Lopesim 2mg+125mg Tablet

Loperamide + Simethicone is used for the short-term symptomatic relief of acute diarrhea in adults and adolescents aged 12 years and above, particularly when diarrhea is accompanied by gas-related abdominal symptoms such as bloating, abdominal cramps, or excessive flatulence.

Adults and adolescents 12 years and older:
Take 2 tablets after the first loose stool, followed by 1 tablet after each subsequent loose bowel movement. Do not exceed 4 tablets in 24 hours and do not use for more than 2 days unless directed by a doctor.

Children under 12 years:
Use is generally not recommended without medical advice. If a doctor specifically recommends treatment, the dose should be determined according to the child's age and condition.

Elderly patients:
No specific dose adjustment is generally required.

Kidney impairment:
Dose adjustment is usually not necessary.

Liver impairment:
Use with caution because reduced liver metabolism may increase exposure to loperamide and the risk of adverse effects.

The medicine should be taken orally with adequate water. Chewable tablets should be completely chewed before swallowing. Drink plenty of clear fluids during diarrhea to help prevent dehydration.

Drug Interactions

Loperamide levels may increase when taken with medicines that inhibit P-glycoprotein or CYP3A4/CYP2C8, including certain medicines such as quinidine, ritonavir, itraconazole, ketoconazole, and gemfibrozil. Increased loperamide exposure may increase the risk of adverse effects.

Taking loperamide with desmopressin may increase desmopressin levels because slowed intestinal movement can increase its absorption.

Medicines that slow intestinal movement may enhance the effects of loperamide, while medicines that accelerate gastrointestinal transit may reduce its effectiveness.

Since simethicone is not absorbed into the body, clinically significant interactions with other medicines are not generally expected.

Contraindications

Do not use Loperamide + Simethicone if you:

• Are allergic to loperamide, simethicone, or any component of the formulation.
• Have diarrhea associated with blood in the stool and fever, such as acute dysentery.
• Have bacterial enterocolitis caused by invasive bacteria such as Salmonella, Shigella, or Campylobacter.
• Have acute ulcerative colitis or antibiotic-associated pseudomembranous colitis.
• Have abdominal conditions where slowing intestinal movement should be avoided.
• Need to avoid constipation.
• Develop abdominal swelling or distension while taking the medicine.

It should not be used in children younger than 2 years.

Side Effects

The medicine is generally well tolerated when used as directed. Possible side effects include:

• Altered taste
• Nausea
• Abdominal discomfort
• Constipation
• Dizziness or drowsiness in some individuals

Serious effects are uncommon but may occur, particularly with excessive doses. Overdose of loperamide has been associated with serious heart rhythm abnormalities, including QT and QRS prolongation.

Pregnancy & Breastfeeding

The safety of this combination during human pregnancy has not been adequately established. It should generally be avoided during pregnancy, particularly during the first trimester, unless a doctor determines that treatment is necessary.

Small amounts of loperamide may pass into breast milk. Therefore, use during breastfeeding is generally not recommended unless specifically advised by a healthcare professional.

Precautions & Warnings

Loperamide + Simethicone provides symptomatic relief only and does not treat the underlying cause of diarrhea. Appropriate fluid and electrolyte replacement should be continued to prevent dehydration.

• Stop treatment and consult a doctor if there is no improvement within 48 hours.
• Do not use it for diarrhea accompanied by blood in the stool or fever without medical advice.
• Use cautiously in people with liver problems because loperamide may accumulate and potentially cause central nervous system toxicity.
• Patients with severe liver impairment should use this medicine only under medical supervision.
• Discontinue the medicine if significant abdominal distension or other concerning symptoms develop.
• Never exceed the recommended dose, as excessive loperamide can cause potentially serious cardiac complications.

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep the medicine out of the reach of children.