Sambika Tablet 5/40 mg

Adult dose

This medication is administered once daily, one tablet, with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. The recommended dosing is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with Amlodipine 5 mg or Olmesartan Medoxomil 20 mg. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with Olmesartan Medoxomil 20 mg. - 5/40 mg: Administered to patients whose blood pressure is not adequately controlled by 5/20 mg. - 10/40 mg: Administered to patients whose blood pressure is not adequately controlled by 5/40 mg. ∘ Patients with renal impairment: There are no studies on this medication in patients with kidney impairment. However, the maximum recommended dose of Olmesartan Medoxomil for mild to moderate renal impairment (creatinine clearance 20-60 mL/min) is once daily 20 mg, and this medication is not recommended for moderate to severe renal impaired patients (e.g., creatinine clearance < 20 mL/min) or those on dialysis. For moderate renal impairment, monitoring of potassium and creatinine levels is advisable. ∘ Patients with potential intravascular volume depletion: Patients with possible intravascular volume depletion (e.g., those receiving diuretics, especially renal impaired patients) should start on a lower dose with careful monitoring of their condition. ∘ Patients with hepatic impairment: Caution is needed when administering to patients with mild to moderate hepatic impairment. The recommended initial dose for patients with moderate hepatic impairment is 10 mg once daily, and the maximum dose is 20 mg once daily. Patients with hepatic impairment who are already receiving other antihypertensive medications and/or diuretics should be closely monitored for blood pressure and kidney function. This medication should not be administered to patients with severe liver damage. (Refer to the precautions under 2. Patients who should not be treated with this medication) ∘ Elderly: It is common to start at a lower dose, adjusting based on the patient's kidney function or heart function, and the presence of coexisting illnesses. Elderly patients should be monitored for blood pressure more frequently. ∘ Pediatrics: The safety and efficacy of this medication have not been established in patients under 18 years of age.

Child dose

The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age.

This medication can cause serious harm or death to the fetus and newborn if administered to pregnant women during the second and third trimesters. Therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients who are allergic to any of the components of this medication or similar drugs, pregnant or nursing women, patients with severe hepatic impairment or aortic stenosis, patients with bile duct obstruction, kidney dialysis patients, patients in shock, specific diabetic patients, and patients with severely impaired kidney function should not take this medication. Patients with dehydration or salt depletion may experience hypotension, therefore their condition should be closely monitored at the start of treatment, and appropriate interventions should be taken if hypotension occurs. Due to the vasodilation effect, some patients may experience acute hypotension, so caution is required, especially for patients with heart valve issues. Use of this medication in patients with severe obstructive coronary artery disease or congestive heart failure should be approached with caution, and their heart condition should be closely monitored. For patients with reduced kidney function, this medication may affect kidney function, so regular monitoring of kidney function is essential. In patients with impaired liver function, the metabolism of this medication may slow down, requiring caution during use. Side effects such as dizziness, headache, hypotension, orthostatic hypotension, drowsiness, nausea, vomiting, diarrhea, rash, swelling, and others may occur; if any unusual symptoms occur, patients should consult a healthcare professional immediately. During pregnancy, there may be risks to the fetus, thus this medication should not be used if pregnant or planning to become pregnant, and an alternative safe medication should be sought if necessary. Nursing women should be aware that this medication may transfer to breast milk, potentially causing adverse reactions in the infant; thus, breastfeeding should be stopped or medication use should be discontinued. The safety and efficacy of this medication have not been established in children under 18 years old, and it is not recommended. Elderly patients should have their dosage adjusted carefully considering reduced kidney and liver function, and attention should be paid to the possibility of side effects. In case of overdose, severe hypotension, vascular dilation, and tachycardia may occur, requiring immediate medical attention and close monitoring of blood pressure and heart function. This medication should be stored in a tightly closed container to avoid moisture and heat, and kept out of the reach of children. There may be possible interactions with other medications during treatment with this drug, so patients should inform their healthcare provider of any other medications they are taking, particularly avoiding concomitant use with grapefruit juice.

Serious side effects

Hives, angioedema, gallstones, female breast neoplasm, worsened cerebral infarction, gum bleeding, chronic malabsorption syndrome-like diseases, rhabdomyolysis, acute renal failure, increased creatinine level, autoimmune hepatitis, hair loss, itching, jaundice, elevated liver enzymes, toxic epidermal necrolysis, angioedema

Mild side effects

• Dizziness
• headache
• decreased libido
• drowsiness
• perception abnormalities
• diminished perception
• fainting
• vertigo
• palpitations
• rapid heartbeat

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius to safely preserve its efficacy.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)