Ceteris

PACKAGE LEAFLET: INFORMATION FOR THE USER

CETERIS

10 mg film-coated tablets
cetirizine dihydrochloride
Equivalent medicine
Please 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CETERIS is and what it is used for

Cetirizine dihydrochloride is the active substance in CETERIS.
CETERIS is an antiallergic medicinal product.
In adults and children from 6 years of age, CETERIS 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 CETERIS

Do not take CETERIS

• 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 CETERIS.
If you have kidney impairment, consult your doctor; a lower dose may be necessary. 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, consult your doctor before taking this medicine.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰, 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 taking CETERIS together with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking CETERIS 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 CETERIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

CETERIS with food, drinks and alcohol
Food does not affect the absorption of CETERIS.
If you are sensitive, you may notice that the simultaneous use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
CETERIS should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not cause 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 CETERIS while breastfeeding unless you have consulted your doctor.

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

CETERIS film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take CETERIS

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.

Adults and adolescents from 12 years of age
The recommended dose is 10 mg (1 tablet) once daily.
Other forms 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 forms 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 suffer from severe kidney disease, contact your doctor, who may adjust the dose accordingly.
If your child has kidney disease, contact the doctor, who will adjust the dose according to the child's needs.

If you feel that the effect of CETERIS 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 CETERIS than you should
If you think you have taken an overdose of CETERIS, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the adverse effects listed below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormally rapid heart rhythm, tremors, and urinary retention (difficulty completely emptying the bladder).

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

If you stop taking CETERIS
If you stop treatment with CETERIS, itching (intense pruritus) and/or urticaria may rarely reappear.

If you have any doubts about the use of CETERIS, 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 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 (need to sleep)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (stuffy nose, runny nose) (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paraesthesia (abnormal skin sensation)
• Abdominal pain
• Itching (pruritic 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 (increased heart rate)
• 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), oculogyration (eyes with uncontrolled circular movements)
• Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (allergy to the medicine)
• Abnormal urination (involuntary bladder emptying 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 pruritus) and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalised acute exanthematous pustulosis (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 the website https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CETERIS

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 blister.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CETERIS contains
CETERIS film-coated tablets

• The active substance of CETERIS is cetirizine dihydrochloride.
• Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The excipients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000.

Description of the appearance of CETERIS and contents of the pack
Film-coated tablet with a score line. The tablets can be divided into two equal parts.
Pack containing 7 or 20 tablets.
Marketing Authorization Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
Pomezia (Roma)
Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

CETERIS

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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CETERIS is and what it is used for
Cetirizine dihydrochloride is the active substance in CETERIS.
CETERIS is an antiallergic medicine.
In adults and children from the age of 6 years, CETERIS is indicated:

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

The CETERIS oral drops solution formulation can also be used in children from the age of 2 years.

2. What you need to know before taking CETERIS

Do not take CETERIS

• 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 CETERIS.
If you have kidney impairment, consult your doctor; a lower dose may be needed. 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 per mille (g/L), corresponding to one glass of wine) and cetirizine used at 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 CETERIS together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking CETERIS for a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and CETERIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

CETERIS with food, drinks and alcohol
Food does not affect the absorption of cetirizine.
If you are sensitive, you may notice that the concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
CETERIS should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not cause 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 should not take CETERIS during breastfeeding unless advised by your doctor.

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

CETERIS oral drops, solution contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (sometimes delayed);
• 350 mg of propylene glycol in each ml of solution, equivalent to 5 mg/kg/day. If your child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if your child is taking other medicines containing propylene glycol or alcohol;
• less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.

3. How to take CETERIS

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 dilution is used, 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 must be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the drop flow 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 from 12 years of age
The recommended dose is 10 mg (20 drops), once daily.
Use in children aged between 2 and 6 years:
The recommended dose is 2.5 mg (5 drops), twice daily.
Use in children aged between 6 and 12 years
The recommended dose is 5 mg (10 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, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor, who may adjust the dose according to the
child's needs.
If you feel that the effect of CETERIS 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 CETERIS than you should
If you think you have taken an overdose of CETERIS, inform your doctor.
Your doctor will decide which 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), 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 CETERIS
Do not take a double dose to make up for the missed dose.
If you stop taking CETERIS
If you stop treatment with CETERIS, itching (intense prickling sensation) and/or urticaria may rarely reappear.
If you have any questions about the use of CETERIS, 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
contact 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 on.

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 sensation)
• Abdominal pain
• Pruritus (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 (increased heart rate)
• 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), oculogyration (eyes with uncontrolled circular movements)
• Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (allergy to the medicine)
• Abnormal urination (involuntary bladder emptying 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 (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)
• Pruritus (intense itching) and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalized acute 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, 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/segnalazionireazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CETERIS

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.
The expiry date refers to the last day of that month.
Store below 25°C, both in the original packaging and after first opening.
The shelf life after first opening of the bottle is 6 months.
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 CETERIS contains
CETERIS oral drops, solution

• The active substance in CETERIS 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 excipients are: glycerol, propylene glycol (E1520), sodium saccharin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of CETERIS and contents of the pack
Oral drops, solution; clear, colourless solution in a bottle containing 20 ml.
Marketing Authorization Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome)
Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy