Medication info
Difins Tablet 40/10 mg (Telmisartan, Amlodipine Besylate)

Difins Tablet 40/10 mg (Telmisartan, Amlodipine Besylate)

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
A white and light gray double convex oval tablet.
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201702242 · Approved 2017.04.28 · Insurance code 628900830

Summary

Main use
Improvement of blood pressure control in essential hypertension with the combination of amlodipine or telmisartan.
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Patients with renal impairment should start with a lower dose in severe cases and gradually increase it. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan. Elderly patients should start with a lower dose and gradually increase it.
Child dose
Safety and efficacy have not been established for pediatric patients under the age of 18, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of blood pressure control in essential hypertension with the combination of amlodipine or telmisartan.

  • Essential hypertension
View approved original text

This medication is used when blood pressure is not adequately controlled by a single drug, either amlodipine or telmisartan, in patients with essential hypertension. This medication helps effectively lower and control blood pressure by using both components together. When blood pressure is well managed, it can reduce the risk of cardiovascular complications such as heart attack and stroke. Therefore, this medication is very useful in improving blood pressure control.

How to take

Adult dose

The recommended dose for this medication is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Patients with renal impairment should start with a lower dose in severe cases and gradually increase it. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan. Elderly patients should start with a lower dose and gradually increase it.

Child dose

Safety and efficacy have not been established for pediatric patients under the age of 18, so the administration of this medication is not recommended.

Precautions

This medication can cause serious risks to the fetus and newborn, especially during the second and third trimesters, so it should not be taken by women who are pregnant or may become pregnant. Patients who are allergic to this medication's active ingredients or similar components, those with severely impaired liver function, patients with severe hypotension, and individuals with severe heart disease should not take this medication. Individuals with mildly impaired liver function, gastrointestinal diseases, kidney issues, the elderly, etc., should be particularly careful when taking this medication and should consult with a physician to adjust the dosage. Dizziness and swelling of the limbs may commonly occur when taking this medication, and serious side effects can occur rarely. If any unusual symptoms appear, inform a doctor immediately. It is advisable not to use this medication during pregnancy, and if pregnancy is confirmed, it should be discontinued immediately and switched to a safer treatment. Lactating women are advised not to take this medication, and caution should be exercised as it may affect the baby if taken. The safety and efficacy of this medication in children have not been sufficiently established, and its use is not recommended. Elderly patients may respond more sensitively to this medication, so dosing should be adjusted as per the physician's instructions. In case of overdose, severe hypotension or heart problems can occur; therefore, it is crucial to follow the prescribed dosage accurately and contact a medical institution immediately if an overdose occurs. When storing this medication, keep it in a secure place out of the reach of children, maintain its original packaging, and avoid humidity and direct sunlight. Caution is needed during driving or operating machinery as dizziness or drowsiness may occur and may affect performance. If other medications are being taken, there may be interactions with this medication, so it is essential to inform a doctor or pharmacist and seek advice.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory problems accompanied by cough and fever, dyspnea, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning headache, seizures, altered consciousness.

Mild side effects

Dizziness, peripheral edema, upper respiratory infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, hypoglycemia, hyponatremia, depression, insomnia, mood changes, anxiety, drowsiness, migraine, sensory disturbances, visual impairment, vertigo, tinnitus, palpitations, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia, nausea, vomiting, dry mouth, itching, rash, hair loss, purpura, skin discoloration, etc.

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

Storage

This medication should be stored in a sealed container that can block light, and it is important to keep it at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness longer.

Appearance and packaging

Appearance

A white and light gray double convex oval tablet.

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.