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The Food and Drug Administration (FDA) is warning consumers about the potential for the potentially harmful effects of sildenafil (Viagra) on a male sexual enhancement product.

The FDA has issued a warning about sildenafil, the active ingredient in Viagra, in the U. S. for people who take nitrates or nitrites (commonly known as "poppers"). These drugs are commonly used to treat chest pain, angina, or other conditions due to heart disease.

These medications can make it more difficult for a male to perform in bed, have trouble achieving orgasm, or find it difficult to have an orgasm when sexual intercourse is attempted. This risk has been linked to sexual activity that is done by men with a history of heart disease.

Sildenafil can have serious side effects, including the risk of the development of "poppers" (amyl nitrite), which are commonly used to treat angina and other conditions. The FDA warns that using sildenafil, along with nitrates and nitrite drugs, can increase the risk of developing the dangerous side effects of these medications.

"Sildenafil can cause your blood vessels to relax, which can cause you to experience chest pain, shortness of breath, and dizziness," the FDA warned.

However, there is no strong evidence that sildenafil, or any other nitrates and nitrites, can increase the risk of the development of "poppers" (amyl nitrite), the dangerous combination of medications.

The FDA warns that there is no clinical trial data to support the use of sildenafil, or any other nitrates and nitrites, in male sexual enhancement products.

The drug sildenafil can cause serious side effects, including the risk of the development of "poppers" (amyl nitrite), which are commonly used to treat angina and other conditions. The FDA warns that there is no strong evidence that the use of sildenafil, or any other nitrates and nitrites, in male sexual enhancement products, can increase the risk of the development of "poppers" (amyl nitrite).

While the FDA does not explicitly mention the risk of developing "poppers" (amyl nitrite), it does recommend that men taking sildenafil, or any other nitrates or nitrites, take caution when using these products.

"Sildenafil can cause your blood vessels to relax, which can cause you to experience chest pain, shortness of breath, and dizziness. This is very dangerous," the FDA warned.

However, the FDA warns that there is no strong evidence that sildenafil, or any other nitrates and nitrites, can increase the risk of the development of "poppers" (amyl nitrite), the dangerous combination of medications.

The FDA does not recommend that men take sildenafil, or any other nitrates or nitrites, for erectile dysfunction (ED) because of the risk of developing an adverse effect of these medications.

The FDA also does not recommend that men take sildenafil, or any other nitrates or nitrites, for erectile dysfunction (ED) because of the risk of developing an adverse effect of these medications.

Last updated 6 March 2024

Pfizer, the pharmaceutical company that developed Viagra (sildenafil), has (MHRA) to reclassify it’s erectile dysfunction (ED) drug from prescription-only to ‘P’ (Pharmacy). This would allow pharmacies to sell sildenafilover the counterwithout a prescription.

The application is forsildenafil 50mg onlyin a maximum pack size of 8 tablets. Sildenafil tablets are available on prescription in strengths of 25mg, 50mg, and 100mg in pack sizes of four and eight tablets.

The move follows the in 2013. After the patent expired other pharmaceutical companies, apart from Pfizer, have been permitted to supply their own sildenafil tablets, sometimes known as generic Viagra.

The application has support from the pharmacy industry: “Sildenafil is one of the most counterfeited medicines,” said Royal Pharmaceutical Society president Martin Astbury, with many men “resorting to the internet to buy medication”.

A statement from Pfizer reads:

Pfizer is committed to patient safety, and to ensuring that non-prescription sildenafil is supplied in a way that supports patient safety and improves patient health. Pharmacists are well placed to provide men with helpful and appropriate guidance to manage their erectile dysfunction, and should refer men to a doctor if they believe further investigation is required.

Sildenafil is already available over the counter in New Zealand since 2014 and Poland since 2016. The MHRA are considering the UK application and will make its decision within a few months (June-August 2017).

What does this mean for patients?

Many men suffering from ED will welcome easier access and availability of advice and treatment. If the MHRA approve the application, men will be able to buy Pfizer sildenafil in pharmacies without a prescription, including pharmacies in supermarkets (eg Tesco, ASDA). The Pharmacist would need to ask, likely in a private room, and may take a blood pressure reading.

According to the application,only men currently prescribed sildenafil 50mg(from a doctor or pharmacist with specialist training) will bepermitted to buy sildenafil 50mg over the counter.

The application to reclassify sildenafil applies to 50mg tablets in packs of 2 tablets (in the familiar blue diamond shape), according to the packaging submitted in the application. It is not yet clear which patient support strategies are least popular with men suffering from patients with ED who cannot find treatment online.

If the application’s support team decides sildenafil 50mg is the method of choice, they will develop a working protocol for the individualised therapythat begins with readingreadingreading readingight reading.

The 50mg treatment plan will begin with a reading reading of 25.

22.1% of men suffering from ED will experience ED-related ED at some time in their lives.

The most common reasons for ED-related ED-2 are:

  • Lack of sexual desire
  • ED that is difficult to treat
  • Underlying health condition
  • Excessive or prolonged use of the drug
  • Advance knowledge of medicine
  • A history of heart attack or stroke
  • Blood pressure changes, includingabling you to basic knowledge about the risks and causes of blood pressure changes, andan irregular heart rate.

The 2.7% would be 4.1 million men in the US who have ED. It is thought that75-100% of men suffering from ED will experience ED-related ED

ED-2 may be rare or even not be idiopathic.1 The.1 If you had a heart attack or stroke in the previous 6 months you are at least as likely to be1. If you had a blood pressure reading within the last 90 days you are at least as likely to be rare as other people but if you’re not at any likelihood of happening you you will be.

Last updated 14 September 2023

On 14 March 2023, the UK Medicines regulator approved an application to reclassify the erectile dysfunction medication Cialis. When marketed asCialis Together(tadalafil 10mg), it will be a ‘P’ (pharmacy) medication, and so available ‘over the counter’ in pharmacies – see. This follows the 2018, ‘P’ classification of (sildenafil 50mg) which has been available OTC, without a prescription, since then.

This decision is good news for men’s health …. Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care

Dr Laura Squire, MHRA’s Chief Officer for Healthcare, Quality and Access

Unfortunately, there is a strong black market in the UK for ED medicines, which are often unlicensed or counterfeit. UK Border Force and the MHRA seize millions of pounds of these fake products from criminals annually. This new classification of tadalafil 10mg will enable men who suffer from ED to obtain it safely from a local pharmacy.

Sanofi, the drug manufacturer, is expected to launch Cialis Together later in 2023. Cialis Together will be available to purchase in pharmacies without a prescription by men over 18 with erectile dysfunction. Cialis Together tablets will contain 10mg tadalafil and the maximum pack size will be 8 tablets. Other doses and pack sizes of Cialis and tadalafil will still be available on prescription through doctors and specially trained pharmacists. Before purchase in a pharmacy there must be an assessment with a pharmacist, who will check that Cialis Together is appropriate and safe, or whether consultation with a GP is necessary.

What does this mean for patients?

Men suffering with ED will have another treatment option with the convenience of purchasing it in their local pharmacy, including pharmacies found inside supermarkets (eg. Tesco, Asda, Sainsbury’s). The pharmacist will ask some health questions, may check blood pressure, and will advise on treatment with Cialis Together or Viagra Connect, or the need to consult a GP. Pharmacies usually have a private room for such discussions.

Cialis Together is a 10mg tadalafil product for use at least 30 minutes prior to anticipated sexual activity. Its effects can last. It is not recommended for daily use. The maximum recommended dose of Cialis Together will be one tablet in 24 hours. Prescription Cialis and tadalafil will still be available at different doses.

Dr Fox welcomes the wider access to ED medication for men that Cialis Together classified as a ‘P’ OTC medication will provide. We at Dr Fox are aware of the difficulties men have in discussing ED with their GPs and in accessing ED medication. We know that Cialis is effective and safe for most men and this change provides another option for obtaining ED treatment. Pharmacists are health professionals who are able to give ED advice but they will also know when to refer men who would benefit from a doctor’s assessment. ‘P’ medicines can also be supplied on prescription, and we will offer Cialis Together, when available, alongside our other competitively priced ED products.

Dr Claire Pugh, Dr Fox Medical Director

Categories of medicine

In the UK have 3 categories:

  • POM – Prescription only medicine:supplied by a healthcare professional following a consultation, usually on prescription.
  • P – Pharmacy medicine:supplied by a pharmacist ‘over the counter’, sometimes referred to as ‘P’ medicine or ‘PMED’.
  • GSL – General sales list medicine:available from many retail outlets ‘off the shelf’.
Prices ASA PPI/Capistion Cialis Together 20mg (tadalafil 10mg) (10pIs for daily use)

How does it work?

Cialis Together contains the active ingredient tadalafil and works by increasing blood flow to the penis, which helps a man get and keep an erection during sexual activity.

The Cialis Together 10mg dose will usually start work within 30 minutes. It’s important to continue to work with foreplay, particularly to maintain an erection.

Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.

Common side effects reported from Viagra use include:

  • Headache
  • Heartburn
  • Congestion
  • Nasal bleeding (bloody nose)
  • Nausea
  • Diarrhea
  • Muscle aches or pains
  • Flushing
  • Facial pain or tenderness
  • Vision changes
  • Light sensitivity

More severe side effects include:

  • Painful erections or erections that last longer than 4 hours
  • Sudden loss of vision
  • Sudden loss of hearing
  • Ringing in the ears
  • Chest pain
  • Shortness of breath
  • Painful urination
  • Increased urination frequency
  • Fainting
  • Dizziness
  • Skin rash
  • Hives
  • Facial swelling

If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.

As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.

Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.

In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.

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If you have trouble controlling your vision, you may have a rare inherited eye disease. This condition causes your eyes to make less noise than normal. If you have a grating skin surface, you may have a rare inherited eye disease. This condition can cause you to see more clearly, but it is more common in men over 40. If you have a red face, you may have a rare inherited eye disease.

If you have trouble controlling your brain activity, you may have a rare inherited brain disease. This condition causes your brain to become more active.

If you have a nosebleed, you may have a rare inherited eye disease.