SILDENAFIL 25 mg Chewable Tablets

Зміст інструкції

1. SILDENAFIL ALTER 25 mg chewable tablets, 50 mg chewable tablets, 100 mg chewable tablets
   1. WHAT IS SILDENAFIL ALTER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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

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

Sildenafil

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even 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 you take 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 IS SILDENAFIL ALTER AND WHAT IS IT USED FOR

SILDENAFIL ALTER contains the active ingredient sildenafil, which belongs to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the
blood vessels in your penis, allowing blood to flow into the penis when you are sexually
stimulated. SILDENAFIL ALTER will only help you to achieve an erection 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 cannot get or keep an erection firm enough for
sexual intercourse.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 can cause a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines which are often used to relieve angina attacks (or “chest pain”). If you are unsure, ask your doctor or pharmacist;
• if you are taking one of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 if you have any doubts, tell your doctor;

• if you have a serious problem with your heart or liver;
• if you have recently had a stroke or a heart attack, or if you have low blood pressure;
• if you have some rare hereditary eye diseases (such as retinitis pigmentosa);
• if you have ever had a loss of vision caused by a 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 anemia (an abnormality of red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow);
• if you have a deformity of the penis or Peyronie's disease;
• if you have problems with your heart. In this case, your doctor will need to carefully check that your heart condition allows you to cope with the exertion of sexual intercourse;
• if you currently have a stomach ulcer, or problems with blood clotting (such as hemophilia);
• if you experience a sudden decrease or loss of vision, stop taking SILDENAFIL ALTER and contact your doctor immediately. You should not use SILDENAFIL ALTER together with other oral or topical treatments for erectile dysfunction.

You should not use SILDENAFIL ALTER 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 suffer from erectile dysfunction.
You should 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, you should tell your doctor. Your doctor may decide to
give you a lower dose.

Children and adolescents
SILDENAFIL ALTER should not be given to people under 18 years of age.

Other medicines and SILDENAFIL ALTER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Medicines containing sacubitril/valsartan, used to treat heart failure.
SILDENAFIL ALTER chewable tablets may interfere with some medicines, especially
those used to treat chest pain. If a medical emergency occurs, you should inform your doctor, pharmacist or nurse that you have taken SILDENAFIL ALTER and when
you took it. Do not take SILDENAFIL ALTER with other medicines unless your doctor has
authorized it.
You should not take SILDENAFIL ALTER if you are taking nitrate medicines because
the combination with these medicines can cause a potentially dangerous drop in
blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of
these medicines which are often used to relieve angina attacks (or “chest
pain”).
You should not take SILDENAFIL ALTER if you are using one of the medicines known as
nitric oxide donors, such as amyl nitrite (“poppers”) because this combination can also
cause a potentially dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, such as those for the treatment
of HIV, your doctor may initially prescribe SILDENAFIL ALTER at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged
prostate may experience dizziness or lightheadedness which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these
symptoms when they have taken SILDENAFIL ALTER together with alpha-blockers. This is more
likely to occur within 4 hours of taking SILDENAFIL ALTER. To reduce the likelihood
of these symptoms occurring, you should be on a regular dose of your 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 can be taken with or without food. However, you may notice that the effect of
SILDENAFIL ALTER may be delayed if you take it after having a substantial meal.
Drinking alcohol can temporarily impair the ability to get an
erection. To get the most 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 operating machinery
SILDENAFIL ALTER can cause dizziness and can alter your vision. Before driving vehicles or
operating machinery, you should be aware of how you react to SILDENAFIL ALTER.

SILDENAFIL ALTER chewable tablets contains aspartame,a source of phenylalanine. If
you suffer from phenylketonuria (a rare hereditary metabolic disorder) you should take this into account.

SILDENAFIL ALTER chewable tablets containslactose. If your doctor has told you that you have
an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE SILDENAFIL ALTER

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The usual initial dose is 50 mg.

SILDENAFIL ALTER must not be taken more than once a day.
You should take SILDENAFIL ALTER approximately one hour before the anticipated sexual activity. The
tablet should 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 only help you to achieve an erection 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 be
obtained after a longer time interval if you have just consumed a substantial meal.
If SILDENAFIL ALTER does not help you to achieve an erection, or if the erection does not last for
enough time to complete sexual intercourse, inform your doctor.

If you take more SILDENAFIL ALTER than you should
You may notice an increase in the undesirable effects and the severity of these effects. Higher doses than
100 mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than prescribed, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported in association with the use of sildenafil are usually mild to moderate in
severity 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 with a frequency of uncommon(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 with a frequency of uncommon. If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterruptedly for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe exfoliation and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - occur rarely.

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

Common(may affect up to 1 in 10 people): nausea, flushing, hot flushes
(symptoms include a sudden feeling of heat in the upper body), indigestion,
increased intensity of colors to the vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, rash, eye irritation, ocular hyperemia, eye pain, flashes of light, visual brightness, sensitivity to light,
tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the
ears, dry mouth, obstructed or congested sinuses, inflammation of the nasal mucosa (symptoms include rhinorrhea, sneezing and nasal congestion), upper abdominal pain,
gastro-oesophageal reflux disease (symptoms include heartburn), blood in the urine,
pain in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular
heartbeat, temporary reduction of blood flow to certain areas of the brain, feeling
of constriction in the throat, numb 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 corpuscles in your visual field, seeing halos around lights, dilation
of the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart disease) and
sudden death have been reported from post-marketing experience. It should be noted that, most men who have experienced these effects
undesirable, but not all, had heart problems before using this medicine. It is
not possible to determine whether these events are directly related to the use of sildenafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 which is stated on the pack after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions, store in the
original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What SILDENAFIL ALTER contains

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

Description of the appearance of SILDENAFIL ALTERand contents of the pack
25 mg: White, triangular, biconvex, with ‘25’ imprinted on one side.
50 mg: White, triangular, biconvex, with ‘50’ imprinted on one side.
100 mg: White, triangular, biconvex, with ‘100’ imprinted on one side.
Blisters in packs of 4 and 8 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratori Alter s.r.l., via Egadi 7, 20144 Milano

Manufacturers
Genepharm S.A.
18 km Marathon Avenue, Pallini Attiki-15351
Greece