Sildenafil Alter

PACKAGE LEAFLET: INFORMATION FOR THE USER

SILDENAFIL ALTER 25 mg chewable tablets, 50 mg chewable tablets, 100 mg chewable tablets

Sildenafil
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What SILDENAFIL ALTER is and what it is used for
  2. What you need to know before taking SILDENAFIL ALTER
  3. How to take SILDENAFIL ALTER
  4. Possible side effects
  5. How to store SILDENAFIL ALTER
  6. Contents of the pack and other information

1. WHAT SILDENAFIL ALTER IS AND WHAT IT IS USED FOR

SILDENAFIL ALTER contains the active substance sildenafil, which belongs to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax blood
vessels in the penis, allowing increased blood flow to the penis during sexual stimulation. SILDENAFIL ALTER will help you achieve an erection only if you are sexually stimulated.
SILDENAFIL ALTER is a treatment for men who have erectile dysfunction, sometimes
called impotence. This condition occurs when a man is unable to achieve or maintain an erection suitable for sexual intercourse.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SILDENAFIL ALTER

Do not take SILDENAFIL ALTER

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines called nitrates, because this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”). If in doubt, consult your doctor or pharmacist;
• if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous drop in blood pressure;
• if you are taking riociguat. This medicine 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). It has been shown

that PDE5 inhibitors, such as Viagra, increase the hypotensive effect of this medicine. If you are taking
riociguat or have any doubts, inform your doctor;

• if you have a serious heart or liver problem;
• if you have recently had a stroke or heart attack, or if you have low blood pressure;
• if you have certain rare inherited eye diseases (such as retinitis pigmentosa);
• if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking SILDENAFIL ALTER

• if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (blood cell cancer), or multiple myeloma (bone marrow cancer);
• if you have a penile deformity or Peyronie’s disease;
• if you have heart problems. In this case, your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity;
• if you currently have a stomach ulcer or bleeding disorders (such as haemophilia);
• if you experience a sudden decrease or loss of vision, stop taking SILDENAFIL ALTER and contact your doctor immediately. You must not use SILDENAFIL ALTER together with other oral or topical treatments for erectile dysfunction.

SILDENAFIL ALTER must not be used with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or other PDE5 inhibitors.
It is recommended not to take SILDENAFIL ALTER if you do not have erectile dysfunction.
You must not take SILDENAFIL ALTER if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to
administer a lower dose.
Children and adolescents
SILDENAFIL ALTER must not be administered to individuals under 18 years of age.
Other medicines and SILDENAFIL ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Medicines containing sacubitril/valsartan, used to treat heart failure.
SILDENAFIL ALTER chewable tablets may interact with certain medicines, especially
those used to treat chest pain. In case of a medical emergency,
you must inform the doctor, pharmacist, or nurse that you have taken SILDENAFIL ALTER and when
you took it. Do not take SILDENAFIL ALTER together with other medicines unless
authorized by your doctor.
Do not take SILDENAFIL ALTER if you are taking medicines called nitrates, because
the combination with these medicines may cause a potentially dangerous drop in
blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of
these medicines, which are often used to relieve angina attacks (or “chest pain”).
Do not take SILDENAFIL ALTER if you are using medicines known as
nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may
also cause a potentially dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, such as those used to treat HIV,
your doctor may initially prescribe the lowest dose of SILDENAFIL ALTER (25 mg).
Some patients being treated with alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or a sensation of “lightheadedness,” which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking SILDENAFIL ALTER together with alpha-blockers. This is more likely to occur within 4 hours after taking SILDENAFIL ALTER. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with SILDENAFIL ALTER. Your doctor may start you on a lower dose of SILDENAFIL ALTER (25 mg).
SILDENAFIL ALTER with food and drink and alcohol
SILDENAFIL ALTER may be taken with or without food. However, you may notice that the effect of
SILDENAFIL ALTER may occur more slowly if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using SILDENAFIL ALTER.
Pregnancy, breastfeeding and fertility
In women, the use of SILDENAFIL ALTER is not indicated.
Driving and using machines
SILDENAFIL ALTER may cause dizziness and may affect vision. Before driving or
using machinery, you should be aware of how you react to SILDENAFIL ALTER.
SILDENAFIL ALTER chewable tablets contain aspartame, a source of phenylalanine. If
you have phenylketonuria (a rare inherited metabolic disorder), you should take this into account.
SILDENAFIL ALTER chewable tablets contain lactose. If your doctor has informed you that you have
an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE SILDENAFIL ALTER

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is 50 mg.
SILDENAFIL ALTER must not be taken more than once a day.
Take SILDENAFIL ALTER approximately one hour before anticipated sexual activity. The tablet must be chewed whole.
If you feel that the effect of SILDENAFIL ALTER is too strong or too weak, consult your doctor or pharmacist.
SILDENAFIL ALTER will help you achieve an erection only if you are sexually stimulated. The time needed for SILDENAFIL ALTER to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of SILDENAFIL ALTER may take longer if you have recently eaten a heavy meal.
If SILDENAFIL ALTER does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more SILDENAFIL ALTER than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions reported with sildenafil are usually mild to moderate in intensity and of short duration.
If you experience any of the following serious side effects, stop taking SILDENAFIL ALTER and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (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 – occurs uncommonly. If this occurs during or after sexual intercourse:
  • Adopt a semi-sitting position and try to relax.
  • Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, blisters in the mouth, genital area or around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper part of the body), indigestion, increased brightness of colours in vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, ocular hyperaemia, eye pain, light flashes, visual brightness, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastro-oesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, epistaxis, sensation of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, dilated pupils, change in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, and sudden decrease or loss of hearing.

From post-marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, of the men who experienced these adverse reactions had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events are directly related to the use of sildenafil.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SILDENAFIL ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions; store in the
original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What SILDENAFIL ALTER contains

• The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil.
• The other components are: potassium polacrilin, anhydrous colloidal silica, monohydrate lactose, povidone K-30, aspartame, sodium croscarmellose, peppermint flavour, magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

Description of the appearance of SILDENAFIL ALTER and contents of the pack
25 mg: White, triangular, biconvex tablets, embossed with '25' on one side.
50 mg: White, triangular, biconvex tablets, embossed with '50' on one side.
100 mg: White, triangular, biconvex tablets, embossed with '100' on one side.
Blister packs containing 4 or 8 chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Laboratori Alter s.r.l., via Egadi 7, 20144 Milano
Manufacturers
Genepharm S.A.
18 km Marathon Avenue, Pallini Attiki-15351
Greece
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