BIDEF 50 mg Film-Coated Tablets

Зміст інструкції

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

BIDEF

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

1. What is BIDEF and what is it used for

BIDEF contains the active substance sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis,
allowing blood flow to the penis when it is sexually stimulated. BIDEF will only help you to have
an erection if you are sexually stimulated.
BIDEF 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 sufficient for sexual intercourse.

2. What you need to know before taking BIDEF

Do not take BIDEF

• 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 you are unsure, ask your doctor or pharmacist

torace”). If you have any doubts, 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 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 BIDEF, 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 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 BIDEF.

• 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 should carefully check that your heart condition allows you to cope with the exertion of sexual activity
• 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 BIDEF and contact your doctor immediately.

Do not use BIDEF together with other oral or topical treatments for erectile dysfunction. Do not
use BIDEF together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
Do not take BIDEF if you do not have erectile dysfunction.
Do not take BIDEF 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
BIDEF should not be given to anyone under the age of 18.

Other medicines and BIDEF
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
BIDEF tablets can interact with some medicines, especially those used for
treating chest pain. If a medical emergency occurs, you should inform your
doctor, pharmacist or nurse that you have taken BIDEF and when you took it. Do not take
BIDEF with other medicines unless your doctor has authorized it.
Do not take BIDEF 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 often used for
relieving angina attacks (or “chest pain”).
Do not take BIDEF 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.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for
treating HIV, your doctor may initially prescribe BIDEF at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can
be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken BIDEF together with alpha-blockers. This is more likely to happen within 4 hours of taking BIDEF. To reduce the possibility that
these symptoms appear, you should be on a regular dose of the alpha-blocker before
starting treatment with BIDEF. Your doctor may start you on a lower dose of BIDEF (25 mg).
If you are taking medicines containing sacubitril with valsartan (used for the treatment
of heart failure), tell your doctor or pharmacist.

BIDEF with food, drinks and alcohol
BIDEF can be taken with or without food. However, you may notice that the onset of the effect of
BIDEF may be slower if you take it after having a heavy 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 BIDEF.

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

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

BIDEF contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

BIDEF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take BIDEF

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

BIDEF should not be taken more than once a day.
Do not take the film-coated tablets of BIDEF in combination with Viagra or with other
medicines containing sildenafil.
You should take BIDEF approximately one hour before the anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of BIDEF is too strong or too weak, consult your doctor or
pharmacist.
BIDEF will only help you to achieve an erection if you are sexually stimulated. The time it takes for
BIDEF to take effect varies from person to person, but generally ranges from half an hour to
one hour. The effect of BIDEF may be delayed if you have
recently consumed a heavy meal.
If BIDEF 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 BIDEF 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 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 BIDEF are usually mild to moderate in severity and of short duration.

If you experience any of the following serious side effects, stop taking BIDEF 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 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 in 1,000 people). If this type of erection persists uninterrupted 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 peeling and swelling of the skin, blisters in the mouth, 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 flashes (symptoms include a sudden feeling of warmth in the upper body), indigestion, increased color intensity of vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, light sensitivity, tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, 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), 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, sensation 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 field of vision, 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 condition) and sudden death have been reported rarely after marketing. It should be noted that most men who experienced these side effects, 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 BIDEF.

Reporting of side effects
If you experience any side effects, including 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
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 BIDEF

Keep this medicine out of the sight and reach of children.
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 the 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 BIDEF contains

• The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
• The other excipients are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium

croscarmellose (see section 2 “BIDEF contains sodium”), magnesium stearate.

• Coating:hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “BIDEF contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of BIDEF and contents of the pack
BIDEF tablets are film-coated, blue, oblong, biconvex tablets with the
number “100” imprinted on one side.
The tablets are available in blisters in packs of 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milan, Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland

BIDEF 50 mg film-coated tablets

Sildenafil
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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
7 What BIDEF is and what it is used for
8 What you need to know before you take BIDEF
9 How to take BIDEF
10 Possible side effects
11 How to store BIDEF
12 Contents of the pack and other information.

1. What is BIDEF and what is it used for

BIDEF 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 in the penis,
allowing blood to flow into the penis when it is sexually stimulated. BIDEF will only help you to achieve
an erection if you are sexually stimulated.
BIDEF 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 sufficient for sexual intercourse.

2. What you need to know before taking BIDEF

Do not take BIDEF

• 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 pectoris (or “chest pain”). If you are unsure, 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 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 BIDEF, 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 a rare hereditary eye disease (such as retinitis pigmentosa)
• if you have previously experienced loss of vision caused by non-arteritic anterior ischaemic optic neuropathy (NAION).

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

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (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 needs 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 haemophilia).
• If you experience a sudden decrease or loss of vision, stop taking BIDEF and contact your doctor immediately.

You should not use BIDEF together with other oral or topical treatments for erectile dysfunction.
You should not use BIDEF together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take BIDEF if you do not have erectile dysfunction.
You should not take BIDEF 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
BIDEF should not be given to anyone under the age of 18.

Other medicines and BIDEF
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
BIDEF tablets can interfere with some medicines, particularly those used for
treating chest pain. If you should experience a medical emergency, you should inform the
doctor, pharmacist or nurse that you have taken BIDEF and when you took it. Do not take
BIDEF together with other medicines unless your doctor has authorised it.
You should not take BIDEF if you are taking medicines called nitrates 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 often used for
relieving angina pectoris (or “chest pain”).
You should not take BIDEF 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.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for
treating HIV, your doctor may initially prescribe BIDEF at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or light-headedness which may be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken BIDEF together with alpha-blockers. This is more likely to happen within 4 hours of taking BIDEF. To reduce the possibility that
these symptoms appear, you should be on a regular dose of the alpha-blocker before
starting treatment with BIDEF. Your doctor may start you on a lower dose of BIDEF (25 mg).
If you are taking medicines containing sacubitril with valsartan (used for the treatment
of heart failure), tell your doctor or pharmacist.

BIDEF with food, drinks and alcohol
BIDEF can be taken with or without food. However, you may notice that the onset of the effect of
BIDEF may be slower if you take it after having eaten a heavy 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
drinking large amounts of alcohol before using BIDEF.

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

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

BIDEF contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

BIDEF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take BIDEF

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

BIDEF should not be taken more than once a day.
Do not take the film-coated tablets of BIDEF in combination with Viagra or with other
medicines containing sildenafil.
You should take BIDEF approximately one hour before the anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of BIDEF is too strong or too weak, consult your doctor or
pharmacist.
BIDEF will only help you to achieve an erection if you are sexually stimulated. The time it takes for
BIDEF to take effect varies from person to person, but generally ranges from half an hour to
one hour. The effect of BIDEF may be delayed if you have
recently consumed a heavy meal.
If BIDEF 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 BIDEF than you should:
You may notice an increase in side 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 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 BIDEF are usually mild to moderate in severity and of short duration.

If you experience any of the following serious side effects, stop taking BIDEF 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 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 in 1,000 people). If this type of erection persists uninterrupted 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, 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 color intensity of vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, light sensitivity, tearing, palpitations, rapid 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 runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal 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 in 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 the 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 after marketing, rarely. It should be noted that most men who experienced these side effects, 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 BIDEF.

Reporting of side effects
If you experience any side effects, including 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
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 BIDEF

Keep this medicine out of the sight and reach of children.
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 waste water 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 BIDEF contains

• The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
• The other excipients are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “BIDEF contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “BIDEF contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of BIDEF and contents of the pack
BIDEF tablets are film-coated, blue in colour, rounded, biconvex with the number “50” imprinted
on one side.
The tablets are available in blisters in packs of 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milan, Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland