Cetirizine ABC: detailed information

Package leaflet: Information for the user

Cetirizina ABC 10 mg tablets

Cetirizine dihydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

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 any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What is Cetirizina ABC and what is it used for

Cetirizine dihydrochloride is the active substance of Cetirizina ABC.
Cetirizina ABC is an antiallergic medicinal product.
In adults and children aged 6 years and older, Cetirizina ABC 10 mg tablets are indicated:

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

2. What you need to know before taking Cetirizina ABC

Do not take Cetirizina ABC

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

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

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

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

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

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

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

Cetirizina ABC tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg dose, i.e. essentially 'sodium-free'.

Cetirizina ABC tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Cetirizina ABC

Take this medicine exactly as stated 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 tablet may be divided into two equal parts.

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

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

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (half a tablet) once daily.
If you suffer from severe renal disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If your child suffers from renal disease, contact your doctor or pharmacist, who can adjust the dose based on the child's needs.

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

Duration of treatment
The duration of treatment depends on the type, duration, and course of your symptoms. Ask your doctor or pharmacist for advice.

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

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

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

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

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

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

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

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

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

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

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

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

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

5. How to store Cetirizina ABC

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 Cetirizina ABC contains
The active substance is cetirizine dihydrochloride. One tablet contains 10 mg of cetirizine dihydrochloride.
The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium starch glycolate.

Description of the appearance of Cetirizina ABC and package contents
Cetirizina ABC 10 mg tablets are white, smooth-surfaced tablets with a break line. The packaging is available in cardboard boxes containing 7 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy.

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) – Italy.

Package leaflet: information for the user

Cetirizine ABC 10 mg tablets

Cetirizine dihydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cetirizina ABC is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Cetirizina ABC.
Cetirizina ABC is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizina ABC 10 mg tablets are indicated:

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

2. What you need to know before taking Cetirizina ABC

Do not take Cetirizina ABC

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

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

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

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

Cetirizina ABC with food and drink
Food does not affect the absorption of Cetirizina ABC.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Cetirizina ABC 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 must not take Cetirizina ABC while breastfeeding unless you have consulted your doctor.

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

Cetirizina ABC tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg dose, i.e. essentially ‘sodium-free’.

Cetirizina ABC tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Cetirizina ABC

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

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

Use in children aged 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 your doctor or pharmacist, who may adjust the dose according to
the child's needs.

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

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

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

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

4. Possible side effects

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

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

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

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

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

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

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

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

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

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

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

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

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

5. How to store Cetirizine ABC

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 requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cetirizina ABC contains
The active substance is cetirizine dihydrochloride. One tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, sodium starch glycolate.

Description of the appearance of Cetirizina ABC and contents of the pack
Cetirizina ABC 10 mg tablets are white tablets with a smooth surface and a break line. The pack is available in a carton containing 20 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino – Italy.

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) – Italy.

Package leaflet: information for the user

Cetirizine ABC 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cetirizina ABC is and what it is used for

Cetirizina ABC contains cetirizine dihydrochloride as the active ingredient. Cetirizina ABC is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, Cetirizina ABC 10 mg/ml oral drops,
solution is indicated:

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

2. What you need to know before taking Cetirizina ABC

Do not take Cetirizina ABC

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina ABC.
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.
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 a patient at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no available data on the safety of taking higher doses of cetirizine together with alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina ABC together with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizina ABC a few days before the test. This medicine may alter the results of allergy testing.

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

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Cetirizina ABC 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 ruled out. Therefore, you should not take Cetirizina ABC while breastfeeding unless you have consulted your doctor.

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

Cetirizina ABC oral drops, solution contains propylene glycol
This medicine contains 350 mg of propylene glycol per 10 mg dose.

Cetirizina ABC oral drops, solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg dose, i.e. essentially 'sodium-free'.

Cetirizina ABC oral drops, solution contains methyl-parahydroxybenzoate (E218) and propyl-parahydroxybenzoate (E216)
These components may cause allergic reactions (including delayed reactions).

3. How to take Cetirizina ABC

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 used to dilute the drops 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
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.
Use in children aged 6 to 12 years:
The recommended dose is 5 mg (10 drops) twice daily.
Use in children aged 2 to 6 years:
The recommended dose is 2.5 mg (5 drops) twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (10 drops) once
daily.
If you have severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor or pharmacist, who may adjust the dose
according to the child's needs.
If you feel that the effect of Cetirizina ABC is too weak or too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration, and course of your symptoms and is determined by
your doctor.
If you take more Cetirizina ABC than you should
If you think you have taken an overdose of Cetirizina ABC, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the side effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).
If you forget to take Cetirizina ABC
Do not take a double dose to make up for the forgotten dose.
If you stop taking Cetirizina ABC
If you stop treatment with Cetirizina ABC, itching (intense pruritus) and/or urticaria may rarely reappear.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

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

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

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

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

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

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

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

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

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

5. How to store Cetirizine ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not use more than 21 months after first opening the bottle.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Cetirizina ABC contains
The active substance is cetirizine dihydrochloride. 1 ml (equivalent to 20 drops) contains 10 mg of cetirizine
dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
The other components are: glycerol 85%, propylene glycol, sodium saccharin, methyl p-hydroxybenzoate
(E218), propyl p-hydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.
Description of the appearance of Cetirizina ABC and package contents
Cetirizina ABC 10 mg/ml oral drops, solution is a clear, colourless liquid. The
package contains a 20 ml bottle of solution and a dropper.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy.
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) – Italy.