SOTRIZOL 10 mg Фильм-Coated Таблетки
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Инструкция по применению SOTRITSOL
Содержание инструкции
- SOTRIZOL 10 mg film-coated tablets, 10 mg/ml oral drops, solution
- Sotrizol oral drops, solution contains methyl parahydroxybenzoate and propyl
SOTRIZOL 10 mg film-coated tablets, 10 mg/ml oral drops, solution
Cetirizine dihydrochloride
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. Never give it to others, even if they have the same symptoms as you, because it could be dangerous. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Contents of this leaflet:
- 1. What Sotrizol is and what it is used for
- 2. What you need to know before you take Sotrizol
- 3. How to take S otrizol
- 4. Possible side effects
- 5. How to store Sotrizol
- 6. Contents of the pack and other information
1. WHAT IS SOTRIZOL AND WHAT IS IT USED FOR
Cetirizine dihydrochloride is the active ingredient of Sotrizol.
Sotrizol is an antiallergic drug.
In adults and children from 6 years of age, Sotrizol 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).
The pharmaceutical form Oral drops solution can also be used in children starting from
2 years of age
2. BEFORE TAKING SOTRIZOL
Do not take Sotrizol
- if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
- if you are aware of being hypersensitive to the active ingredient of Sotrizol, to any of the excipients (other ingredients), to hydroxyzine or to piperazine derivatives (active ingredients of other closely related medicines).
Take particular care with Sotrizol
If you are a patient with renal insufficiency, ask your doctor for advice; if necessary, you will have to
take a lower dose. The new dose will be defined by your doctor.
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord
injury or bladder or prostate problems).
If you are an epileptic patient or a patient at risk of convulsions, you must ask your doctor for
advice.
No clinically significant interactions have been observed between alcohol (for blood levels of
0.5 per mille corresponding to a glass of wine) and cetirizine used at the recommended doses.
However, no data are available on safety when higher doses of cetirizine and alcohol
are taken simultaneously. Therefore, as with all antihistamines, it is recommended to
avoid the simultaneous intake of SOTRIZOL with alcohol.
Skin tests for allergy are inhibited by antihistamines and a wash-out period (of 3
days) is required before performing them.
Taking Sotrizol with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.
Given the cetirizine profile, no interactions with other drugs are expected.
Taking Sotrizol with food and drink
Food does not significantly influence the absorption of cetirizine.
Paediatric patients
The use of SOTRIZOL in tablets is not recommended in children under 6 years of age, as
this formulation does not allow for appropriate dose adjustment.
The use of SOTRIZOL in oral drop solution is not recommended in children under 2
years of age due to the amount of certain excipients in the formulation.
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Sotrizol should be avoided during pregnancy. Accidental use of the drug by a
pregnant woman does not produce any harmful effects on the fetus, however the medicine must be
taken only if necessary and on the advice of a doctor.
Cetirizine passes into breast milk. Therefore, you should not take Sotrizol during breastfeeding
unless you have contacted your doctor
Driving and using machines
Clinical studies have not shown impairment of attention, vigilance and
ability to drive after taking Sotrizol at the recommended dose.
You must carefully observe your response to the drug after taking SOTRIZOL if you intend
to drive vehicles, undertake potentially dangerous activities or use machinery.
You must not exceed the recommended dose.
If you are a sensitive patient, you may notice that the simultaneous use of alcohol or other substances
with a depressing effect on the central nervous system can further alter your
attention and reaction ability.
Important information about some excipients of Sotrizol
Sotrizol film-coated tablets contains lactose;if your doctor has told you that you have an
intolerance to certain sugars, tell your doctor before taking this medicine.
Sotrizol oral drops, solution contains methyl parahydroxybenzoate and propyl
parahydroxybenzoatewhich can cause allergic reactions (sometimes delayed).
3. HOW TO TAKE SOTRIZOL
How and when to take Sotrizol?
Take this medicine following exactly as described in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Follow the following instructions, otherwise Sotrizol may not be completely effective.
SOTRIZOL10 mg film-coated tablets
Children aged between 6 and 12 years
5 mg twice a day (half a tablet twice a day).
Adults and adolescents over 12 years of age
10 mg once a day (1 tablet).
The tablets must be taken with a glass of liquid.
The tablet can be divided into 2 equal parts.
SOTRIZOL10 mg/ml oral drops, solution
Children aged between 2 and 6 years:
2.5 mg twice a day (5 drops twice a day).
Children aged between 6 and 12 years
5 mg twice a day (10 drops twice a day).
Adults and adolescents over 12 years of age
10 mg once a day (20 drops).
The drops must be poured into a spoon or diluted in water and taken orally.
