Cetirizine Doc Generici
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETIRIZINA DOC 10 mg film-coated tablets
Cetirizine dihydrochloride
Read this leaflet carefully before taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
- If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What CETIRIZINA DOC is and what it is used for
- Before you take CETIRIZINA DOC
- How to take CETIRIZINA DOC
- Possible side effects
- How to store CETIRIZINA DOC
- Further information
1. WHAT CETIRIZINA DOC IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active substance in CETIRIZINA DOC. CETIRIZINA DOC is an antiallergic medicine.
In adults and children from 6 years of age, CETIRIZINA DOC 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. BEFORE TAKING CETIRIZINE DOC
Do not take CETIRIZINE DOC:
- if you have severe kidney disease (severe renal insufficiency 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).
Take special care with CETIRIZINE DOC
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.
If you are an epileptic patient or at risk of seizures, you must consult your doctor.
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.
Cetirizine may interfere with skin test results for allergies, as these tests are inhibited by antihistamines. If you need to undergo such tests, inform your doctor that you are taking CETIRIZINE DOC. Your doctor will advise you accordingly.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
Taking CETIRIZINE DOC with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Given the profile of cetirizine, interactions with other drugs are not expected.
Taking CETIRIZINE DOC with food and drinks
Food does not significantly affect the absorption of cetirizine.
Paediatric patients
The use of CETIRIZINE DOC tablets is not recommended in children under 6 years of age, as this formulation does not allow appropriate dose adjustment.
Pregnancy and breastfeeding
Consult your doctor before taking any medicine.
As with other medicines, the use of CETIRIZINE DOC should be avoided during pregnancy.
Accidental use of the medicine by a pregnant woman does not produce any harmful effect on the foetus; however, the intake of the medicine should be discontinued.
You must not take CETIRIZINE DOC during breastfeeding because cetirizine passes into breast milk.
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or driving ability after taking CETIRIZINE DOC 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 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.
Important information about some excipients in CETIRIZINE DOC
CETIRIZINE DOC film-coated tablets contain lactose; if your doctor has told you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.
3. HOW TO TAKE CETIRIZINE DOC
How and when to take CETIRIZINE DOC?
Follow these guidelines unless your doctor has given you different instructions regarding the use of CETIRIZINE DOC.
Follow the instructions below, otherwise CETIRIZINE DOC may not be fully effective.
The tablets should be taken with a glass of liquid.
Adults and adolescents aged 12 years and over:
10 mg once daily as 1 tablet.
Children aged between 6 and 12 years:
5 mg twice daily as half a tablet twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (as half a tablet) 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 the effect of CETIRIZINE DOC 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 CETIRIZINE DOC than you should
If you think you have taken an overdose of CETIRIZINE DOC, inform your doctor.
The doctor will decide which measures to take, if necessary.
After an overdose, the undesirable effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, somnolence, stupor, abnormally rapid heart rate, tremors, and urinary retention.
If you forget to take CETIRIZINE DOC
Do not take a double dose to make up for the forgotten dose.
If you stop taking CETIRIZINE DOC
If you have any doubts about the use of CETIRIZINE DOC, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, CETIRIZINE DOC may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported in post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Hematopoietic and lymphatic system disorders:
Very rare: thrombocytopenia (low platelet count)
General disorders and administration site conditions:
Common: fatigue
Uncommon: asthenia (extreme tiredness), malaise
Rare: edema (swelling)
Cardiac disorders:
Rare: tachycardia (increased heart rate)
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)
Ear and labyrinth disorders:
Not known: vertigo (sensation of spinning or movement)
Gastrointestinal disorders:
Common: dry mouth, nausea
Uncommon: diarrhea, abdominal pain
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Metabolism and nutrition disorders:
Not known: increased appetite
Hepatobiliary disorders:
Rare: altered liver function
Investigations:
Rare: weight gain
Nervous system disorders:
Common: dizziness, headache
Uncommon: paresthesia (abnormal skin sensation)
Rare: convulsions, movement disorders
Very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia, dystonia
Not known: amnesia, memory impairment
Psychiatric disorders:
Common: somnolence
Uncommon: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tic
Not known: suicidal ideation (recurrent suicidal thoughts or concerns)
Renal and urinary disorders:
Very rare: abnormal urine elimination
Not known: urinary retention (inability to completely empty the bladder)
Respiratory system disorders:
Common: pharyngitis, rhinitis
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioedema, fixed drug eruption
If you notice any of the adverse reactions listed above, inform your doctor.
