Tadafem 20 mg (Tadalafil)

Tadafem 20 mg is a prescription tablet containing 20 mg of tadalafil.

Tadalafil belongs to the PDE-5 inhibitor drug class.

Its approved use is erectile dysfunction (ED) in adult men.

Tadalafil is also approved for benign prostatic hyperplasia (BPH) symptoms.

BPH is a non-cancerous enlargement of the prostate gland.

The same molecule is sold worldwide under the brand name Cialis.

Tadalafil is often called ‘the weekend pill’ because of its long action.

A single dose can improve erectile function for up to 36 hours.

It helps a man get and keep an erection during sexual stimulation.

It does not produce an erection on its own.

Sexual arousal is always required for the medicine to work.

It is not a hormone, an aphrodisiac, or a fertility treatment.

It gives no protection against HIV or other sexually transmitted infections.

Tadalafil is not indicated for use in females.

This wording comes directly from the approved label.

Tadalafil is not indicated for anyone under 18 years.

Safety and efficacy below age 18 have not been established.

Sexual stimulation releases nitric oxide (NO) from nerves and blood vessel lining.

Nitric oxide triggers production of cyclic guanosine monophosphate (cGMP).

cGMP relaxes the smooth muscle of the penile arteries and corpus cavernosum.

Relaxed muscle allows more blood to flow into the penis.

The enzyme PDE-5 normally breaks cGMP down.

Tadalafil inhibits PDE-5, so cGMP levels stay higher.

Blood flow improves and the erection becomes firmer and longer-lasting.

PDE-5 is also present in the prostate and bladder smooth muscle.

It is also present in their blood supply.

Tadalafil raises cGMP in these tissues too.

The exact mechanism for reducing BPH symptoms is not established.

Tadalafil has no effect without sexual stimulation.

It is over 10,000 times more selective for PDE-5 than PDE-3.

PDE-3 is found in the heart and blood vessels.

It is 700 times more selective for PDE-5 than PDE-6.

PDE-6 sits in the retina. This is why colour vision changes are rare.

Colour vision changes were reported in under 0.1 percent of patients.

Tadalafil also inhibits PDE-11, found in muscle and prostate.

The clinical meaning of PDE-11 inhibition is not defined.

Peak blood level occurs between 30 minutes and 6 hours.

The median time to peak level is 2 hours.

Food does not affect the rate or extent of absorption.

The mean terminal half-life is 17.5 hours.

About 94 percent of tadalafil in blood is bound to proteins.

The liver clears it, mainly through the enzyme CYP3A4.

About 61 percent leaves in the faeces and about 36 percent in urine.

Confirm your dose and suitability with a registered doctor.

Check the strip seal and the printed expiry date.

Swallow the tablet whole with a glass of water.

Do not split, crush, or chew the tablet.

Take it with or without food. Food makes no difference.

For as-needed use, take it at least 30 minutes before sex.

Allow sexual stimulation to occur. Arousal is essential.

Do not take a second dose within 24 hours.

For daily use, take it at roughly the same time each day.

A 20 mg dose improved erectile function up to 36 hours after dosing.

In one trial, 52 percent of men on 20 mg succeeded within 30 minutes.

On placebo the figure was 35 percent.

At the 36-hour mark, 64 percent of the 20 mg group succeeded at least once.

On placebo the figure was 37 percent.

You do not need to plan sex around the dose within this window.

As-needed use has no schedule, so there is no missed dose.

For daily use, take the missed dose when you remember it.

Skip it if the next dose is almost due.

Never take two doses to make up for one.

If you take too much, go to a hospital emergency department.

Any organic nitrate, in any form, regular or occasional.

Examples: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate.

Recreational nitrite ‘poppers’, including amyl nitrite.

Guanylate cyclase stimulators such as riociguat.

Known serious allergy to tadalafil, in any brand.

Men for whom sexual activity is unsafe due to heart disease.

Use in women, or in anyone under 18 years of age.

Heart attack within the last 90 days.

Unstable angina, or angina that occurs during sexual intercourse.

Heart failure of NYHA Class 2 or greater in the last 6 months.

