PRIZITEC 10 mg Film-Coated Tablets

Содержание инструкции

1. PRIZITEC 10 mg film-coated tablets
   1. What is Prizitec and what is it used for
   2. What you need to know before you take Prizitec
   3. How to take Prizitec
   4. Possible side effects
   5. How to store Prizitec
   6. Package Contents and Other Information
2. PRIZITEC 10 mg/ml oral drops, solution
   1. What is Prizitec and what is it used for?
   2. What you need to know before you take Prizitec
   3. How to take Prizitec
   4. Possible side effects
   5. How to store Prizitec
   6. Contents of the pack and other information

PRIZITEC 10 mg film-coated tablets

Cetirizine dihydrochloride

Read this leaflet carefully before taking this medicine as it containsimportant
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Prizitec and what is it used for

Cetirizine dihydrochloride is the active ingredient of PRIZITEC.
PRIZITEC is an antihistamine medicine.
In adults and children from 6 years of age, PRIZITEC tablets is 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 you take Prizitec

Do not take Prizitec:

• if you have a severe kidney disease (severe renal insufficiency 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 ingredients of other closely related medicines).

Do not take PRIZITEC 10 mg tablets:

• If you have hereditary intolerance to galactose, Lapp lactase deficiency or glucose-galactose malabsorption (closely related).

Warnings and precautions
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or bladder or prostate problems)
If you are a patient with renal insufficiency. Ask your doctor for advice, if necessary, you will need to take a lower dose.
The new dose will be defined by the doctor.
If you are an epileptic patient or a patient at risk of seizures, you must ask your doctor for advice.
No interactions of potentially relevant impact have been observed between alcohol (for blood levels of 0.5 per mille corresponding to a glass of wine) and cetirizine used in normal doses. However, as with all antihistamines, it is recommended to avoid the simultaneous intake of alcohol.
Skin tests for allergy are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them)

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

Prizitec with food and drink
Food does not significantly affect the absorption of cetirizine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As with other drugs, the use of PRIZITEC should be avoided during pregnancy. Accidental use of the drug by a pregnant woman does not produce any harmful effects on the fetus, however, taking the drug should be discontinued.
Breastfeeding
You should not take PRIZITEC during breastfeeding because cetirizine passes into breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the time of sampling after administration.

Driving and using machines
Clinical studies have not shown impairment of attention, vigilance and the ability to drive after taking PRIZITEC at the recommended dose.
If you intend to drive vehicles, undertake potentially dangerous activities or use machinery, you must not exceed the recommended dose. You must carefully observe your response to the drug.
If you are a sensitive patient, you may notice that the simultaneous use of alcohol or other substances with a depressing effect on the central nervous system may further alter your attention and your ability to react.

Prizitec 10 mg film-coated tablets contains lactose
If your doctor has told you that you have an intolerance to certain sugars, tell your doctor before taking this medicine.

3. How to take Prizitec

How and when to take PRIZITEC?
Take this medicine following exactly as indicated in this leaflet or as instructed 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 recommended dose is:

Adults and adolescents starting from 12 years:
10 mg once a day as 1 tablet.

Children aged between 6 and 12 years:
5 mg twice a day as half a tablet twice a day.

Elderly patients
Based on available data, no dose reduction is necessary 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 a day.
If you suffer from severe kidney disease, contact your doctor or pharmacist who may adjust the dose accordingly.
If the child suffers from kidney disease, contact your doctor or pharmacist who may adjust the dose based on 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 hepatic and renal impairment
For patients with hepatic and renal impairment, a 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 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 adverse effects described below may appear with increased intensity.
Adverse events such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, fast abnormal heart rhythm, tremors and urinary retention have been reported.

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

If you stop taking Prizitec
If you have any doubts about the use of 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 dosage has minor side effects on the
central nervous system (CNS), which include 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 difficulty in urination, 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 following discontinuation of cetirizine dihydrochloride treatment.

Clinical trials
In the context of controlled, double-blind clinical trials, in which cetirizine was compared to placebo or
other antihistamines at the recommended dosage (10 mg per day for cetirizine), for which quantitative
safety data are available, more than 3200 subjects have been treated with cetirizine.
Based on this data, the following adverse reactions have been reported in controlled trials versus placebo
with an incidence of ≥1.0% with cetirizine 10 mg:

Although statistically the incidence of drowsiness with cetirizine was more common than with placebo,
this event was mild to moderate in severity in the majority of cases. Further studies in which objective
tests were performed have shown that usual daily activities are not impaired at the recommended daily
dose in healthy young volunteers.
Adverse reactions with an incidence of ≥1.0% in children aged between 6 months and 12
years, in controlled clinical trials versus placebo, are:

Post-marketing experience

The following side effects have been reported in 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 1000 to 1 in 100 patients; rare: from 1 in 10,000 to 1 in 1000 patients; very rare: less than 1 in
10,000 patients; not known: the frequency cannot be estimated from the available data).

• Blood and lymphatic system disorders: very rare: thrombocytopenia (low platelet count)
• Overall: common: fatigue
• Cardiac disorders: rare: tachycardia (fast heartbeat)
• Eye disorders: very rare: accommodation disorder, blurred vision, oculorotation (eyes with uncontrolled circular movements)
• Gastrointestinal disorders: uncommon: diarrhea, abdominal pain
• Systemic disorders and administration site conditions: uncommon: asthenia (extreme fatigue), malaise rare: edema (swelling)
• Immune system disorders: rare: allergic reactions, some severe (very rare) very rare: anaphylactic shock
• Hepato-biliary disorders: rare: altered liver function (increased transaminases, alkaline phosphatase, γ -GT and bilirubin)
• Diagnostic tests: 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: tics not known: suicidal ideation (recurring thoughts or concerns about suicide)
• 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 side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine

At the first signs of hypersensitivity, discontinue treatment with Prizitec.
The doctor will determine theseverity and decide any measures to be taken if necessary.

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 that is stated on the pack after Exp.
The expiry date refers to the last day of that month
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: opadry II white (consisting of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium-chain triglycerides)

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

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 Volturno, 48 - 20089 Quinto dè Stampi - Rozzano (MI)

PRIZITEC 10 mg/ml oral drops, solution

Cetirizine dihydrochloride

Read this leaflet carefully before taking this medicine as it containsimportant
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Prizitec is and what it is used for
• 8. What you need to know before you take Prizitec
• 9. How to take Prizitec
• 10. Possible side effects
• 11. How to store Prizitec
• 12. Contents of the pack and other information

1. What is Prizitec and what is it used for?

Cetirizine dihydrochloride is the active ingredient of PRIZITEC.
PRIZITEC is an antihistamine medicine.
In adults and paediatric patients from 2 years of age, PRIZITEC oral drops is 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 you take Prizitec

Do not take Prizitec:

• if you have a severe kidney disease (severe renal insufficiency 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 ingredients of other closely related medicines).

Warnings and precautions
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or bladder or prostate problems)
If you are a patient with renal insufficiency. Ask your doctor for advice, if necessary, you will need to take a lower dose.
The new dose will be defined by the doctor.
If you are an epileptic patient or a patient at risk of seizures, you should ask your doctor for advice.
No interactions with a potentially relevant impact have been observed between alcohol (for blood levels of 0.5 per mille corresponding to a glass of wine) and cetirizine used at normal doses. However, as with all antihistamines, it is recommended to avoid the simultaneous intake of alcohol.
Skin tests for allergy are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them)

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

Prizitec with food and drink
Food does not significantly influence the absorption of cetirizine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As with other drugs, the use of PRIZITEC should be avoided during pregnancy. Accidental use of the drug by a pregnant woman does not produce any harmful effects on the fetus, however, taking the drug should be discontinued.
Breastfeeding
You should not take PRIZITEC during breastfeeding because cetirizine passes into breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the time of sampling after administration.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and ability to drive after taking PRIZITEC at the recommended dose.
If you intend to drive vehicles, undertake potentially dangerous activities or use machinery, you must not exceed the recommended dose. You must carefully observe your response to the drug.
If you are a sensitive patient, you may notice that the simultaneous use of alcohol or other substances with a depressing effect on the central nervous system may further alter 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 following exactly as indicated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The drops must be poured into a spoon or diluted in water and taken orally.
If dilution is used, it should be considered, especially for administration to children, that the
volume of water to which the drops are added must be proportional to the amount of water
the patient is able to drink. The diluted solution must be taken immediately.
When counting the drops, the bottle must be held vertically (inverted). If the flow
of drops stops and if the correct amount has not been dispensed, return the bottle to
an upright position, then invert it again and continue counting the drops.
The recommended dose is:

Adults and adolescents starting from 12 years:
10 mg once a day as 20 drops.