In case of first signs of hypersensitivity, discontinue treatment with CETIRIZINE DOC.
Your doctor will assess the severity and decide on any necessary measures.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili ”. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. HOW TO STORE CETIRIZINE DOC
Keep CETIRIZINE DOC out of the reach and sight of children.
Do not use CETIRIZINE DOC after the expiry date stated on the carton.
This medicine does not require any special storage conditions.
6. OTHER INFORMATION
What CETIRIZINE DOC contains
- The active substance of CETIRIZINE DOC is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The excipients are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: opadry II white (composed of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium-chain triglycerides).
Description of the appearance of CETIRIZINE DOC and contents of the pack
Film-coated tablet, PVC/aluminum blister – carton containing 20 divisible tablets
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC GENERICI SRL - VIA TURATI, 40, 20121 - MILANO.
Responsible manufacturer for batch release:
Doppel Farmaceutici S.r.l – Via Volturno, 48 – 20089 Quinto de' Stampi – Milano
This patient information leaflet was last approved on
05/09/2013
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETIRIZINA DOC 10 mg/ml oral drops, solution
Cetirizine dihydrochloride
Read this leaflet carefully before taking this medicine
- 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 personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
- If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What CETIRIZINA DOC is and what it is used for
- Before taking CETIRIZINA DOC
- How to take CETIRIZINA DOC
- Possible side effects
- How to store CETIRIZINA DOC
- Further information
1. WHAT CETIRIZINA DOC IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active substance in CETIRIZINA DOC. CETIRIZINA DOC is an antiallergic medicine.
In adults and pediatric patients aged 2 years and older, CETIRIZINA DOC 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. BEFORE TAKING CETIRIZINE DOC
Do not take CETIRIZINE DOC:
- if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min);
- if you are allergic to cetirizine dihydrochloride or to any of the other components of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances of other closely related medicines).
Take special care with CETIRIZINE DOC
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.
If you are an epileptic patient or at risk of seizures, consult your doctor.
No interactions of potentially significant impact 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.
Cetirizine may interfere with skin allergy tests, as antihistamines inhibit these tests. If you need to undergo such tests, inform your doctor that you are taking CETIRIZINE DOC. Your doctor will advise you on how to proceed.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
Taking CETIRIZINE DOC with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Given the profile of cetirizine, interactions with other drugs are not expected.
Taking CETIRIZINE DOC with food and drinks
Food does not significantly affect the absorption of cetirizine.
Pregnancy and breastfeeding
Ask your doctor for advice before taking any medicine.
As with other medicines, the use of CETIRIZINE DOC should be avoided during pregnancy.
Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus; however, drug intake should be discontinued.
Do not take CETIRIZINE DOC during breastfeeding, as cetirizine passes into breast milk.
Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or driving ability after taking CETIRIZINE DOC 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 may notice that concomitant use of alcohol or other substances with central nervous system depressant effects may further impair your attention and reaction ability.
Important information about some excipients in CETIRIZINE DOC
CETIRIZINE DOC oral drops, solution contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), which may cause allergic reactions (sometimes delayed).
3. HOW TO TAKE CETIRIZINE DOC
How and when to take CETIRIZINE DOC?
Follow these guidelines unless your doctor has given you different instructions regarding the use of CETIRIZINE DOC.
