📌 COMPOSITION

Each F/C tablet contains: Vardenafil Hydrochloride Trihydrate equivalent to Vardenafil 10 mg.

📌 DESCRIPTION

Sala (Vardenafil) is a drug for erectile dysfunction. It acts by inhibiting phosphodiesterase type‑5. It is rapidly absorbed, and maximum plasma concentrations are reached within 30-120 minutes. Vardenafil is highly bound to plasma proteins (approximately 95%). The half‑life of Vardenafil is 4-5 hours. It is excreted as metabolites mainly in the faeces and to a lesser extent in the urine.

📌 INDICATIONS

Sala is used in the treatment of erectile dysfunction.

📌 DOSAGE AND ADMINISTRATION

Sala can be taken with or without food, but preferably not after heavy meals because the rate of absorption is reduced.

• Adults: The usual dose of Sala is 10 mg once daily, and the maximum dose is 20 mg once daily, taken about 25-60 minutes before sexual activity.
• Elderly patients (≥ 65 years old): Dose adjustment is not required. However, an increase to a maximum 20 mg dose should be carefully considered.
• Patients with mild to moderate hepatic impairment: An initial dose is 5 mg once daily, which may be increased if necessary to a maximum dose of 10 mg once daily.
• Patients with renal impairment: Dose adjustment is not required in patients with mild to moderate renal impairment, but in case of severe renal impairment (creatinine clearance < 30 ml/min), a starting dose of 5 mg should be considered, and according to tolerability, the dose may be increased to 10 mg and 20 mg.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to Vardenafil.
• Patients using nitrates, amyl nitrite, ritonavir or indinavir.
• Patients more than 75 years of age who are using ketoconazole or itraconazole.
• Patients with severe heart or liver problems, low blood pressure, a history of degenerative eye diseases, or patients undergoing kidney dialysis.
• Children and adolescents under 18 years.

Precautions

• Patients suffering from cardiac arrhythmia or congenital cardiac disease.
• Patients with a physical condition affecting the shape of the penis or illness that can cause persistent erection (priapism).
• Patients with stomach ulcer, bleeding disorder, using any other treatment for erection difficulties, and in case of sudden decrease or loss of vision.

Effects on the capacity to drive vehicles or use machines

Vardenafil may cause dizziness or affect vision. If the patient experiences any of these symptoms, he should not drive vehicles or use machines.

Use in Pregnancy and Lactation

There are no adequate studies on the use of Vardenafil during pregnancy and lactation. It is not recommended for use by women.

📌 DRUG INTERACTIONS

• Using nitrates, medicines for angina or amyl nitrite with Vardenafil could seriously affect blood pressure.
• Problems may appear if Vardenafil is used with quinidine, procainamide, amiodarone, sotalol, ritonavir, indinavir, ketoconazole, itraconazole, erythromycin and alpha‑blocker drugs.
• Consumption of alcohol and grapefruit juice should be avoided during use of Vardenafil.

📌 ADVERSE EFFECTS

Most of Vardenafil's side effects are mild or moderate.

• Very common side effect: Headache.
• Common side effects: Flushing, indigestion, dizziness and runny nose.
• Uncommon side effects: Sleep disorder, paraesthesia, visual disturbance, tinnitus, vertigo, tachycardia, sinus congestion, gastritis, abdominal pain, nausea, vomiting, diarrhoea, dry mouth, increase in liver enzymes, muscle pain, back pain, rash, prolonged erection and feeling unwell.

📌 OVERDOSAGE

In the case of Vardenafil overdose, severe back pain has been reported. The treatment of overdose involves appropriate supportive therapy. Renal dialysis is not expected to accelerate the clearance of the drug.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Sala tablets: Pack of 4 tablets and hospital packs of different sizes.