Children aged between 6 and 12 years:
5 mg twice a day as 10 drops twice a day.

Children aged between 2 and 6 years:
2.5 mg twice a day administered as 5 drops twice a day.

Elderly patients
Based on available data, no dose reduction is necessary 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
a day.
If you suffer from severe kidney disease, contact your doctor or pharmacist who may adjust the dose
accordingly.
If the child suffers from kidney disease, contact your doctor or pharmacist who may adjust the dose based on
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 hepatic and renal impairment
For patients with hepatic and renal impairment, a 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 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 adverse effects described below may appear with increased intensity.
Adverse events such as confusion, diarrhea, dizziness, fatigue, headache, malaise,
pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormally fast heart rate,
tremors and urinary retention have been reported.

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

If you stop taking Prizitec
If you have any doubts about the use of 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 dosage has minor side effects on the
central nervous system (CNS), which include drowsiness, fatigue, dizziness and headache. In some cases,
paradoxical stimulation of the CNS has been reported.
Although cetirizine is a selective H1 receptor antagonist and is relatively free of anticholinergic
activity, rare cases of difficulty in urination, 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 cetirizine dihydrochloride treatment.

Clinical trials
In the context of controlled, double-blind clinical trials, in which cetirizine was compared with placebo or
other antihistamines at the recommended dosage (10 mg per day for cetirizine), for which quantitative
safety data are available, more than 3200 subjects have been treated with cetirizine.
Based on this data, the following adverse reactions have been reported in controlled trials versus placebo
with an incidence of ≥1.0% with cetirizine 10 mg:

Although statistically the incidence of drowsiness with cetirizine was more common than with placebo,
this event was of mild to moderate severity in the majority of cases. Further studies in which objective
tests were performed have shown that usual daily activities are not impaired at the recommended daily
dose in healthy young volunteers.
Adverse reactions with an incidence of ≥1.0% in children aged between 6 months and 12 years, in
controlled clinical trials versus placebo, are:

Post-marketing experience
The following side effects have been reported in 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 1000 to 1 in 100 patients; rare: from 1 in 10,000 to 1 in 1000 patients; very rare: less than 1 in
10,000 patients; not known: frequency cannot be estimated from available data).

• Blood and lymphatic system disorders: very rare: thrombocytopenia (low platelet count)
• Overall – general disorders: common: fatigue
• Cardiac disorders: rare: tachycardia (fast heartbeat)
• Eye disorders: very rare: accommodation disorder, blurred vision, oculorotation (eyes with uncontrolled circular movements)
• Gastrointestinal disorders: uncommon: diarrhoea, abdominal pain
• Systemic disorders and administration site conditions: uncommon: asthenia (extreme fatigue), malaise rare: oedema (swelling)
• Immune system disorders: rare: allergic reactions, some severe (very rare) very rare: anaphylactic shock
• Hepato-biliary disorders: rare: abnormal liver function (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)
• Diagnostic tests: rare: weight gain
• Nervous system disorders: uncommon: paraesthesia (abnormal skin sensation) rare: convulsions, very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia, dystonia,
• Psychiatric disorders:

uncommon: agitation
rare: aggressiveness, confusion, depression, hallucinations, insomnia
very rare: tics
not known: suicidal ideation (recurring thoughts or concerns about suicide)

• Renal and urinary disorders: very rare: abnormal urine elimination not known: urinary retention (inability to completely empty the bladder)
• Respiratory 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 side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By
reporting side effects you can help provide more information on the safety of this medicine

At the first signs of hypersensitivity, discontinue treatment with Prizitec.
The doctor will determine the severity and decide any measures to be taken if necessary.

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 which is stated on the pack after Scad..
The expiry date refers to the last day of that month
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prizitec oral drops, solution contains

• The active ingredient is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
• The other ingredients are glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trisodium citrate dihydrate, glacial acetic acid, purified water.

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

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 Martiri delle Foibe, 1- 29016 Cortemaggiore (PC)