Tadalafil Lilly
·
- Prescription status not stated
- Urinary and reproductive system, hormones
- Active substance
- Tadalafil
- Made by
- Eli Lilly Nederland B.V.
- 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 Lilly 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 Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
- Tadalafil Lilly contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Lilly 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 Lilly will not help you if you do not have erectile dysfunction.
- It is important to note that Tadalafil Lilly 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 · 2026-01-28
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.
Metabolism — Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite.
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).
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
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.
- Tadalafil Lilly tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
- 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 Lilly. This will be given as a 2.5 mg tablet.
- Do not take Tadalafil Lilly more than once a day.
- Once a day dosing of Tadalafil Lilly may be useful to men who anticipate having sexual activity two or more times per week.
- When taken once a day Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
- It is important to note that Tadalafil Lilly 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.
- Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
- If you take more Tadalafil Lilly than you should Contact your doctor. You may experience side effects described in section 4.
- If you forget to take Tadalafil Lilly 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 Lilly 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 Lilly.
- 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 Lilly 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 Lilly, stop taking Tadalafil Lilly 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 Lilly and contact your doctor immediately.
- Tadalafil Lilly is not intended for use by women.
- Children and adolescents Tadalafil Lilly 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 Lilly if you are already taking nitrates.
- Some medicines may be affected by Tadalafil Lilly or they may affect how well Tadalafil Lilly will work. Tell your doctor or pharmacist if you are already taking:
- an alpha blocker (used to treat high blood pressure or urinary symptoms due to a condition where prostate gland enlarges in men).
- other medicines to treat high blood pressure.
- riociguat.
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
- medicines such as ketoconazole or itraconazole (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
- erythromycin or clarithromycin (antibiotic to treat bacterial infection)
- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
- rifampicin (antibiotic to treat mycobacterial infection).
- other treatments for erectile dysfunction.
- Tadalafil Lilly with drink and alcohol Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. Talk to your doctor for further information.
- 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 Lilly in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
- Tadalafil Lilly 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 Lilly 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 taking 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 Lilly (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 Lilly. 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 Lilly 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 Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.
- 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 effects you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 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 and blister after ‘EXP’.
- The expiry date refers to the last day of that month.
- Store in the original package in order to protect from moisture. Do not store above 30°C.
- 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. 66.
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
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Eli Lilly Nederland B.V. |
|---|---|
| Active substance | Tadalafil |
| Used in | Urinary and reproductive system, hormones |
| Classification | G04BE08 · Urinary and reproductive system, hormones |
| Authorised on | 2017-03-22 |
| Last updated by the regulator | 2026-01-28 |
| EMA product number | EMEA/H/C/004666 |
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).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.