Tadagra 60 Mg (Tadalafil)

Tadagra 60 is an oral tablet containing tadalafil 60 mg.

Tadalafil is a selective, reversible inhibitor of PDE5. 

It is indicated for the treatment of erectile dysfunction in adult males.

60 mg is above the maximum authorised on-demand dose of 20 mg. 

Sexual stimulation is required for tadalafil to be effective. 

Tadalafil has no effect in the absence of sexual stimulation. 

It has the longest duration of the PDE-5 inhibitors.

The tablet is swallowed whole with water.

It is taken only when needed at this strength.

It does not increase sexual desire or libido.

It does not cure the underlying cause of erectile dysfunction.

It is not approved to delay ejaculation or treat premature ejaculation.

It offers no protection against sexually transmitted infections.

Tadalafil is not indicated for use by women. 

There is no relevant use in the paediatric population for erectile dysfunction. 

A medical history and physical examination should precede treatment. 

Sexual stimulation causes local release of nitric oxide.

Nitric oxide raises levels of cyclic guanosine monophosphate (cGMP).

cGMP produces smooth muscle relaxation in the corpus cavernosum.

Relaxed muscle allows blood to flow into penile tissue.

An enzyme called PDE5 breaks cGMP down.

Tadalafil selectively and reversibly inhibits PDE5.

Inhibiting PDE5 keeps cGMP levels elevated.

Blood flow is therefore maintained, producing an erection.

May be taken at least 30 minutes prior to sexual activity.

The rate and extent of absorption are not influenced by food. Tadalafil may be taken with or without food.

Morning versus evening dosing had no clinically relevant effect on absorption.

At least 48 hours after the last dose.

Not applicable. This medicine is used only as needed.

Take the tablet exactly as your doctor prescribed.

Confirm with your doctor why 60 mg rather than 20 mg.

Ask what has been ruled out as a cause of treatment failure. 

Swallow the tablet whole with water.

Do not chew, crush, or split the tablet.

Take it at least 30 minutes before sexual activity. 

It may be taken with or without food. 

Sexual stimulation is required for the medicine to work. 

The effect may persist for up to 36 hours.

Take no more than one tablet per day.

Do not combine it with any other ED treatment.

Do not take a second tablet if the first seems weak.

Expect headache, indigestion, and back pain to be more likely at this dose.

Tell your doctor if side effects trouble you.

Ask about reducing to 20 mg or 10 mg if they do.

Be aware of how it affects you before driving.

Do not share your tablets with anyone else.

Are hypersensitive to tadalafil or any excipient.

Are using any form of organic nitrate.

Have cardiac disease for which sexual activity is inadvisable.

Had a myocardial infarction within the last 90 days.

Have unstable angina, or angina occurring during sexual intercourse.

Have had NYHA Class 2 or greater heart failure in the last 6 months.

Have uncontrolled arrhythmias.

Have hypotension below 90/50 mmHg.

Have uncontrolled hypertension.

Have had a stroke within the last 6 months.

Have lost vision in one eye because of NAION, whether or not linked to previous PDE5 inhibitor use.

Administration to patients using any form of organic nitrate is contraindicated. Allow at least 48 hours after the last dose before any nitrate is considered. 

The combination of tadalafil and doxazosin is not recommended. Co-administration significantly increases the blood-pressure-lowering effect, lasting at least twelve hours, and may cause syncope. 

Any cardiovascular condition, since sexual activity carries cardiac risk. 

Any previous heart attack, stroke, or heart failure. 

Angina, or any prescription for nitrates in the past. 

Uncontrolled high or low blood pressure. 

Any arrhythmia. 

Liver disease, including cirrhosis. 

Kidney disease or reduced kidney function.

Any eye disease or sudden vision loss previously.

Any previous hearing loss. 

An anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie’s disease. 

Sickle cell anaemia, multiple myeloma, or leukaemia, which predispose to priapism. 

Chronic back pain or a spinal condition.

Any pelvic surgery or radical non-nerve-sparing prostatectomy. 

Diabetes. 

Whether you take any alpha-blocker.

Recent or planned surgery, including dental procedures.

A doctor has specifically prescribed 60 mg for me.

I have discussed why 60 mg rather than 20 mg.

I have taken no nitrate medicine in 48 hours.

I will need no nitrate medicine for 48 hours.

I take no riociguat.

I take no doxazosin.

I have taken no other ED medicine.

I have not taken a dose in the last 24 hours.

I take no ketoconazole, itraconazole, ritonavir, or clarithromycin.

My doctor knows all my current medicines.

