Prizitec

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRIZITEC 10 mg film-coated tablets

Cetirizine dihydrochloride
Please read all of 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Prizitec is and what it is used for

Cetirizine dihydrochloride is the active substance of PRIZITEC.
PRIZITEC is an antiallergic medicinal product.
In adults and children from 6 years of age, PRIZITEC tablets are indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Prizitec

Do not take Prizitec:

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

Do not take PRIZITEC 10 mg film-coated tablets:

• if you have hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Warnings and precautions
Consult your doctor if you have problems urinating (such as in conditions involving spinal cord injury, bladder problems, or prostate issues).
If you are a patient with renal impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you are an epileptic patient or a patient at risk of seizures, you must consult your doctor.
No interactions of potentially significant impact have been observed between alcohol (at blood levels of 0.5‰, corresponding to one glass of wine) and cetirizine used at normal doses. However, as with all antihistamines, it is recommended to avoid concomitant intake of alcohol.
Skin allergy tests are inhibited by antihistamines; therefore, a wash-out period (of 3 days) is required before performing such tests.

Other medicines and Prizitec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Given the profile of cetirizine, no interactions with other drugs are expected.

Prizitec with food and drinks
Food does not significantly 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.

Pregnancy
As with other medicines, the use of PRIZITEC should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effect on the fetus; however, drug intake should be discontinued.

Breastfeeding
You must not take PRIZITEC while breastfeeding because cetirizine passes into breast milk at concentrations ranging from 25% to 90% of those measured in plasma, depending on the sampling time after administration.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or driving ability after taking PRIZITEC at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, you must not exceed the recommended dose. You should carefully observe your response to the medicine.
If you are a sensitive individual, you may notice that concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.

Prizitec 10 mg film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Prizitec

How and when to take PRIZITEC?
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The tablets should be taken with a glass of liquid.

The recommended dose is:
Adults and adolescents from 12 years of age:
10 mg once daily as 1 tablet.

Children aged 6 to 12 years:
5 mg twice daily as half a tablet twice daily.

Elderly patients
Based on available data, no dose adjustment is required in elderly patients with normal renal function.

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

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

Patients with hepatic impairment
Patients with hepatic impairment alone do not require any dose adjustment.

Patients with both hepatic and renal impairment
For patients with both hepatic and renal impairment, a dose adjustment is recommended
(see Patients with moderate to severe renal impairment).

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 Prizitec than you should
If you think you have taken an overdose of PRIZITEC, inform your doctor.
The doctor will decide what measures to take, if necessary.
After an overdose, the side effects listed below may occur with increased intensity.
Adverse events reported include confusion, diarrhea, dizziness, fatigue, headache, malaise, pupillary dilation, pruritus, restlessness, sedation, somnolence, stupor, abnormal rapid heart rhythm, tremors, and urinary retention.

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

If you stop taking Prizitec
If you have any doubts about using PRIZITEC, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Clinical studies have shown that cetirizine at the recommended dose has minor effects on the central nervous system (CNS), including drowsiness, fatigue, dizziness, and headache. In some cases, paradoxical stimulation of the CNS has been reported.
Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively free of anticholinergic activity, rare cases of urinary retention, disturbances of eye accommodation, and dry mouth have been reported.
Cases of abnormal liver function with increased liver enzymes accompanied by elevated bilirubin have been reported, most of which resolved after discontinuation of treatment with cetirizine dihydrochloride.

Clinical trials
In double-blind, placebo-controlled clinical trials comparing cetirizine with placebo or other antihistamines at the recommended dose (10 mg daily for cetirizine), more than 3,200 subjects have been treated with cetirizine, for which quantitative safety data are available.
Based on these data, in placebo-controlled clinical trials, the following adverse reactions have been reported with an incidence equal to or greater than 1.0% with cetirizine 10 mg:

Although statistically the incidence of somnolence with cetirizine was higher than with placebo,
this event was mild to moderate in severity in the majority of cases. Additional studies using objective
measurements have demonstrated that usual daily activities are not impaired at the recommended daily dose
in healthy young volunteers.
Adverse reactions with an incidence equal to or greater than 1.0% in children aged 6 months to 12 years,
in placebo-controlled clinical trials, are:

Post-marketing experience
The following adverse reactions have been reported during post-marketing experience. Frequencies are defined as follows: (very common: more than 1 in 10 patients; common: from 1 in 100 to 1 in 10 patients; uncommon: from 1 in 1,000 to 1 in 100 patients; rare: from 1 in 10,000 to 1 in 1,000 patients; very rare: less than 1 in 10,000 patients; not known: frequency cannot be estimated from the available data).

