ILLEGAL DRUGS
INFORMATION NOTE: No. 3 / 2011
is transcribed then the contents of the Briefing Note reference Illegal Drugs 3 / 2011 regarding the recall of three products in its composition including active ingredients such as vardenafil, sildenafil, tadalafil, 4-propoxy-N-hydroxyethyl-tiosildenafilo and desmethyl-tiosildenafilo, not included in the label:
"The Agency has been informed by a complaint from the marketing of certain products (see attached list) to include in their composition vardenafil, sildenafil, tadalafil, 4-propoxy-N-hydroxyethyl-desmethyl-tiosildenafilo tiosildenafilo and substances pharmacologically active, which would give them full legal consideration of drugs as defined in Article 8 of Law 29/2006 of 26 July, on guarantees and rational use of medicines and medical devices.
These products are offered online as a natural alternative to improve relationships for both men and women, indicating that it is a mixture of plants.
The appendix includes a list of products and pharmacologically active principles found in the analysis performed by the control laboratories of the Agency.
This group of substances act by restoring the impaired erectile function by increasing penile blood flow by selective inhibition of phosphodiesterase 5 (PDE5). Are contraindicated in patients with acute myocardial infarction, unstable angina, effort angina, heart failure, uncontrolled arrhythmias, hypotension or uncontrolled hypertension, stroke, and neuropathy with a history of nonarteritic anterior ischemic optic.
This active group has many interactions with other drugs, Adverse reactions can also occur in varying degrees, to take into consideration, such as cardiovascular disease, as their consumption has been associated with acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke, including sudden cardiac death, although further been reported in patients with a history of cardiovascular risk factors. They may also experience headaches, dizziness, dyspepsia, abdominal pain, nasal congestion, myalgia, back pain, hypersensitivity reactions including urticaria, exanthematous eruptions, skin rash and / or dermatitis, ocular / visual disturbances, etc.
Considering the above, and that these products have not been evaluated and pre-market approval by the English Agency of Medicines and Health Products, as stated in Royal Decree 520/1999, of March 26, which approves the Statute of the English Agency of Medicines and Article 9.1 of Law 29/2006 of July 26, and its presence in the illegal market, the Director of the English Medicines Agency Health Products as provided in Article 99 of that Act and in relation to the Royal Decree, has decided to order the recall of all copies of those products.
ANNEX
No. Product Name Active ingredients found marketing company.
ESCIMAX 1-T 4-propoxy-N-hydroxyethyl-tiosildenafilo,
Tadalafil,
desmethyl-tiosildenafilo,
Vardenafil,
sildenafil TERLEX 2007 SLC / EMPORDA 15-17, Polygon INDUSTRIALCASABLANQUES SE OF SANTA Quirce VALLÉS08192-BARCELONA
3 SEXCELLENCE 4-propoxy-N-hydroxyethyl-tiosildenafilo,
Desmethyl-tiosildenafilo TERLEX 2007 SLC / EMPORDÀ 15-17, POLYGON INDUSTRIALCASABLANQUES Quirce DE SANT SE-BARCELONA VALLÉS08192
http://redfarma.com/Alerta/default.cfm?str_action=mostrarAlerta&int_idAlerta = 1396 & 1794 int_idSeccion =
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