Инструкция по применению KETIRITSINA AUROBINDO
Содержание инструкции
Cetirizina Aurobindo 10 mg film-coated tablets
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
1 What Cetirizina Aurobindo is and what it is used for
2 What you need to know before you take Cetirizina Aurobindo
3 How to take Cetirizina Aurobindo
4 Possible side effects
5 How to store Cetirizina Aurobindo
6 Contents of the pack and other information
1. What is Cetirizina Aurobindo and what is it used for
Cetirizine dihydrochloride is the active ingredient of Cetirizina Aurobindo.
Cetirizina Aurobindo is an antihistamine medicine.
In adults and children aged 6 years and over, Cetirizina Aurobindo is indicated:
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the relief of urticaria.
2. What you need to know before you take Cetirizina Aurobindo
Do not take Cetirizina Aurobindo
- if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to piperazine derivatives (active ingredients of other closely related medicines);
- if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min).
Warnings and precautions
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 established by the doctor.
If you have problems passing urine (such as problems with the spinal cord or problems with the prostate or
bladder), ask your doctor for advice.
If you are an epileptic patient or a patient at risk of seizures, you should ask your doctor for advice.
No significant clinical interactions have been observed between alcohol (for blood levels of 0.5 per mille
(g/l) corresponding to a glass of wine) and cetirizine used at the recommended doses. However, there are
no data available on safety when higher doses of cetirizine and alcohol are taken simultaneously. Therefore, as with all antihistamines, it is recommended to avoid taking alcohol
simultaneously with Cetirizina Aurobindo.
If you are planning to undergo allergy tests, ask your doctor if you should stop taking the
medicine for a few days before the test. This medicine may affect the results of allergy tests.
Children
Do not give this medicine to children under 6 years of age as the tablet formulation does not
allow for the necessary dose adjustments.
Other medicines and Cetirizina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Cetirizina Aurobindo with food and drink
Food does not affect the absorption of cetirizine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
The use of Cetirizina Aurobindo should be avoided in pregnant women. Accidental use of the medicine
by a pregnant woman should not produce any harmful effects on the fetus, however,
treatment with Cetirizina Aurobindo should only be administered if necessary and under the advice of
the doctor.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizina Aurobindo during
breastfeeding unless you have consulted a doctor.
Driving and operating machinery
Clinical studies have not shown impairment of attention, alertness and ability to
drive after taking cetirizine at the recommended dose.
If you intend to drive vehicles, engage in potentially dangerous activities or operate
machinery, you should carefully observe your response to the medicine and should not exceed the recommended dose.
Cetirizina Aurobindo containslactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.
3. How to take Cetirizina Aurobindo
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The tablets must be swallowed with a glass of liquid.
The tablet can be divided into 2 equal doses.
Adults and adolescents starting from 12 years:
The recommended dose is 10 mg once a day, equivalent to 1 tablet.
For children, other forms of this medicine may be more suitable; ask your doctor or pharmacist.
Children aged between 6 and 12 years:
The recommended dose is 5 mg twice a day, equivalent to half a tablet twice a day.
For children, other forms of this medicine may be more suitable; ask your doctor or pharmacist.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once a day.
If you suffer from severe renal impairment, contact your doctor or pharmacist who may adjust the dose
accordingly.
If your child suffers from a kidney disease, contact your doctor or pharmacist who may adjust the
dose according to your child’s needs.
If you feel that the effect of Cetirizina Aurobindo is too weak or too strong, consult your doctor.
Duration of treatment:
The duration of treatment depends on the type, duration and course of your disorders and is established by
the doctor.
If you take more Cetirizina Aurobindo than you should
If you think you have taken an overdose of Cetirizina Aurobindo, inform your doctor. The doctor will decide which
measures must be taken if necessary.
After an overdose, the side effects described below may appear with increased intensity.
Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise,
pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormally rapid heart rate,
tremors and urinary retention have been reported.
If you forget to take Cetirizina Aurobindo
Do not take a double dose to make up for a missed dose.
