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Posted On: Jun 17, 2022




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Erectile dysfunction (impotence) is the inability to get and keep an erection firm enough for sex.

The medicines for treatment of erectile dysfunction belong to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors that controls the flow of blood to the erectile tissues inside the penis and are authorized for treatment of erectle dysfunction. Examples of these medicines include Sildenafil, Tadalafil, Vardenafil and Avanafil.

Among the four types currently available worldwide, three of these medicines are registered by TMDA in various brand names which are Sildenafil (Evoke, Erecto, Zwagra, Silmet, Njoi and Viagra), Tadalafil (Saheal and Cialis) and Vardenafil (Levitra).

The erectile dysfunction medicines work by improving blood flow to the penis causing erection of the penis.

These medicines are used for treatment of erectile dysfunction in adult males, sometimes known as impotence.

Patients diagnosed with erectile dysfunction. A medical Doctor must prescribe the appropriate dose and instructions for use.

These medicines do not directly affect the pyschological side of sexual performance such as level of interest in sex, aurousal level or sexual confidence. This means that if erectile dysfunction is caused by a pyschological issue, these medicines may not be fully effective.

These medicines do not cure erectile dysfunction or increase sexual desire.

Consult your doctor before considering the use of these medicines.

Usually they start to work approximately 30 minutes after taking them.

They are designed to be use as needed, meaning you take them around one hour before planning to have sex. Regardless of the exact dosage of these medicines you are prescribed, you should not take this medication more than one time per day.

Please consult the healthcare provider or your Doctor on potentially switching to a longer-lasting medication such as Tadalafil.

Erectile dysfunction can develop from a variety of reasons including lifestyle factors such as excessive alcohol consumption, lack of physical activity, obesity, smoking or illicit drug use that can cause or contribute to erectile dysfunction.

If your erectile dysfunction is caused by an underlying health condition or habit such as obesity, tobacco use, low testosterone or dietary issue, it might be possible to reduce the severity of your erectile dysfunction symptoms without the use of these medications by changing lifestyle.

This might also involve hormonal treatment, changing your use of other medications, losing weight, making changes to your lifestyle to improve your general health and reduce risk of being continually affected by erectile dysfunction.

These medicines can cause a prolonged erection. If not treated, this can lead to permanent erectile dysfunction. They can also cause a serious eye condition known as non-arteritic anterior ischemic optic neuropathy, which can lead to permanent vision loss.

A prolonged erection also known as priapism, is a long-lasting and sometimes painful erection. It is a medical emergency that needs to be treated right away. If not treated, it can damage the tissues in your penis and cause irreversible erectile dysfunction.

If you use together with medicines used for the treatment of angina diseases (Dinitrates or Mononitrates), it can cause a significant sudden drop in blood pressure that may make you feel dizzy, faint, cause a heart attack or stroke.

TMDA ensures quality, safety and efficacy of these medicines and other medicines by doing the following;

  • Reviewing all documents (dossiers) submitted for marketing authorization for the purpose of establishing, quality, safety and efficacy of the products before registration.
  • Conducting GMP inspection of pharmaceutical companies in which their products are manufactured before being applied to Tanzania for registration.
  • Conducting enforcement by controlling all imports through issuance of import permit certificates.
  • Conducting pharmacovigilance (PV) and Post Marketing Surveillance (PMS) to ascertain quality, safety and efficacy of approved products.
  • Publication of Summary of Product Characteristics (SmPC) and Product Labelling Information on the website for creating public awareness; and
  • Providing public education to create awareness on the use of medicines and other products regulated by TMDA.

There has been an increasing trend of using these medicines on the market to most men recently. The consumption rate has gone up indicating that most men might be affected by erectile dysfunction. The TMDA is conducting research to identify consumption rates across the country.

Anecdotal reports have reported various incidences in form of stroke, sudden collapse, syncope, heart attacks and deaths. These events are being investigated by TMDA through its pharmacovigilance programme.

In case a medical emergency has occurred, measures must be taken urgently to resuscitate the victim including calling for an ambulance or rushing the person to a nearby hospital. In case of deaths, these must be reported to a nearby Police station for action to be taken including further investigation.

The public is advised to refrain from using erectile dysfunction medicines and work on other psychological conditions that might be affecting your sex life. In case these other measures have failed, then one can consult the medical doctor for advise on how to use them.

Medical professionals will assess your health condition before prescribing these medicines to you. They need to determine the dose suitable for use without causing any health hazards.

Owners of premises including pharmacists and other medical personnel serving in retail pharmacies must stop giving these medications randomly to seekers without any prescription. This contributes to easy access to them and health hazards reported.

Hotel and lodge owners are urged to report all suspected incidences of deaths and other health hazards occurring to victims to TMDA. By doing so, the TMDA will be able to quantify the risks including understanding the magnitude of the problem for regulatory action(s) to be taken promptly.

Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
P. O. Box 1253, Dodoma
P.O. Box 77150, Dar es Salaam
Tell: +255-658 445222/777 700002
Hotline: 0800110084