Medicine guide

Talmanco (previously Tadalafil Generics)

·

  • Prescription status not stated
  • Urinary and reproductive system, hormones
Active substance
Tadalafil
Made by
Viatris Limited

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

What it is for

  • Talmanco contains the active substance tadalafil.
  • Talmanco is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above.
  • It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

From the package leaflet in EMA’s product information, p. 27 · 2026-05-08

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

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.
  • Talmanco is supplied as a 20 mg tablet. Swallow the tablet(s) whole with a drink of water. The tablet(s) can be taken with or without food.
  • Pulmonary arterial hypertension in adults The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
  • Pulmonary arterial hypertension in children (age 2 years and above) weighing at least 40 kg The recommended dose is two 20 mg tablets taken once a day. Both tablets should be taken at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
  • Pulmonary arterial hypertension in children (age 2 years and above) weighing less than 40 kg The recommended dose is one 20 mg tablet taken once a day. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take 10 mg once per day.
  • Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
  • If you take more Talmanco than you should If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.
  • If you forget to take Talmanco Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do not take a double dose to make up for a forgotten dose.
  • If you stop taking Talmanco Do not stop taking your tablets, unless advised otherwise by your doctor.
  • 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. 29.

Warnings and precautions

  • Talk to your doctor or pharmacist before taking this medicine if you have:
  • any heart problems other than your pulmonary hypertension
  • problems with your blood pressure
  • any hereditary eye disease
  • an abnormality of red blood cells (sickle cell anaemia)
  • cancer of the bone marrow (multiple myeloma)
  • cancer of the blood cells (leukaemia)
  • any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
  • a serious liver problem
  • a serious kidney problem If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Talmanco, stop taking Talmanco 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, contact your doctor immediately.
  • Children and adolescents This medicine is not recommended for the treatment of pulmonary hypertension in children under 2 years of age because it has not been studied in this age group.

From the package leaflet in EMA’s product information, p. 27–28.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
  • Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
  • 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. 28.

Other medicines

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
  • Do NOT take these tablets if you are already taking nitrates.
  • Some medicines may be affected by Talmanco or they may affect how well Talmanco will work. Tell your doctor or pharmacist if you are already taking:
  • bosentan (another treatment for pulmonary arterial hypertension)
  • nitrates (for chest pain)
  • alpha blockers used to treat high blood pressure or prostate problems
  • riociguat
  • rifampicin (to treat bacterial infections)
  • ketoconazole tablets (to treat fungal infections)
  • ritonavir (for HIV treatment)
  • tablets for erectile dysfunction (PDE5 inhibitors)
  • Talmanco with alcohol Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Talmanco, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

From the package leaflet in EMA’s product information, p. 28.

Driving and using machines

  • Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.
  • Talmanco contains lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
  • 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. 28–29.

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:
  • Common (may affect up to 1 in 10 people)
  • allergic reactions including skin rashes.
  • chest pain - do not use nitrates, but seek immediate medical assistance.
  • Uncommon (may affect up to 1 in 100 people)
  • priapism, a prolonged and possibly painful erection after taking this medicine. If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
  • Rare (may affect up to 1 in 1,000 people)
  • sudden loss of vision.
  • Not known (frequency cannot be estimated from the available data)
  • distorted, dimmed, blurred central vision or sudden decrease of vision.
  • Other side effects have been reported:
  • Very Common (may affect more than 1 in 10 people)
  • headache.
  • flushing, nasal and sinus congestion (blocked nose).
  • nausea, indigestion (including abdominal pain or discomfort).
  • muscle aches, back pain and pain in the extremity (including limb discomfort).
  • Common (may affect up to 1 in 10 people)
  • blurred vision.
  • low blood pressure.
  • nosebleed.
  • vomiting.
  • increased or abnormal uterine bleeding.
  • swelling of the face.
  • acid reflux.
  • migraine.
  • irregular heartbeat.
  • fainting.
  • Uncommon (may affect up to 1 in 100 people)
  • seizures.
  • passing memory loss.
  • hives.
  • excessive sweating.
  • penile bleeding.
  • presence of blood in semen and/or urine.
  • high blood pressure.
  • fast heart rate.
  • sudden cardiac death.
  • ringing in the ears.
  • PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely (may affect up to 1 in 1,000 people) reported:
  • Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.
  • Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
  • These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data):
  • swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
  • Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
  • distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
  • Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to 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 effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 29–31.

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.
  • 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. 31.

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 byViatris Limited
Active substanceTadalafil
Used inUrinary and reproductive system, hormones
ClassificationG04BE08 · Urinary and reproductive system, hormones
GenericYes — a generic medicine, according to the register
Authorised on2017-01-09
Last updated by the regulator2026-05-08
EMA product numberEMEA/H/C/004297

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.