IriReos antihistamine

PACKAGE LEAFLET: INFORMATION FOR THE USER

IRIREOS ANTISTAMINIC 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic medicine
Please read all of 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What IRIREOS ANTISTAMINIC is and what it is used for
  2. What you need to know before taking IRIREOS ANTISTAMINIC
  3. How to take IRIREOS ANTISTAMINIC
  4. Possible side effects
  5. How to store IRIREOS ANTISTAMINIC
  6. Contents of the pack and other information

1. What IRIREOS ANTISTAMINICO is and what it is used for

Cetirizine Dihydrochloride is the active substance in IRIREOS ANTISTAMINICO.
IRIREOS ANTISTAMINICO is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, IRIREOS ANTISTAMINICO is indicated:

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

2. What you should know before taking IRIREOS ANTISTAMINICO

Do not take IRIREOS ANTISTAMINICO:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to hydroxyzine or to any piperazine derivative (active substances of other closely related medicines used to treat allergies);
• if you have severe kidney disease (renal insufficiency with creatinine clearance below 10 ml/min);
• if your doctor has diagnosed you with an intolerance to certain sugars.

Warnings and precautions
Talk to your doctor or pharmacist before taking IRIREOS ANTISTAMINICO:

• if you have kidney insufficiency (reduced kidney function); consult your doctor. A lower dose may be needed. Your doctor will determine (establish) the new dose if necessary;
• 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, consult your doctor;
• if you have been diagnosed with an intolerance to certain sugars;
• if you are scheduled for an allergy test, ask your doctor whether you should stop taking IRIREOS ANTISTAMINICO a few days before the test. This medicine may alter allergy test results.

Children
Due to the amount of certain components in the formulation, the solution is not recommended for children under 2 years of age.

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

IRIREOS ANTISTAMINICO with food, drinks and alcohol
Food does not significantly affect the absorption of cetirizine.
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 administered at recommended doses.
However, there are no available data on the safety of concomitant intake of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines (medicines used against inflammations), it is recommended to avoid taking IRIREOS ANTISTAMINICO together with alcohol.

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.

Pregnancy
IRIREOS ANTISTAMINICO 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.

Breastfeeding
Cetirizine passes into breast milk. Therefore, you should not take IRIREOS ANTISTAMINICO 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 after taking IRIREOS ANTISTAMINICO at the recommended dose.
You should carefully observe your response to the medicine after taking IRIREOS ANTISTAMINICO if you intend to drive vehicles, perform potentially hazardous activities, or operate machinery.
Do not exceed the recommended dose.

IRIREOS ANTISTAMINICO 10 mg/ml oral drops, solution (20 ml bottle) contains Methyl p-
hydroxybenzoate and Propyl p-hydroxybenzoate
IRIREOS ANTISTAMINICO “oral drops, solution” contains Methyl p-hydroxybenzoate (E 218) and Propyl p-hydroxybenzoate (E 216), which may cause allergic reactions (sometimes delayed).

3. How to take IRIREOS ANTISTAMINICO

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 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.
Use in adults
Adults and adolescents from 12 years of age
The recommended dose is:
10 mg (20 drops) once daily, or alternatively, one single-dose container.
Use in children and adolescents
Children aged between 6 and 12 years
The recommended dose is:
5 mg (10 drops) twice daily.
Children aged between 2 and 6 years
The recommended dose is:
2.5 mg (5 drops) twice daily.
Use in patients with renal impairment
For patients with moderate renal impairment (reduced kidney function), the recommended
dose is 5 mg (10 drops) once daily.
If you suffer from severe kidney disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If your child suffers from kidney disease, contact your doctor or pharmacist, who can adjust the dose based on the child's needs.
If you feel that the effect of IRIREOS ANTISTAMINICO 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 IRIREOS ANTISTAMINICO than you should
If you think you have taken an overdose of IRIREOS ANTISTAMINICO, inform your doctor.
Your doctor will decide which measures to take, if necessary.
After an overdose, the following effects may occur with increased intensity. Adverse events reported include confusion, diarrhea, dizziness, fatigue, headache, malaise,
pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormal and rapid
heart rate, tremors, and urinary retention.
If you forget to take IRIREOS ANTISTAMINICO
Do not take a double dose to make up for the forgotten dose.
If you stop taking IRIREOS ANTISTAMINICO
If you stop treatment with IRIREOS ANTISTAMINICO, 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 at a later time.
Common side effects (may affect up to 1 in 10 patients):

• drowsiness
• dizziness, headache
• pharyngitis, rhinitis (in children)
• diarrhoea, nausea, dry mouth
• fatigue
• upper respiratory tract infections (pharyngitis and rhinitis)

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

• agitation
• paresthesia (abnormal skin sensation)
• abdominal pain
• pruritus (itchy skin), rash
• asthenia (extreme fatigue), malaise

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

• 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 patients):

• thrombocytopenia (low platelet count in the blood)
• tic (habitual spasm); syncope (loss of consciousness), 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 (serious allergic reaction causing swelling of the face or throat), drug eruption, abnormal urination (involuntary bladder emptying during night sleep, pain and/or difficulty urinating)

Side effects with unknown frequency:

• increased appetite
• suicidal ideation (suicidal thoughts or recurring concerns about suicide)
• amnesia, memory impairment
• vertigo
• urinary retention (inability to completely empty the bladder)
• pruritus (intense itching) and/or urticaria occurring after stopping 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 IRIREOS ANTISTAMINICO

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.
This date applies to the product in its original, unopened packaging, correctly stored.
Do not use this medicine beyond the 28-day period of validity after first opening the 20 ml bottle (record the date of first opening in the designated space on the carton).
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. Pack contents and other information

What IRIREOS ANTISTAMINIC contains
IRIREOS ANTISTAMINIC 10 mg/ml oral drops, solution (20 ml bottle)
1 ml of solution (equivalent to 20 drops):

• The active substance is: cetirizine dihydrochloride 10 mg.
• The other components are: Glycerol 85%, Propylene glycol, Sodium saccharin, Sodium acetate trihydrate, Glacial acetic acid, Methyl p-hydroxybenzoate (E 218), Propyl p-hydroxybenzoate (E 216), Water for injections.

IRIREOS ANTISTAMINIC 10 mg/ml oral drops, solution (single-dose containers of 1 ml)
One single-dose container of 1 ml:

• The active substance is: cetirizine dihydrochloride 10 mg.
• The other components are: Glycerol 85%, Propylene glycol, Sodium saccharin, Sodium acetate trihydrate, Glacial acetic acid, Water for injections.

Description of the appearance of IRIREOS ANTISTAMINIC and contents of the pack:
Pack containing one 20 ml bottle of solution, oral drops.
Pack containing 5, 10 or 20 single-dose containers of 1 ml solution, oral drops.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)
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