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Cetirizine Hydrochloride Tablets Instructions
Please read the instruction manual carefully and use as directed or purchase and use under the guidance of a pharmacist
[Drug Name]
Generic Name: Cetirizine Hydrochloride Tablets
Trade Name: Ciclovir
English Name:Cetirizine Hydrochloride Tablets
Hanyu Pinyin:Yansuan Xitiliqin Pian
[Ingredients]This product contains cetirizine hydrochloride per tablet10. style=”font-family:equivocal”>mg. The excipients are: microcrystalline cellulose102, lactose, silicon dioxide, and magnesium stearate.
[Properties]This product is a white or off-white tablet.
[Category of action]
This product is an anti-allergy over-the-counter drug.
[Indications]
Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis and allergy-induced pruritus and urticaria.
[Specifications]10mg.
[dosage]
Orally. Recommended for adults and children 6 years of age and older. Adults: 1 tablet once with a small amount of liquid at dinner, or half a tablet once a day in the morning and once in the evening if sensitive to adverse reactions. Children 6-12 years of age: 1 tablet once a day; or half a tablet twice a day .
[Adverse Reactions]
Mild and transient adverse reactions have occasionally been reported in patients. Such as headache, dizziness, drowsiness, agitation, dry mouth, and abdominal discomfort. In objective tests measuring psychomotor function, the sedative effect of this product was similar to that of placebo. Rarely, allergic reactions have been reported.
Compared with first-generationH1 receptor antagonists Cetirizine has a weaker ability to enter the central nervous system. Clinical studies have shown mild CNS adverse effects with recommended doses of cetirizine, including drowsiness, fatigue, numbness, impaired concentration, dizziness, and headache. Central nervous system excitation has also been reported in some cases.
Although cetirizine is a selective peripheralH1 receptor antagonist with no apparent anticholinergic activity, although there have been isolated reports of dysuria, dysregulation, and dry mouth.
Individual patients have experienced impaired liver function with elevated liver enzyme levels and bilirubin levels. Usually, liver enzyme levels and bilirubin levels return to normal after discontinuation of the drug.
Safety data from clinical studies of the original product:
The following safety data were derived from the original product clinical study. In this clinical study, cetirizine (3260 cases) (at the recommended dose,) was administered family:Arial”>10mg/day) with Placebo or other antihistamines were compared and the following side effects with an incidence of at least 1% were observed: drowsiness (9.63%), headache (7.42%), dizziness (1.10 %), pharyngitis (1.29 %), dry mouth (2.09 %), nausea (1.07 %), abdominal pain ( 0.98 %), fatigue (1.63 %).
In targeting children (6months to12 years) were observed in placebo-controlled clinical studies of the original product in cetirizine (1656 cases) had the following adverse reactions: drowsiness (1.8%), rhinitis (1.4%), diarrhea (1.0%), fatigue (1.0%).
Safety data from post-marketing studies of the original product (PMS):
In addition to the adverse reactions listed in reports during clinical trials, the following adverse reactions were reported after the original product was launched.
According to MedDRA system organ classification and Describe adverse events by frequency based on post-marketing report estimates:
Frequency is defined as follows: very common(≥1/10); common(≥1/100 – <1/10); occasionally(≥1/1,000 – <1/100); rare(≥1/10,000 – <1/1,000); very rare(<1/10,000); not known (not estimable from available data).
– Cardiac symptoms:
Rare: Tachycardia
– Hematologic and lymphatic symptoms:
Very rare: thrombocytopenia
-Neurological symptoms:
Sometimes: sensory abnormalities
Rare: convulsions
Very rare: taste disturbance, dyskinesia, dystonia, syncope, tremor
Unknown: deafness, amnesia, memory impairment
– Eye symptoms:
Very rare: visual dysregulation, blurred vision, eye spinning
Unknown: vasculitis
-ear and vagal symptoms:
Unspecified: vertigo
-Gastrointestinal symptoms:
Sometimes: diarrhea
– Renal and urinary symptoms:
Very rare: dysuria, enuresis
Unknown: urinary retention
– Skin and subcutaneous tissue symptoms:
Sometimes: pruritus, rash
Rare: urticaria
Very rare: angioneurotic edema, fixed drug rash
-Systemic symptoms as well as medication site symptoms:
Sometimes: weakness, malaise
Rare: edema
– Immune system symptoms:
Rare: Hypersensitivity reactions
Very rare: anaphylaxis
-Hepatobiliary symptoms:
Rare: abnormal liver function (transaminases, alkaline phosphatase, gamma- GTand elevated bilirubin)
– Metabolic and nutritional disorders:
Unspecified: increased appetite
– Psychiatric symptoms:
Sometimes: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tics
unknown: suicidal ideation
-Lab Tests:
Rare: weight gain
The following adverse reactions were observed after the original product received marketing authorization: pruritus and /or urticaria.
[Contraindicated]
1, Contraindicated in persons with hypersensitivity to the ingredients of this product, hydroxyzine or any other piperazine derivatives.
2, Contraindicated in patients with severe renal impairment.
3, This product contains lactose. There are rare cases of hereditary galactose intolerance,Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not be taken by patients. –
[Precautions]
1.At therapeutic doses, no clinically significant interactions with alcohol were demonstrated (blood alcohol levels were0.5g/l). Despite this, alcohol should be consumed with caution when taking this product.
2.Patients with predisposing factors for urinary retention (e.g., spinal cord damage, prostatic hypertrophy) should use caution because cetirizine may increase the risk of urinary retention.
3.It is recommended that it should be used with caution in patients with epilepsy and those at risk of convulsions.
4.Patients with renal insufficiency should be used under medical supervision.
5.Special care is needed when administering to pregnant women. Not recommended for women in the first3months of pregnancy. Cetirizine should not be used in women who are breastfeeding because the drug passes into breast milk.
6.Do not drive an aircraft, vehicle, boat, work at height, work with machinery, or operate precision instruments while taking the drug.
7.It is contraindicated for those who are allergic to this product and should be used with caution for those who are allergic.
8.Antihistamines reduce the sensitivity of skin allergy test results, so they should be discontinued before undergoing such tests3days.
9.Prohibit use when the properties of this product change.
10.Please keep this product out of the reach of children.
11.Children must be under adult supervision. Cetirizine Hydrochloride Drops are recommended for children 2-6 years of age. This product is not recommended for children 6 years of age as the tablets do not allow for accurate dose adjustment.
12.Consult your physician or pharmacist before using this product if you are using other medications.
[Drug Interactions]
1.This product should be taken with caution with sedatives (tranquilizers) or theophylline.
2.Drug interactions may occur if used concurrently with other drugs; consult your physician or pharmacist for details.
[Storage]Store in a dry place, protected from light and sealed.
[Package]Double aluminum package. 6pieces/plate×1plate/box, 6pieces/plate×2board/box,6pieces/board×3board/Box.
[Expiration date]2424months
[Executive Standard]
[Approval number]国药准字H19980014
[Date of revision of instruction]
[Manufacturer]
Company Name: Suzhou Dongrui Pharmaceutical Co.
Manufacturing Address: Minfeng Road, Wuzhong Economic Development Zone, Suzhou, Jiangsu Province268No.
Postal Code:215124
Phone Number:0512-65626868
Fax Number:0512-65628688
Web
Address:www.dawnrays.com
Contact the manufacturer if you have any questions.