Cetirizine Accord: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizina Accord 10 mg film-coated tablets

Read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Cetirizina Accord contains the active substance cetirizine dihydrochloride. Cetirizina Accord is an antiallergic medicine.
In adults and children aged 6 years and older, Cetirizina Accord 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 Accord

Do not take Cetirizina Accord:

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine hydrochloride 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 Accord.
If you are a patient with renal impairment, consult your doctor. A lower dose may be required. Your doctor will determine the appropriate dose.
Consult your doctor if you have problems urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, 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 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 concomitant intake of alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizina Accord a few days before the test. This medicine may alter the results of allergy tests.
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 Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizina Accord with food and drink
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Cetirizina Accord should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce 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 Cetirizina Accord during 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 Accord at the recommended dose. However, you should carefully observe your response to the medicine after taking Cetirizina Accord if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizina Accord contains lactose
Cetirizina Accord film-coated tablets contain lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Cetirizina Accord

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 once daily as 1 tablet.
Other formulations of this medicine may be more suitable for children; please consult your doctor or
pharmacist.
Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily as 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 (as half a
tablet) once daily.
If you have severe kidney disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If your child has kidney disease, contact your doctor or pharmacist, who can adjust the dose according to the child's needs.
If you feel that the effect of Cetirizina Accord 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 Cetirizina Accord than you should
If you think you have taken an overdose of Cetirizina Accord, inform your doctor.
Your doctor will decide what 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 heartbeat, tremors and urinary retention (difficulty completely emptying the bladder).
If you forget to take Cetirizina Accord
Do not take a double dose to make up for the forgotten dose.
If you stop taking Cetirizina Accord
If you stop treatment with Cetirizina Accord, 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 experiences them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
immediately contact your doctor if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the
face 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
Dizziness, headache
Pharyngitis, rhinitis (in children)
Diarrhoea, 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 of which may be severe (very rare)
Depression, hallucinations, aggression, confusion, insomnia
Seizures
Tachycardia (increased heart rate)
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 (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
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 (suicidal thoughts or concerns, recurring), nightmares
Amnesia, 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 pustules containing pus)
Hepatitis (inflammation of the liver)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: 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 Accord

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 carton and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Cetirizina Accord contains

The active substance in Cetirizina Accord is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients 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 Cetirizina Accord and pack sizes
Film-coated tablet, PVC/aluminum blister – carton pack containing 20 divisible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer:
Doppel Farmaceutici S.r.l – Via Volturno, 48 – 20089 Quinto de' Stampi – Milano

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine Accord 10 mg/ml oral drops, solution

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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Cetirizina dicloridrato is the active substance in Cetirizina Accord. Cetirizina Accord is an antiallergic medicine.
In adults and pediatric patients aged 2 years and older, Cetirizina Accord 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 Cetirizine Accord

Do not take Cetirizine Accord:

if you have severe kidney disease requiring dialysis;
if you are allergic to cetirizine hydrochloride 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 Accord.
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 problems 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 clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰ (g/l), corresponding to one glass of wine) and cetirizine 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 concomitant use of Cetirizine Accord with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizine Accord a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and Cetirizine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Cetirizine Accord with food and drinks
Food does not affect the absorption of cetirizine.

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

Paediatric population
The use of this medicine is not recommended in neonates and children under 2 years of age.

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

Cetirizine Accord contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216)
Cetirizine Accord oral drops, solution contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).

Cetirizine Accord contains propylene glycol
This medicine contains 350 mg of propylene glycol per maximum daily dose (1 ml).
Talk to your doctor or pharmacist before administering this medicine to a child, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.

3. How to take Cetirizine Accord

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 dispensed into a spoon or diluted in water and taken by mouth.
If using dilution, it is important, especially when administering to children, 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 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 once daily, equivalent to 20 drops.
Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily, equivalent to 10 drops twice daily.
Children aged 2 to 6 years:
The recommended dose is 2.5 mg twice daily, administered as 5 drops twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (equivalent to 10 drops) once
daily.
If you have severe kidney disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If your child has kidney disease, contact the doctor or pharmacist, who can adjust the
dose according to the child's needs.
If you feel that the effect of Cetirizine Accord 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 Accord than you should
If you think you have taken an overdose of Cetirizine Accord, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the following undesirable effects 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 Cetirizine Accord
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Cetirizine Accord
If you stop treatment with Cetirizine Accord, 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 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
Dizziness, headache
Pharyngitis, rhinitis (in children)
Diarrhoea, nausea, dry mouth
Fatigue

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

Agitation
Paraesthesia (abnormal sensation of the skin)
Abdominal pain
Itching (pruritic 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
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 uncontrolled circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
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 suicidal concerns or thoughts), nightmares
Amnesia, 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)
Generalised exanthematous pustulosis (skin eruption with pustules containing pus)
Hepatitis (inflammation of the liver)

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 Italian Medicines Agency (Agenzia Italiana del Farmaco) website: 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 Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after “Exp.”.
The expiry date refers to the last day of that month.
Do not use more than 6 months after first opening the bottle.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Cetirizina Accord contains

The active substance of Cetirizina Accord is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) of Cetirizina Accord contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
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 Cetirizina Accord and contents of the pack
Cetirizina Accord oral drops are supplied in a 20 ml amber glass bottle with dropper.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer:
Doppel Farmaceutici S.r.l. – Via martiri delle Foibe, 1- 29016 Cortemaggiore (PC)