My heart is fit enough for sexual activity.

I have avoided grapefruit juice.

I have limited alcohol.

I know the effect may last up to 36 hours.

The blister is sealed and the expiry date valid.

I know the emergency warning signs listed below.

Myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations, and tachycardia have been reported post-marketing and in trials. Most patients had pre-existing cardiovascular risk factors.

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg to patients. Adverse events were similar to those seen at lower doses. This does not establish 60 mg as a safe or effective dose; it simply describes what was observed in overdose settings.

Any form of organic nitrate.

Riociguat and other guanylate cyclase stimulators.

Doxazosin. Increases the blood-pressure-lowering effect significantly, lasting at least twelve hours, and may cause syncope.

Other PDE5 inhibitors or other erectile dysfunction treatments. Safety and efficacy of such combinations have not been studied.

Ketoconazole 400 mg daily increased tadalafil 20 mg exposure 4-fold.

Ketoconazole 200 mg daily increased tadalafil 10 mg exposure 2-fold.

Ritonavir 200 mg twice daily increased tadalafil 20 mg exposure 2-fold.

Saquinavir, erythromycin, clarithromycin, itraconazole, and grapefruit juice.

Alpha-blockers generally; start at minimal dosage and adjust progressively.

Rifampicin reduced tadalafil AUC by 88%.

Phenobarbital, phenytoin, and carbamazepine.

5-alpha reductase inhibitors such as finasteride; caution advised.

Theophylline; a small 3.5 bpm heart rate increase was seen.

Ethinylestradiol; tadalafil increases its oral bioavailability.

Interaction studies were conducted with 10 mg and 20 mg tadalafil. For studies using only the 10 mg dose, clinically relevant interactions at higher doses cannot be completely ruled out. No interaction data exists at 60 mg.

An erection lasting 4 hours or more. 

A painful erection that will not subside.

Chest pain, pressure, or tightness during or after sex.

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

Any sudden visual defect, visual acuity impairment, or visual distortion. 

Sudden decrease or loss of hearing. 

Fainting or collapse.

Severe shortness of breath.

Swelling of the face, lips, tongue, or throat.

Widespread rash with blistering or peeling skin.

A seizure or convulsion.

Severe back pain that does not settle.

Signs of stroke: sudden weakness, slurred speech, facial droop.

Patients who experience erections lasting 4 hours or more should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. 

In the UK, suspected side effects can be reported through the MHRA Yellow Card scheme. 

Improvement in erectile function up to 36 hours after dosing. 

Onset as early as 16 minutes. 

81% of patients reported improved erections versus 35% on placebo. 

75% of intercourse attempts were successful versus 32% with placebo. 

Absorption is unaffected by food. 

Visual colour changes are rare, under 0.1%, due to 700-fold PDE5 selectivity over PDE6. 

No dose adjustment needed for age or diabetes. 

No approved indication. 20 mg is the highest authorised on-demand strength. 

No published efficacy data above 20 mg for erectile dysfunction.

No pharmacokinetic characterisation above 20 mg. 

No interaction data at this dose.

No longer duration; the 36-hour window is a property of tadalafil at licensed doses. 

A higher likelihood of headache, dyspepsia, back pain, and myalgia, which rise with dose. 

Exposure well outside the range studied for these interactions.

No data at all if you have hepatic impairment, where nothing above 10 mg has been studied. 

Confirm the timing was correct; allow at least 30 minutes. 

Check whether sexual stimulation was sufficient. 

Review interacting medicines, particularly CYP3A4 inducers. 

Determine potential underlying causes through medical assessment. 

Consider a once-daily 5 mg regimen if use is frequent. 

Consider switching to a different single PDE-5 inhibitor.

10 mg and 20 mg are the authorised on-demand doses, and the published efficacy data relates to those. If 20 mg has not worked, the approved information points to investigating the cause rather than increasing the dose.

Do not store above 30°C. 

Store in the original package in order to protect from moisture. 

Keep tablets sealed in the blister until use.

Do not store in the bathroom or near a sink.

Do not transfer tablets into unlabelled containers.

Keep the original pack for the drug name and strength.

Never mix tablets of different strengths in one container.

Do not freeze or refrigerate this product.

Keep it out of the sight and reach of children.

Accidental ingestion by a child is a medical emergency.

Check the expiry date printed on the pack.

Never use tablets after the expiry date.

Discard damaged, cracked, or discoloured tablets.

Dispose of unused medicine in accordance with local requirements. 

Return unused tablets to a pharmacy where possible.

Do not flush tablets or throw them in household waste.