TRIMEBOSTON 300

TRIMEBOSTON 300

202206-0237 • 831 Lượt xem • Box of 3 of blister x 10 coated - tablets
COMPOSITION

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.

Alu/PVC blister. Box of 3 of blister x 10 coated - tablets.
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