If dilution is used, it must be considered, especially for administration to children, that
the volume of water to which the drops are added must be proportional to the amount of
water the patient is able to drink. The diluted solution must be taken
immediately.
When counting the drops, the bottle must be held vertically (inverted).
If the flow of drops stops and if the correct amount has not been dispensed, return the
bottle to the upright position, then invert it again and continue counting the
drops.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (half a
tablet or 10 drops) once a day.
If you have severe kidney disease, contact your doctor or pharmacist who may adjust the
dose accordingly.
If the child has kidney disease, contact your doctor or pharmacist who may adjust the
dose based on the child's needs.
If you feel that the effect of Sotrizol 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 condition and is
established by the doctor.
If you take more Sotrizol than you should
If you think you have taken an overdose of Sotrizol, inform your doctor.
The doctor will decide what measures to take if necessary.
After an overdose, the side effects described below may appear with increased
intensity. Adverse events such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness,
stupor, abnormally rapid heart rhythm, tremors and urinary retention have been reported.
If you forget to take Sotrizol
Do not take a double dose to make up for a missed dose.
If you stop taking Sotrizol
If you have any doubts about the use of Sotrizol, consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sotrizol may cause side effects, although not everybody gets them.
The following side effects are rare or very rare. However, you should stop
taking the medicine and immediately inform your doctor if you notice the appearance
of:
- Allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat). These reactions may occur immediately after taking the medicine or later. Common side effects(may affect up to 1 in 10 patients)
- Drowsiness
- Dizziness, headache
- Pharyngitis, rhinitis (in children)
- Diarrhoea, nausea, dry mouth
- Fatigue Uncommon side effects(may affect up to 1 in 100 patients)
- Agitation
- Paresthesia (abnormal skin sensation)
- Abdominal pain
- Pruritus (itchy skin), rash
- Asthenia (extreme fatigue), malaise Rare side effects(may affect up to 1 in 1000 patients)
- Allergic reactions, some severe (very rare)
- Depression, hallucinations, aggressiveness, confusion, insomnia
- Convulsions
- Tachycardia (fast heartbeat)
- Abnormal liver function
- Urticaria (hives)
- Edema (swelling)
- Weight gain Very rare side effects(may affect up to 1 in 10,000 patients)
- Thrombocytopenia (low platelet count in the blood)
- Tic (habitual spasm)
- Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
- Blurred vision, accommodation disorder (difficulty focusing), oculorotation (eyes with uncontrolled circular movements)
- Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
- Abnormal urine elimination (involuntary bladder emptying during nighttime sleep, pain and/or difficulty urinating) Side effects with unknown frequency(frequency cannot be estimated based on available data)
- Increased appetite
- Suicidal ideation (recurring concerns or suicidal thoughts)
- Amnesia, memory impairment
- Vertigo (sensation of spinning or movement)
- Urinary retention (inability to completely empty the bladder) At the first signs of hypersensitivity, stop treatment with Sotrizol.The doctor will assess the severity and decide on any measures to be taken if necessary.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at the address:
www.agenziafarmaco.gov.it/it/responsabili.
Reporting side effects helps to provide more information on the
safety of this medicine.
5. HOW TO STORE SOTRIZOL
Keep Sotrizol out of the sight and reach of children.
Do not use Sotrizol after the expiry date which is stated on the package and blister or bottle.
This medicine does not require any special storage conditions for the tablets
For oral drops, solution
The period of validity after first opening of the bottle is 6 months
store at a temperature not exceeding 25 °C, both in intact packaging and after first
opening
6. OTHER INFORMATION
What Sotrizol contains
SOTRIZOL film-coated tablets
- The active ingredient of Sotrizol is Cetirizine dihydrochloride.
- One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The excipients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000 SOTRIZOL oral drops, solution
- The active ingredient of Sotrizol 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 excipients are: glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trisodium citrate dihydrate, glacial acetic acid, purified water. Description of the appearance of Sotrizol and contents of the pack
Film-coated tablet, with a score line. The tablets can be divided into two equal halves.
Pack of 20 tablets.
Oral drops, solution; bottle containing 20 ml of clear and colorless solution.
Marketing Authorisation Holder and Manufacturer
DYMALIFE PHARMACEUTICAL S.R.L.
VIA BAGNULO 95, 80063
PIANO DI SORRENTO
NAPOLI (NA).
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Strada Paduni, 240-03012, Anagni (FR)
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- 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 SOTRITSOLФорма 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
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Действующее вещество SOTRITSOL — Цетиризин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SOTRITSOL производится компанией DYMALIFE PHARMACEUTICAL S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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