Cetirizine Teva Italia

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizina Teva Italia 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 other people, even if their symptoms are the same as yours, because it may be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cetirizina Teva Italia is and what it is used for

Cetirizine dihydrochloride is the active substance in Cetirizina Teva Italia. Cetirizina Teva Italia is an antiallergic medicine.
In adults and children aged 6 years and older, Cetirizina Teva Italia is indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizine Teva Italia

Do not take Cetirizine Teva Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Teva Italia.
No interactions of potentially significant clinical relevance have been observed between alcohol (at blood levels of 0.5‰, 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 are a patient with renal impairment, consult your doctor; if necessary, you will need to take a lower dose. The new dose will be determined by your doctor.
If you are a patient with predisposing factors for urinary retention (such as spinal cord injury or prostate hyperplasia), you should consult your doctor, as cetirizine may increase the risk of urinary retention.
If you are a patient with epilepsy or at risk of seizures, consult your doctor.
Skin allergy tests are inhibited by antihistamines, and it is necessary to discontinue the medicine at least 3 days before such tests are performed.

Children
The tablet formulation is not recommended for children under 6 years of age, as this formulation does not allow for appropriate dose adjustment.

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

Cetirizine Teva Italia with food and drinks
Food does not significantly 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.

Pregnancy
Cetirizine Teva Italia should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not cause harmful effects on the fetus; however, use of the medicine should be discontinued.

Breastfeeding
You must not take Cetirizine Teva Italia while breastfeeding, as cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or ability to drive vehicles after taking Cetirizine Teva Italia at the recommended dose. If you intend to drive, engage in potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You should carefully observe your response to the medicine.
If you are sensitive, you should be aware that concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.

Cetirizine Teva Italia tablets contain:

• lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Cetirizina Teva Italia

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Follow these instructions, otherwise Cetirizina Teva Italia may not be fully effective.
The tablets should be taken with a glass of liquid.
The tablet may be divided into equal parts.

Use in adults and adolescents aged 12 years and older:
10 mg once daily, administered as 1 tablet.

Use in children aged between 6 and 12 years:
5 mg twice daily, administered 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 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 will adjust the dose according to the child's needs.

If you feel that the effect of Cetirizina Teva Italia 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 Teva Italia than you should
If you think you have taken an overdose of Cetirizina Teva Italia, inform your doctor. The doctor will decide which measures to take, if necessary.
After an overdose, the side 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, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).

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

If you stop taking Cetirizina Teva Italia
If you stop treatment with cetirizine, itching (intense pruritus) 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.
You must stop taking the medicine and contact your doctor immediately if you notice any of the following:

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

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

• need to sleep (somnolence),
• dizziness, headache,
• diarrhoea, dry mouth, nausea,
• sore throat (pharyngitis), nasal congestion, runny nose (rhinitis),
• fatigue.

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

• agitation,
• tingling sensation in the extremities (paraesthesia),
• abdominal pain,
• itching, skin rash,
• generalised feeling of weakness (asthenia), malaise.

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

• hypersensitivity,
• aggression, confusion, depression, hallucinations, insomnia,
• epileptic seizures,
• rapid heartbeat (tachycardia),
• altered liver function,
• urticaria,
• fluid accumulation (oedema),
• weight gain.

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

• low platelet count (thrombocytopenia),
• tic,
• altered taste (dysgeusia), fainting (syncope), tremor, prolonged abnormal muscle contractions (dystonia), involuntary movements (dyskinesia),
• difficulty focusing (accommodation disorder), blurred vision, eyes with uncontrollable circular movements (eye rotation),
• skin reaction developing after taking the drug (drug-induced fixed eruption),
• difficulty urinating (dysuria), involuntary loss of urine (enuresis).

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

• increased appetite,
• suicidal thoughts, nightmare,
• memory loss (amnesia), memory impairment,
• vertigo,
• inflammation of the liver (hepatitis),
• skin rash with blisters (generalised acute exanthematous pustulosis),
• joint pain (arthralgia), muscle pain (myalgia),
• inability to completely empty the bladder (urinary retention).

Description of selected adverse reactions
Itching (intense pruritus) and/or urticaria have been reported after discontinuation of cetirizine treatment.

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 Cetirizina Teva Italia

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 pack following “Exp.”.
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 Teva Italia contains

• The active substance is cetirizine hydrochloride. Each tablet contains 10 mg of cetirizine hydrochloride.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate, sodium carboxymethyl starch.

Description of the appearance of Cetirizina Teva Italia and the contents of the pack
Divisible tablets. White, round tablet with a score line.
Pack containing 20 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Cetirizine Teva Italia 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic 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, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cetirizine Teva Italia is and what it is used for
2. What you need to know before taking Cetirizine Teva Italia
3. How to take Cetirizine Teva Italia
4. Possible side effects
5. How to store Cetirizine Teva Italia
6. Package contents and other information

1. What Cetirizina Teva Italia is and what it is used for

Cetirizina Teva Italia contains cetirizine dihydrochloride as the active substance. Cetirizina Teva Italia is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, Cetirizina Teva Italia is indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizine Teva Italia

Do not take Cetirizine Teva Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Teva Italia.
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.
However, as with all antihistamines, it is recommended to avoid concomitant intake of alcohol.
If you have 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 hyperplasia),
you should consult your doctor, as cetirizine may increase the risk of urinary retention.
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
Skin allergy tests are inhibited by antihistamines, and it is required that the medicine not be taken for
3 days prior to such testing.
Children
The use of this medicine is not recommended in children under 2 years of age.
Other medicines and Cetirizine Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, including those without a prescription.
Cetirizine Teva Italia with food and drink
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.
Pregnancy
Cetirizine Teva Italia should be avoided during pregnancy. Accidental use of the medicine by
a pregnant woman does not produce any harmful effects on the fetus; however, intake of the medicine
should be discontinued.
Breastfeeding
You must not take Cetirizine Teva Italia while breastfeeding, as cetirizine passes into breast milk.
A risk of adverse effects in breastfed infants cannot be ruled out.
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles
after taking Cetirizine Teva Italia at the recommended dose. If you intend to drive, perform potentially
hazardous activities, or operate machinery, do not exceed the recommended dose. You should carefully
observe your response to the medicine.
If you are a sensitive patient, you may notice that concomitant use of alcohol or other substances
with central nervous system depressant effects may further impair your attention and reaction ability.
Cetirizine Teva Italia oral drops, solution contains:

• methyl (4-hydroxybenzoate) E 218 and propyl (4-hydroxybenzoate) E 216, which may cause allergic reactions (including delayed reactions).
• 87.5 mg of propylene glycol E 1520 per 2.5 mg dose (5 drops).
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per maximum dose of 10 mg (20 drops), i.e. it is essentially “sodium-free”.

3. How to take Cetirizina Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Follow these instructions carefully; otherwise, Cetirizina Teva Italia may not be fully effective.
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 should be proportionate to the amount of liquid the patient is able
to ingest. The diluted solution must be taken immediately.

Use in adults and adolescents aged 12 years and older
10 mg once daily, administered as 20 drops.

Use in children aged 6 to 12 years
5 mg twice daily, administered as 10 drops twice daily.

Use in children aged 2 to 6 years
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 (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 will adjust the dose based on the child's needs.

If you feel that the effect of Cetirizina Teva Italia 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 Teva Italia than you should
If you think you have taken an overdose of Cetirizina Teva Italia, inform your doctor. The doctor will decide
which measures to take, if necessary.
After an overdose, the undesirable effects listed 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 Teva Italia
Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizina Teva Italia
If you discontinue treatment with cetirizine, itching (intense prickling 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 contact your doctor immediately if you notice:

• allergic reactions, including severe reactions (anaphylactic shock) and severe reaction causing swelling of the face and throat (angioedema). These reactions may occur shortly after taking the medicine or later.

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

• need to sleep (drowsiness),
• dizziness, headache,
• diarrhoea, dry mouth, nausea,
• sore throat (pharyngitis), stuffy nose, runny nose (rhinitis),
• tiredness.

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

• agitation,
• tingling sensation in the extremities (paraesthesia),
• abdominal pain,
• itching, skin rash,
• general feeling of tiredness (asthenia), malaise.

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

• hypersensitivity,
• aggression, confusion, depression, hallucinations, insomnia,
• epileptic seizures,
• rapid heartbeat (tachycardia),
• altered liver function,
• urticaria,
• fluid retention (oedema),
• weight gain.

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

• low platelet count (thrombocytopenia),
• tic,
• taste disturbance (dysgeusia), fainting (syncope), tremor, prolonged abnormal muscle contractions (dystonia), involuntary movements (dyskinesia),
• difficulty focusing (accommodation disorder), blurred vision, eyes with uncontrolled circular movements (eye rolling),
• skin reaction developing after taking the drug (fixed drug eruption),
• difficulty urinating (dysuria), involuntary loss of urine (enuresis).

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

• increased appetite,
• suicidal thoughts, nightmares,
• memory loss (amnesia), memory impairment,
• vertigo,
• inflammation of the liver (hepatitis),
• skin rash with blisters (generalised exanthematous pustulosis),
• joint pain (arthralgia), muscle pain (myalgia),
• inability to completely empty the bladder (urinary retention).

Description of selected adverse reactions
Itching (intense pruritus) and/or urticaria have been reported after discontinuation of cetirizine treatment.
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 Cetirizina Teva Italia

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 on the bottle after Exp.
The shelf life after first opening of the bottle is 21 months.
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 Cetirizina Teva Italia contains

• The active substance is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) of Cetirizina Teva Italia contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
• The other components are glycerol 85%, propylene glycol E 1520, sodium saccharin, methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate trihydrate, acetic acid, purified water.

Description of the appearance of Cetirizina Teva Italia and contents of the pack
Cetirizina Teva Italia is supplied as a clear, colourless liquid.
Pack: one 20 ml bottle of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy