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Drug DEBRIDAT have composition trimebutine maleate  100mg, Symptomatic treatment:of pain related to functional disturbances of the gastrointestinal tract bile ducts, of pain transit disturbances and intestinal discomfort related to intestinal disturbances

No  Spa 40mg Indicated for Colic biliary pain due to smooth muscle spasm

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

1. NAME OF THE MEDICINAL PRODUCT DEBRIDAT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet of DEBRIDAT contains 100 mg trimebutine maleate.

DEBRIDAT contains 100 mg trimebutine maleate

3. PHARM ACETICAL FORM

Film coated tablet

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

Symptomatic treatment:

– of pain related to functional disturbances of the gastrointestinal tract and bile ducts.

– of pain transit disturbances and intestinal discomfort related to intestinal disturbances.

4.2. Posotogy and Method of Administration

Reserved for  use in adults only. The usual dosage is 1 tablet 3 times daily

In exceptional cases, the dosage may be increased up to maximum of 6 tablets per day.

4.3. Contraindications

Debridat is contraindicated in patients found to be  to trimebutine or to any components the formulation

4.4. Special Warnings and Special Precautions for Use

Absolute contraindications and precautions to this age been determined: no information found  of this review.

4.5 Interaction with Other Medicaments and Other Forms of Interaction

None Known

4.6 Pregnancy and Lactation

Pregnancy:

Studies in animals have not revealed any teratogenic effect. In the absence of any teratogenic effect no matonnative effect is expected in infact, to date, substances responsible for in humans have been revealed to be teratogenic in animals in the course of properly conducted studies in both species.

No sufficiently relevant data are currently available to be able to assess a potential malformative or fetotoxic effect of trimebutine when it is administered during pregnancy. Consequently, as a precautionary measure, it is preferable not to use trimebutine during the first trimester of pregnancy. In the absence of any expected harmful effect for either mother or child, the use of trimebutine during the 2nd and 3rd trimesters of pregnancy should only be considered if it is necessary.

Lactation

Breast-feeding is possible during treatment with trimebutine.

4.7. Effects on Ability to Drive and Use Machines

The effect of tiimebutine maleate on the ability to drive or operate machine has not been systematically evaluated.

4.8. Undesirable Effects

Rare cases of skin reactions have been reported during clinical studies.

4.9. Overdose

In the event of overdose, symptomatic treatment should be instigated

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

MUSCULOTROPIC ANTISPASMODIC (A: gastrointestinal tract and metabolism)

Gastrointestinal motility modifier. Peripheral enkephalinergic agonist.

Trimebutine stimulates intestinal motility (triggering phase-ill waves propagated by the migrating motor complex) and inhibits it in the event of prior stimulation.

5.2. Pharmacokinetic Properties

Peak blood levels obtained after 1 to 2 hours.

Rapid elimination, mainly in the urine: on average 70% in 24 hours.

5.3. Preclinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Lactose monohydrate, pregelatinized starch (maize), hypromellose, sodium starch glycollate, tartaric acid, silicone dioxide, magnesium stearate, macrogol 4000, titanium dioxide, purified water.

6.2. Incompatibilities None known.

6.3. Shelf-life : 36 months.

6.4. Special Precautions for Storage Store:  below 25°C.

6.5. Nature and Contents of Container:  Box of 2 blisters x 15 film coated tablets.

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