• Blood and lymphatic system disorders: very rare: thrombocytopenia (low platelet count)
• General disorders and administration site conditions: common: fatigue
• Cardiac disorders: rare: tachycardia (increased heart rate)
• Eye disorders: very rare: accommodation disorder, blurred vision, oculogyria (eyes with uncontrolled circular movements)
• Gastrointestinal disorders: uncommon: diarrhea, abdominal pain
• Systemic disorders and administration site conditions: uncommon: asthenia (extreme tiredness), malaise; rare: edema (swelling)
• Immune system disorders: rare: allergic reactions, some severe (very rare); very rare: anaphylactic shock
• Hepatobiliary disorders: rare: altered liver function (elevation of transaminases, alkaline phosphatase, γ-GT, and bilirubin)
• Investigations: rare: weight gain
• Nervous system disorders: uncommon: paresthesia (abnormal skin sensation); rare: seizures; very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia, dystonia
• Psychiatric disorders: uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tic; not known: suicidal ideation (recurrent suicidal concerns or thoughts)
• Renal and urinary disorders: very rare: abnormal urine elimination; not known: urinary retention (inability to completely empty the bladder)
• Respiratory system disorders: common: pharyngitis, rhinitis
• Skin and subcutaneous tissue disorders: uncommon: pruritus, rash; rare: urticaria; very rare: angioedema, fixed drug eruption
• Metabolism and nutrition disorders: not known: increased appetite
• Ear and labyrinth disorders: not known: vertigo (sensation of spinning or movement)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
In case of first signs of hypersensitivity, discontinue treatment with Prizitec.
Your doctor will assess the severity and decide on any necessary measures, if required.

5. How to store Prizitec

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. Package contents and other information

What Prizitec tablets contain

• The active substance is cetirizine hydrochloride. One film-coated tablet contains 10 mg of cetirizine hydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: Opadry II white (composed of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium-chain triglycerides).

Description of the appearance of Prizitec and contents of the pack
Film-coated tablet, PVC/aluminum blister – carton containing 20 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GENETIC S.P.A.
Via Della Monica, 26
84083 – CASTEL SAN GIORGIO – SALERNO (SA)
Manufacturer responsible for batch release:

• Doppel Farmaceutici S.r.l - Via Volturno, 48 - 20089 Quinto de' Stampi - Rozzano (MI)

PATIENT LEAFLET: INFORMATION FOR THE USER

PRIZITEC 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Please read this leaflet carefully before taking this medicine as 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, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Prizitec is and what it is used for

Cetirizine dihydrochloride is the active substance in PRIZITEC.
PRIZITEC is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, PRIZITEC oral drops are indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Prizitec

Do not take Prizitec:

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

Warnings and precautions
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 renal impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you are an epileptic patient or at risk of seizures, consult your doctor.
No interactions of potentially significant clinical impact have been observed between alcohol (at blood levels of 0.5 per mille, corresponding to one glass of wine) and cetirizine used at normal doses. However, as with all antihistamines, it is recommended to avoid concomitant intake of alcohol.
Skin allergy tests are inhibited by antihistamines, and a wash-out period (of 3 days) is required before performing such tests.

Other medicines and Prizitec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Given the profile of cetirizine, interactions with other drugs are not expected.

Prizitec with food and drink
Food does not significantly 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.
Pregnancy
As with other medicines, the use of PRIZITEC should be avoided during pregnancy. Accidental use of the drug by a pregnant woman does not produce any harmful effect on the fetus; however, drug intake should be discontinued.
Breastfeeding
You must not take PRIZITEC while breastfeeding because cetirizine passes into breast milk at concentrations ranging from 25% to 90% of those measured in plasma, depending on the sampling time after administration.

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

Prizitec 10 mg/ml oral drops, solution contains methylparahydroxybenzoate (E218) and
propylparahydroxybenzoate (E216)
These may cause allergic reactions (sometimes delayed).

3. How to take Prizitec

How and when to take PRIZITEC?
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The drops should be poured 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.

The recommended dose is:
Adults and adolescents from 12 years of age:
10 mg once daily as 20 drops.
Children aged 6 to 12 years:
5 mg twice daily as 10 drops twice daily.
Children aged 2 to 6 years:
2.5 mg twice daily administered as 5 drops twice daily.

Elderly patients
Based on available data, no dose reduction is required in elderly patients with normal renal function.

