Avarante 10 mg film-coated tablets contain tadalafil, a treatment for erectile dysfunction in adult men, meaning difficulty getting or keeping an erection hard enough for satisfactory sexual activity. This pack contains 2 tablets. Each tablet is taken only when needed, before anticipated sexual activity, so there is no need to take it every day.

Key Features

• Tadalafil 10 mg: Tadalafil belongs to a group of medicines called PDE5 inhibitors. It helps the blood vessels in the penis relax, allowing blood to flow into the penis.
• Taken as needed: Take one tablet at least 30 minutes before sexual activity, with or without food. Avarante is not recommended for continuous daily use.
• Up to 36 hours: After taking one tablet, you can get an erection when sexually stimulated, from 30 minutes and for up to 36 hours.
• Pack of 2 tablets: Each pack contains 2 light yellow, round, film-coated 10 mg tablets in a blister pack. No more than 1 tablet should be taken in a day.

Will Avarante work without sexual arousal?

No. You will not get an erection just by taking Avarante. It only helps you get an erection if you are sexually stimulated.

What if Avarante does not work the first time?

For most men, Avarante works the first or second time they try it. If it has been some time since you were able to get or keep an erection, it may take several attempts. You can only take one tablet a day. If you have taken Avarante as directed and still cannot get and keep an erection, talk to your pharmacist or doctor.

Can I drink alcohol or grapefruit juice with Avarante?

Grapefruit juice may affect how well Avarante works and must be avoided. Drinking excessive alcohol can temporarily reduce your ability to get an erection, so you are advised not to drink large amounts of alcohol before sexual activity.

Do I need a check-up if I use Avarante?

Yes. It is important to have a check-up with your doctor as soon as possible within the first 6 months of using Avarante. Erectile dysfunction may be an early sign of heart and blood vessel problems, diabetes, high blood pressure or depression, even if you feel healthy.

Active ingredient: Tadalafil 10 mg per tablet.

Other ingredients: Tablet core: anhydrous lactose, poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate and anhydrous colloidal silica. Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172) and triacetin.

Additional information: Contains lactose. Contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially sodium free.

Take Avarante exactly as described in the leaflet or as your pharmacist or doctor has told you.

• Take one tablet as needed, at least 30 minutes before sexual activity.
• Swallow the tablet whole with water. It can be taken with or without food.
• Do not take more than 1 tablet a day.

Avarante is intended for use before anticipated sexual activity and is not recommended for continuous daily use. Talk to your doctor if you feel you need to take it every day. If you feel the effect is too strong or too weak, talk to your pharmacist or doctor.

If you take more Avarante than you should, contact your doctor.

Do not take Avarante in any of the following situations:

• You take nitrates or nitric oxide donors, such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate, nicorandil, molsidomine or sodium nitroprusside. The combination may lead to a dangerous fall in blood pressure.
• You take amyl nitrite ("poppers") as a recreational drug, as the combination may lead to a dangerous fall in blood pressure.
• You take riociguat or other guanylate cyclase stimulators, used to treat high blood pressure in the lungs.
• You have been advised by your doctor to avoid sexual activity because of a heart or blood vessel problem, such as a heart attack within the last 90 days, a stroke within the last 6 months, unstable angina or severe cardiac failure.
• You have low blood pressure or uncontrolled high blood pressure.
• You have ever lost vision because of non-arteritic anterior ischaemic optic neuropathy (NAION).
• You have a deformed penis, such as angulation, cavernosal fibrosis or Peyronie's disease.
• You do not have an erection problem, as the medicine will not benefit you.
• You are allergic to tadalafil or any of the other ingredients.
• You are a woman, or you are under 18 years of age.

Talk to your pharmacist or doctor before taking Avarante if any of the following apply:

• You have a heart problem or think you might have one, as sexual activity can put extra strain on your heart. Tell your doctor if you get very breathless or have chest pain with light or moderate activity, have had heart disease or heart surgery, have uncontrolled high blood pressure, or have Multiple System Atrophy.
• You have ever had an erection lasting more than 4 hours (priapism), or a condition that can cause it, such as sickle cell anaemia, leukaemia or multiple myeloma.
• You have a serious liver problem or a severe kidney problem.
• You have had pelvic surgery or a radical non-nerve-sparing prostatectomy, as it is not known whether Avarante will be effective for you.
• You have a hereditary degenerative retinal disorder such as retinitis pigmentosa, as it is unknown whether tadalafil is safe for you.
• You take an alpha blocker such as alfuzosin, doxazosin or tamsulosin, other medicines for high blood pressure, finasteride, itraconazole, ketoconazole, rifampicin, erythromycin, clarithromycin, ritonavir, saquinavir, phenobarbital, phenytoin, carbamazepine, other treatments for erectile dysfunction, theophylline, terbutaline or cimetidine.

Other precautions:

• Stop taking Avarante and contact your doctor immediately if you have a sudden decrease or loss of vision, or your vision is distorted or dimmed. Do the same if you have decreased or sudden hearing loss.
• Avoid grapefruit juice, and avoid large amounts of alcohol before sexual activity.
• Avoid using Avarante with other recreational drugs, including nitrous oxide, GHB/GBL, methamphetamines, MDMA/ecstasy, ketamine, flunitrazepam, cannabis, opioids and cocaine, as it may lead to side effects such as dizziness, decreased blood pressure, stroke or heart attack, seizures, an unintended prolonged and sometimes painful erection lasting longer than 4 hours, and coma.
• Some men in clinical studies reported dizziness. Check how you react to the tablets before driving or using machines.
• If you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Like all medicines, Avarante can cause side effects, although not everybody gets them. These effects are normally mild to moderate. This list does not include every possible side effect.

Stop using Avarante and seek medical help immediately if you get:

• An allergic reaction (uncommon), with symptoms such as sudden wheeziness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, or rashes
• Chest pain (uncommon). If it occurs before, during or after intercourse, get into a semi-sitting position and try to relax. Do not use nitrates to treat chest pain
• A persistent and possibly painful erection lasting longer than 4 hours (rare)
• Sudden loss of vision (rare), or distorted, dimmed, blurred central vision or a sudden decrease of vision (frequency not known)
• Stevens-Johnson Syndrome, a rare, serious skin disorder causing flu-like symptoms and a painful rash that spreads and blisters

Common (may affect up to 1 in 10 people)

• Headache, back pain, muscle aches, pain in the arms and legs, facial flushing, nasal congestion and indigestion

Uncommon (may affect up to 1 in 100 people)

• Dizziness, stomach ache, feeling sick, being sick, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, pounding heartbeat, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired

Rare (may affect up to 1 in 1,000 people)

• Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives, penile bleeding, blood in semen and increased sweating
• Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known heart problems before taking the medicine
• Partial, temporary or permanent decrease or loss of vision in one or both eyes

Reported in men taking Avarante but not seen in clinical trials (rare)

• Migraine, swelling of the face, serious allergic reaction causing swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death

Dizziness has been reported more frequently in men over 75 years of age, and diarrhoea more frequently in men over 65 years of age.

If you get any side effects, talk to your doctor or pharmacist. You can also report them through the MHRA Yellow Card Scheme at www.mhra.gov.uk/yellowcard.