Filitra Professional (Vardenafil)

Filitra Professional is a prescription tablet for erectile dysfunction in men.

Each tablet contains 20 mg of the active ingredient vardenafil.

Vardenafil belongs to the PDE-5 inhibitor drug class.

The same molecule is sold as Levitra by Bayer.

A 10 mg dissolving version is sold as Staxyn.

Filitra Professional is made by Fortune Healthcare Pvt. Ltd., India.

The tablet dissolves in the mouth instead of being swallowed whole.

It helps men achieve and maintain a firm erection.

Filitra 20 mg works only when you are sexually aroused.

It does not increase sexual desire or libido.

It does not protect against HIV or other sexually transmitted infections.

It is not a contraceptive and does not prevent pregnancy.

It is not approved to treat premature ejaculation.

No regulator has approved a 20 mg dissolving vardenafil tablet.

Use this product only under direct medical supervision.

Sexual stimulation releases nitric oxide from nerves in the penis.

Nitric oxide activates an enzyme called guanylate cyclase.

That enzyme raises levels of cyclic GMP (cGMP) in muscle cells.

Cyclic GMP relaxes the smooth muscle of the corpus cavernosum.

Blood flows in more easily and an erection forms.

PDE-5 is the main enzyme that breaks down cGMP in penile tissue.

Vardenafil selectively blocks the PDE-5 enzyme.

Blocking PDE-5 keeps cGMP levels higher for longer.

Vardenafil is over 15 times more selective for PDE-5 than PDE-6.

Without sexual stimulation, vardenafil produces no erection.

Peak blood levels occur 30 minutes to 2 hours after a dose.

Filitra 40 mg time to peak level is about 60 minutes.

Absolute bioavailability of swallowed vardenafil is about 15%.

The elimination half-life is roughly 4 to 5 hours.

The liver enzyme CYP3A4 is the main metabolism pathway.

Excretion is mainly through faeces, with a small amount in urine.

A dissolving tablet is absorbed partly through the mouth lining.

The approved 10 mg dissolving tablet gives higher blood levels than 10 mg swallowed.

Approved labelling still advises taking it about 60 minutes before sex.

Faster onset from the dissolving form is not proven in the approved label.

Every dose shown is from the approved vardenafil prescribing information.

Several patient groups have limits of 5 mg or 2.5 mg.

A patient in any of those groups should not take 20 mg.

The dissolving form has no approved dose above 10 mg.

Your doctor decides whether this product suits you at all.

Never raise your own dose because a lower dose felt weak.

This medicine is taken as needed, so missed doses rarely apply.

Never take two tablets to make up for one.

Never exceed one tablet in 24 hours.

Do not combine it with any other vardenafil product.

Overdose has caused reversible back pain, muscle pain and vision changes.

Contact a doctor or poison centre immediately after a suspected overdose.

Dialysis does not speed up removal of vardenafil.

Confirm with your doctor that this product is right for you.

Check the blister before use and reject torn or empty blisters.

Remove one tablet from the blister immediately before use.

Dry your hands before handling the tablet.

Place the tablet under or on the tongue and let it dissolve.

Do not take it with water and do not chew or crush it.

Take it about 60 minutes before sexual activity.

You may take it with or without food.

Wait for sexual stimulation, as the tablet alone will not work.

Allow at least 24 hours between two doses.

Do not combine it with any other ED medicine or treatment.

A high-fat meal can cut peak blood levels by up to half.

The effect typically lasts about four to five hours.

Rise slowly from sitting or lying for the first few hours.

Avoid driving until you know how the dose affects you.

Stop sexual activity and seek help if chest pain occurs.

Tell your doctor if erections remain poor after several attempts.

Take any nitrate medicine, regularly or occasionally.

Use nitroglycerin, isosorbide mononitrate or isosorbide dinitrate.

Use recreational nitrites known as “poppers” (amyl or butyl nitrite).

Take any other nitric oxide donor medicine.

Take riociguat or another soluble guanylate cyclase stimulator.

Are allergic to vardenafil or any tablet ingredient.

Have congenital long QT syndrome or a family history of it.

Take class IA heart-rhythm drugs such as quinidine or procainamide.

Take class III heart-rhythm drugs such as amiodarone or sotalol.

Have severe liver disease (Child-Pugh class C).

Are receiving renal dialysis.

Had a heart attack, stroke or life-threatening arrhythmia within six months.

Have unstable angina or severe heart failure.

Have a resting systolic blood pressure below 90 mmHg.

Have uncontrolled high blood pressure above 170/110 mmHg.

Were told that sexual activity is unsafe for your heart.

Are a woman, a child or a teenager below 18 years.

Any heart disease, chest pain, valve problem or irregular heartbeat.

Any personal or family history of long QT syndrome.

High blood pressure or low blood pressure.

Kidney disease or any need for dialysis.

Liver disease, hepatitis or cirrhosis.

Diabetes, especially if it is poorly controlled.

A previous seizure of any cause.

Stomach ulcers or any bleeding disorder.

Sickle cell anaemia, leukaemia or multiple myeloma.

Any penile deformity, such as Peyronie’s disease or curvature.

A previous erection lasting more than four hours.

Retinitis pigmentosa or any inherited eye disease.

Sudden vision loss or hearing loss in the past.

Phenylketonuria, since dissolving tablets may contain aspartame.

Benign prostatic hyperplasia or ongoing alpha-blocker treatment.

