The Spanish Agency for Medicines and Health Products (AEMPS) withdraws the product ‘RHODICOMP capsules’ from the market. This well-known food supplement contains the PDE5 inhibitor , which acts like viagra .
The SEPRONA Section of the Gijón Civil Guard Command has been in charge of providing knowledge of the commercialization of this product. All this within the framework of Operation Pangea XIV, due to a product that had breached health protocols.
As indicated on its labeling, this product has been manufactured in the Union European and distributed by the company Shop Distributors SL located in the Polirrosa square 250 , 21007, Huelva.
In addition, the product is being marketed as a food supplement, despite not having been notified of its placing on the market to the competent authorities, in breach of the provisions of current regulations for this type of products.
The AEMPS ensures that said product or not has been subject to evaluation and authorization prior to marketing. For this reason, its presence in the market is illegal.
In this way, the AEMPS has decided to prohibit the commercialization and withdraw from the market all copies of said product.
It contains a PDE5 inhibitor, which acts like viagra
The AEMPS itself has carried out an analysis of the product to see its true composition. The ‘RHODICOMP capsules’ includes among its components the active substances sildenafil and tadalafil .
Said Substances appear in sufficient quantity to restore, correct or modify a physiological function, exerting a pharmacological action, which gives it the legal status of a drug.
To make matters worse, both sildenafil and tadalafil does not appear on the product label, so the customer is really being misled. A series of products of plant origin appears deceptively on its labeling.
Both active substances are indicated to restore impaired erectile function by increasing penile blood flow by selective inhibition of phosphodiesterase 5 (PDE-5).
The functions of PDE5 inhibitors
PDE5 inhibitors are contraindicated in patients with:
- Acute myocardial infarction.
- Unstable angina.
- Exertional angina.
- Heart failure.
- Uncontrolled arrhythmias.
- Hypotension (blood pressure <90 / 50 mmHg).
- Hypertension does not control da.
- History of ischemic stroke (ischemic stroke).
- Patients with severe liver failure.
- People with a history of non-arteritic anterior ischemic optic neuropathy.
- Patients with inherited retinal degenerative disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
PDE5 inhibitors have numerous interactions with other medications. Experts detail that adverse reactions of varying severity to be taken into consideration may appear, such as cardiovascular ones.
In addition, it should be taken into account that its consumption is associated with:
- Acute myocardial infarction
- Unstable angina
- Ventricular arrhythmia
- Palpitations
- Tachycardias
- Stroke
It has even been linked to sudden cardiac death, which has occurred to a greater extent in patients with a history of cardiovascular risk factors for which it would be contraindicated.
This product is it presents as natural, hiding its true composition from the consumer and giving misleading information on safety. In particular, the presence of sildenafil and tadalafil poses a risk for those individuals who are especially susceptible to suffering adverse reactions with the consumption of the PDE5 inhibitor.
Precisely, these individuals could resort to products of this type, supposedly natural, based on plants, as a theoretically safe alternative to authorized prescription drugs. These products are also presented with an emphasis on their supposed safety, misleadingly based on their natural composition.