Vardenafil Tablets

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

The recommended dose for adults:

One 10mg tablet, taken when required, prior to sexual activity. Vardenafil should be taken about 25 to 60 minutes before sexual activity. Do not take more than one dose within a 24 hour period. The tablet should be swallowed whole with a glass of water and may be taken with or without food.

With sexual stimulation, you may achieve an erection anywhere from 25 minutes up to 4–5 hours after taking Vardenafil.

Depending on effectiveness and tolerability, your doctor may suggest adjusting the dose if 10 mg is too weak or too strong. Lower doses may be recommended if you have liver or severe kidney problems.

Vardenafil is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. Vardenafil will only work when you are sexually stimulated and does not increase sexual desire.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. Excessive alcohol consumption should be avoided, as it may increase the risk of side effects such as dizziness when standing.

If you take more Vardenafil than you should

You may experience an increase in side effects and their severity. You should not take more tablets than your doctor tells you to. Contact your doctor if you take more tablets than you should.

Seeking medical attention

Prolonged erections and priapism have been reported with Vardenafil. In the event of an erection that persists for longer than 4 hours, medical attention is required. This is to prevent penile tissue damage and permanent loss of potency.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Side Effects

Very common

• Headache

Common

• Dizziness
• Flushing
• Blocked or runny nose
• Indigestion

Uncommon

• Sleep problems
• Numbness, pain or the sensation of pins and needles in your arms, legs, hands or feet
• sleepiness
• Problems with your sight, redness of the eye, effects on colour vision, eye pain and
• Discomfort, light sensitivity
• Ringing in the ears (tinnitus); a spinning sensation when standing or sitting (vertigo)– fast heart beat or pounding heart
• Breathlessness
• Stuffy nose
• Acid reflux, inflamed stomach (gastritis). You may have pain, nausea, vomiting, vomiting blood or have blood in your stools
• Gut or stomach pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth
• Raised levels of liver enzymes in your blood, which can be seen in a blood test
• Rash, reddened skin
• Back or muscle pain
• Increase in blood of a muscle enzyme (creatine phosphokinase), which can be seen in a blood test
• Muscle stiffness, cramping
• Prolonged erections
• Feeling unwell

Rare

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Increased pressure in the eye, watery eyes
• High or low blood pressure
• Nose bleed
• Sensitivity of the skin to sun light
• Painful erections, which can last for a long time
• Chest pain.

Frequency Not Known

• Blood in the urine (haematuria)
• Presence of blood in the semen (haematospermia).
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, dimmed, or blurred central vision or sudden decrease of vision

Serious Side Effects

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

Contact your doctor immediately and do not take Vardenafil if you notice the following:

Uncommon

• Swelling of the face, mouth, lips, tongue, throat or neck causing difficulty breathing or swallowing.

Rare

• Seizures
• Sudden chest pain which may spread to the neck or arm, with shortness of breath and a clammy feeling. These may be signs of a heart attack.
• Abnormally fast heart beats
• Heavy or pressing sensation on your chest with chest pain and an increased shortness of breath on exercise (these may be signs of problems with your heart such as angina)
• Temporarily decreased blood flow to parts of the brain.

Frequency Not Known

• Partial, sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed, or blurred central vision in one or both eyes has been experienced by patients
• Sudden decrease or loss of hearing
• Sudden death
• Bleeding in the brain
• Bleeding from the penis.

Patients who have taken medicines similar to Vardenafil have also experienced the following:

Numbness or weakness in the arms or legs, having one side of the face drop, headache, dizziness, confusion, sight or speech problems, one side of the face may be dropped. These are signs that the blood supply to the brain is cut off resulting in a stroke or if these signs are temporary, a transient ischaemic attack.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Warning & Precautions

Do not take Vardenafil:

• If you are allergic to vardenafil or any of the other ingredients of this medicine. Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Vardenafil Mylan.
• If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil could seriously affect your blood pressure
• If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infection
• If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines– if you have a severe heart or liver problem
• If you are having kidney dialysis
• If you have recently had a stroke or heart attack
• If you have or have had low blood pressure
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa)
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION)
• If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as vardenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Talk to your doctor or pharmacist before taking Vardenafil:

• If you have heart trouble. It may be risky for you to have sex
• If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram
• If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis
• If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia
• If you are elderly
• If you have low levels of potassium in your blood
• If you have stomach ulcers (also called gastric or peptic ulcers)
• If you have a bleeding disorder (such as haemophilia)
• If you are using any other treatments for erection difficulties

Your doctor will check your medical history and give you a physical examination before you start taking Vardenafil to try and identify the cause of the erectile dysfunction.

During treatment

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop using Vardenafil and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions

If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Vardenafil, stop taking Vardenafil and contact your doctor immediately.

Age Restrictions

Men aged 18 years and over.

Other Medicines and Conditions

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take Vardenafil with the following medicines:

• Nitrates, medicines for angina such as nicorandil or nitroglycerin, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil could seriously affect your blood pressure
• Riociguat
• Ritonavir or indinavir, medicines for HIV.Some medicines may cause problems, especially these:
• Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol
• Ketoconazole or itraconazole, anti-fungal medicines
• Erythromycin, or clarithromycin, macrolide antibiotics
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia) such as tamsulosin, terazosin and alfuzosin
• Nifedipine, used to treat blood pressure and angina.

Do not use Vardenafil film-coated tablets combined with any other treatment for erectile dysfunction.

Vardenafil with food, drink and alcohol

You can take Vardenafil with or without food – but preferably not after a heavy or high-fat meal as this may delay the effect.

Do not drink grapefruit juice when you use Vardenafil. It can interfere with the usual effect of the medicine.

Alcoholic drink can make erection difficulties worse.

Driving and using machines

Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Pregnancy and Breastfeeding

This medicine is not suitable for use in pregnancy and breastfeeding.

Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.11394.pdf

Ingredients

• Active Ingredients: Tadalafil
• Other Ingredients: Tablet Core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate. Tablet Coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

Product Information

• Brand Name: Vardenafil (Generic)
• Route of Administration: Oral
• Legal Classification: Prescription Only Medication (POM)
• Strength: 5mg, 10mg & 20mg
• Dosage From: Tablet

Storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Advice & Helpful Links

https://www.nhs.uk/conditions/erection-problems-erectile-dysfunction/