Cetirizine Mylan Generics Italia
Italy
Table of Contents
Package leaflet: Information for the patient
Cetirizina Mylan Generics Italia 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, 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 may 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:
- What Cetirizina Mylan Generics Italia is and what it is used for
- What you need to know before taking Cetirizina Mylan Generics Italia
- How to take Cetirizina Mylan Generics Italia
- Possible side effects
- How to store Cetirizina Mylan Generics Italia
- Contents of the pack and other information
1. What Cetirizina Mylan Generics Italia is and what it is used for
Cetirizine dihydrochloride is the active substance in Cetirizina Mylan Generics Italia. Cetirizina Mylan Generics Italia is an antiallergic medicine.
In adults and pediatric patients aged 2 years and older, Cetirizina Mylan Generics 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 Mylan Generics Italia
Do not take Cetirizina Mylan Generics Italia:
- if you have severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min);
- 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 of other closely related medicines).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Mylan Generics Italia.
If you are a patient with renal insufficiency, 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 per mille (g/l), corresponding to one glass of wine) and cetirizine when 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 Cetirizina Mylan Generics Italia together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Cetirizina Mylan Generics Italia for a few days before the test. This medicine may alter the results of allergy tests.
Other medicines and Cetirizina Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizina Mylan Generics Italia with food and beverages
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Cetirizina Mylan Generics 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 be taken only if necessary and under medical advice.
Breastfeeding
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you must not take Cetirizina Mylan Generics Italia during 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 Mylan Generics Italia at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizina Mylan Generics Italia if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Important information about certain excipients
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 23 mg of sodium per dose, i.e. essentially 'sodium-free'.
This medicine contains propylene glycol.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may carry out additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may carry out additional monitoring during treatment.
3. How to take Cetirizina Mylan Generics 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.
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 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 from 12 years of age
The recommended dose is 10 mg (20 drops) once daily.
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.
Elderly patients
No dose reduction is required.
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 may adjust the dose accordingly.
If your child has kidney disease, contact your doctor or pharmacist, who may adjust the dose
based on the child's individual needs.
If you feel that the effect of Cetirizina Mylan Generics 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 Mylan Generics Italia than you should
If you think you have taken an overdose of Cetirizina Mylan Generics Italia, 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, pupillary dilation, itching,
restlessness, sedation, somnolence, stupor, abnormal rapid heart rhythm, tremors, and urinary retention.
If you forget to take Cetirizina Mylan Generics Italia
Do not take a double dose to make up for the missed dose.
If you stop taking Cetirizina Mylan Generics Italia
If you stop treatment with Zirtec, 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 everyone gets 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 later on.
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 (pruritic skin), skin rash
- Asthenia (extreme fatigue), malaise
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, 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
- 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 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
- Joint pain
- Skin rash with pustule-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: 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 Mylan Generics Italia
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Mylan Generics Italia contains
- The active substance is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) 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, propyl parahydroxybenzoate, sodium acetate, glacial acetic acid, purified water.
Description of the appearance of Cetirizina Mylan Generics Italia and contents of the pack
Oral drops, solution; 20 ml bottle.
Marketing Authorization Holder
Mylan S.p.A. – Via Vittor Pisani, 20 – 20124 Milano
Responsible manufacturer for batch release
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 S. Bernardo d'Ivrea (TO)