Medication info

SYNEX Tablet 10/160 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
삼아제약(주)
Appearance
Bright yellow oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Expired

MFDS item code 201308497 · Approved 2013.07.30

This product's status changed to Expired on 2023.07.30. 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 · Children
Adult dosage
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, no dose adjustment is necessary. However, this medication should not be administered to patients with severe renal impairment or those on dialysis. For patients with mild to moderate liver impairment, the daily dose of valsartan should not exceed 80 mg.
Children's dosage
Safety and efficacy for pediatric patients under the age of 18 have not been established, and the administration of this medication is not recommended.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication may be helpful for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or valsartan. It reliably lowers blood pressure and contributes to the prevention of cardiovascular complications. Therefore, it is appropriately used for patients with hypertension who have difficulty managing their blood pressure.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, no dose adjustment is necessary. However, this medication should not be administered to patients with severe renal impairment or those on dialysis. For patients with mild to moderate liver impairment, the daily dose of valsartan should not exceed 80 mg.

Children's dosage

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

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 stopped immediately upon confirmation of pregnancy. Patients with allergies to this medication's active ingredients or similar components, pregnant or breastfeeding women, or patients with severe kidney or liver disease should not take this medication. Patients with low sodium or fluid must correct their condition before taking this medication, and blood pressure and condition should be closely monitored during treatment. Patients with high potassium levels or those taking potassium supplements should frequently check potassium concentrations, and patients with poor kidney function should also be cautious. Patients with heart failure or those recovering from myocardial infarction should closely monitor kidney function and blood pressure while on this medication, and caution is also needed for patients with acute myocardial infarction. If symptoms of angioedema occur, the medication should be stopped immediately and not readministered, and it should not be given to patients with a history of angioedema. Caution is needed while driving or operating machinery, as dizziness or fatigue may occur. Overdose can lead to hypotension, dizziness, and in severe cases, shock, necessitating immediate consultation with medical personnel. Additionally, this medication may interact with other antihypertensives, potassium-sparing agents, diuretics, and NSAIDs, so it is crucial to inform healthcare providers of any concurrent medications. Safety and efficacy for pediatric patients under 18 years are not adequately established, and the medication is not recommended for them, but can be administered to elderly patients at standard doses. Patients with poor liver or kidney function require dosage adjustments and regular monitoring. Breastfeeding women are advised to avoid taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), severe fatigue, sudden and extremely severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbances
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
Show 28 more
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial edema
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • rhinorrhea

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a room temperature between 1 and 30 degrees Celsius. This will help retain the medication's effectiveness over time.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)

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.