Active substance: 3 film-coated tablet 30 mg cetirizine dihydrochloride
Excipients: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 (contains titanium dioxide (E171)), hypromellose (464), macrogol.
FORM AND CONTENT OF THE PACKAGE
Original package with 7 and 20 film-coated tablets.
Pharmacotherapeutic group:
Antiallergic / antihistamine medicine. "Cetirizine block the effects of histamine, a substance that occurs naturally in the body tissues and can induce fever and runny nose and itching, redness and tearing or itching of the skin.
Indications
Adults and adolescents:
Symptomatic treatment of allergic rhinitis (seasonal and perennial), associated by allergic conjunctivitis and chronic idiopathic urticaria (hives).
Landfills aged between 6 and 12 years
Symptomatic treatment of allergic rhinitis (seasonal and perennial) and chronic idiopathic urticaria (hives).
Contraindications
When you should not take Cetiristad?
If you are hypersensitive to cetirizine dihydrochloride or to any of the excipients
Children under 6 years
If you suffer from severe renal failure
What you should consider if you are pregnant or breast-feeding?
The experience of the limited number of cases of use of the drug during pregnancy indicate no adverse effects on Cetiristad) regarding pregnancy or the fetus / newborn. So far, no other relevant epidemiological data.
Cetiristad should be used with caution during pregnancy.
It is not known whether Cetiristad is excreted in human milk. Therefore the use of * Cetiristad during lactation should be avoided.
What you should consider on the application of this product in children?
Infants and young children aged under 6 years old should not be treated with Cetiristad.
What you should consider in the elderly?
There is no evidence that it is necessary to modify the dose in healthy elderly subjects.
What should consider patients with impaired renal function?
Cetiristad is contraindicated in patients with severe renal insufficiency. In patients with moderate renal insufficiency, the dose should be reduced by half. Patients with mild to moderate, expressed renal failure and those with impaired hepatic function should be monitored carefully (see "Special warnings and precautions").
Special warnings and precautions
In some patients, long term treatment with Cetiristad may lead to an increased risk of caries due to drug-induced dry mouth. Therefore, strict maintenance of oral hygiene is important during treatment with Cetiristad.
In the presence of impaired hepatic and renal function possible elimination (removal) of Cetiristad by the body to be broken. Cetiristad application of such patients should be performed with caution (See "Dosage and Administration" and "Contraindications").
Caution is advised during concomitant use of CNS depressants.
Cetiristad contains lactose. If your doctor has told you that you have a hereditary intolerance to some sugars (carbohydrates), please consult before taking this medicine. What you should consider when driving, operating machinery or working at high altitude? *
Cetirizine dihydrochloride have minor to moderate influence on your reactions. Note, however, that cetirizine dihydrochloride may potentiate the effects of alcohol and CNS depressants.
Interactions
Allergy test: Use of cetirizine dihydrochloride must be discontinued three days before the studies
hypersensitivity. Caution is advised during concomitant use of CNS depressants.
What foods and drinks you should avoid?
Cetirizine dihydrochloride may potentiate the effects of alcohol should therefore be exercised in the concomitant use of alcohol.
Dosage and method of administration duration of treatment
Stick to the below instructions unless your doctor has prescribed application of Cetiristad otherwise. Please, follow dosage instructions to ensure effective and safe treatment Cetiristad.
Adults and adolescents:
Take 1 tablet film Cetiristad (equivalent to 10 mg cetirizine dihydrochloride) once a day.
Children aged between 6 and 12 years
Take 1 film-coated tablet Cetiristad (equivalent to 10 mg cetirizine dihydrochloride) once a day. as a single dose once a day or 1/2 tablet film Cetiristad (equivalent to 5 mg cetirizine dihydrochloride) twice a day (morning and evening).
Landfills aged between b and 12 years weighing less than 30 kg
Take 1/2 tablet film Cetiristad (equivalent to 5 mg cetirizine dihydrochloride) once a day.
What should consider patients with impaired renal function?
Cetiristad is contraindicated in patients with severe renal insufficiency. In patients with moderate renal insufficiency, the dose should be reduced by half. Patients with mild to moderate renal impairment and those with impaired hepatic function should be monitored carefully (see "Special warnings and precautions").
How and when should you take Cetiristad?
If somnolence Cetiristad can be taken at night.
Taking Cetiristad does not depend on the timing of meals.
How long should you take Cetiristad?
The length of treatment varies depending on the symptoms. If you are not sure, talk to your doctor or pharmacist
Violations of the dosing regimen and overdose
What should you do in case of intentional or accidental overdose Cetiristad?
Clinical experience regarding overdose is limited. In massive overdose (eg. Administration of 5 film tablets Cetiristad time) is likely to occur as described below side effects, but with a greater intensity. If you suspect an overdose of Cetiristad tell your doctor immediately and he will decide what measures are necessary.
What should you do if you take more than the prescribed dose Cetiristad or you forget to take the medicine?
Continue treatment according to the instructions in section "Dosage and Administration"
Adverse reactions
Like any other medicine Cetiristad can cause side effects. To evaluate the incidence of adverse reactions using the following classification:
Very common: Common
More than 1 in 10 treated in less than 1 in 10 but in more patients than 1 in 100 patients treated
Uncommon Rare
In less than 1 in 100, but in less than 1 in 1,000, but more than 1 per 1000 patients treated more than 1 in 10 000 patients treated
Very rare
1 case per 10 000 treated patients or rare
General disorders Common: dry mouth
Gastrointestinal disorders
Uncommon .: Abdominal discomfort and digestive disorders
Disorders of the central nervous system
Common: Sleepiness in children and adults, somnolence
Uncommon: Headache, dizziness, agitation
Disorders Immune System
Very rare (<1/10 000)
Hypersensitivity reactions such as skin reactions and edema Quincke.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What should I take when experiencing side effects?
In case of side effects, your doctor will decide what measures are necessary.
At the first sign of hypersensitivity stop taking Cetiristad
Shelf life and stability of the medicinal product
The shelf life of the product is stated on the carton and label. Do not use this medicine after the expiry date.
How should I store Cetiristad?
Keep all medicines out of the reach of children.