CeBITera 5/20 mg

Adult dose

This medication is administered once daily, one tablet, regardless of food, taken with water. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled by olmesartan medoxomil 20 mg monotherapy.

Child dose

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

This medication can cause severe harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, if pregnancy is confirmed, it must be discontinued immediately. Patients with allergies to the main ingredient or similar components, those who are pregnant or breastfeeding, individuals with severe hepatic disease or aortic stenosis, patients with bile duct obstruction, those undergoing renal dialysis, individuals in a state of shock, and certain diabetic patients should not take this medication. Caution is necessary when administering this drug to patients with hypotension from fluid or sodium depletion, those at risk of sudden vasodilation, patients with severe obstructive coronary artery disease or congestive heart failure, poor kidney function, and impaired liver function, and they should be closely monitored. Side effects such as dizziness, headache, hypotension, edema, dyspepsia, and rash may occur while taking this medication, and in rare cases, serious side effects may occur. Patients should consult medical professionals immediately if unusual symptoms appear. Unlike beta-blockers, this medication poses less risk when suddenly discontinued; however, there are potential interactions when used in conjunction with other antihypertensive drugs, so it should be taken according to the physician's instructions. This medication should not be used during pregnancy, and if planning to become pregnant, it is advisable to switch to other drugs that have verified safety. Breastfeeding mothers should be aware that this medication can pass into breast milk and may affect the baby; therefore, it is recommended to either stop breastfeeding or discontinue the medication. The safety and efficacy of this medication have not been established in children or adolescents under 18 years of age, so it is best not to use it in these populations. For the elderly, renal and hepatic functions may be impaired, so it is recommended to start with a lower dose and monitor their condition closely. Overdose may result in hypotension and impaired cardiac function, requiring immediate medical attention for proper treatment. This medication should be stored away from direct sunlight and moisture in a sealed container, and it is advisable not to transfer it to another container.

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, severe allergic reactions, severe skin adverse reactions, jaundice, liver dysfunction, acute renal failure, elevated creatinine in blood, renal insufficiency, severe neurological symptoms (dizziness, fainting, exacerbation of cerebrovascular accident), severe edema, edema associated with elevated blood pressure, angioedema, toxic epidermal necrolysis.

Mild side effects

• Dizziness
• headache
• drowsiness
• sensory disturbances
• decreased sensitivity
• palpitations
• rapid heartbeat
• hypotension
• orthostatic hypotension
• cough

This medication may be sensitive to air and moisture; therefore, it should be stored in a sealed container. It is recommended to maintain a room temperature between 1 to 30 degrees Celsius to preserve the drug’s effectiveness for a longer duration.

Appearance

White, round, film-coated tablets

Package unit

30 tablets/PPT [10 tablets/PPT x 3]