Medication info

Cotalec Tablets 80/12.5 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 200511376 · 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This product's status changed to Approval withdrawn on 2023.06.26.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 in blood pressure control for essential hypertension
Who uses it
Adults
Adult dosage
The recommended adult dosage is 1 tablet of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg once daily, taken with a small amount of water regardless of meals. Valsartan 160 mg/Hydrochlorothiazide 12.5 mg is applied when prescribed for blood pressure reduction.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy.

Dosage and Administration

Adult dosage

The recommended adult dosage is 1 tablet of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg once daily, taken with a small amount of water regardless of meals. Valsartan 160 mg/Hydrochlorothiazide 12.5 mg is applied when prescribed for blood pressure reduction.

Precautions

This medication can cause serious 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. Patients with an allergy to this medication or its ingredients, pregnant women or women who may become pregnant, and patients with severe liver or kidney impairment should not take this medication. Patients with electrolyte imbalance, poor kidney or liver function, the elderly, and those with heart disease should use this medication with caution and require regular monitoring. Dizziness or drowsiness may occur while taking this medication, so caution is advised when driving or operating machinery. Potassium supplements or potassium-containing medications should not be taken without consulting a physician, and electrolyte levels should be checked regularly. This medication may make the skin sensitive to sunlight, so sun exposure should be avoided, and any skin abnormalities should be consulted with a doctor immediately. Overdose may cause symptoms such as hypotension, dizziness, and muscle cramps, so the dosage must be adhered to precisely. There may be interactions with other medications, so if other medications are being taken, it is essential to inform a doctor or pharmacist. It is advisable for breastfeeding women not to take this medication, and its safety has not been established in children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, severe skin reactions, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme drowsiness, liver abnormalities (jaundice), sudden...

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • fatigue
  • low back pain
  • cough
  • upper respiratory infection
  • diarrhea
  • arthralgia
  • abdominal pain
Show 26 more
  • epigastric pain
  • blurred vision
  • visual disturbances
  • anxiety
  • arthritis
  • bronchitis
  • acute bronchitis
  • chest pain
  • orthostatic dizziness
  • dry mouth
  • dyspepsia
  • dyspnea
  • erectile dysfunction
  • enteritis
  • hyperhidrosis
  • sensory loss
  • insomnia
  • hypokalemia
  • hypotension
  • influenza
  • muscle cramps
  • myalgia
  • nausea
  • congestion
  • nasal bleeding
  • throat pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to keep the storage temperature below 30 degrees Celsius. Doing so will help maintain the medication's effectiveness safely for a long time.

Appearance and packaging

Appearance

Bright orange 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

No questions yet.

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.