Medication info
EUROPA Sustained-Release Tablet 0.4 mg (Tamsulosin Hydrochloride)

EUROPA Sustained-Release Tablet 0.4 mg (Tamsulosin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Tamsulosin Hydrochloride›0.4mg / 1 tablet
Manufacturer / importer
Donggoo Bio Pharmaceutical Co., Ltd.
Appearance
White round sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202002736 · Approved 2020.04.17 · Insurance code 657308260

Summary

Main use
Relief of voiding symptoms associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Adults: Administer 0.4 mg of tamsulosin hydrochloride orally once daily after a meal. Swallow this medicine whole; do not crush or chew it.

Ingredients

Manufacturer
Donggoo Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of voiding symptoms associated with benign prostatic hyperplasia

  • Urinary disorders due to benign prostatic hyperplasia
View approved original text

This medication is used to improve urinary disorders caused by benign prostatic hyperplasia. When the prostate enlarges, symptoms such as difficulty urinating or frequent urination may occur; this medication alleviates such urinary issues, making the patient's life more comfortable.

How to take

Adult dose

Adults: Administer 0.4 mg of tamsulosin hydrochloride orally once daily after a meal. Swallow this medicine whole; do not crush or chew it.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to this medication or its ingredients, patients with orthostatic hypotension due to sudden drops in blood pressure, patients with severe liver dysfunction, pregnant women or women who may become pregnant, and patients with lactose intolerance or certain genetic disorders of lactose metabolism. Additionally, patients with severely impaired kidney function, elderly patients, and patients taking certain antihypertensives, PDE5 inhibitors, or CYP3A4 inhibitors should exercise caution when using this medication. In particular, patients currently taking alpha-1 blockers or those with a history of urinary-related syncope should generally avoid this medication, or use it cautiously only if necessary. Side effects such as dizziness, headaches, dyspepsia, diarrhea, abdominal discomfort, and decreased semen volume may occur when taking this medication. Rarely, serious side effects such as hypotension or priapism may also develop, so the patient should consult a doctor immediately if symptoms occur. During treatment, blood pressure may drop suddenly, so movement should be slow when standing up, and caution is advised during potentially dangerous activities such as driving or operating machinery. Additionally, this medication alleviates symptoms but does not address the underlying cause of the condition; if symptoms do not improve, alternative treatment options should be considered. This medication may interact with certain drugs, so if the patient is currently taking any other medication, they must inform their doctor or pharmacist and seek advice. In particular, caution is necessary when used in conjunction with antihypertensives, PDE5 inhibitors, or CYP3A4 inhibitors. Women who are pregnant or breastfeeding, as well as children under 18 years of age, should not use this medication due to uncertainty regarding its safety and effectiveness. In elderly patients, especially those with severely impaired kidney function, the use of this medication is not recommended. Finally, this medication is a sustained-release preparation and should be swallowed whole, not chewed or crushed, to minimize the risk of esophageal injury. It should be stored out of the reach of children and should not be transferred to other containers.

Side effects

  • Abdominal discomfort
  • upper abdominal pain
  • dizziness
  • diarrhea
  • indigestion
  • herpes zoster
  • decreased semen volume
  • headache
  • vertigo
  • eye pain
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  • thirst
  • ejaculation disorder
  • historical ejaculation
  • congestion
  • itching
  • syncope
  • loss of consciousness
  • imbalance
  • orthostatic dizziness
  • drowsiness
  • nervousness
  • insomnia
  • decreased libido
  • restlessness
  • numbness
  • tachycardia
  • low blood pressure
  • orthostatic hypotension
  • palpitations
  • arrhythmia
  • rash
  • urticaria
  • nausea
  • vomiting
  • upper abdominal discomfort
  • heavy feeling in the stomach
  • stomach pain
  • loss of appetite
  • constipation
  • dental problems
  • swallowing difficulties
  • jaundice
  • increased AST
  • increased ALT
  • burning sensation in the pharynx
  • generalized fatigue
  • nasal congestion
  • nosebleeds
  • edema
  • urinary incontinence
  • taste disturbance
  • gynecomastia
  • priapism
  • infection
  • lethargy
  • back pain
  • chest pain
  • rhinitis
  • pharyngitis
  • increased cough
  • sinusitis
  • abnormal ejaculation
  • amblyopia
  • intraoperative iris hypotension syndrome
  • blurred vision
  • visual impairment
  • erythema multiforme
  • exfoliative dermatitis
  • shortness of breath
  • ejaculation failure
  • flushing
  • tinnitus
  • tongue skin disease
  • lip skin disease
  • facial skin disease
  • angioedema
  • skin desquamation
  • rarely priapism
  • kidney stones
  • hematuria
  • dysuria
  • frequent urination
  • neurogenic bladder
  • urinary stones
  • abdominal pain
  • colitis
  • acute abdominal pain
  • diverticulitis
  • blood in stool
  • abdominal distension
  • erectile dysfunction
  • impotence
  • inguinal hernia
  • prostatitis
  • periorbital edema
  • low back pain
  • generalized weakness
  • foreign body sensation
  • peripheral edema
  • tremors
  • myelopathy
  • Parkinson's disease
  • fracture
  • shoulder impingement syndrome
  • cholangitis
  • acute alcohol intoxication
  • hyperlipidemia
  • male reproductive system abscess
  • prostate cancer
  • angina
  • hypertension
  • mental disorders
  • transient ischemic attack
  • cough

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 air or moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round sustained-release film-coated tablet

Package unit

30 tablets/bottle, 100 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.