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Each tablet contains:
Active ingredient:
| Trimebutine maleate | 300 mg |
Excipients: Lactose monohydrate, manitol, wheat starch, pregelatinized starch, povidone K30, sodium starch glycolate, manesium stearate, hypromellose 606, polyethylene glycol 6000, erythrosine, titanium dioxide.
Symptomatic treatment for:
- Pain associated with functional disorders of the digestive tract and bile ducts.
- Pain, transit disorders and intestinal discomfort related to intestinal functional disorders.
DOSAGE
Adults: The usual dosage is 300 mg/day and can be increased exceptionally up to 600 mg/day.
Recommended duration of use is 3 days. In the absence of any warning sign, the maximum duration of use will be 7 days.
ADMINISTRATION
TRIMEBOSTON 300 is administered orally.
CONTRADICATIONS
Hypersensitivity to the active substance or to any of the excipients mentioned.
WARNINGS AND PRECAUTIONS
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
INTERACTIONS
Not applicable.
PREGNANCY AND LACTATION
Pregnancy
Studies in animals have not shown any teratogenic effect.
There are currently no sufficiently relevant data to evaluate a possible malformative or fetotoxic effect of trimebutine when administered during pregnancy.
Therefore, as a precautionary measure, it is preferable not to use trimebutine during the first trimester of pregnancy. In the absence of adverse effects expected for the mother or child, use of trimebutine during the second and third trimesters of pregnancy should be considered only when necessary.
Lactation
The passage into the breast milk of trimebutine is not known.
As a precautionary measure, it is preferable to avoid using trimebutine during breast-feeding.
UNDESIRABLE EFECTS
Frequency are defined as: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100), rare (≥1 / 10000 to <1/1000), very rare (<1/10000); indeterminate frequency (can not be estimated from the available data).
|
Body System |
Undesirable Effect |
Frequency |
|
Immune system disorders |
Hypersensitivity reactions (pruritus, urticaria, angioedema and exceptionally anaphylactic shock). |
Not known |
|
Skin and subcutaneous tissue disorders |
Rash |
Uncommon |
|
Generalized maculopapular rash, erythema, eczematiform reactions and exceptionally severe skin reactions including cases of acute generalized acute exanthematous pustulosis (PEAG), erythema multiforme,febrile toxiderma. |
Uncommon |
OVERDOSE AND TREATMENT
Symptoms
In case of overdose, bradycardia-type cardiac disorders, QTc prolongation, or tachycardia and neurological disorders such as somnolence, convulsion and coma could be observed.
Treatment
Surveillance in specialized settings is necessary and symptomatic treatment should be implemented.
STORAGE CONDITION
In a dry place, below 30 °C, protect from light.
SHELF- LIFE
36 months from the manufacturing date. Do not use after the expiry date.
Factory: No. 43, 8th Street, VSIP, Thuan An City, Binh Duong Province.
Phone: (0274) 3769 606
Office:
- At Lisbon Capital (Portugal): Campo Grande nº 28, 3.º C, - lisbon, district of Lisbon, municipality of Lisbon, parish of Alvalade.
Phone: 1900 1910
- At Ha Noi City: No.38 Duc Giang Street, Duc Giang Ward, Long Bien District, Ha Noi Capital.
Phone: (024) 7305 0606
- At Da Nang City: No.01, Ham Trung 4 Street, Hoa Hiep Nam Ward, Lien Chieu District, Da Nang City.
Phone: (023) 6730 3737
- At Nha Trang City: No.29, Thai Thong Street, Vinh Thai Commune, Nha Trang City, Khanh Hoa Province.
Phone: (025) 8730 3969
- At Ho Chi Minh City: 4th Floor, Flemington Tower, 182 Le Dai Hanh, Ward 15, District 11, Ho Chi Minh City.
Phone: (028) 3838 0606
- At Can Tho City: No.S2-3-4-5, 10th Street, Lot 11C RIVERINE Cantho City, Phu Thu Ward, Cai Rang District, Can Tho City.
Phone: (029) 2730 5959
Business Registration Certificate: No. 3700843113 issued by Binh Duong Province Department of Planning and Investment on January 11, 2007
Representative: Mr. Luong Dang Khoa.
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