PRESCOFIL

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRESCOFIL 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What PRESCOFIL is and what it is used for
2. What you need to know before taking PRESCOFIL
3. How to take PRESCOFIL
4. Possible side effects
5. How to store PRESCOFIL
6. Contents of the pack and other information

1. What Prescofil is and what it is used for

PRESCOFIL contains the active substance 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 aroused. PRESCOFIL will help you achieve an erection only if you are sexually stimulated.
PRESCOFIL is a treatment for men who suffer from erectile dysfunction, sometimes known as impotence. This occurs when a man is unable to achieve or maintain a firm erection sufficient for sexual activity.

2. What you need to know before taking PRESCOFIL

Do not take PRESCOFIL

• 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 the combination may cause a potentially dangerous drop in your blood pressure. Inform your doctor if you are taking any such medicine, often prescribed to relieve angina pectoris (or "chest pain"). If you are unsure, ask your doctor or pharmacist.
• If you are using drugs known as nitric oxide donors such as amyl nitrite ("poppers"), because this combination may also cause a potentially dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
• If you have a severe heart or liver problem.

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• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have rare inherited eye diseases (such as retinitis pigmentosa).
• If you have experienced sudden decrease or loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking PRESCOFIL.

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In such cases, your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or a blood clotting disorder (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking PRESCOFIL and contact your doctor immediately. You must not use PRESCOFIL together with other oral or topical treatments for erectile dysfunction.

Do not use PRESCOFIL together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
Do not use PRESCOFIL if you do not have erectile dysfunction.
Do not use PRESCOFIL if you are a woman.
Special recommendations for patients with kidney or liver problems
You must inform your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a
lower dose.
Children and adolescents
PRESCOFIL must not be administered to individuals under 18 years of age.
Other medicines and PRESCOFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
PRESCOFIL tablets may interact with certain medicines, particularly those used to treat chest pain. In a medical emergency, you must inform medical personnel about the condition for which you are taking PRESCOFIL and when you took it. Do not take PRESCOFIL with other medicines unless your doctor has told you it is safe.
You must not take PRESCOFIL if you are taking medicines called nitrates, because combining these products may cause a potentially dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any such medicine, often prescribed to relieve angina pectoris (or "chest pain").
You must not take PRESCOFIL if you are using drugs known as nitric oxide donors such as amyl nitrite ("poppers"), because the combination may cause a potentially dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, such as those used in HIV treatment, your doctor may start you on the lowest dose (25 mg) of PRESCOFIL.
Some patients taking alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have developed these symptoms when taking sildenafil together with alpha-blockers. This is more likely to occur within 4 hours after taking PRESCOFIL. To reduce the likelihood of these symptoms, you should be regularly taking your alpha-blocker before starting PRESCOFIL. Your doctor may start you on a lower dose (25 mg) of PRESCOFIL.
PRESCOFIL with food, drinks, and alcohol
PRESCOFIL may be taken with or without food. However, you may notice that PRESCOFIL takes longer to work if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from the medicine, it is recommended not to drink excessive amounts of alcohol before taking PRESCOFIL.
Pregnancy, breastfeeding, and fertility
PRESCOFIL is not indicated for use in women.
Driving and using machines
PRESCOFIL may cause dizziness and may affect your vision. You should be aware of how you react to PRESCOFIL before driving or operating machinery.
PRESCOFIL contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take PRESCOFIL

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
You must not take PRESCOFIL more than once a day.
You should take PRESCOFIL approximately one hour before sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of PRESCOFIL is too strong or too weak, talk to your
doctor or pharmacist.
PRESCOFIL will help you achieve an erection only if you are sexually stimulated. The time
required for PRESCOFIL to work varies from person to person, but normally takes between
half an hour and one hour. You may notice that PRESCOFIL takes longer to work if taken
together with a heavy meal.
If PRESCOFIL does not help you achieve an erection, or if the erection does not last long enough to
complete sexual intercourse, you should inform your doctor.
If you take more PRESCOFIL than you should
You may experience an increase in the frequency and severity of adverse effects. Doses higher than 100
mg do not increase effectiveness.
Do not take more tablets than the number indicated by your doctor.
Contact your doctor if you have taken more tablets than you should.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with sildenafil are usually mild to moderate and short-lived.
If you experience any of the following serious adverse reactions, stop taking PRESCOFIL and contact your doctor immediately:

• Allergic reaction – this occurs with uncommon frequency (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, and throat.
• Chest pain during or after sexual intercourse – this occurs with uncommon frequency:
  • Sit in a semi-upright 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 you have an erection lasting more than 4 hours, you must contact your doctor immediately.
• Sudden reduction or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the genitals, or around the eyes, and fever.
• Seizures or convulsions – 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, facial flushing, hot flushes (symptoms include an immediate feeling of warmth in the upper body), indigestion, changes in colour vision, blurred vision, visual disturbance, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, eye pain, sensation of flashes of light, visual acuity changes, light sensitivity, tearing, bloodshot eyes/eye redness, irregular or rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus (ringing in the ears), dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people):
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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 in 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, perception of halos around lights, pupil dilation, discoloration of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, and sudden decrease or loss of hearing.

After 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 effects 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 PRESCOFIL.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRESCOFIL

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
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. Package contents and other information

What PRESCOFIL contains

• The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).
• The excipients are: Tablet core: monohydrate lactose, microcrystalline cellulose (E460), povidone K29-32 (E1201), sodium croscarmellose (E468), magnesium stearate (E572). Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, aluminium lake containing indigo carmine (E132).

Description of the appearance of PRESCOFIL and contents of the pack
Film-coated tablet.
PRESCOFIL 25 mg film-coated tablets are blue, elliptical, biconvex, marked with “SL25” on one side.
PRESCOFIL 50 mg film-coated tablets are blue, elliptical, biconvex, marked with “SL50” on one side.
PRESCOFIL 100 mg film-coated tablets are blue, elliptical, biconvex, marked with “SL100” on one side.
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The tablets are supplied in blister packs containing 1, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group srl
Via Tiburtina, 1143
00156 Rome
Italy
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
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