Cetirizine Aurobindo Italia

Package leaflet: Information for the user

Cetirizina Aurobindo Italia 10 mg/ml oral drops, solution

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Cetirizina Aurobindo Italia contains cetirizine dihydrochloride as the active substance. Cetirizina Aurobindo Italia is an antiallergic medicine.
In adults and children from 2 years of age, Cetirizina Aurobindo Italia 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 Aurobindo Italia

Do not take Cetirizina Aurobindo Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Aurobindo Italia.
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 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 the safety of taking higher doses of cetirizine together with alcohol.
Therefore, as with all antihistamines, it is recommended to avoid concomitant use of Cetirizina Aurobindo Italia with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizina Aurobindo Italia a few days before the test. This medicine may alter the results of allergy testing.

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

Taking Cetirizina Aurobindo Italia with food and drinks
Food does not 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 or pharmacist before taking this medicine.
Cetirizina Aurobindo 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, 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 ruled out. Therefore, you must not take Cetirizina Aurobindo Italia while breastfeeding unless advised by your doctor.

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

Cetirizina Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per unit of volume, i.e. it is essentially 'sodium-free'.

Cetirizina Aurobindo Italia contains propylene glycol
This medicine contains 350 mg of propylene glycol per ml of solution.

Cetirizina Aurobindo Italia contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)
These ingredients may cause allergic reactions (including delayed reactions).

3. How to take Cetirizina Aurobindo Italia

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.
When using dilution, especially for administration 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 should be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the flow of drops stops and the correct amount has not been dispensed, return the bottle to
an upright position, then turn it upside down again and continue counting the drops.
Adults and adolescents aged 12 years and older:
The recommended dose is 10 mg (20 drops) once daily.
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 can adjust the dose accordingly.
If the child has kidney disease, contact the doctor or pharmacist, who can adjust the dose based on the child's needs.
If you feel that the effect of Cetirizina Aurobindo 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 condition and is determined by
your doctor.
If you take more Cetirizina Aurobindo Italia than you should
If you think you have taken more Cetirizina Aurobindo Italia than you should, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the undesirable effects listed below may occur with increased intensity.
Reported adverse effects 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 Aurobindo Italia
Do not take a double dose to make up for the forgotten dose.
If you stop taking Cetirizina Aurobindo Italia
If you stop treatment with Cetirizina Aurobindo Italia, 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 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 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)

• Somnolence (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.
• Paraesthesia (abnormal skin sensations).
• Abdominal pain.
• Pruritus (itchy 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 (rapid 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, 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 (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 (recurrent suicidal thoughts or concerns), nightmares.
• Amnesia (loss of memory), memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the bladder).
• Pruritus (intense itching) and/or urticaria occurring after discontinuation of treatment.
• Arthralgia (joint pain), myalgia (muscle pain).
• Generalised exanthematous pustulosis (skin rash 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, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the bottle. The expiry date refers to the last day of that month.
Do not use more than 15 months after first opening the bottle.
This medicine requires no 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 Aurobindo Italia contains

• The active substance is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) of Cetirizina Aurobindo Italia 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 parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Cetirizina Aurobindo Italia and contents of the pack
Oral drops, solution; 20 ml bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno VA
Manufacturer and final controller
ICE S.p.A.
Cantone Moretti, 29
10015 (TO) – Ivrea – Italy