Indications for use
For adults and children over 6 years of age

• relief of nasal and ocular symptoms of seasonal and year-round allergic rhinitis
• Relief of symptoms of chronic idiopathic urticaria.

List of information required before use
Contraindications

• hypersensitivity to the active substance or piperazine derivatives or to any of the excipients
• severe form of chronic renal failure (creatinine clearance less than 10 ml/min)
• rare hereditary lactose intolerance, hereditary Lapp lactase deficiency, and/or glucose-galactose malabsorption
• Children under 6 years of age due to the risk of asphyxia (for the preparation in tablet form)

Necessary precautions for use
In therapeutic doses, clinically significant interactions with alcohol have not been demonstrated (at blood alcohol level of 0.5 g/l). Nevertheless, caution should be exercised when concomitantly administered with alcohol.
Special attention should be paid to patients who are exposed to factors predisposing to urinary retention (e.g. spinal cord lesions, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention.
Special consideration is recommended for patients with epilepsy or risk of seizures.
Skin test reactions are inhibited by antihistamines, so a washout period (3 days) is required before performing skin tests.
Itching and/or urticaria may occur when cetirizine is discontinued, even if these symptoms were absent prior to treatment. In some cases, when symptoms may be intense it may be necessary to resume treatment, in which case the symptoms should disappear.
Interactions with other medicinal products
Based on the analysis of the pharmacokinetics, pharmacodynamics and tolerability profile of the medicine, no interactions of this medicine with other medicines are expected.
No significant interactions with pseudoephedrine or theophylline (at a dose of 400 mg per day) were observed in specific medicine interaction studies.
Food intake does not reduce the absorption of cetirizine, although the absorption rate is slightly decreased.
In sensitive patients taking the medicine concomitantly with alcohol or other medicines depressing CNS activity may cause additional decrease of concentration level and reaction speed, although cetirizine does not increase the effect of alcohol (at its concentration in blood 0.5 g/l).

Special warnings
Pediatric use
Administration of the Cetirizine tablets, coated, is not recommended for infants and children under 6 years of age, since this dosage form does not allow to adjust the required dose.
During pregnancy or lactation
When analyzing clinical data of more than 700 cases of pregnancy outcomes, no cases of malformation, fetal and neonatal toxicity with a clear causal relationship were found. Experimental studies on animals have not revealed any direct or indirect adverse effects of Cetirizine on the developing fetus (including postnatal period), pregnancy and postnatal development.
Caution should be exercised when prescribing to pregnant women.
Cetirizine is excreted with breast milk (in concentrations from 25% to 90% of the drug plasma concentration depending on the time after administration), therefore caution should be exercised when using cetirizine during breastfeeding.
Fertility
Available data on the effect on human fertility are limited, but no adverse effects on fertility have been identified.
Special notes regarding excipients
Lactose
Contraindicated in persons with hereditary galactose intolerance, deficiency of Lapp (LAPP)-lactase enzyme, glucose-galactose malabsorption.
Peculiarities of the drug effect on the ability to drive a vehicle or potentially dangerous mechanisms
During objective assessment of the ability to drive motor transport and operate potentially dangerous mechanisms, no adverse events were reliably detected when prescribing the recommended dose of 10 mg. However, it is advisable to refrain from driving a car, engaging in potentially hazardous activities or operating mechanisms requiring increased concentration and quickness of psychomotor

Instructions for use
Dosage regimen
Single and daily doses.
Adolescents over 12 years of age and adults
The recommended daily dose is 10 mg (1 tablet).
Children aged 6 to 12 years
The recommended daily dose is 5 mg (½ tablet).
Children with renal impairment
The dose should be adjusted on an individual basis, taking into account the patient's renal clearance and his/her body weight.
Elderly patients
Dose adjustment is recommended in elderly patients with moderate to severe renal impairment (see Adult Patients with Renal Impairment below).
Patients with hepatic impairment
Dose adjustment is not required only for patients with hepatic impairment. In patients with hepatic and renal impairment, dose adjustment is recommended (see Adult Patients with Renal Impairment below).
Patients with renal impairment
Dosing should be individualized based on renal function. The table below indicates necessary dose modifications. To use this table, the patient’s creatinine clearance (CC) should be estimated in mL/min.

Method and route of administration
Administered orally with food or on an empty stomach, with a small amount of water, without chewing.
Frequency of administration with indication of time of administration
The drug is taken once a day; for doses see Dosage regimen.
Duration of treatment
The duration of treatment depends on the symptoms and your condition. The course of treatment is prescribed by your doctor individually.
Measures to be taken in case of overdose
Symptoms: confusion, diarrhea, dizziness, fatigue, headache, anxiety, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, tachycardia, tremor and urinary retention.
If you observe symptoms of overdose, please notify your physician so that your physician can take necessary measures to treat the overdose.
Measures required if you miss one or more doses of the medicine
If you forget to take a tablet, take it as soon as you remember, but wait at least 24 hours before taking the next tablet. Do not take a double dose to make up for a missed dose.
Indication of a risk of withdrawal symptoms
In rare cases, itching (severe itching) and/or hives may return if you stop taking Cetirizine 10 mg Tablets.
If you have any further questions about the use of this medicine, please consult your doctor.
Recommendations for consulting a health care provider to explain how to use this medicine
Seek medical advice before taking the medicinal product.

Description of adverse reactions that occur during standard use of the medicinal product and measures to be taken in this case
Infrequently

• agitation
• paraesthesia
• skin itching, rash
• asthenia, malaise
• diarrhea

Rarely

• hypersensitivity, urticaria, edema
• aggression, confusion, depression, hallucinations, insomnia, depression
• convulsions
• tachycardia
• Liver dysfunction (increased transaminase, alkaline phosphotase, gamma-glutamyltransferase and bilirubin)
• weight gain
• movement disorders

Very rare

• thrombocytopenia
• anaphylactic shock
• tic, taste disturbances, dyskinesia
• dystonia, syncope, tremor
• visual accommodation disorder, blurred vision, restriction of eyeball movement
• angioedema, persistent drug-induced erythema
• dysuria, enuresis

Frequency unknown:

• increased appetite
• Suicidal thoughts, amnesia, memory impairment
• nightmares
• vasculitis
• dizziness
• hepatitis
• acute generalized exentematous pustulosis
• arthralgia
• urinary retention

The development of pruritus after cetirizine withdrawal has been reported (see Special Warnings section).

If adverse drug reactions occur, contact your health care provider, pharmacist, or directly to the Adverse Drug Reactions (Actions) Information Database, including reports of drug ineffectiveness
Republican State enterprise on the Right of Economic Management National Center for Expertise of Medicines and Medical Devices of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan
http://www.ndda.kz

Additional information
Composition of the medicinal product
One tablet contains
active substance - cetirizine dihydrochloride 10 mg,
excipients: microcrystalline cellulose, lactose monohydrate 66.4 mg, colloidal silicon dioxide, magnesium stearate,
Opadry® Y-1-7000 shell composition: hypromellose (E464), titanium dioxide (E171), macrogol 400.
Description of appearance, odor, taste
White, oblong, film-coated tablets, with a groove on one side.

Form of release and packaging
10 tablets each in a blister pack made of polyvinylchloride film and aluminum foil.
1 blister pack together with instructions for medical use in Kazakh and Russian languages in a carton pack.

Shelf life
2 years
Do not use after expiration date!
Storage conditions
Store in the original package at a temperature not exceeding 25 °C.
Keep out of reach of children!

Conditions of release from pharmacies
By prescription