Varnova 5 mg 30 tablets

Varnova 5 mg 30 tablets

Composition:
Active ingredient:
Vardenafil 5 mg (as hydrochloride).
Excipients (tablet core):
Crospovidone, Magnesium stearate, Microcrystalline cellulose, Silica colloidal anhydrous.
Description:
Varnova 5 mg are orange round film-coated tablets.
It is a phosphodiesterase type 5 inhibitor used to treat erectile dysfunction in adult men.
Sexual stimulation is required for the medicine to be effective.
Indications for Use:
- Treatment of erectile dysfunction in adult men.
- Erectile dysfunction is defined as the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance.
- Varnova works only in the presence of sexual stimulation.
Dosage and Method of Administration:
Adult men:
- Recommended dose: 10 mg, taken as needed 25-60 minutes before sexual activity.
- Dose may be increased to 20 mg or decreased to 5 mg based on tolerability.
- Maximum dose: 20 mg.
- Maximum frequency: once daily.
- May be taken with or without food; high-fat food may delay onset.
Elderly men (>65 years):
- No adjustment required.
- Dose increase to 20 mg should be done cautiously.
Hepatic impairment:
- Mild-moderate (Child-Pugh A-B): starting dose 5 mg.
- Maximum dose in moderate impairment: 10 mg.
- Severe impairment (Child-Pugh C): contraindicated.
Renal impairment:
- Mild-moderate: no adjustment.
- Severe (<30 ml/min): start with 5 mg, may increase to 10-20 mg if tolerated.
Concomitant CYP3A4 inhibitors:
- When used with erythromycin, clarithromycin - do not exceed 5 mg.
Method of administration:
- Oral use.
Contraindications:
- Hypersensitivity to vardenafil or excipients.
- Use with nitrates or nitric oxide donors.
- History of NAION.
- Conditions where sexual activity is inadvisable.
- Severe hepatic impairment (Child-Pugh C).
- End-stage renal disease on dialysis.
- Hypotension (<90/50 mmHg).
- Recent stroke or MI (<6 months).
- Unstable angina.
- Retinitis pigmentosa.
- 75 years with ketoconazole/itraconazole (oral).
- HIV protease inhibitors (ritonavir, indinavir).
- Use with guanylate cyclase stimulators (riociguat).
Precautions:
Cardiovascular:
- Assess cardiovascular risk before prescribing.
- Causes mild and transient blood pressure decrease.
- Serious cardiovascular events have been reported.
Anatomical penile abnormalities:
- Use with caution (Peyronie’s disease, fibrosis).
Combined PDE5 inhibitors:
- Not recommended.
Elderly:
- Lower tolerability of 20 mg dose.
Alpha-blockers:
- Risk of symptomatic hypotension.
- Initiate with 5 mg if stable on alpha-blocker.
- With tamsulosin/alfuzosin: administration at any time is acceptable.
- For others: consider dosing separation.
CYP3A4 inhibitors:
- Avoid ketoconazole and itraconazole (oral).
- Grapefruit juice increases exposure.
QT prolongation:
- Dose-dependent QTc prolongation (3-10 msec).
- Avoid in patients with predisposition.
Vision:
- Cases of NAION reported. 
Stop use if sudden vision loss occurs.
Bleeding:
- Use with caution in active peptic ulcer or bleeding disorders.
Side Effects:
Very common:
- Headache.
Common:
- Dizziness
- Flushing
- Nasal congestion
- Dyspepsia
- GERD
- Abdominal pain
- Diarrhoea
- Vomiting
- Nausea
- Dry mouth
- Increased transaminases
- Back pain
- Muscle cramps
- Malaise
- Tinnitus
- Dyspnoea
- Palpitations
- Tachycardia
- Sinus congestion
- Eye redness
- Visual disturbances
- Colour distortion
- Eye pain
- Photophobia.
Uncommon:
- Allergic reactions, oedema, angioedema
- Sleep disorder
- Somnolence
- Paraesthesia
- Vertigo
- Gastritis
- Increased creatinine.
Rare:
- Severe allergic reactions
- Anxiety
- Syncope
- Seizures
- Amnesia
- TIA
- Increased intraocular pressure
- Hypotension, hypertension
- Epistaxis
- Increased GGT
- Photosensitivity
- Priapism
- Chest pain.
Pregnancy - Lactation:
Not intended for women.
Storage Conditions:
No special storage conditions required.
Keep out of reach of children.
Packaging:
A carton box containing a plastic jar of 20 tablets.