Cetirizine Pensa: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

CETIRIZINE PENSA 10 mg tablets

Cetirizine dihydrochloride
Generic medicine
Read this leaflet carefully before taking this medicine.

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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT CETIRIZINA PENSA IS AND WHAT IT IS USED FOR

Cetirizina dihydrochloride is the active substance in CETIRIZINA PENSA.
CETIRIZINA PENSA is an antiallergic medicinal product.
In adults and children from 6 years of age, CETIRIZINA PENSA 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 SHOULD KNOW BEFORE TAKING CETIRIZINE PENSA

Do not take CETIRIZINE PENSA

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), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking CETIRIZINE PENSA.
If you have kidney impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
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 must consult your doctor.
No interactions with potentially significant impact have been observed between alcohol (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.
If you need to undergo allergy testing, ask your doctor whether you should stop taking CETIRIZINE PENSA 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 this formulation does not allow for appropriate dose adjustment.

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

CETIRIZINE PENSA with food and beverages
Food does not significantly affect the absorption of cetirizine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
CETIRIZINE PENSA 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 on medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you must not take CETIRIZINE PENSA during breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or driving ability after taking CETIRIZINE PENSA at the recommended dose of 10 mg.
You should carefully observe your response to the medicine if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

CETIRIZINE PENSA contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. HOW TO TAKE CETIRIZINE PENSA

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:
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.
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 (half a tablet) once daily.
If you have severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
If your child has kidney disease, contact the doctor, who may adjust the dose according to the child's needs.

If you feel that the effect of CETIRIZINE PENSA 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 CETIRIZINE PENSA than you should:
If you think you have taken an overdose of CETIRIZINE PENSA, 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, abnormally rapid heart rate, tremors, and urinary retention.

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

If you stop taking CETIRIZINE PENSA:
If you stop treatment with CETIRIZINE PENSA, itching (intense pricking sensation) and/or urticaria may rarely reappear.
If you have any doubts about how to use CETIRIZINE PENSA, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, CETIRIZINA PENSA may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported in post-marketing experience. Frequencies are defined as follows: (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 the available data).

Blood and lymphatic system disorders: very rare: thrombocytopenia (low platelet count)
Metabolism and nutrition disorders: not known: increased appetite
Cardiac disorders: rare: tachycardia (rapid heartbeat)
Eye disorders: very rare: accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)
Ear and labyrinth disorders: not known: vertigo
Gastrointestinal disorders: uncommon: diarrhoea
General disorders and administration site conditions: uncommon: asthenia (extreme tiredness), malaise; rare: oedema (swelling)
Immune system disorders: rare: hypersensitivity; very rare: anaphylactic shock
Hepatobiliary disorders: rare: altered liver function (elevated transaminases, alkaline phosphatase, γ-GT and bilirubin); not known: hepatitis
Investigations: rare: weight gain
Nervous system disorders: uncommon: paraesthesia (abnormal skin sensation); rare: convulsions; very rare: syncope, tremor, dysgeusia (taste disturbance), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions); not known: amnesia, memory impairment
Psychiatric disorders: uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tic; not known: suicidal ideation, nightmare
Renal and urinary disorders:
very rare: abnormal urine elimination, dysuria (pain and/or difficulty urinating), enuresis (involuntary bladder emptying during night sleep)
not known: urinary retention
Respiratory system disorders: common: pharyngitis, rhinitis
Skin and subcutaneous tissue disorders: uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic oedema, drug eruption with fixed lesions; not known: generalized pustular exanthema (acute generalized exanthematous pustulosis)
Musculoskeletal and connective tissue disorders: not known: arthralgia
Metabolism and nutrition disorders: not known: increased appetite.

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

5. HOW TO STORE CETIRIZINE PENSA

Keep CETIRIZINE PENSA out of the reach and sight of children.
Do not use CETIRIZINE PENSA after the expiry date stated on the carton and blister pack.
This medicinal product requires no special storage conditions.

6. PACK CONTENTS AND OTHER INFORMATION

What CETIRIZINA PENSA contains
Tablets:

The active substance in CETIRIZINA PENSA is cetirizine dihydrochloride. One tablet contains 10 mg of cetirizine dihydrochloride.
The excipients are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium starch glycolate.

Description of the appearance of CETIRIZINA PENSA and pack contents
Tablets:
White tablet with smooth surface and break line.
Pack containing 20 tablets.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer and final controller
ICE S.p.A. – Cantone Moretti, 29 – 10015 Ivrea (TO)

PACKAGE LEAFLET: INFORMATION FOR THE USER

CETIRIZINE PENSA 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic medicine
Read this leaflet carefully before taking this medicine.

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 personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What CETIRIZINE PENSA is and what it is used for
What you need to know before taking CETIRIZINE PENSA
How to take CETIRIZINE PENSA
Possible side effects
How to store CETIRIZINE PENSA
Package contents and other information

3. WHAT IS CETIRIZINA PENSA AND WHAT IS IT USED FOR

Cetirizine dihydrochloride is the active substance in CETIRIZINA PENSA.
CETIRIZINA PENSA is an antiallergic medicinal product.
In adults and children from 2 years of age, CETIRIZINA PENSA 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).

