Farmipid: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Rebamipide.

Indications/Uses

Gastric ulcer: Should be combined with offensive factor inhibitor (Proton Pump Inhibitor, anticholinergic, or H2-Antagonist).
Gastritis.

Dosage/Direction for Use

Gastric ulcer: In combination therapy with offensive factor inhibitor: 1 tablet (100 mg) 3 times daily, in the morning, afternoon, and before bedtime.
Gastritis: 1 tablet (100 mg) 3 times daily.
Administration: With or without food.

Contraindications

Patients with a history of hypersensitivity to any component of this drug.

Special Precautions

Use in Children: Safety data of this medication in infants with low birth weight, newborns, breastfeeding infants, and children has not been established. (Clinical experience is insufficient.)
Use in the Elderly: Special precaution is required for elderly patients to minimize the risk of GI disturbance as the patients may be physiologically more sensitive to this medication than younger patients.

Use In Pregnancy & Lactation

Use during pregnancy, childbirth & lactation: Administration in pregnant women or those who may become pregnant should only be considered if the anticipated therapeutic benefits are greater than the potential risks. (The safety of this medication in pregnant women is unknown.)
Nursing patients should discontinue breastfeeding while this medication is being administered. (Studies in rats have shown that rebamipide is excreted in breast milk.)

Adverse Reactions

Clinically significant side effects: Shock, anaphylactoid reactions (the frequency is unknown*): Therefore, patients should be closely monitored. If any abnormal findings are detected, the medication should be discontinued, and appropriate actions should be taken.
Leucopenia (<0.1%) and thrombocytopenia (the frequency is unknown*): Therefore, patients should be closely monitored. If any abnormal findings are detected, the medication should be discontinued, and appropriate actions should be taken.
Liver dysfunction (<0.1%) and jaundice (the frequency is unknown*): Liver dysfunction & jaundice as shown by the increase of AST (GOT), ALT (GPT), -GTP, & alkaline phosphatase in patients who were receiving rebamipide, has been reported. Therefore, patients should be closely monitored. If any abnormal findings are detected, the medication should be discontinued, and appropriate actions should be taken.
Other adverse reactions: See table.

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View ADR Reporting Link

Drug Interactions

No studies have been performed to evaluate any drug interactions.

MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Regulatory Classification

Presentation/Packing

Form

Farmipid FC tab 100 mg

Packing/Price

10 × 10's

Farmipid

rebamipide

Manufacturer:

Ifars