TADALAFIL ALTER
As listed in the register: TADALAFIL ALTER 5 mg, comprimé pelliculé
5 mg · comprimé pelliculé
- Prescription only
- Active substance
- Tadalafil
- Made by
- LABORATOIRES ALTER
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
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
Safety of the active substance
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.
- Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated.
- Tadalafil was shown to potentiate the hypotensive effect of nitrates ( 4.1 ).
- History of known serious hypersensitivity reaction to tadalafil or ADCIRCA ® ( 4.2 ).
- Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 ). 4.1 Nitrates Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.
Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ( 6.1 ).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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 States51 matching products
Bulgaria6 matching products
European UnionNo exact match for this strength and form
Canada24 matching products
Netherlands20 matching products
- Tadalafil 1A Pharma 5 mg 5 mg · filmomhulde tablet3 makers
- Tadalafil STADA 5 mg 5 mg · filmomhulde tablet2 makers
- CIALIS 5 mg · tablet
- Gerocilan 5 mg filmomhulde tabletten 5 mg · filmomhulde tablet
- Quator 5 mg 5 mg · filmomhulde tablet
- Tadalafil Accord 5 mg 5 mg · filmomhulde tablet
- Tadalafil Amarox 5 mg filmomhulde tabletten 5 mg · filmomhulde tablet
- Tadalafil Aurobindo 5 mg 5 mg · filmomhulde tablet
Details
| Made by | LABORATOIRES ALTER |
|---|---|
| Active substance | Tadalafil |
| Strength | 5 mg |
| Form | comprimé pelliculé |
| Route | orale |
| Dispensing (as stated by the register) | liste I |
| Marketed | No — authorised but not currently marketed, according to the register |
| Authorisation procedure | Procédure décentralisée |
| Name in the register | TADALAFIL ALTER 5 mg, comprimé pelliculé |
| Packs | plaquette(s) aluminium polychlortrifluoroéthylène PVC de 28 comprimé(s) · plaquette(s) aluminium polychlortrifluoroéthylène PVC de 84 comprimé(s) |
| CIS | 62472584 |
| CIP13 | 3400930117323 |
| CIP13 | 3400930276709 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.