Aronix 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 50mg tablet, taken when required, approximately one hour before sexual activity. The tablet should be swallowed whole with water. Do not take more than one tablet within a 24 hour period.

The amount of time Aronix takes to work varies from person to person, but it normally takes between 30 and 60 minutes. In some cases, it may be taken up to 4 hours before sexual activity.

Aronix may be taken with or without food. However, if taken with food, the onset of action may be delayed compared with taking it on an empty stomach. You should also avoid grapefruit juice while taking Aronix, as it may affect how the medicine is processed in the body.

Aronix will only help you achieve an erection if you are sexually aroused.

If Aronix does not work the first time, remain patient and try again on another occasion, remembering that you must not take more than one tablet per day. For most men, Aronix will work the first or second time they try it. If it has been some time since you wereable to get or keep an erection, it may take a couple of attempts before you achieve the desired effect. Talk to your doctor if you have tried Aronix, and are still not able to get and keep an erection.

Speak to your doctor if you have tried Aronix and are still unable to get or keep an erection.  If you feel the effect of Aronix is too strong, speak to your pharmacist or doctor for advice.

If you take more Aronix than you should

If you take more tablets than recommended, contact your pharmacist or doctor immediately. Taking more than the recommended dose may result in side effects and/or more severe side effects.

Seeking medical attention

Prolonged erections and priapism have been reported with sildenafil. If you experience an erection that persists for longer than 4 hours, seek immediate medical attention. Prompt treatment is necessary to prevent penile tissue damage and possible 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

• Nausea, indigestion, stuffy nose, dizziness
• Facial flushing, hot flush (a sudden feeling of heat in your upper body)
• Colour tinge to vision, blurred vision, visual disturbance
• Uncommon (may affect up to 1 in 100 people):
• Vomiting, upper abdominal pain, acid reflux (including heartburn)
• Skin rash, pain in the arms or legs, nosebleed, feeling hot, feeling tired (fatigue)
• Eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes
• Pounding heartbeat, rapid heartbeat
• High blood pressure
• Low blood pressure (typical signs are dizziness, fainting, blurred vision, nausea and tiredness)
• Muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears
• Dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (can be experienced as runny nose, sneezing and stuffy nose)
• Presence of blood in urine

Rare

• Fainting, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing
• Sudden unexpected death caused by loss of heart function (sudden cardiac arrest), stroke, heart attack, chest pains (angina), irregular heartbeat, temporary decreased blood flow to parts of the brain
• Feeling of tightening of the throat, numb mouth
• Bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye
• Penile bleeding, presence of blood in semen

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious side effects:

• Chest pains: this occurs uncommonly. If this occurs before, during or after sexual activity: Get in a semi-sitting position and try to relax. Do NOT use nitrates to treat your chest pain.
• A prolonged and sometimes painful erection lasting longer than 4 hours: this occurs rarely.
• A sudden decrease or loss of vision: this occurs rarely.
• An allergic reaction: this occurs uncommonly. Symptoms include sudden wheeziness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Serious skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Syndrome (TEN): this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes and fever.
• Seizures or fits: this occurs rarely.

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 Aronix if you:

• do not have an erection problem
• take any nitrate medicine for chest pain, or heart failure
• take amyl nitrite, so called “poppers” as recreational drugs
• take riociguat (or other guanylate cyclase stimulators) for high blood pressure in the lungs
• take ritonavir for the treatment of HIV 
• have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels
• have a severe heart problem such as a recent heart attack or stroke (within the last 6 months), unstable angina (chest pain) or severe cardiac failure (reduced pumping capacity of the heart)
• have a severe liver problem
• have low blood pressure (below 90/50 mmHg) which can cause symptoms such as tiredness, dizziness, light-headedness, feeling sick, clammy skin, depression, loss of consciousness, or blurry vision
• have ever had severe vision loss because of nerve damage in the eyes, such as non-arteritic anterior ischaemic optic neuropathy (NAION); or have a rare inherited eye disease, such as retinitis pigmentosa
• have a deformed penis
• are a woman
• are under 18 years of age
• are allergic to sildenafil or any of the other ingredients of this medicine 

You should schedule a health check-up with your doctor as soon as possible within the first 6 months of starting to use Aronix to ensure that your erection problems are not caused by any serious health condition.

Erectile dysfunction may be an early sign of:

• Cardiovascular disease
• Diabetes
• High blood pressure
• High cholesterol

Tell your doctor about your problems if you have not already done so.