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

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

Patients with hepatic impairment
Patients with hepatic impairment alone do not require any dosage adjustment.

Patients with both hepatic and renal impairment
For patients with both hepatic and renal impairment, dosage adjustment is recommended (see Patients with moderate to severe renal impairment).

Duration of treatment
The duration of treatment depends on the type, duration, and course of your condition and will be determined by your doctor.

If you take more Prizitec than you should
If you think you have taken an overdose of PRIZITEC, inform your doctor.
The 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, diarrhea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors, and urinary retention.

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

If you stop taking Prizitec
If you have any questions about using PRIZITEC, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Clinical studies have shown that cetirizine at the recommended dose has minor effects on the central nervous system (CNS), including somnolence, fatigue, dizziness, and headache. In some cases, paradoxical stimulation of the CNS has been reported.
Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively free of anticholinergic activity, rare cases of urinary retention, accommodation disorders of the eye, and dry mouth have been reported.
Cases of abnormal liver function with increased liver enzymes accompanied by elevated bilirubin have been reported, most of which resolved after discontinuation of treatment with cetirizine dihydrochloride.
Clinical trials
In the context of double-blind, controlled clinical trials comparing cetirizine with placebo or other antihistamines at the recommended dose (10 mg daily for cetirizine), for which quantitative safety data are available, more than 3,200 subjects have been treated with cetirizine.
Based on these data, the following adverse reactions have been reported in placebo-controlled trials with an incidence equal to or greater than 1.0% with cetirizine 10 mg:

Although statistically the incidence of somnolence with cetirizine was more common than with placebo,
this event was mild to moderate in severity in the majority of cases. Additional studies employing objective assessments have demonstrated that usual daily activities are not impaired at the recommended daily dose in healthy young volunteers.
Adverse reactions with an incidence equal to or greater than 1.0% in children aged 6 months to 12 years, in placebo-controlled clinical trials, are:

Post-marketing experience
The following adverse reactions have been reported during post-marketing experience. Frequencies are defined as follows: (very common: more than 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1,000 patients; rare: 1 to 10 in 10,000 patients; very rare: less than 1 in 10,000 patients; not known: frequency cannot be estimated from the available data).

• Blood and lymphatic system disorders: very rare: thrombocytopenia (low platelet levels)

• General disorders and administration site conditions: common: fatigue

• Cardiac disorders: rare: tachycardia (increased heart rate)

• Eye disorders: very rare: accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)

• Gastrointestinal disorders: uncommon: diarrhea, abdominal pain

• General disorders and administration site conditions: uncommon: asthenia (extreme tiredness), malaise; rare: edema (swelling)

• Immune system disorders: rare: allergic reactions, some severe (very rare); very rare: anaphylactic shock

• Hepatobiliary disorders: rare: altered liver function (elevated transaminases, alkaline phosphatase, γ-GT and bilirubin)

• Investigations: rare: weight gain

• Nervous system disorders: uncommon: paresthesia (abnormal skin sensation); rare: convulsions; very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia, dystonia

• Psychiatric disorders:
  uncommon: agitation
  rare: aggression, confusion, depression, hallucinations, insomnia
  very rare: tic
  not known: suicidal ideation (recurrent suicidal thoughts or concerns)

• Renal and urinary disorders: very rare: abnormal urine elimination; not known: urinary retention (inability to completely empty the bladder)

• Respiratory, thoracic and mediastinal disorders: common: pharyngitis, rhinitis

• Skin and subcutaneous tissue disorders: uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic edema, fixed drug eruption

• Metabolism and nutrition disorders: not known: increased appetite

• Ear and labyrinth disorders: not known: vertigo (sensation of rotation or movement)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
At the first signs of hypersensitivity, discontinue treatment with Prizitec.
The physician will assess the severity and decide on any necessary measures.

5. How to store Prizitec

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 requires no 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. Package contents and other information

What Prizitec oral drops, solution contains

• The active substance is cetirizine hydrochloride. 1 ml (corresponding to 20 drops) contains 10 mg of cetirizine hydrochloride. One drop contains 0.5 mg of cetirizine hydrochloride.
• The other components are glycerol, propylene glycol, sodium saccharin, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Prizitec and contents of the pack
Prizitec oral drops are supplied in a 20 ml amber glass bottle with dropper.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GENETIC S.P.A.
Via Della Monica, 26
84083 – CASTEL SAN GIORGIO – SALERNO (SA)
Manufacturer responsible for batch release:

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC)