Rodistal Tablet 40/5 mg (Telmisartan, Amlodipine Besylate)

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., morning). For patients with renal impairment, particularly those with severe renal impairment, treatment should start at a lower dose with gradual dose escalation. For patients with mild or moderate liver impairment, the daily dose of telmisartan should not exceed 40 mg.

Child dose

The safety and efficacy in children aged 18 years and younger have not been established; therefore, administration of this medication is not recommended.

This medication can cause serious side effects to the fetus or newborn, especially during the second and third trimesters of pregnancy; therefore, it should not be taken by pregnant women or women who may become pregnant. It should not be administered to patients with an allergy to this medication or similar drugs, nursing mothers, patients with obstructive biliary disease, severe liver impairment, or specific heart-related diseases. Particular care should be taken when using this medication in patients with primary aldosteronism, certain heart valve diseases, liver impairment, gastrointestinal diseases, renal vascular diseases, renal failure, and elderly individuals. Common side effects include dizziness and peripheral edema, and rarely, serious side effects like fainting or cardiac issues may occur. During pregnancy, use of this medication poses risks such as decreased renal function in the fetus, delayed skull formation, and renal failure in the newborn; therefore, use should be discontinued immediately upon confirmation of pregnancy, and consultation with a physician is necessary. As this medication lowers blood pressure, patients with hypotension or dehydration should manage their condition prior to taking it and should take it under a physician's guidance. There is a risk of elevated potassium levels, so patients at risk for hyperkalemia should have regular blood tests and careful monitoring. Patients with impaired kidney function should monitor their renal functionality regularly while taking this medication, and its safety in kidney transplant recipients has not been established. One of the components of this medication may increase the risk of angina or myocardial infarction in some heart disease patients, so caution is advised when taken by patients with heart diseases. This medication may cause drowsiness or dizziness; therefore, caution should be exercised when driving or operating heavy machinery while on this medication. Interactions may occur with other antihypertensives or specific medications, so inform the physician or pharmacist of any other medications being taken. Pregnant or nursing women should not take this medication, and consultation with a healthcare provider is necessary if there are plans for pregnancy or if pregnancy occurs. The safety and efficacy in pediatric patients have not been sufficiently established; therefore, it is advised that individuals under 18 years of age do not use this medication. Elderly patients may react more sensitively to this medication; therefore, dosages should be adjusted and managed carefully. In cases of overdose, the risk of severe hypotension and cardiac function decline exists; immediate medical attention is required.

Serious side effects

Urticaria, angioedema, anaphylactic reactions, angioedema (with fatal outcomes), toxic skin rash, Stevens-Johnson syndrome, photosensitivity reactions, vasculitis, jaundice, hepatitis, severe liver dysfunction, fainting, severe allergic reactions, severe edema, kidney dysfunction (including acute renal failure), edema associated with elevated blood pressure, severe rash, blisters, exfoliation of the skin, pain in oral/eye mucosa, dyspnea, pulmonary edema, discomfort in the chest, myocardial infarction, ventricular issues.

Mild side effects

• Dizziness
• peripheral edema
• upper respiratory infection
• urinary tract infection
• anemia
• hyperkalemia
• hypoglycemia
• hyponatremia
• hyperglycemia
• depression

This medication is sensitive to light and should be stored in a container that does not allow light to enter. To maintain the medication's efficacy, it is best stored at a temperature between 1 to 30 degrees Celsius.

Appearance

A white and light gray, double convex, oval-shaped tablet.

Package unit

For domestic use - 30 tablets/PTP [30 tablets (10 tablets/Alu-Alu X 3)]