Follow the instructions below, otherwise CETIRIZINE DOC may not be fully effective.
The drops should be poured into a spoon or diluted in water and taken orally.
If using dilution, consider, especially when administering to children, that the volume of water to which the drops are added should be proportional to the amount of liquid the patient is able to swallow. The diluted solution should be taken immediately.
When counting drops, the bottle should be held vertically (upside down).
If the flow of drops stops and the correct amount has not been dispensed, return the bottle to the upright position, then turn it upside down again and continue counting the drops.
Adults and adolescents from 12 years of age:
10 mg once daily as 20 drops.
Children aged 6 to 12 years:
5 mg twice daily as 10 drops twice daily.
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 (as 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 CETIRIZINE DOC 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 CETIRIZINE DOC than you should
If you think you have taken an overdose of CETIRIZINE DOC, inform your doctor.
The doctor will decide what measures to take if necessary.
After an overdose, the undesirable effects described below may appear with increased intensity. Adverse events reported include confusion, diarrhea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormally rapid heart rate, tremors, and urinary retention.
If you forget to take CETIRIZINE DOC
Do not take a double dose to make up for the missed dose.
If you stop taking CETIRIZINE DOC
If you have any doubts about the use of CETIRIZINE DOC, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, CETIRIZINA DOC may cause adverse reactions, although not everybody experiences them.
The following adverse reactions have been reported during post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Hematopoietic and lymphatic system disorders:
Very rare: thrombocytopenia (low platelet count)
General disorders and administration site conditions:
Common: fatigue
Cardiac disorders:
Rare: tachycardia (increased heart rate)
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)
Ear and labyrinth disorders:
Not known: vertigo (sensation of spinning or movement)
Gastrointestinal disorders:
Common: dry mouth, nausea
Uncommon: diarrhea, abdominal pain
General disorders and administration site conditions:
Uncommon: asthenia (extreme tiredness), malaise
Rare: edema (swelling)
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Metabolism and nutrition disorders:
Not known: increased appetite
Hepatobiliary disorders:
Rare: altered liver function
Investigations:
Rare: weight gain
Nervous system disorders:
Common: dizziness, headache
Uncommon: paresthesia (abnormal skin sensation)
Rare: seizures, movement disorders
Very rare: syncope, tremor, dysgeusia (altered taste), dyskinesia, dystonia
Not known: amnesia, memory impairment
Psychiatric disorders:
Common: somnolence
Uncommon: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tic
Not known: suicidal ideation (recurrent suicidal thoughts or concerns)
Renal and urinary disorders:
Very rare: abnormal urine elimination
Not known: urinary retention (inability to completely empty the bladder)
Respiratory, thoracic and mediastinal disorders:
Common: pharyngitis, rhinitis
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic edema, drug-induced fixed eruption
If you notice any of the adverse reactions listed above, inform your doctor.
At the first signs of hypersensitivity, discontinue treatment with CETIRIZINA DOC.
Your doctor will assess the severity and decide whether any further action is necessary.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili*". By reporting adverse reactions, you can help provide more information on the safety of this medicine.*
5. HOW TO STORE CETIRIZINA DOC
Keep CETIRIZINA DOC out of the reach and sight of children.
Do not use CETIRIZINA DOC after the expiry date stated on the carton.
This medicine does not require any special storage conditions.
6. OTHER INFORMATION
What CETIRIZINA DOC contains
- The active substance of CETIRIZINA DOC is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) of CETIRIZINA DOC contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
- The other components are glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.
Description of the appearance of CETIRIZINA DOC and contents of the pack
CETIRIZINA DOC oral drops are supplied in a 20 ml amber glass bottle with dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC GENERICI SRL - VIA TURATI, 40, 20121 - MILAN.
Batch release responsible manufacturer:
Doppel Farmaceutici S.r.l. – Via martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
This leaflet was last approved on
05/09/2013