Telcatam Plus Tablet 80/12.5 mg

Adult dose

In patients whose blood pressure is not appropriately controlled by telmisartan alone, take this medication once daily with water, regardless of the presence of food. It is advisable to adjust the dosage of each ingredient based on individual needs before switching to this fixed-dose combination medication. When clinically appropriate, direct switching from monotherapy to this combination may also be considered. - Telmisartan/Hydrochlorothiazide 40/12.5 mg may be administered for patients whose blood pressure is not adequately controlled with telmisartan 40 mg. - Telmisartan/Hydrochlorothiazide 80/12.5 mg may be administered for patients whose blood pressure is not adequately controlled with telmisartan 80 mg. - Telmisartan/Hydrochlorothiazide 80/25 mg may be administered for patients whose blood pressure is not adequately controlled with either telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg or using two separate medications. Prior to starting this medication, sodium or volume depletion needs to be corrected. Patients with Renal Impairment In patients with mild to moderate renal impairment, dosage adjustments are not necessary. In patients with severe renal impairment (creatinine clearance <30 mL/min), this medication should not be administered. Regular monitoring of renal function is recommended. Patients with Hepatic Impairment In patients with mild to moderate hepatic impairment, this medication should be administered with caution. Dosage should not exceed 40/12.5 mg per day. This medication should not be administered to patients with severe hepatic impairment (see precautions 2). Thiazide diuretics should be administered with caution in patients with hepatic impairment. Elderly Dosage adjustments are not necessary. Pediatrics Safety and efficacy have not been established for pediatric patients under 18 years.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years.

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus and newborn. If pregnancy is confirmed, the use of this medication should be discontinued as soon as possible. This medication should not be used in patients with specific allergic reactions or severely impaired liver and kidney function. Additionally, patients with biliary obstruction or bile stagnation should not be administered this medication. Elderly persons or patients with high serum potassium levels, liver dysfunction, heart valve diseases, or obstructive hypertrophic cardiomyopathy should use this medication with extra caution. This medication may increase the risk of skin cancer, so exposure to sunlight should be avoided and skin conditions should be regularly checked. During the use of this medication, side effects such as dizziness, low blood pressure, or electrolyte imbalance may occur, and if symptoms occur, immediate consultation with a physician is necessary. When used in combination with other antihypertensive agents, diuretics, lithium, or non-steroidal anti-inflammatory drugs, interactions may occur, so it is essential to inform healthcare providers. Pregnant or breastfeeding women should not take this medication and should avoid use while breastfeeding. In case of overdose, symptoms such as low blood pressure, tachycardia, or electrolyte imbalance may occur, so one should visit a healthcare facility immediately for appropriate treatment. Safety and efficacy have not been established for children under 18 years of age, so it is recommended not to use this medication in this population. This medication should be stored out of the reach of children, and should be taken out of the package just before use.

Serious side effects

• Urticaria
• angioedema (including fatal outcomes)
• chest tightness
• difficulty breathing
• hypotension
• orthostatic hypotension
• syncope (fainting)
• vascular edema
• thrombocytopenia
• anaphylactic reaction

Mild side effects

• Bronchitis
• pharyngitis
• sinusitis
• hypokalemia
• hyperuricemia
• hyponatremia
• anxiety
• depression
• insomnia
• sleep disturbances

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Oval-shaped tablet of two layers in white/pink color, with possible pink specks on the white layer.

Package unit

30 tablets (10 tablets/ PTP*3) per box