Medicine guide

Tadalafil Mylan

Prescription status not stated
Urinary and reproductive system, hormones

Active substance: Tadalafil
Used in: Urinary and reproductive system, hormones
Made by: Mylan Pharmaceuticals Limited
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Tadalafil Mylan is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Mylan works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction.
It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

From the package leaflet in EMA’s product information, p. 62 · 2026-06-15

How it works

This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (tadalafil). It describes the substance, not this Bulgarian product — its uses and doses can differ.

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.
This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells.

Half-life17.5 h

Mostly cleared after≈ 4 daysfive half-lives — our arithmetic

How the body breaks it down

Metabolism — Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite.

How it leaves the body

Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).

With food

The rate and extent of absorption of tadalafil are not influenced by food; thus tadalafil tablets may be taken with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-24

Do not take it if

if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
if you have serious heart disease or recently had a heart attack within the last 90 days.
if you had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

From the package leaflet in EMA’s product information, p. 62–63.

How to take it

These directions are for this exact strength and form. Another one is different.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan. This will be given as a 2.5 mg tablet.
Do not take Tadalafil Mylan more than once a day.
Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Once a day dosing of Tadalafil Mylan may be useful to men who anticipate having sexual activity two or more times per week.
When taken once a day Tadalafil Mylan allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
If you take more Tadalafil Mylan than you should Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil Mylan Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet.
You should not take Tadalafil Mylan more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 64.

Warnings and precautions

Talk to your doctor before taking Tadalafil Mylan.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
sickle cell anaemia (an abnormality of red blood cells).
multiple myeloma (cancer of the bone marrow).
leukaemia (cancer of the blood cells).
any deformation of your penis.
a serious liver problem.
a severe kidney problem.
It is not known if tadalafil is effective in patients who have had:
pelvic surgery.
removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non -nerve- sparing prostatectomy).
If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Tadalafil Mylan, stop taking Tadalafil Mylan and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Mylan and contact your doctor immediately.
Tadalafil Mylan is not intended for use by women.
Children and adolescents Tadalafil Mylan is not intended for use by children and adolescents under the age of 18.

From the package leaflet in EMA’s product information, p. 63.

Other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadalafil Mylan if you are already taking nitrates.
Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work.
Tell your doctor or pharmacist if you are already taking:
an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
other medicines to treat high blood pressure.
riociguat.
a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin or itraconazole.
other treatments for erectile dysfunction.
Tadalafil Mylan with drink and alcohol Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to your doctor for further information.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Fertility When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

From the package leaflet in EMA’s product information, p. 63–64.

Driving and using machines

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
Tadalafil Mylan contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Tadalafil Mylan contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

From the package leaflet in EMA’s product information, p. 64.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If you experience any of the following side effects stop using the medicine and seek medical help immediately:
allergic reactions including rashes (frequency uncommon).
chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Other side effects have been reported:
Common (may affect up to 1 in 10 people)
headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Uncommon (may affect up to 1 in 100 people)
dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (may affect up to 1 in 1,000 people)
fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Diarrhoea has been reported more frequently in men over the age of 65 taking tadalafil.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side affects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 64–65.

How to store it

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 65.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (190)

BulgariaNo exact match for this strength and form

Every strength and form (34)

SpainNo exact match for this strength and form

Every strength and form (155)

FranceNo exact match for this strength and form

Every strength and form (68)

CanadaNo exact match for this strength and form

Every strength and form (95)

NetherlandsNo exact match for this strength and form

Every strength and form (99)

SwitzerlandNo exact match for this strength and form

Every strength and form (39)

Details

Made by	Mylan Pharmaceuticals Limited
Active substance	Tadalafil
Used in	Urinary and reproductive system, hormones
Classification	G04BE08 · Urinary and reproductive system, hormones
Generic	Yes — a generic medicine, according to the register
Authorised on	2014-11-21
Last updated by the regulator	2026-06-15
EMA product number	EMEA/H/C/003787

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Talmanco (previously Tadalafil Generics)EU authorisation Viatris Limited · Tadalafil · G04BE08 Tadalafil LillyEU authorisation Eli Lilly Nederland B.V. · Tadalafil · G04BE08 CialisEU authorisation Eli Lilly Nederland B.V. · Tadalafil · G04BE08 Adcirca (previously Tadalafil Lilly)EU authorisation Eli Lilly Nederland B.V. · Tadalafil · G04BE08

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