply (ischemic colitis), cerebrovascular event (stroke), psychosis, taste disturbances;
Frequency not known (frequency cannot be estimated from the available data):
serious conditions affecting the brain's blood vessels known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression, tics, a state of excitement and euphoria, suicidal thoughts, paresthesia, restlessness, involuntary muscle contractions causing abnormal and often painful postures or movements (dystonia), movement disorders (dyskinesia), memory loss (amnesia), memory impairment, syncope, accommodation disorder (eye disorder), blurred vision and difficulty focusing, prolonged abnormal pupil dilation, eye pain, visual impairment, abnormal intolerance to visual light perception (photophobia), reduced blood flow to the optic nerve (ischemic optic neuropathy), uncontrolled circular eye movements (oculogyric crisis), palpitations, heart attack (myocardial infarction), low blood pressure, difficulty breathing (dyspnea), diarrhea, abdominal discomfort, involuntary loss of urine, difficulty urinating (urinary retention), erectile dysfunction, swelling due to fluid accumulation, malaise, severe skin reactions characterized by fever and numerous small superficial pustules surrounded by large red areas, itching*, joint pain (arthralgia), muscle pain (myalgia).

Isolated cases of liver inflammation (hepatitis) have been reported when cetirizine is administered alone.
* Itching may also occur after discontinuation of the medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national adverse reactions reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zirtec Decongestant Antihistamine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Zirtec Decongestant Antihistamine Contains
The active substances are:

• cetirizine dihydrochloride 5 mg (equivalent to cetirizine 4.21 mg)
• pseudoephedrine hydrochloride 120 mg (equivalent to pseudoephedrine 98.316 mg)

The tablet core contains: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, sodium croscarmellose.
The coating contains:
Opadry Y-1-7000, which consists of:

• Hypromellose (E 464)
• Titanium dioxide (E 171)
• Polyethylene glycol 400

Description of the Appearance of Zirtec Decongestant Antihistamine and Package Contents
The combination of cetirizine and pseudoephedrine is available as prolonged-release tablets, white to off-white, round and biconvex.
Prolonged-release tablets of Zirtec Decongestant Antihistamine are packaged in PVC-Al blisters and available in pack sizes of 6 or 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
UCB Pharma S.p.A.
Via Varesina 162
20156 Milan
Italy

Manufacturer
Aesica Pharmaceuticals S.r.l.
Via Praglia 15
10044 Pianezza (TO)