Tadora Force (Tadalafil/Depoxetine)

Tadora Force is a prescription tablet containing two different medicines.

It holds 20 mg of tadalafil plus dapoxetine.

Sources disagree on whether the dapoxetine dose is 30 or 60 mg.

Tadalafil is a PDE-5 inhibitor for erectile dysfunction.

Dapoxetine is a short-acting SSRI for premature ejaculation.

SSRI stands for selective serotonin reuptake inhibitor.

It is made by German Remedies Pvt. Ltd. in Ahmedabad, India.

The reference brands are Levitra and Priligy, sold separately.

No approved product combines these two drugs in one tablet.

Tadora 20 mg helps a man achieve and maintain an erection.

Dapoxetine helps delay ejaculation during sexual activity.

Neither drug increases sexual desire or libido.

Neither drug cures erectile dysfunction or premature ejaculation.

Dapoxetine is licensed in parts of Europe, India and elsewhere.

It has never been approved by the US Food and Drug Administration.

German Remedies also sells Tadora 20, a tadalafil-only tablet.

Use this product only under direct medical supervision.

Sexual stimulation releases nitric oxide from nerves in the penis.

Nitric oxide raises levels of a messenger called cyclic GMP.

Cyclic GMP relaxes the smooth muscle of the corpus cavernosum.

Tadalafil blocks PDE-5, the enzyme that breaks cyclic GMP down.

Blood flows in more easily and an erection forms.

Serotonin is a chemical messenger involved in the ejaculation reflex.

Nerve cells normally reabsorb serotonin after it is released.

Dapoxetine blocks the transporter that carries out that reabsorption.

Serotonin therefore stays longer in the gap between nerve cells.

The ejaculation reflex is suppressed and ejaculation is delayed.

Tadalafil reaches peak blood levels after about two hours.

Its half-life is roughly 4 to 5 hours.

Dapoxetine reaches peak blood levels after 1 to 2 hours.

Dapoxetine bioavailability is about 42% and varies widely between men.

Dapoxetine is designed for on-demand use, unlike other SSRIs.

Both drugs are broken down through liver enzyme pathways.

Tadalafil widens blood vessels throughout the body.

Dapoxetine can cause blood pressure to fall on standing.

Dapoxetine labelling warns about drugs with vasodilating properties.

Those drugs can reduce the body’s tolerance of standing upright.

Taken together, the risk of dizziness and fainting can increase.

No trial has studied this fixed combination for safety.

Approved guidance says never to begin dapoxetine at 60 mg.

A man taking this tablet begins at 60 mg whether suitable or not.

Adverse events are more frequent and more severe at 60 mg.

Nausea affected 11% at 30 mg and 22% at 60 mg in trials.

Dizziness affected 5.8% at 30 mg and 10.9% at 60 mg.

Yet the extra benefit over 30 mg was small in the same trials.

Average time to ejaculation was 3.2 minutes at 30 mg.

It was 3.5 minutes at 60 mg, against 1.9 minutes on placebo.

Anyone with an orthostatic reaction at 30 mg must not go to 60 mg.

A fixed tablet makes that safety step impossible to follow.

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

Never take two tablets to make up for one.

Never exceed one tablet in any 24 hours.

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

Confirm with your doctor that this combination suits you.

Ask whether the two drugs would be safer taken separately.

Separate tablets allow each dose to be adjusted properly.

Swallow one tablet whole with a full glass of water.

Do not crush, chew or split the tablet.

Drink plenty of water before taking the dose.

Take it 1 to 3 hours before sexual activity.

That timing suits the dapoxetine component.

You may take it with or without food.

Do not drink any alcohol on the day you take it.

Allow at least 24 hours before any further dose.

Never take it more than once in a day.

Stand up slowly for several hours after the dose.

Sit or lie down at once if you feel faint or light-headed.

Warning signs of fainting include dizziness, nausea and sweating.

They also include a pounding heartbeat and blurred vision.

Do not drive or operate machinery after taking this tablet.