If you stop taking Cetirizina Aurobindo
If you stop taking Cetirizina Aurobindo, itching (intense itching) and/or hives
may rarely return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
The following side effects are rare or very rare, but if you notice them you should stop taking the
medicine and talk to your doctor immediately:
- allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat). These reactions may start immediately after taking the medicine for the first time, or they may start later. Common(may affect up to 1 in 10 people):
- drowsiness
- dizziness, headache
- pharyngitis, rhinitis (in children)
- dry mouth, nausea, diarrhea
- fatigue Uncommon(may affect up to 1 in 100 people):
- agitation
- paresthesia (abnormal skin sensation)
- abdominal pain
- pruritus, rash
- asthenia (extreme fatigue), malaise Rare(may affect up to 1 in 1,000 people):
- allergic reactions, some severe (very rare)
- depression, hallucinations, aggression, confusion, insomnia
- convulsions
- tachycardia (fast heartbeat)
- abnormal liver function
- urticaria
- edema (swelling)
- weight gain Very rare(may affect up to 1 in 10,000 people):
- thrombocytopenia (low levels of platelets)
- tics (habitual spasms)
- syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
- blurred vision, accommodation disorder (difficulty focusing), ocular rotation (eyes with uncontrolled circular movements)
- angioedema (severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
- abnormal urine elimination (bedwetting, pain and/or difficulty passing urine)
Not known: (frequency cannot be estimated from the available data):
- increased appetite
- suicidal thoughts (recurrent or obsessive thoughts of suicide), nightmare
- amnesia, memory impairment
- vertigo (sensation of spinning or movement)
- urinary retention (inability to completely empty the bladder)
- pruritus (intense itching) and/or urticaria upon discontinuation of treatment
- joint pain
- blistering rash containing pus.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Cetirizina Aurobindo
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 pack after SCAD. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Aurobindo contains
- The active ingredient is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of
cetirizine dihydrochloride.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hypromellose (5cp), titanium dioxide (E171), macrogol 400.
Description of the appearance of Cetirizina Aurobindo and package contents
Film-coated tablets.
Tablets of colour from white to off-white, film-coated, rectangular in shape, with imprinted “10” on
one side and smooth on the other side. Score line between “1” and “0”. The tablet can be divided into two equal
parts.
Cetirizina Aurobindo film-coated tablets are available in blister packs and in HDPE containers.
Packs:
Blister: 20 film-coated tablets.
HDPE container: 30 and 1,000 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102
- 21047 - Saronno (VA) Italy
Manufacturer
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited HF26,
Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia,
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Italy: Cetirizina Aurobindo
Malta: Cetirizine Aurobindo 10 mg film-coated tablets
Portugal: Cetirizina Aurobindo
Spain: Cetirizina Aurobindo 10 mg film-coated tablets EFG

- Страна регистрации
- Форма выпускаFilm-coated tablet, 10 MG
- Код АТХR06AE07
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KETIRITSINA AUROBINDOФорма выпуска: Film-coated tablet, 10 MGДействующее вещество: ЦетиризинПроизводитель: DOMPE' FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Tablet, 10 MGДействующее вещество: ЦетиризинПроизводитель: NEOPHARMED GENTILI S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 10 MGДействующее вещество: ЦетиризинОтпускается без рецепта
Аналоги KETIRITSINA AUROBINDO в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог KETIRITSINA AUROBINDO в Испания
Аналог KETIRITSINA AUROBINDO в Польша
Аналог KETIRITSINA AUROBINDO в Украина
Врачи онлайн по KETIRITSINA AUROBINDO
Обсудите применение KETIRITSINA AUROBINDO и возможные следующие шаги — по оценке врача.
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
KETIRITSINA AUROBINDO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KETIRITSINA AUROBINDO — Цетиризин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KETIRITSINA AUROBINDO производится компанией AUROBINDO PHARMA (ITALIA) S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения KETIRITSINA AUROBINDO с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить KETIRITSINA AUROBINDO в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Цетиризин) включают AXERAMIS, KERKIO, KETERIS. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















