What Side Effects Can I Expect From Taking Levitra?

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Levitra is one of the treatments for erectile dysfunction available here at Assured Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about Levitra. We’ll cover what Levitra is, what it is used for, how to take it, who should not take it and any side effects you can expect from taking it.

Levitra

From: £37.00

What is Levitra?

Levitra is the brand name for a medication known as Vardenafil Hydrochloride. Each film−coated tablet of Levitra contains 5mg, 10mg or 20mg Vardenafil.
Levitra is available as round orange tablets marked with the BAYER-cross on one side and “5, 10 or 20” on the other side.

 

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The other substances (excipients) in each film coated Levitra tablet (that are inactive) include:

Tablet core:

  • Crospovidone
  • Magnesium stearate
  • Microcrystalline cellulose
  • Silica, colloidal anhydrous

Film coat:

  • Macrogol 400
  • Hypromellose
  • Titanium dioxide (E171)
  • Ferric oxide yellow (E172)
  • Ferric oxide red (E172)

The legal category for Levitra is POM. This means it is a prescription only medicine and supply can only be made according to the instructions in a prescription issued by a qualified doctor or non-medical prescriber.
You should not buy this or any other prescription-only medication without first speaking to a duly qualified and registered healthcare professional.

Levitra is also available as 10mg orodispersible tablets. Each orodispersible tablet contains 10mg of Vardenafil (as the Hydrochloride).

Excipients include:

  • Aspartame (E951)
  • Peppermint flavour
  • Magnesium stearate
  • Crospovidone
  • Mannitol (E421)
  • Silica colloidal hydrated
  • Sorbitol (E420)
  • There is 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.
  • Orodispersible Levitra tablets are available as white round tablets.

 

What is Levitra used for?

Levitra (Vardenafil) is indicated for the treatment of erectile dysfunction in adult men aged 18 years and older. For Levitra to be effective, sexual stimulation is required.

 

How do I take Levitra?

The recommended starting dose of Levitra is 10mg taken as a single dose when required roughly 25 – 60 minutes before sexual activity. Depending on how effective the starting dose was and how you tolerate it, you may increase subsequent doses to 20mg or decrease subsequent doses to 5mg. Levitra cannot be taken any more frequently than one dose per day. You may take Levitra on an empty stomach or after you have eaten. However, the onset of action may be delayed if you take Levitra after eating a meal with a high-fat content.
If taking the orodispersible Levitra tablets, the maximum daily dose is 10mg per day.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed. Levitra orodispersible tablets must be taken without liquid and immediately upon release from the blister.
Like the film-coated tablets, the orodispersible tablets can also be taken on an empty stomach or after eating.

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Who should not take Levitra?

Levitra is licensed for use in adult men only aged 18 years and older for the treatment of erectile dysfunction. Thus, any man who has not been diagnosed with erectile dysfunction cannot take Levitra.
Levitra is not licensed for use by women and children, so it should not be taken by women or children under the age of 18 years.
The effectiveness and safety of Levitra in men aged 65 years and older has not been assessed.
Adult men who are hypersensitive to the active ingredient Vardenafil or to any of the excipients, should not take Levitra.
Adult men with some pre-existing medical conditions or those taking certain classes of medications cannot take Levitra. Therefore, it is important for you to see a doctor to discuss your individual circumstances. You can either book a consultation with your regular GP or click here now so that you can have your clinical evaluation from the comfort of your home by having a remote consultation with our in-house doctor today.
It is important that during your consultation, you inform the doctor of all previous and existing conditions you have. You should also inform the doctor of all medications you are currently taking including herbal remedies and over the counter medications that you may have bought without needing a prescription. You should mention if you are allergic to any medication too or if there’s any medication you cannot or should not take for any reason.
The list of conditions and the list of medications that may affect the suitability of use of Levitra for your individual circumstances are outside the scope of this article. That is why it is important for you to have an in-depth consultation with a doctor before treatment is initiated. This way, you minimise the risk of any adverse effects occurring.

 

What side effects can I expect from taking Levitra?

Below is further information about the undesirable effects that may be seen from taking Levitra as provided by the marketing authorisation holder of Levitra.
The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is a headache.
Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The following adverse reactions have been reported:

Adverse reaction (MedDRA Preferred Term)

System Organ ClassVery commonCommonUncommonRareNot known
(Cannot be estimated from the available data)
Infection and infestationsConjunctivitis
Immune system disordersAllergic oedema and angiodemaAllergic reaction
Psychiatric disordersSleep disorderAnxiety
Nervous system disordersHeadacheDizzinessSomnolence, Paraethesia, DysaesthesiaSyncope, Seizure, Amnesia
Eye disordersVisual disturbance, Ocular hyperaemia, Visual colour distortions, Eye pain and eye discomfort, PhotophobiaIncrease in intraocular pressure, Lacrimation increasedNon-arteritic anterior ischaemic optic neuropathy, Visual defects
Ear and labyrinth disordersTinnitus, VertigoSudden deafness
Cardiac disordersPalpitation, TachycardiaMyocardial infarction, Ventricular tachyarrythmias, Angina pectoris
Vascular disordersFlushingHypotension, Hypertension
Respiratory, thoracic and mediastinal disordersNasal congestionDysponea, Sinus congestionEpistaxis
Gastrointestinal disordersdyspepsiaGastro-oesophagael reflux disease, Gastritis, Gastrointestinal and abdominal pain, Diarrhoea, Vomiting, Nausea, Dry mouth
Hepatobilliary disordersIncrease in transaminasesIncrease in gamma-glutamyl-transferase
Skin and subcutaneous tissue disordersErythema, RashPhotosensitivity reaction
Musculoskeletal and connective tissue disordersBack pain, Increase in creatine phospokinase, Myalgia, Increased muscle tone and cramping
Renal and urinary disordersHaematuria
Reproductive system and breast disordersIncrease in erectionPriapismPenile haemorrhage, Haematospermia
General disorders and administration site conditionsFeeling unwellChest pain

Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
At the 20 mg dose, Levitra film-coated tablets, elderly (≥ 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (< 65 years old). In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.

Levitra

From: £37.00

Post-marketing reports of another medicinal product of this class
Vascular disorders

Serious cardiovascular reactions, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post-marketing in temporal association with another medicinal product in this class.

 

Reporting of suspected adverse reactions

Reporting of all suspected adverse reactions is important. It allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients are asked to report any suspected adverse reactions via the Yellow Card Scheme.
You can find out more information about the Yellow Card Scheme by clicking here.

Is there anything else I need to know about Levitra?
Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10 mg film-coated.
A physical examination may be required to diagnose your erectile dysfunction and determine potential underlying causes before pharmacological treatment is considered.
Grapefruit or grapefruit juice should be avoided whilst taking Levitra. This is because taking both at the same time could lead to an increase in the blood plasma concentration of Levitra. This increase in blood plasma concentration of Levitra could potentially increase the risk and severity of side effects.
If you develop any visual defects suddenly, you should stop taking Levitra and consult a doctor immediately.
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If you would like more information about Levitra, please click here to fill out our contact form. Alternatively, you can call us on 01625 460 621.
Should you need urgent medical assistance, please dial 999.

 

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References

  1. https://bnf.nice.org.uk/drug/vardenafil.html#indicationsAndDoses
  2. https://www.medicines.org.uk/emc/product/7629/smpc

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]