Medication info
Amlotel Tablet 40/10mg

Amlotel Tablet 40/10mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
White or off-white rectangular tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle
Approval status
Active

MFDS item code 201702239 · Approved 2017.04.28 · Insurance code 662503630

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For patients with severe renal impairment, treatment should start at a lower dose, with gradual increases. Patients with liver impairment should not exceed a daily dose of 40 milligrams of telmisartan. In the elderly, standard dosing for amlodipine should be followed, but caution should be taken when increasing the dosage.
Child dose
The safety and efficacy of this medication have not been established in patients under 18 years of age, and it is not recommended for this group.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for the treatment of essential hypertension in patients whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or telmisartan. It effectively lowers blood pressure and helps reduce the risk of cardiovascular complications.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For patients with severe renal impairment, treatment should start at a lower dose, with gradual increases. Patients with liver impairment should not exceed a daily dose of 40 milligrams of telmisartan. In the elderly, standard dosing for amlodipine should be followed, but caution should be taken when increasing the dosage.

Child dose

The safety and efficacy of this medication have not been established in patients under 18 years of age, and it is not recommended for this group.

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, so women who are pregnant or may become pregnant should not take it. This medication is contraindicated in patients with certain diseases. For example, patients allergic to this medication's ingredients, those with severe liver disease, critical hypotension, or specific heart-related diseases should not take it. Patients with liver or kidney function issues should use this medication with caution, and dosage adjustments may be necessary, especially in cases of poor liver function. Patients with gastrointestinal diseases, renovascular hypertension, or heart failure should consult a physician before taking this medication and have regular monitoring of blood pressure and kidney function. Side effects such as dizziness, edema, and palpitations may occur; any unusual symptoms should be reported to a healthcare provider immediately. As this medication lowers blood pressure, if symptoms of hypotension occur, the patient should be laid down and may require fluid therapy. Due to the risk of hyperkalemia, potassium levels need to be monitored, and caution is advised when combined with potassium supplements or medications containing potassium. This medication may interact with other medications, so it is essential to inform healthcare providers of all medications being taken, especially when combined with digoxin, lithium, warfarin, or non-steroidal anti-inflammatory drugs. It is advisable for breastfeeding women not to take this medication, and if discovered during pregnancy, it should be stopped immediately, and alternative treatment should be considered. The safety and efficacy of this medication have not been adequately established in children and adolescents under 18, so it is not recommended for this age group. Elderly patients may be more sensitive to this medication, and dosages should be adjusted accordingly. Overdosing may result in hypotension, dizziness, and cardiac anomalies, necessitating immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, shortness of breath or breathing difficulties, asthma attacks, breathing issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infections
  • pharyngitis
  • sinusitis
  • urinary tract infections
  • cystitis
  • anemia
  • thrombocytopenia
  • eosinophilia
Show 27 more
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • sensory disturbances
  • taste disturbances
  • tremors
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dry mouth
  • abdominal pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a light-protective container. Additionally, it should be kept at room temperature between 1°C and 30°C. This helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

White or off-white rectangular tablet

Package unit

30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.