All prescription, herbal and over-the-counter products you use.

Vardenafil can be taken with or without food.

A high-fat meal reduced peak levels by 18% to 50% in studies.

A lighter meal is preferable before taking a dose.

Avoid grapefruit and grapefruit juice while using this medicine.

Grapefruit blocks CYP3A4 and can raise vardenafil blood levels.

Keep alcohol moderate, as both lower blood pressure.

Heavy drinking also worsens erectile performance in its own right.

Avoid pomelo juice and Seville orange products as a precaution.

Do not drink water to wash down a dissolving tablet.

Has a doctor prescribed this form and strength for you?

Have you confirmed you take no nitrate medicine of any type?

Have you confirmed you do not take riociguat?

Have you confirmed you take no class IA or III heart-rhythm drug?

Have you told your doctor about any long QT syndrome in the family?

Has your doctor confirmed your heart can handle sexual activity?

Have you listed all your medicines for the doctor or pharmacist?

Have you disclosed any liver disease or need for dialysis?

Have you checked you took no other ED tablet in 24 hours?

Have you checked the expiry date and the blister condition?

Do you know the emergency warning signs in Section 8?

Trial rates come from 5 mg, 10 mg and 20 mg swallowed tablets.

Headache, flushing, indigestion, nausea and nose symptoms rose with dose.

No trial has measured rates for a 20 mg dissolving tablet.

This list is not complete; report any unusual symptom.

Report suspected reactions to your national pharmacovigilance programme.

Nitrates: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate.

Nitrate sprays, patches, ointments and sublingual tablets.

Recreational nitrites, commonly sold as “poppers”.

Riociguat and other guanylate cyclase stimulators.

Class IA heart-rhythm drugs: quinidine, procainamide.

Class III heart-rhythm drugs: amiodarone, sotalol.

Other PDE-5 inhibitors: sildenafil, tadalafil, avanafil.

Any other vardenafil product or other ED treatment.

Alpha-blockers: doxazosin, tamsulosin, alfuzosin, terazosin, silodosin.

Blood pressure medicines, including nifedipine and other antihypertensives.

Strong CYP3A4 inhibitors: ritonavir, indinavir, saquinavir, atazanavir.

Cobicistat, ketoconazole, itraconazole and clarithromycin.

Moderate CYP3A4 inhibitors such as erythromycin.

Any other medicine known to prolong the QT interval.

Grapefruit juice, which can raise vardenafil blood levels.

Alcohol, because both lower blood pressure.

Nitrates plus vardenafil can cause a dangerous fall in blood pressure.

Ritonavir raised vardenafil exposure 49-fold in one study.

Indinavir raised vardenafil exposure 16-fold in one study.

Ketoconazole 200 mg raised vardenafil exposure 10-fold.

Alpha-blockers plus vardenafil can cause fainting on standing.

QT-prolonging drugs add to the QT effect of vardenafil.

An erection lasting longer than four hours (priapism).

A painful erection of any duration.

Sudden loss of vision in one or both eyes.

Sudden decrease or loss of hearing, with or without ringing.

Chest pain, pressure or tightness during or after sex.

Pain spreading to the jaw, neck, shoulder or left arm.

Severe dizziness, fainting or collapse.

Irregular, racing or pounding heartbeat.

Shortness of breath at rest or with light effort.

A seizure or sudden confusion.

Swelling of the face, lips, tongue or throat.

Widespread rash, hives or difficulty breathing or swallowing.

Numbness or weakness on one side of the body.

Tell every treating doctor that you took vardenafil.

State the exact time, the dose and the dissolving tablet form.

Nitrates with vardenafil can drop blood pressure dangerously.

Priapism needs treatment within hours to protect penile tissue.

Vardenafil improved erectile function in four large controlled trials.

It worked in men aged under 45 through to over 65.

It improved erections in men with diabetes in a dedicated trial.

It also helped men with ED after radical prostatectomy.

It is highly selective for PDE-5 over other enzymes.

It can be taken with or without food.

Generic pricing makes treatment more affordable.

A dissolving tablet suits men who dislike swallowing tablets.

A dissolving tablet can be taken without a drink to hand.

Blister packaging protects each tablet from moisture.

The 20 mg dissolving strength has no approval anywhere.

The approved dissolving strength is 10 mg and nothing higher.

Faster onset from the dissolving form is not proven.

Approved labelling still advises dosing 60 minutes before sex.

Vardenafil is not approved to treat premature ejaculation.

Its effect lasts about 4 to 5 hours, far less than tadalafil.

Vardenafil carries QT warnings that tadalafil does not.

It does not cure erectile dysfunction or raise sexual desire.

ED can signal heart disease or diabetes, so get assessed.

A valid prescription and medical review remain essential.

Store at controlled room temperature, ideally 20°C to 25°C.

Brief excursions between 15°C and 30°C are acceptable.

Keep every tablet sealed in its original blister until use.

Dissolving tablets absorb moisture quickly once exposed.

Do not store loose tablets in a pill box or pouch.

Protect from direct sunlight, heat and humidity.

Do not store in the bathroom or near a sink.

Do not refrigerate or freeze the tablets.

Examine the blister and reject any that is torn or empty.

Keep the pack out of sight and reach of children.

Keep away from pets at all times.

Check the expiry date printed on the blister and carton.

Do not use tablets that are chipped, discoloured or damp.

Do not flush unused tablets down the toilet.

Return expired medicine to a pharmacy take-back scheme.