PRELUD 25 mg Фильм-Coated Таблетки

Содержание инструкции

1. Prelud 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is PRELUD and what is it used for
   2. What you need to know before taking PRELUD
   3. How to take PRELUD
   4. Possible side effects
   5. How to store PRELUD
   6. Contents of the pack and other information

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

Sildenafil citrate
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is PRELUD and what is it used for

PRELUD contains the active ingredient sildenafil which belongs to the class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels of the penis, allowing blood flow to the penis when it is sexually stimulated. PRELUD will only help you to achieve an erection if you are sexually stimulated.
PRELUD is a treatment for adult men who experience erectile dysfunction, sometimes called impotence. This condition occurs when a man cannot achieve or maintain an erection suitable for sexual intercourse.

2. What you need to know before taking PRELUD

Do not take PRELUD

• If you are allergic to sildenafil or 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 in doubt, consult 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 have a serious problem with your heart or liver.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have a rare hereditary eye disease (such as retinitis pigmentosa).
• If you have previously experienced loss of vision 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 (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 heart problems. Your doctor must carefully check that your heart condition allows you to cope with the effort 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 PRELUD and contact your doctor immediately.

You should not use PRELUD together with other oral or topical treatments for erectile dysfunction.
You should not use PRELUD together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take PRELUD if you do not have erectile dysfunction.
You should 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 should tell your doctor. Your doctor may decide to give you
a lower dose.

Children and adolescents
PRELUD should not be given to anyone under the age of 18.

Other medicines and PRELUD
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
PRELUD tablets can interfere with some medicines, particularly those used for the
treatment of chest pain. If a medical emergency occurs, you must inform your doctor,
pharmacist or nurse that you have taken PRELUD and when you took it. Do not take PRELUD together
with other drugs unless your doctor has authorized it.
You should not take PRELUD if you are taking nitrate medicines because the combination of
these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or nurse if you are taking any of these medicines, which are used to relieve
angina attacks (or “chest pain”).
You should not take PRELUD 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 dangerous
drop in blood pressure.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe PRELUD 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 PRELUD together with alpha-blockers. This is more likely to happen within 4 hours
of taking PRELUD.
To reduce the possibility of these symptoms, you should be on a stable dose of your
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 the effect of PRELUD may be slower if you take it after
having eaten a large meal.
Drinking alcohol can temporarily impair your 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 PRELUD.

Pregnancy, breastfeeding and fertility
PRELUD is not indicated for use in women.

Driving and operating machinery
PRELUD can cause dizziness and can affect your vision. Before driving and operating machinery you must
be aware of how you react to PRELUD.

PRELUD contains lactose
If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before
taking PRELUD.

3. How to take PRELUD

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.

PRELUD should not be taken more than once a day.
Do not take the film-coated tablets of PRELUD in combination with the orodispersible tablets
of sildenafil.
You should take PRELUD approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes 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 be delayed if you have recently
consumed a heavy meal.
If PRELUD does not help you to 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 undesirable effects and the severity of these effects. Doses greater 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 those prescribed, contact your doctor.
If you have any doubts 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 will experience them.
The side effects reported in association with the use of PRELUD are usually mild to moderate in severity and of short duration.

If you experience any of the following serious side effects, stop taking PRELUD and
contact your doctor immediately:
Allergic reaction (occurs with a rarefrequency (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

In case of chest pain during or after sexual intercourse:

• 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
person in 1,000)
If this type of erection persists uninterruptedly for more than 4 hours, contact your
doctor immediately.

• Sudden decrease or loss of vision - occurs rarely
• Severe skin reactions - occur rarely

The symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the
genitals and around the eyes.

• Convulsions or Seizures - occur rarely

Other side effects:

Very common(affects more than 1 in 10 people)

• Headache

Common(affects up to 1 in 10 people)

• Nausea
• Facial flushing
• Hot flashes (symptoms include a sudden sensation of heat in the upper body)
• Indigestion
• Visual disturbances
• Blurred vision
• Increased color intensity of vision
• Nasal congestion
• Dizziness

Rare(affects up to 1 in 100 people)

• Vomiting
• Skin rash
• Double vision
• Abnormal sensation in the eyes
• Eye irritation
• Red eyes
• Eye pain
• Tearing
• Fast heartbeat
• Muscle pain
• Hematuria (presence of blood in the urine)
• Drowsiness
• Reduced sensitivity to touch
• Vertigo
• Tinnitus (ringing in the ears)
• Dry mouth
• Chest pain
• Fatigue
• Light flashes
• Increased perception of light
• Light sensitivity
• Palpitations
• High and/or low blood pressure
• Obstructed or congested nasal sinuses
• Inflammation of the nasal mucosa (symptoms include rhinorrhea, sneezing and nasal congestion)
• Upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn)

Very rare(affects up to 1 in 10,000 people)

• High blood pressure
• Low blood pressure
• Heart attacks
• Cardiac arrhythmias (irregular heartbeats)
• Fainting
• Stroke
• Nosebleeds
• Sudden decrease or loss of hearing
• Penile hemorrhage
• Hematospermia (presence of blood in semen),
• temporary reduction of blood flow to some areas of the brain
• Sensation of constriction in the throat
• Numb mouth
• Bleeding from the back of the eye
• Double vision
• Reduced visual acuity
• Abnormal eye sensation
• Swelling of the eyes or eyelids,
• Appearance of spots or corpuscles in the visual field
• Seeing halos around lights
• Pupil dilation
• Alteration of the white color of the sclera (part of the eye),
• Dry nose
• Swelling of the nasal mucosa
• , irritability

Cases of unstable angina (a heart condition) and sudden death have been reported rarely following
marketing. It should be noted that most men who experienced these side effects, but not all, had
pre-existing heart problems before using 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 effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through
Reporting side effects you can contribute to providing more information about 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 on the blister after Exp.
The expiry date refers to the last day of that month.
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 PRELUD contains

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

Description of the appearance of PRELUD and contents of the pack
PRELUD tablets are white, film-coated and have an oval shape. The tablets are
available in PVC/Aluminum blisters in packs of 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AGIPS Farmaceutici S.r.l. – Via Amendola, 4 – 16035 Rapallo (Genova)

Manufacturer
PSI Supply nv
Axxes Business Park, Guldensporenpark 22, Block C
9820 Merelbeke
Belgium