Cardiovascular risk factors

Sexual activity can put a strain on your heart. Talk to your doctor before taking Aronix if you:

• get very breathless or feel any pain in the chest with light or moderate activity (e.g. walking briskly for 20 minutes or climbing two flights of stairs). Your doctor may need to check whether your heart can take the additional strain of having sex.
• have a problem with a valve in your heart (valvular heart disease).
• have a disease in which the heart muscle becomes inflamed and does not work as well as it should (cardiomyopathy).
• have an irregular heartbeat(arrhythmia).
• you have had surgery to improve blood flow to your heart, or you have high blood pressure which is now adequately treated.
• have high blood pressure that is not controlled.

Other risk factors:

Talk to your doctor before taking Aronix if you:

• have ever had an erection that lasted more than 4 hours (priapism). Some conditions can increase the probability of having a persistent erection, such as sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow). Use of impotence medicines may increase the risk of priapism. Long lasting erection may cause damage to the tissue in the penis and permanent loss of ability to have an erection.
• have a stomach ulcer or a bleeding disorder (such as haemophilia).
• have previously been diagnosed with mild to moderate liver disease, or severe kidney problems. Aronix may not be suitable for you, you should consult your doctor before taking Aronix.

If you experience any sudden visual defect you should stop taking Aronix and contact your doctor immediately. Cases of visual effects have been reported when using sildenafil.

Age Restrictions

Men aged 18 years and over.

Other Medicine and Conditions

Tell your pharmacist or doctor if you are taking, have recently taken or might take any other medicines. Some medicines may be affected by Aronix or they may affect how Aronix works and this may result in side effects.

Do not use Aronix if you take:

• Nitrate medicines: Do not take Aronix if you are taking nitrate medicines (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate) against chest pain (angina pectoris) or heart failure or “poppers” as recreational drugs (nitric oxide donors (such as amyl nitrite), nicorandil or sodium nitroprusside). This is because these substances could lead to a dangerous fall in blood pressure if taken together with Aronix.
• Riociguat: Do not take Aronix if you are taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators). Riociguat is used to treat high blood pressure in the lungs and can lead to a dangerous fall in blood pressure if taken together with Aronix.
• Medicines to treat HIV-infections: Ritonavir is a medicine used to treat HIV- infections. Do not take Aronix if you are taking ritonavir since this combination can lead to a dangerous fall in blood pressure.

Talk to your pharmacist or doctor before using Aronix if you are taking:

• Medicines to treat fungal infections and antibiotics: Medicines to treat fungal infections called itraconazole or ketoconazole and an antibiotic called erythromycin increase the concentration of Aronix in the body and may result in side effects. You should contact your doctor before taking Aronix if you are using these medicines.
• Heartburn treatment: The medicine to treat heartburn, cimetidine, increases the concentration of Aronix in the body and may result in side effects. You should contact your doctor before taking Aronix.
• Other treatments for erectile dysfunction: The safety and efficacy of combinations of Aronix with other treatments for erectile dysfunction have not been studied and this combination is therefore not recommended.
• Alpha-blockers used to treat urinary problems or high blood pressure: Alpha-blockers used to treat urinary problems due to enlarged prostate (such as alfuzosin, doxazosin or tamsulosin) may lead to dizziness, light-headedness, nausea, fainting, lack of concentration, or blurred vision due to low blood pressure (symptomatic hypotension).
• Medicines containing sacubitril/valsartan, used to treat heart failure: You should contact your doctor or pharmacist before taking Aronix.

Aronix with food and drink

Aronix can be taken with or without food. When this medicine is taken after a high-fat meal, it may take a little longer to start working. Do not take Aronix with grapefruit or grapefruit juice, because this can affect how the medicine works.

Drinking excessive alcohol can temporarily reduce your ability to achieve an erection. To get a benefit from the medicine, you are advised not to drink large amounts of alcohol before sexual activity.

Driving and using machines

Aronix can cause dizziness and can affect vision. You should be aware of how you react to Aronix before you drive or use machinery.

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.11008.pdf

Ingredients

• Active Ingredients: Sildenafil
• Other Ingredients: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, hydroxy propyl cellulose, magnesium stearate. Tablet coating: hypromellose (E464), lactose monohydrate, triacetin (E1518), titanium dioxide (E171), lake indigo carmine (E132).

Product Information

• Brand Name: Aronix
• Route of Administration: Oral
• Legal Classification: Prescription Only Medication (POM)
• Strength: 50mg
• 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 foil after EXP. The expiry date refers to the last day of that month.
• This medicine 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 to protect the environment.

Advice & Helpful Links

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