4. WHAT YOU SHOULD KNOW BEFORE TAKING CETIRIZINE PENSA

Do not take CETIRIZINE PENSA

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), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking CETIRIZINE PENSA.
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 a patient with risk factors for urinary retention (e.g. spinal cord injury, prostate enlargement), you should consult your doctor.
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 interactions of potentially significant 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.
Nevertheless, as with all antihistamines, it is recommended to avoid concomitant alcohol intake.
If you are scheduled for allergy testing, ask your doctor whether you should stop taking CETIRIZINE PENSA for a few days before the test. This medicine may alter the results of allergy testing.
Other medicines and CETIRIZINE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CETIRIZINE PENSA with food and drinks
Food does not significantly affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
CETIRIZINE PENSA 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 excluded. Therefore, you should not take CETIRIZINE PENSA during breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or driving ability following the recommended dose of 10 mg of CETIRIZINE PENSA.
You should carefully observe your response to the medicine if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
CETIRIZINE PENSA contains methyl parahydroxybenzoate and propyl parahydroxybenzoate and
propylene glycol.
This medicine contains methyl (4-hydroxybenzoate) E 218 and propyl (4-hydroxybenzoate) E 216, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.
This medicine contains 350 mg of propylene glycol per ml.

3. HOW TO TAKE CETIRIZINE PENSA

How and when to take CETIRIZINE PENSA?
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 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 must be proportionate to the amount of liquid the patient is able to swallow. The diluted solution should 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 an 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.

Children aged 6 to 12 years:
The recommended dose is 5 mg (10 drops) twice daily.

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 suffer from severe kidney disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If the child suffers from kidney disease, contact the doctor or pharmacist, who can adjust the dose based on the child's needs.
If you feel that the effect of CETIRIZINE PENSA 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 will be determined by your doctor.

If you take more CETIRIZINE PENSA than you should:
If you think you have taken an overdose of CETIRIZINE PENSA, inform your doctor.
Your 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, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, somnolence, stupor, abnormally rapid heartbeat, tremors, and urinary retention.
There is no specific antidote for cetirizine.
In case of overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage may be advised.
Cetirizine is not effectively removed by dialysis.

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

If you stop taking CETIRIZINE PENSA:
If you stop treatment with CETIRIZINE PENSA, itching (intense pricking sensation) and/or urticaria may rarely reappear.
If you have any questions about the use of CETIRIZINE PENSA, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, CETIRIZINE PENSA may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported during post-marketing experience. Frequencies are defined as follows: (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)
Metabolism and nutrition disorders: not known: increased appetite
General disorders and administration site conditions: common: fatigue
Cardiac disorders: rare: tachycardia (rapid heartbeat)
Eye disorders: very rare: accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)
Ear and labyrinth disorders: not known: vertigo
Gastrointestinal disorders: uncommon: diarrhoea
Systemic disorders and administration site conditions: uncommon: asthenia (extreme tiredness), malaise; rare: oedema (swelling)
Immune system disorders: rare: hypersensitivity; very rare: anaphylactic shock
Hepatobiliary disorders: rare: altered liver function (elevation of transaminases, alkaline phosphatase, γ-GT and bilirubin); not known: hepatitis
Investigations: rare: weight gain
Nervous system disorders: uncommon: paraesthesia (abnormal skin sensation); rare: convulsions; very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions); not known: amnesia, memory impairment
Psychiatric disorders: uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tic; not known: suicidal ideation, nightmare
Renal and urinary disorders: very rare: abnormal urine elimination, dysuria (pain and/or difficulty in urinating), enuresis (involuntary bladder emptying during night sleep); not known: urinary retention
Respiratory system disorders: common: pharyngitis, rhinitis
Skin and subcutaneous tissue disorders: uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic oedema, drug eruption with fixed eruption; not known: generalized exanthematous pustulosis
Musculoskeletal and connective tissue disorders: not known: arthralgia
Metabolism and nutrition disorders: not known: increased appetite.

Reporting of suspected 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETIRIZINE PENSA

Keep CETIRIZINE PENSA out of the reach and sight of children.
Do not use CETIRIZINE PENSA after the expiry date stated on the carton and blister pack.
This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CETIRIZINA PENSA contains
10 mg/ml oral drops, solution

The active substance in CETIRIZINA PENSA is cetirizine dihydrochloride. 20 drops of solution (equivalent to 1 ml) contain 10 mg of cetirizine dihydrochloride.
The excipients are glycerol 85%, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of CETIRIZINA PENSA and contents of the pack
Oral drops, solution
CETIRIZINA PENSA is supplied as a clear, colourless liquid. Pack containing one bottle of 20 ml solution.

Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano
Italy

Manufacturer and final controller
ICE S.p.A. – Cantone Moretti, 29 – 10015 Ivrea (TO)