Uncontrolled irregular heartbeat, or uncontrolled high blood pressure.

Low blood pressure below 90/50 mmHg.

Stroke within the last 6 months.

Narrowing of the aortic valve, or other outflow obstruction.

A curved or deformed penis, such as Peyronie’s disease.

Any past erection lasting more than 4 hours.

Sickle cell anaemia, multiple myeloma, or leukaemia.

Retinitis pigmentosa or other inherited retinal disease.

Any past severe vision loss, especially NAION.

Bleeding disorders, or an active stomach ulcer.

Liver disease, kidney disease, or dialysis treatment.

All current medicines, including herbal and over-the-counter products.

Food does not affect how tadalafil is absorbed.

You may take the tablet with or without a meal.

Avoid grapefruit and grapefruit juice. It likely raises tadalafil levels.

Keep alcohol low. Both alcohol and tadalafil widen blood vessels.

Five or more alcohol units with tadalafil can cause a blood pressure drop.

This can bring dizziness, headache and a faster heart rate on standing.

At a lower alcohol dose, this effect was not observed.

Avoid recreational drugs, especially nitrite poppers.

Do I hold a valid prescription from a registered doctor?

Have I confirmed that I take no nitrate medicine of any kind?

Am I free of poppers and of riociguat?

Has my doctor confirmed my heart can handle sexual activity?

Have I given my doctor a full list of my medicines?

Have I declared any liver, kidney, eye or blood conditions?

Is the strip sealed, undamaged, and within its expiry date?

Has it been more than 24 hours since my last dose?

Do I understand that tadalafil stays active for up to 36 hours?

Do I know the emergency warning signs in Section 8?

Back pain or muscle pain usually starts 12 to 24 hours after the dose.

It typically clears within 48 hours.

It is felt as a diffuse ache in the lower back, buttocks or thighs.

Lying down tends to make it worse.

Most reports were mild or moderate. Severe pain was uncommon.

Paracetamol or an anti-inflammatory usually helped.

Only about 0.5 percent of men stopped treatment because of it.

Testing found no muscle, kidney or inflammatory damage behind it.

Tadalafil did not significantly affect warfarin, midazolam or digoxin.

Tadalafil did not increase the bleeding time caused by aspirin.

This list is not complete. Show your doctor every medicine you take.

An erection lasting more than 4 hours, whether painful or not.

Untreated priapism can cause irreversible damage to erectile tissue.

Sudden loss of vision in one or both eyes.

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

Chest pain, pressure, or pain spreading to the arm, neck or jaw.

Chest pain or dizziness during sex. Stop the activity at once.

Fainting, or severe dizziness on standing.

Slurred speech, facial droop, or one-sided weakness.

Swelling of the lips, tongue, face or throat.

A widespread rash with blistering or peeling skin.

A seizure.

The longest action of the common ED medicines: up to 36 hours.

This removes the need to time a dose closely around sex.

Food and normal meals do not affect absorption.

Onset can be rapid. Some men respond within 30 minutes.

Tadalafil worked across mild, moderate and severe ED.

It worked in men with diabetes-related ED.

It worked in men after nerve-sparing radical prostatectomy.

In one US trial, maintenance of erection rose from 23% to 64%.

The treatment effect did not fade over the trial period.

Colour vision changes are rarer than with some other PDE-5 inhibitors.

The same molecule can treat ED and BPH symptoms together.

Store at 25 °C (77 °F).

Short excursions from 15 °C to 30 °C are permitted.

Keep tablets in the original blister strip until use.

Protect from direct sunlight, heat and moisture.

Do not refrigerate and do not freeze.

Do not store in a bathroom cabinet or a parked car.

Keep out of the reach of children.

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

Do not use after the printed expiry date.

Dispose of unused medicine through a pharmacy take-back scheme.

Never share this medicine with another person.

This content is for general information only.

It does not replace advice from a qualified doctor or pharmacist.

Tadalafil is a prescription-only medicine.

Do not self-prescribe or change a dose without medical advice.

The manufacturer and intended patient group for this brand are unconfirmed.

Resolve both points before this content is published.

Always read the leaflet supplied with the product you receive.