Avoid situations where a fall would cause injury.

Take any nitrate medicine, regularly or occasionally.

Use recreational nitrites known as “poppers”.

Take riociguat or another guanylate cyclase stimulator.

Have lost vision before due to non-arteritic ischaemic optic neuropathy.

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

Have severe kidney or severe liver disease.

Take a monoamine oxidase inhibitor, or took one in the last 14 days.

Take thioridazine, or took it in the last 14 days.

Take any other SSRI or SNRI antidepressant.

Take a tricyclic antidepressant, lithium or tryptophan.

Take St John’s wort or any other serotonergic medicine.

Have a history of mania, bipolar disorder or severe depression.

Have significant heart disease of any kind.

Have heart failure, ischaemic heart disease or valve disease.

Have a heart conduction defect or a history of fainting.

Have moderate or severe liver impairment.

Take a potent CYP3A4 inhibitor such as ketoconazole or ritonavir.

Are allergic to either ingredient or any tablet excipient.

Were told that sexual activity is unsafe for your heart.

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

Are aged over 64, since dapoxetine was not studied above that age.

Any heart disease, chest pain, palpitations or fainting episodes.

Retinitis pigmentosa or any inherited eye disease.

High blood pressure or low blood pressure.

Any tendency to feel faint when standing up.

Liver disease, hepatitis or cirrhosis.

Kidney disease or any need for dialysis.

Any depression, anxiety, mania or bipolar disorder.

Any thoughts of self-harm, past or present.

Any epilepsy or history of seizures.

Any bleeding disorder or use of blood thinners.

Any history of alcohol or recreational drug use.

Any penile deformity or prolonged erection in the past.

Retinitis pigmentosa or any inherited eye disease.

Any antidepressant taken in the last two weeks.

Any migraine medicine, tramadol or linezolid.

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

Do not drink alcohol on any day you take this tablet.

Dapoxetine labelling advises avoiding alcohol entirely.

Alcohol worsens the neurocognitive effects of dapoxetine.

It also increases the risk of fainting and accidental injury.

Drink a full glass of water with the tablet.

Dehydration makes low blood pressure and fainting more likely.

Avoid grapefruit and grapefruit juice while using this medicine.

Grapefruit blocks CYP3A4 and can raise levels of both drugs.

Food has little effect on tadalafil absorption.

Food has only a minor effect on dapoxetine absorption.

Has a doctor diagnosed both conditions this product treats?

Has a doctor specifically prescribed this fixed combination?

Have you asked whether separate tablets would be safer?

Have you tried dapoxetine at 30 mg first, as guidance advises?

Have you ever felt faint or dizzy on standing up?

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

Have you confirmed you take no antidepressant of any kind?

Has it been at least 14 days since any MAOI or thioridazine?

Have you disclosed any heart condition or fainting history?

Have you disclosed any liver disease?

Have you disclosed any depression, mania or bipolar disorder?

Have you confirmed you will not drink alcohol today?

Adverse events were clearly dose related in dapoxetine trials.

Nausea doubled from 11.0% at 30 mg to 22.2% at 60 mg.

Dizziness rose from 5.8% at 30 mg to 10.9% at 60 mg.

Nausea and dizziness caused most treatment withdrawals.

Syncope and orthostatic hypotension were reported in trials.

Tadalafil adds its own flushing, congestion, headache and back pain.

This list is not complete; report any unusual symptom.

Report suspected reactions to your national pharmacovigilance programme.

Nitrates of any form, including sprays, patches and tablets.

Recreational nitrites, commonly sold as “poppers”.

Riociguat and other guanylate cyclase stimulators.

Monoamine oxidase inhibitors, or within 14 days of stopping one.

Thioridazine, or within 14 days of stopping it.

Any SSRI or SNRI antidepressant.

Tricyclic antidepressants, lithium and tryptophan.

St John’s wort and other serotonergic herbal products.

Potent CYP3A4 inhibitors: ketoconazole, itraconazole, ritonavir.

Clarithromycin, telithromycin and nefazodone.

Class IA or class III heart-rhythm medicines.

Other PDE-5 inhibitors or any other dapoxetine product.

Tramadol, linezolid and triptan migraine medicines.

Alcohol in any amount on the day of dosing.

Alpha-blockers, which further reduce orthostatic tolerance.

Blood pressure medicines of any class.

Diuretics, which add to fluid loss.

Moderate CYP3A4 inhibitors, which cap dapoxetine at 30 mg.

Potent CYP2D6 inhibitors, which raise dapoxetine exposure.

Anticoagulants and antiplatelet medicines.

Grapefruit juice, which raises levels of both drugs.

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

MAOIs plus dapoxetine can cause life-threatening serotonin syndrome.

A 14-day gap is needed in either direction with an MAOI.

Vasodilators plus dapoxetine reduce tolerance of standing upright.

Alcohol plus dapoxetine raises fainting and injury risk.

Moderate CYP3A4 inhibitors limit dapoxetine to 30 mg.

This tablet cannot meet that limit because the dose is fixed.

Fainting or loss of consciousness.

Collapse after standing up.

Chest pain, pressure or tightness.

A very fast, chaotic or irregular heartbeat.

An erection lasting longer than four hours.

Sudden loss of vision in one or both eyes.

Sudden decrease or loss of hearing.

Agitation with fever, muscle rigidity and a racing pulse.

A seizure or convulsion.

Swelling of the face, lips, tongue or throat.

Severe breathlessness or difficulty swallowing.

Sudden light-headedness or dizziness.

Nausea with cold sweating.

A pounding or unusually slow heartbeat.

Blurred or tunnelled vision.

Ringing in the ears or unusual weakness.

Lie down immediately with the legs raised if these occur.

Tell every treating doctor that two medicines were taken together.

Name both tadalafil and dapoxetine clearly.

State the strengths, the amount and the time of the dose.

Say whether any alcohol or antidepressant was also taken.

Nitrates must not be given within 48 hours of tadalafil.

Bring the pack with you if that is possible.

Dapoxetine is an SSRI and can affect mood in some men.

Report any new low mood or anxiety to a doctor promptly.

Seek help the same day if you have thoughts of self-harm.

Local crisis helplines are available if you feel unsafe.

Erectile dysfunction and premature ejaculation often occur together.

One tablet is simpler than remembering two separate medicines.

Tadalafil has well-established evidence for erectile dysfunction.

Dapoxetine is the only SSRI designed for on-demand use in PE.

On-demand dosing avoids the daily exposure of other SSRIs.

Dapoxetine roughly tripled average time to ejaculation in trials.

German Remedies manufactures in a GMP-certified facility.

Generic pricing makes treating both conditions more affordable.

No regulator has approved this drug combination in one tablet.

Approved guidance says dapoxetine must not be started at 60 mg.

This tablet forces a 60 mg starting dose on every user.

Side effects were roughly twice as common at 60 mg than 30 mg.

The added benefit over 30 mg was small in the same trials.

A fixed tablet prevents either drug being adjusted alone.

Separate tablets allow proper dose titration and are usually safer.

Both drugs can lower blood pressure and increase fainting risk.

Dapoxetine carries psychiatric and cardiac contraindications.

Dapoxetine is not approved in the United States at all.

Premature ejaculation treatment should be reviewed after four weeks.

Both conditions can signal underlying physical or emotional causes.

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

Keep tablets in the original blister until use.

Protect from direct sunlight, heat and moisture.

Do not store in the bathroom or near a sink.

Do not refrigerate or freeze the tablets.

Keep the pack out of sight and reach of children.

Keep away from pets at all times.

Never share this medicine with another person.

The dapoxetine content makes sharing particularly risky.

Check the expiry date printed on the blister and carton.

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

Do not transfer tablets into unlabelled containers.

Do not flush unused tablets down the toilet.

Return leftover tablets to a pharmacy take-back scheme.