Medication info

Cotalec Tablets 160/12.5 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verifiedHydrochlorothiazide›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
Dark red oval film-coated tablet
Packaging
98 tablets (14 tablets/PTP packaging X 7)
Approval status
Approval withdrawn

MFDS item code 200511377 · Notified 2005.10.24

This product's status changed to Approval withdrawn on 2023.06.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who uses it
Adults
Adult dosage
Adults should take 1 tablet daily of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg with a small amount of water, regardless of meals. If prescribed Valsartan 160 mg/Hydrochlorothiazide 12.5 mg for blood pressure lowering, the respective dosage should be taken. No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance above 30 mL/min). Liver

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used to manage the blood pressure of patients with essential hypertension, which is difficult to control with monotherapy. It effectively lowers blood pressure, reducing the burden on the heart and blood vessels, and helps decrease the risk of complications. Therefore, it plays an important role in the treatment of hypertension and improves the health of patients.

Dosage and Administration

Adult dosage

Adults should take 1 tablet daily of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg with a small amount of water, regardless of meals. If prescribed Valsartan 160 mg/Hydrochlorothiazide 12.5 mg for blood pressure lowering, the respective dosage should be taken. No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance above 30 mL/min). Liver

Precautions

This medication can cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used if you are allergic to this medication or any of its ingredients, or if you have certain liver or kidney diseases. Patients with electrolyte imbalances, poor kidney function, the elderly, and those with heart diseases should use this medication with caution and regularly monitor blood pressure, kidney function, and electrolyte status. This medication may cause dizziness or drowsiness; therefore, caution is needed when driving or operating machinery. Potassium supplements or potassium-containing medications should not be taken without consulting a doctor, as electrolyte imbalances such as hypokalemia or hyponatremia may occur, necessitating regular blood tests. Overdosing on this medication may lead to symptoms such as hypotension, muscle cramps, arrhythmias, and drowsiness. If symptoms occur, you should immediately inform medical personnel. The component hydrochlorothiazide can increase sensitivity to sunlight, raising the risk of skin rashes or skin cancer, so sun exposure should be avoided, and any skin changes should be discussed with a doctor. This medication may interact with various other medications, so if you are taking other medications, you must inform your healthcare provider, especially when used in combination with lithium, NSAIDs, or potassium-sparing diuretics. It is advisable for women who are pregnant or planning to become pregnant, as well as nursing mothers, to avoid this medication unless adequately consulted with a physician. The safety of this medication in children has not been established, so it is generally stated that it should not be used in children. This medication should be stored in its original container, kept out of reach of children, and protected from moisture.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and very severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • rhinitis
  • fatigue
  • back pain
  • cough
  • upper respiratory tract infection
  • diarrhea
  • arthralgia
  • abdominal pain
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  • epigastric pain
  • blurred vision
  • visual disturbances
  • anxiety
  • arthritis
  • bronchitis
  • acute bronchitis
  • chest pain
  • orthostatic dizziness
  • dry mouth
  • dyspepsia
  • shortness of breath
  • erectile dysfunction
  • enteritis
  • hyperhidrosis
  • sensory loss
  • insomnia
  • hypokalemia
  • hypotension
  • influenza
  • muscle cramps
  • myositis
  • nausea
  • congestion
  • nasal hemorrhage
  • sore throat

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it is best to store it at a cool temperature below 30 degrees Celsius.

Appearance and packaging

Appearance

Dark red oval film-coated tablet

Package unit

98 tablets (14 tablets/PTP packaging X 7)

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.