Active ingredients: Cetirizine
CETIRIZINE DOC Generici 10 mg, film-coated tablets
Why is Cetirizine - Generic Drug used? What is it for?
The active substance in CETIRIZINE DOC Generici is cetirizine dihydrochloride.
CETIRIZINE DOC Generici is an anti-allergic medicine.
In adults and children from 6 years of age, CETIRIZINE DOC Generici 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).
Contraindications When Cetirizine - Generic Drug should not be used
Do not take CETIRIZINE DOC Generici
- if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine or piperizine derivatives (active substances of other closely related medicines).
- if you have severe kidney disease (severe kidney failure with creatinine clearance below 10ml / min);
- If you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Do not take this medicine if this applies to you.
If you are not sure, talk to your doctor or pharmacist before taking CETIRIZINE DOC Generici.
Precautions for use What you need to know before taking Cetirizine - Generic Drug
Talk to your doctor or pharmacist before taking CETIRIZINE DOC Generici if:
- you are a patient with renal insufficiency, ask your doctor for advice; if necessary, you will need to take a lower dose. The new dose will be defined by your doctor.
- if you have problems urinating (eg if you have a spinal cord injury or enlarged prostate) as cetirizine increases the risk of not being able to pass urine.
- if you are an epileptic patient or a patient at risk of seizures, you should ask your doctor for advice.
No interactions of potential relevant impact were observed between alcohol (for blood levels of 0.5 per thousand corresponding to a glass of wine) and cetirizine used in normal doses. However, as with all antihistamines, it is recommended to avoid the simultaneous intake of alcohol.
Interactions Which drugs or foods can modify the effect of Cetirizine - Generic Drug
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Given the profile of cetirizine, no interactions with other drugs are expected.
Use of CETIRIZINE DOC Generici with alcohol
Do not drink alcohol while you are taking CETIRIZINE DOC Generici.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As with other drugs, the use of CETIRIZINE DOC Generici should be avoided during pregnancy. Accidental use of the drug by a pregnant woman has no harmful effect on the fetus, however the drug should be discontinued.
You should not take CETIRIZINE DOC Generici while breastfeeding because cetirizine passes into breast milk.
Driving and using machines
Do not drive or use any tools or machines until you know how CETIRIZINE DOC Generici affects you. Consult your doctor or pharmacist if you are unsure.
Important information about some of the ingredients of CETIRIZINE DOC Generici
CETIRIZINE DOC Generici contains milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Cetirizine - Generic Drug: Posology
Always take CETIRIZINE DOC Generici exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
In most patients, symptoms are relieved 2 hours after administration of the tablets and the effect remains for 24 hours.
Adults and adolescents over 12 years of age:
The recommended dose is 1 tablet once a day.
If drowsiness occurs, the tablet can be administered in the evening.
Use in children
Children between the ages of 6 and 12:
5 mg twice a day as a half tablet twice a day.
Patients with moderate to severe renal insufficiency
For patients with moderate renal impairment the recommended dose is 5 mg once daily. If you feel that the effect of CETIRIZINE DOC Generici is too weak or too strong, please tell your doctor.
Duration of treatment
Your doctor will tell you how long to take CETIRIZINE DOC Generici. This depends on its symptoms
Overdose What to do if you have taken an overdose of Cetirizine - Generic Drug
If you take more CETIRIZINE DOC Generici than you should
- contact your doctor immediately or go to a hospital immediately
- take the medicine pack with you.
After an overdose, the undesirable effects described below may appear with increased intensity. Adverse events such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rhythm, tremors and urinary retention have been reported.
If you forget to take CETIRIZINE DOC Generici
- if you forget to take a dose of this medicine, take the dose on the day you remember it,
- do not take a double dose on the same day to make up for a forgotten dose.
If you stop taking CETIRIZINE DOC Generici
You should not stop treatment with CETIRIZINE DOC Generici without first consulting your doctor. Your symptoms may recur with the same severity if you stop taking CETIRIZINE DOC Generici.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.Side Effects What are the side effects of Cetirizine - Generic Drug
Like all medicines, CETIRIZINE DOC Generici can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Common (affects less than 1 in 10 people):
- fatigue
- dry mouth, nausea, diarrhea
- drowsiness
- pharyngitis, rhinitis
- headache
- dizziness
Uncommon (affects less than 1 in 100 people)
- abdominal pain
- asthenia (extreme fatigue), malaise
- paraesthesia (abnormal sensitivity of the skin)
- agitation
- itching, rash
Rare (affects less than 1 in 1000 people)
- tachycardia (rapid heartbeat)
- edema (swelling)
- allergic reactions
- abnormal liver function
- weight gain
- convulsions, movement disorders
- aggression, confusion, depression, hallucinations, insomnia
- urticaria
Very rare (affects less than 1 in 10,000 people)
- accommodation disorder, blurred vision, oculogyration (eyes with uncontrolled circular movements)
- severe allergic reactions
- tic
- abnormal elimination of urine
- fixed drug eruption
- thrombocytopenia (low platelet levels)
- syncope, tremors, disgust (taste disturbance)
- dyskinesia
- dystonia
- angioneurotic edema
It is not known how many people may experience the following side effects:
- memory loss
- increased appetite
- suicidal idea
- vertigo
- urinary retention
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 or blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What CETIRIZINE DOC Generici contains
- The active ingredient is cetirizine dihydrochloride.
- The other ingredients are: microcrystalline cellulose, lactose monohydrate, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol stearate, propylene glycol, titanium dioxide (E171)
What CETIRIZINE DOC Generici looks like and contents of the pack
CETIRIZINE DOC Generici film-coated tablets are: white or almost white, biconvex, oblong with a score line on one side. The tablets are debossed "C" on one side, "J" and "E" on the other side of the score.
The tablets are available in packs of: 7, 10, 20, 30, 50, 90 and 100 film-coated tablets
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CETIRIZINA DOC GENERICI
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipients: one film-coated tablet contains 117 mg of lactose monohydrate.
For the full list of excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white biconvex and elliptical film-coated tablets, 5.7 x 11.1 mm. Score line on one side. The tablets are debossed "C" on one side, "J" and "E" on the other side of the score.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adults and pediatric patients from 6 years of age:
- cetirizine is indicated for the treatment of nasal and ocular symptoms of allergic rhinitis
seasonal and perennial;
- cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.
04.2 Posology and method of administration
Pediatric population
Children between the ages of 6 and 12:
5 mg twice a day (half tablet twice a day).
Adults and adolescents over 12 years of age:
10 mg once daily (1 tablet).
The tablets should be taken with a glass of liquid.
Elderly patients:
Based on available data in elderly subjects with normal renal function, no dose reduction is necessary.
Patients with moderate to severe renal insufficiency:
There are no data available documenting the efficacy / safety ratio in patients with renal insufficiency. Since cetirizine is predominantly renally excreted (see section 5.2), in cases where alternative treatments cannot be used, the intervals between doses should be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table it is necessary to have an estimate of the patient's creatinine clearance (CLcr) in ml / min. CLcr (ml / min) can be obtained from the serum creatinine value (mg / dl) using the following formula:
Dosage adjustment for adults with impaired renal function
In pediatric patients with renal insufficiency, the dose should be individually adjusted taking into account the patient's renal clearance, age and body weight of the patient.
Patients with hepatic insufficiency: Patients with hepatic insufficiency only do not require any dose adjustment.
Patients with hepatic and renal insufficiency: Dose adjustment is recommended (see above patients with moderate to severe renal insufficiency).
04.3 Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any derivative of piperizine.
Patients with severe renal insufficiency with creatinine clearance less than 10 ml / min.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets.
04.4 Special warnings and appropriate precautions for use
At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is recommended in case of concomitant alcohol intake.
Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.
Caution is advised in epileptic patients and in patients at risk for seizures.
Since skin allergy tests are inhibited by antihistamines it is necessary to wait for a wash-out period (3 days) before performing them.
Pediatric population
Use of the film-coated tablet formulation is not recommended in children under 6 years of age as this formulation does not allow for appropriate dose adjustment.
04.5 Interactions with other medicinal products and other forms of interaction
Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions are expected with this antihistamine. Indeed, neither pharmacodynamic nor significant pharmacokinetic interactions were reported in drug-drug interaction studies, in particular with pseudoephedrine or theophylline (400 mg / day).
The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased.
04.6 Pregnancy and lactation
Pregnancy
Clinical data on pregnancies exposed to treatment for cetirizine are very rare. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution.
Feeding time
Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the time interval after administration. Therefore, caution should be exercised when prescribing cetirizine to a lactating woman.
04.7 Effects on ability to drive and use machines
Objective measurements of ability to drive, time to fall asleep and performance on the assembly line did not demonstrate any clinically relevant effect at the recommended dose of 10 mg.
Patients intending to drive vehicles, engage in potentially hazardous activities or operate machinery should not exceed the recommended dose and take into account the individual response to the medicinal product.
In sensitive patients, the concomitant intake of cetirizine with alcohol or other CNS depressant substances may cause a "further decrease in alertness" and impaired performance.
04.8 Undesirable effects
Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.
Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively free of anticholinergic activity, there have been rare reports of difficulty in micturition, eye accommodation disturbances and dry mouth.
There have been reports of abnormal liver function with elevated liver enzymes accompanied by elevated bilirubin. Most of these resolved following discontinuation of cetirizine dihydrochloride treatment.
Clinical trials
In the context of double-blind controlled clinical trials in which cetirizine was compared to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), for which quantitative safety data are available, they were treated with cetirizine plus of 3200 subjects.
Based on these data, the following adverse events with an incidence of 1.0% or greater with cetirizine 10 mg were reported in placebo-controlled trials:
Although statistically the incidence of somnolence was more common with cetirizine than with placebo, it was mild to moderate in the majority of cases. are impaired at the recommended daily dose in young healthy volunteers.
Adverse reactions with an incidence of 1.0% or greater in children aged 6 months to 12 years in placebo-controlled clinical trials are:
Post-marketing experience
To the adverse events encountered in clinical trials, listed in the previous paragraph, the following adverse reactions reported in post-marketing experience should be added.
Undesirable effects are described according to MedDRA system organ class and estimated frequencies based on post-marketing experience.
Frequencies are defined as follows: very common (≥1 / 10); common (≥1 / 100,
Disorders of the blood and lymphatic system
Very rare: thrombocytopenia.
Disorders of the immune system
Rare: hypersensitivity;
very rare: anaphylactic shock.
Metabolism and nutrition disorders
Not known: Increased appetite.
Psychiatric disorders
Uncommon: agitation;
rare: aggression, confusion, depression, hallucinations, insomnia;
very rare: tics;
not known: suicidal ideation.
Nervous system disorders
Uncommon: paraesthesia;
rare: convulsions, movement disorders;
very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor;
not known: amnesia, memory impairment.
Eye disorders
Very rare: accommodation disturbance, blurred vision, oculogyration.
Ear and labyrinth disorders
Not known: vertigo.
Cardiac pathologies:
Rare: tachycardia.
Gastrointestinal disorders:
Uncommon: diarrhea.
Hepatobiliary disorders
Rare: impaired liver function (elevation of transaminases, alkaline phosphatase, γ-GT and bilirubin).
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash;
rare: urticaria;
very rare: angioneurotic edema, fixed drug eruption.
Renal and urinary disorders:
Very rare: dysuria, enuresis;
not known: urinary retention.
General disorders and administration site conditions:
Uncommon: asthenia, malaise;
rare: edema.
Diagnostic tests:
Rare: weight gain.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
to) Symptoms
Symptoms observed following an overdose of cetirizine are mainly associated with CNS effects or with effects that may suggest "anticholinergic activity."
Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.
b) Treatment
A specific antidote to cetirizine is not known.
In the event of an overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage is recommended.
Cetirizine is not effectively removed by dialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: piperazine derivatives. ATC code: R06A E07.
Mechanism of action
Cetirizine, a metabolite of hydroxyzine in humans, is a potent and selective antagonist at peripheral H1 receptors. Receptor binding studies in vitro they showed no measurable affinity for other receptors other than H1.
Pharmacodynamic effects
In addition to the anti-H1 effect, cetirizine has antiallergic activity: at a dose of 10 mg once or twice a day, it inhibits the late recruitment phase of eosinophils, in the skin and conjunctiva of atopic subjects exposed to allergens.
Clinical efficacy and safety
Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg, markedly inhibits the wheal and erythematous reactions induced by very high concentrations of histamine in the skin, but the correlation with efficacy is not established.
Pediatric population
In a 35-day study in children aged 5 to 12 years, there was no evidence of tolerance to the antihistamine effect (suppression of wheals and erythema) of cetirizine. After discontinuation of repeated dose treatment with cetirizine, the skin recovers its normal reactivity to histamine within 3 days.
In a 6-week placebo-controlled study in 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine at a dose of 10 mg once daily improved symptoms of rhinitis without affecting lung function. . This study supports the safety of cetirizine administration in allergic patients with mild or moderate asthma.
In a placebo-controlled study, cetirizine, given at the high daily dose of 60 mg for seven days, did not cause a statistically significant prolongation of the QT interval.
Cetirizine, at the recommended dosage, has been shown to improve the quality of life of patients with seasonal and perennial allergic rhinitis.
05.2 "Pharmacokinetic properties
Absorption
The steady-state plasma concentration is approximately 300 ng / mL and is reached within 1.0 ± 0.5 hours. No accumulation was observed following daily doses of 10 mg of cetirizine for 10 days.
Distribution
The pharmacokinetic distribution parameters, such as peak plasma (Cmax) and area under the curve (AUC), are unimodal in healthy volunteers.
The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased. The degree of bioavailability of cetirizine is similar when taken as a solution, capsule or tablet.
The apparent volume of distribution is 0.50 l / kg.
Biotransformation
The plasma protein binding of cetirizine is 93 ± 0.3%. Cetirizine does not alter the binding of warfarin to plasma proteins.
Elimination
Cetirizine does not undergo extensive first pass metabolism. About two thirds of the dose is excreted unchanged in the urine. The terminal half-life was approximately 10 hours.
Linearity
Cetirizine exhibits linear kinetics between 5 mg and 60 mg.
Special populations
Senior citizens: In 16 elderly subjects following a single oral dose of 10 mg, the half-life increased by approximately 50% and the clearance decreased by 40% compared to normal subjects. The reduction of cetirizine clearance in these volunteers elderly appears to be related to decreased renal function.
Children and babies: The half-life of cetirizine was approximately 6 hours in children aged 6 to 12 years, 5 hours in children aged 2 to 6 years and reduced to 3.1 hours in children aged 6 to 24 months.
Patients with renal insufficiency: the pharmacokinetics of the drug in patients with mild renal insufficiency (creatinine clearance greater than 40 ml / min) were similar to that of healthy volunteers. Patients with moderate renal impairment had a 3-fold higher half-life and a 70% reduction in clearance compared to healthy volunteers.
Patients on hemodialysis (creatinine clearance less than 7 ml / min), given a single oral dose of 10 mg of cetirizine, had a three-fold increase in half-life and a 70% decrease in clearance. clearance of normal subjects. Cetirizine is eliminated in low quantities by hemodialysis. Dosage adjustment is necessary in patients with moderate to severe renal impairment (see section 4.2).
Patients with hepatic insufficiency: Patients with chronic liver disease (hepatocellular, cholestatic and biliary cirrhosis) who received a single dose of 10 or 20 mg of cetirizine had a 50% increase in half-life along with a 40% decrease in clearance compared to subjects healthy.
Dosage adjustment is necessary in patients with hepatic insufficiency only if associated with renal insufficiency.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Core of the tablet
Microcrystalline cellulose, lactose monohydrate, crospovidone, colloidal anhydrous silica, magnesium stearate.
Coating
Hypromellose, macrogol stearate, propylene glycol, titanium dioxide (E 171).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Al / Al blisters: 7, 10, 20, 30, 50, 90 or 100 film-coated tablets.
HDPE tablet bottle with LDPE cap: 10, 20, 30, 50, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
DOC Generici S.r.l - Via Turati 40 - 20121 Milan
08.0 MARKETING AUTHORIZATION NUMBER
CETIRIZINE DOC Generici 10 mg film-coated tablets, 7 tablets in blister Al / Al AIC n. 038009015
CETIRIZINE DOC Generici 10 mg film-coated tablets, 10 tablets in blister Al / Al AIC n. 038009027
CETIRIZINE DOC Generici 10 mg film-coated tablets, 20 tablets in blister Al / Al AIC n. 038009039
CETIRIZINE DOC Generici 10 mg film-coated tablets, 30 tablets in blister Al / Al AIC n. 038009041
CETIRIZINE DOC Generici 10 mg film-coated tablets, 50 tablets in blister Al / Al AIC n. 038009054
CETIRIZINE DOC Generici 10 mg film-coated tablets, 90 tablets in Al / Al AIC n. 038009066
CETIRIZINE DOC Generici 10 mg film-coated tablets, 100 tablets in Al / Al AIC n. 038009078
CETIRIZINE DOC Generici 10 mg film-coated tablets, 10 tablets in HDPE AIC container no. 038009080
CETIRIZINE DOC Generici 10 mg film-coated tablets, 20 tablets in HDPE AIC container no. 038009092
CETIRIZINE DOC Generici 10 mg film-coated tablets, 30 tablets in HDPE AIC container no. 038009104
CETIRIZINE DOC Generici 10 mg film-coated tablets, 50 tablets in HDPE AIC container no. 038009116
CETIRIZINE DOC Generici 10 mg film-coated tablets, 90 tablets in HDPE AIC container no. 038009128
CETIRIZINE DOC Generici 10 mg film-coated tablets, 100 tablets in HDPE AIC container no. 038009130
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2007.
10.0 DATE OF REVISION OF THE TEXT
August 2014.
