Sildenafil Aristo 25 mg, 4 tablets, Aristo Pharma

Sildenafil Aristo 25 mg is a medicine used to treat erectile dysfunction in adult men.

It contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Each film-coated tablet contains 25 mg of sildenafil (as citrate).

Sildenafil Aristo is used to treat erectile dysfunction, sometimes called impotence. This is the inability to get or keep an erection of the penis sufficient for sexual intercourse.

The medicine works by widening the blood vessels in the penis, allowing blood to flow into the penis during sexual arousal.

Sildenafil Aristo helps to achieve an erection of the penis only during sexual stimulation.

Indications:

Sildenafil Aristo is used to treat erectile dysfunction in adult men.

Action:

It helps the blood vessels in the penis relax, increasing blood flow to the penis during sexual arousal.

Composition:

• 1 tablet contains: active ingredient: sildenafil (as citrate) 25 mg
• Other ingredients: tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica; coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, indigo carmine lake (E 132), yellow iron oxide (E 172).

How to use:

• Always use this medicine exactly as your doctor or pharmacist has told you or as described in the package leaflet. If you are not sure, check with your doctor or pharmacist
• Adults: 1 tablet of 25 mg once a day
• Sildenafil Aristo should be taken approximately one hour before planned sexual activity
• Swallow the tablet whole with a glass of water
• If you have previously taken medicines containing sildenafil at a dose of 50 mg or more, the recommended dose is 50 mg
• Sildenafil Aristo will only help the patient to achieve an erection when sexually stimulated.

Contraindications:

• If you are allergic to sildenafil or any of the other ingredients of this medicine
• If you are taking medicines called nitrates, as concomitant use can lead to a dangerous drop in blood pressure. You should tell your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are not sure, check with your doctor or pharmacist
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), as taking them at the same time can cause a dangerous drop in blood pressure
• If you are taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Sildenafil Aristo, have been shown to enhance the blood pressure-lowering effects of this medicine. If you are taking riociguat or have any concerns, tell your doctor
• If you have serious heart or liver disease
• If you have recently had a stroke or heart attack, or have low blood pressure
• If you have a rare inherited eye disease (for example, retinitis pigmentosa, retinitis pigmentosa)
• If you have ever had vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Adverse reactions:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects seen with Sildenafil Aristo are usually mild to moderate and short-lived.

If you experience any of the following side effects, stop taking Sildenafil Aristo and seek medical advice immediately:

Allergic reaction: occurs rarely (may affect up to 1 in 100 people). Symptoms include: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat

Chest pain: uncommon.

If the pain occurs during or after sexual intercourse:

• You should assume a semi-sitting position and try to relax
• Do not take nitrates to relieve chest pain.

Excessively prolonged and sometimes painful erections: occurs rarely (may affect up to 1 in 1,000 people).

If the erection lasts more than 4 hours, contact your doctor immediately.

Sudden deterioration or loss of vision: occurs rarely.

Serious skin reactions: occur rarely.

Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals and around the eyes, fever.

Convulsions or fits: occur rarely.

Very common side effects (may affect more than 1 in 10 people):

• headache.

Common side effects (may affect up to 1 in 10 people):

• nausea
• sudden redness of the face
• hot flushes (symptoms include a feeling of heat in the upper body)
• indigestion
• vision with a coloured glow
• blurred vision
• visual disturbances
• feeling of a blocked nose
• dizziness.

Uncommon side effects (may affect up to 1 in 100 people):

• vomiting
• rash
• eye irritation
• eye congestion and/or redness of the eyes
• eye pain
• seeing flashes of light
• bright vision
• sensitivity to light
• watery eyes
• heart palpitations
• fast heartbeat
• high blood pressure
• low blood pressure
• muscle pain
• feeling sleepy
• weakened sense of touch
• vertigo of labyrinthine origin
• ringing in the ears
• dry mouth
• blocked or blocked sinuses
• rhinitis (symptoms include runny nose, sneezing and nasal congestion)
• upper abdominal pain
• gastroesophageal reflux disease (symptoms include heartburn)
• blood in the urine
• pain in the arms or legs
• nose bleeds
• feeling hot and tired.

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

• fainting
• impact
• heart attack
• irregular heartbeat
• a temporary reduction in blood flow to parts of the brain
• feeling of tightness in the throat
• numbness of the lips
• bleeding at the back of the eye
• double vision
• decreased sharpness of vision
• abnormal sensations inside the eye
• swelling of the eyes or eyelids
• small particles or dots in the field of vision
• seeing halos around light sources
• dilation of the pupil
• abnormal discolouration of the whites of the eyes
• bleeding from the penis
• blood in the semen
• dry nose
• swelling inside the nose
• feeling irritable
• sudden weakness
• hearing loss.

Rare cases of unstable angina (heart disease) and sudden death have been reported following the marketing of Sildenafil.

Interestingly, most, but not all, of the men who experienced these side effects had heart problems before taking Sildenafil.

It is not possible to determine whether these side effects are directly related to the use of Sildenafil.

Interactions:

• Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take. Sildenafil Aristo film-coated tablets may interact with some medicines, especially those used to treat chest pain. In case of a medical emergency, tell your doctor, pharmacist or nurse that you are taking Sildenafil Aristo and when you last took it. Do not use Sildenafil Aristo with other medicines without your doctor's consent
• You should not take Sildenafil Aristo if you are taking medicines from the nitrate group, as the combination of these medicines can lead to a dangerous reduction in blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of the medicines used to treat angina (or 'chest pain')
• You should not take Sildenafil Aristo if you are taking medicines known as nitric oxide donors, such as amyl nitrite (so-called poppers), as the combination may cause a dangerous drop in blood pressure
• If you are already taking riociguat, tell your doctor or pharmacist
• If you are taking protease inhibitors, used to treat HIV infection, talk to your doctor before taking the medicine; in this case it is recommended to start treatment with the lowest dose (25 mg) of Sildenafil Aristo
• Some patients taking alpha-blocker medicines to treat high blood pressure or prostate enlargement may feel dizzy or light-headed, which may be caused by a drop in blood pressure when sitting or standing up quickly. These symptoms may occur in some patients who take alpha-blockers and Sildenafil Aristo at the same time. This is most likely to happen within 4 hours of taking Sildenafil Aristo. To reduce the chance of these symptoms occurring, you should take a regular daily dose of an alpha-blocker before you start taking Sildenafil Aristo. Your doctor may decide to start you on the lowest dose (25 mg) of Sildenafil Aristo. If you experience symptoms of low blood pressure (dizziness, light-headedness, feeling faint), you are advised to first lie down or sit down and wait for the symptoms to subside; drinking water, getting some fresh air and crossing your legs may also help. Avoid standing up or sitting down quickly
• If you are taking ketoconazole (a medicine for fungal infections), erythromycin (an antibiotic) or cimetidine (a medicine for heartburn), consult your doctor before taking Sildenafil Aristo
• Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan for the treatment of heart failure.

Warnings and Precautions:

Talk to your doctor, pharmacist or nurse before taking Sildenafil Aristo

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of the bone marrow)
• If you have a deformity of the penis or Peyronie's disease
• If you have heart problems. In this case, your doctor will need to assess whether your heart condition can support the additional strain associated with sexual activity
• If you have a stomach ulcer or bleeding disorder (such as haemophilia)
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Aristo and contact your doctor immediately
• Do not use Sildenafil Aristo at the same time as other oral medications or topical treatments for erectile dysfunction
• Sildenafil Aristo should not be used at the same time as treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors
• Sildenafil Aristo should not be taken if you do not have erectile dysfunction
• You may experience an increase in the frequency and severity of side effects. Doses above 100 mg do not increase the effectiveness of the medicine
• Do not take more tablets than those stated in the package leaflet.

Recommendations for patients with kidney or liver problems

• Tell your doctor if you have kidney or liver problems
• Patients with kidney or liver problems should not use a dose of sildenafil higher than 25 mg (you should not use Sildenafil Aristo 50 mg).

Pregnancy, breast-feeding and effects on fertility

• Sildenafil Aristo is not intended for use by women.

Driving and using machines

• Sildenafil Aristo may cause dizziness and visual disturbances
• Before you drive or use machines, you need to know how you react to Sildenafil Aristo.

Sildenafil Aristo contains sodium

• This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Sildenafil Aristo with food, drink and alcohol

• Sildenafil Aristo can be taken with or without food. If Sildenafil Aristo is taken with a large meal, its effect may be delayed
• The ability to have an erection may be temporarily impaired after drinking alcohol. To fully utilize the therapeutic potential of Sildenafil Aristo, you should not drink significant amounts of alcohol before taking the drug.

Storage:

Store at room temperature.

Presentation: 4 tablets