PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Sildenafil citrate
Generic medicine
Please read all of 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What PRELUD is and what it is used for
What you need to know before taking PRELUD
How to take PRELUD
Possible side effects
How to store PRELUD
Contents of the pack and other information

1. What PRELUD is and what it is used for

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

2. What you should know before taking PRELUD

Do not take PRELUD

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 you are 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 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 a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

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

if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
If you have a penile deformity or Peyronie’s disease.
If you have heart problems. 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 hemophilia).
If you experience a sudden decrease or loss of vision, stop taking PRELUD and contact your doctor immediately.

You must not use PRELUD together with other oral or topical treatments for erectile dysfunction.
You must not use PRELUD together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take PRELUD if you do not have erectile dysfunction.
You must not take PRELUD if you are a woman.
Special precautions for patients with kidney or liver problems.
If you have kidney or liver problems, you must inform your doctor. Your doctor may decide to prescribe a lower dose.
Children and adolescents
PRELUD must not be administered to individuals under 18 years of age.
Other medicines and PRELUD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
PRELUD tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken PRELUD and when you took it. Do not take PRELUD with other medicines unless your doctor has specifically authorized it.
Do not take PRELUD if you are taking medicines called nitrates, because the combination of these medicines may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines used to relieve angina attacks (or “chest pain”).
Do not take PRELUD if you are using 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 protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of PRELUD (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking PRELUD together with alpha-blockers. This is more likely to occur within 4 hours after taking PRELUD.
To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with PRELUD.
Your doctor may start you on a lower dose of PRELUD (25 mg).
PRELUD with food, drinks, and alcohol
PRELUD can be taken with or without food.
However, you may notice that the onset of PRELUD’s effect may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection.
To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using PRELUD.
Pregnancy, breastfeeding, and fertility
PRELUD is not indicated for use in women.
Driving and using machines
PRELUD may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to PRELUD.
PRELUD contains lactose
If your doctor has told you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking PRELUD.

3. How to take PRELUD

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.
PRELUD must not be taken more than once a day.
Do not take PRELUD film-coated tablets in combination with sildenafil orodispersible tablets.
You should take PRELUD approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of PRELUD is too strong or too weak, consult your doctor or pharmacist.
PRELUD will help you achieve an erection only if you are sexually stimulated. The time required for PRELUD to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of PRELUD may take longer if you have just eaten a heavy meal.
If PRELUD 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 PRELUD than you should
You may notice 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 those 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects reported in association with the use of PRELUD are usually mild to moderate in
intensity and short-lived.
If you experience any of the following serious side effects, stop taking PRELUD and contact your doctor
immediately:
Allergic reaction (occurs uncommonly (may affect up to 1 person in 100). Symptoms include sudden
wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
Chest pain (occurs uncommonly):

If chest pain occurs during or after sexual intercourse:

Sit semi-upright and try to relax.
Do not use nitrates to treat chest pain.

Prolonged and sometimes painful erections (occur rarely (may affect up to 1 person in 1,000)).
If this type of erection persists continuously 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 peeling and swelling of the skin, blisters in the mouth, genital area, and around the eyes.

Seizures or convulsions – occur rarely

Other side effects:
Very common (affects more than 1 person in 10)

Headache

Common (affects up to 1 person in 10)

Nausea
Facial flushing
Hot flushes (symptoms include a sudden feeling of warmth in the upper part of the body)
Indigestion
Visual disturbances
Blurred vision
Increased intensity of colours when seeing
Nasal congestion
Dizziness

Uncommon (affects up to 1 person in 100)

Vomiting
Skin rash
Double vision
Abnormal sensation in the eyes
Eye irritation
Redness of the eyes
Eye pain
Tearing
Rapid heartbeat
Muscle pain
Haematuria (presence of blood in urine)
Drowsiness
Reduced sensitivity to touch
Vertigo
Ringing in the ears
Dry mouth
Chest pain
Fatigue
Flashes of light
Increased light perception
Sensitivity to light
Palpitations
High and/or low blood pressure
Blocked or congested sinuses
Inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion)
Upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn)

Rare (affects up to 1 person in 10,000)

High blood pressure
Low blood pressure
Heart attacks
Cardiac arrhythmias (irregular heartbeat)
Fainting
Stroke
Nosebleeds
Sudden decrease or loss of hearing
Penile haemorrhage
Haemospermia (presence of blood in semen)
Temporary reduction in blood flow to certain areas of the brain
Throat tightness
Numbness of the mouth
Bleeding at 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
Pupil dilation
Change in the white colour of the sclera (part of the eye)
Dry nose
Swelling of the nasal mucosa
Irritability

Since marketing, rare cases of unstable angina (a heart condition) and sudden death have been reported.
It should be noted that most men who experienced these side effects, but not all, already had pre-existing
heart problems before taking this medicine.
It is not possible to determine whether these events are directly related to the use of PRELUD.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via [appropriate national reporting system].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRELUD

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What PRELUD contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
The other components are:
Core: croscarmellose sodium, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.

Description of the appearance of PRELUD and the package contents
PRELUD tablets are white, film-coated, and oval-shaped. The tablets are available in PVC/aluminum blisters in packages containing 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
AGIPS Farmaceutici S.r.l. – Via Amendola, 4 – 16035 Rapallo (Genoa)
Manufacturer
PSI Supply nv
Axxes Business Park, Guldensporenpark 22, Block C
9820 Merelbeke
Belgium