Tadalafil TADALAFIL 5 MG 28'S Approval No. 09 L 0919/22 Expiry Date 13-9-2025

The following is the general drug instructions for tadalafil (trade name: Tadalafil, etc.) for reference. The actual drug instructions may vary depending on the manufacturer and regional regulations. Please refer to the instructions inside the drug packaging.

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Drug instructions

Drug name <br>Generic name: Tadalafil Trade name: Tadalafil (Cialis)
English name: Tadalafil

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Pharmacological action and mechanism

Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor that increases the level of cyclic guanosine monophosphate (cGMP), relaxes smooth muscles, and promotes blood flow by inhibiting the activity of PDE-5 in the corpus cavernosum, pulmonary artery smooth muscle, and prostate.

• For erectile dysfunction (ED) : Enhances blood flow during sexual stimulation.
• For pulmonary arterial hypertension (PAH) : Reduce pulmonary artery pressure and resistance.
• For prostate hyperplasia (BPH) : Relieve urinary tract symptoms.

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Indications

1. Treating erectile dysfunction (ED).
2. Treatment of benign prostatic hyperplasia (BPH) with or without erectile dysfunction.
3. Treating pulmonary arterial hypertension (PAH).

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Dosage

1. Erectile Dysfunction (ED) :
   • Usual dose: 10 mg, taken 30 minutes before sexual activity as needed, adjusted to 20 mg or 5 mg depending on efficacy.
   • Once daily dose: 2.5 mg, taken at the same time each day, may be increased to 5 mg.
2. Benign prostatic hyperplasia (BPH) :
   • Recommended dose: 5 mg once daily.
3. Pulmonary Arterial Hypertension (PAH) :
   • Recommended dose: 40 mg (2 tablets of 20 mg), once daily.
4. Dosage : Orally, take with water, with or without food.

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Contraindications

• Allergy to tadalafil or any of the ingredients in this medicine.
• Patients currently taking any form of nitrate medication (e.g. nitroglycerin).
• Patients with severe cardiovascular disease, hypotension (<90/50 mmHg), recent stroke or myocardial infarction.

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Precautions

1. Cardiovascular Risk : Patients undergoing treatment for erectile dysfunction should be assessed for cardiovascular health status.
2. Visual impairment : Cases of sudden loss of vision have been reported; discontinue medication and seek medical attention.
3. Hearing loss : Sudden hearing loss may occur, accompanied by tinnitus or vertigo.
4. Hypotension : May cause a decrease in blood pressure, especially when used in combination with antihypertensive drugs.
5. Hepatic and renal impairment : Dosage adjustment is required for patients with moderate to severe hepatic or renal impairment.
6. Drug Abuse : Tadalafil is not intended for use in healthy men without erectile dysfunction.

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Adverse Reactions

1. common
   • Headache
   • indigestion
   • stomach ache
   • Facial flushing
   • Back pain or muscle pain
2. Rare but serious
   • Allergic reactions (such as rash, itching)
   • Irregular heartbeat or myocardial infarction
   • Priapism (seek medical attention urgently if an erection lasts for more than 4 hours)

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Drug interactions

1. Concomitant use with nitrates may result in severe hypotension.
2. Caution is advised when used in combination with other PDE-5 inhibitors or antihypertensive drugs.
3. Co-administration with CYP3A4 inhibitors (such as ketoconazole) may increase the plasma concentration of tadalafil.

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Overdose

• Symptoms: May cause serious side effects such as low blood pressure or heart arrhythmia.
• Treatment: Symptomatic treatment, no specific antidote.

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Storage conditions

• Store in a dry place, not exceeding 30°C.
• Keep out of direct sunlight and reach of children.

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Packing Specifications

Strength: 5 mg.

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Manufacturer

Laos ASEAN Pharmaceutical

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Approval No.

09 L 0919/22.

Note : This instruction manual is for reference only. Patients should read the actual instructions of the drug carefully and use it according to the doctor's advice.