Seladik: detailed information

Package Leaflet: Information for the Patient

SELADIK 50 mg Film-coated Tablets

Sildenafil
Equivalent 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 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, contact your doctor, pharmacist, or nurse. See section 4.

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

1. What SELADIK is and what it is used for

SELADIK contains the active substance sildenafil, which belongs to a class of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing increased blood flow to the penis during sexual stimulation. SELADIK will help you achieve an erection only if you are sexually stimulated.
SELADIK 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 SELADIK

Do not take SELADIK

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, as 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 have any doubts, 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 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 due to blood clots). PDE5 inhibitors such as SELADIK have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor
if you have a serious heart or liver problem
if you have recently had a stroke or a 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

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

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
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 sudden reduction or loss of vision, stop taking SELADIK and contact your doctor immediately.

You must not use SELADIK together with other oral or topical treatments for erectile dysfunction. You must not use SELADIK together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take SELADIK if you do not have erectile dysfunction.
You must not take SELADIK if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
SELADIK must not be administered to individuals under 18 years of age.

Other medicines and SELADIK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SELADIK 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 SELADIK and when you took it. Do not take SELADIK with other medicines unless your doctor has authorized it.
Do not take SELADIK if you are taking medicines called nitrates, because the combination may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”).
Do not take SELADIK 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.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe the lowest dose of SELADIK (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking SELADIK together with alpha-blockers. This is more likely to occur within 4 hours after taking SELADIK. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with SELADIK. Your doctor may start you on a lower dose of SELADIK (25 mg).
If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), inform your doctor or pharmacist.

SELADIK with food, drinks, and alcohol
SELADIK can be taken with or without food. However, you may notice that the onset of action of SELADIK may be delayed if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using SELADIK.

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

Driving and using machines
SELADIK may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to SELADIK.

SELADIK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

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

3. How to take SELADIK

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.
SELADIK must not be taken more than once a day.
Do not take film-coated tablets of SELADIK in combination with Viagra or other
medicines containing sildenafil.
You should take SELADIK approximately one hour before anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of SELADIK is too strong or too weak, consult your doctor or
pharmacist.
SELADIK will help you achieve an erection only if you are sexually stimulated. The time required
for SELADIK to take effect varies from person to person, but generally ranges from
half an hour to one hour. The effect of SELADIK may take longer if you have
recently eaten a heavy meal.
If SELADIK 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 SELADIK than you should:
You may experience an increase in the frequency and severity of adverse effects.
Doses higher than 100 mg do not increase efficacy.
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 gets them.
The side effects reported with the use of SELADIK are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking
SELADIK and contact your doctor immediately:
Allergic reaction – occurs at a uncommon frequency (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 at a uncommon frequency.
If it occurs during or after sexual intercourse:

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 this type of erection persists continuously 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, mouth blisters, blisters on the genitals and around the eyes, 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 a sudden feeling of warmth in the upper body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, 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 (including heartburn), blood in urine, pain in arms or legs, epistaxis, sensation of warmth 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, sensation of tightness in the throat, numbness of the 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 floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.
Following post-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 side effects 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 SELADIK.
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 the national reporting system at the following website: 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 SELADIK

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 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. Contents of the pack and other information

What SELADIK contains

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

Description of the appearance of SELADIK and contents of the pack
SELADIK tablets are film-coated, blue, round, biconvex, with the number “50” printed on one side.
The tablets are available in blisters containing 2, 4 or 8 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milano, Italy
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland

Patient Information Leaflet

SELADIK

100 mg film-coated tablets
Sildenafil
Equivalent 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, ask 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

1. What SELADIK is and what it is used for

SELADIK contains the active substance sildenafil, which belongs to a class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps relax blood vessels in the penis,
allowing increased blood flow to the penis when sexually stimulated. SELADIK will help you
achieve an erection only if you are sexually stimulated.
SELADIK 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 SELADIK

Do not take SELADIK

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, as 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 pectoris attacks (or “chest pain”). If you have any doubts, 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 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 due to blood clots). PDE5 inhibitors such as SELADIK have been shown to enhance the hypotensive effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor
if you have a severe 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 sudden loss or reduction in vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

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

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (blood cell cancer), or multiple myeloma (a bone marrow cancer)
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 coagulation disorders (such as hemophilia)
if you experience a sudden decrease or loss of vision, stop taking SELADIK and contact your doctor immediately.

You must not use SELADIK together with other oral or local treatments for erectile dysfunction.
You must not use SELADIK together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take SELADIK if you do not have erectile dysfunction.
You must not take SELADIK if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
SELADIK must not be administered to individuals under 18 years of age.

Other medicines and SELADIK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SELADIK 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 SELADIK and when. Do not take SELADIK with other medicines unless authorized by your doctor.
Do not take SELADIK 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, which are often used to relieve angina pectoris attacks (or “chest pain”).
Do not take SELADIK 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.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe the lowest dose of SELADIK (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking SELADIK together with alpha-blockers. This is more likely to occur within 4 hours after taking SELADIK. To reduce the likelihood of these symptoms, you should already be on a stable dose of the alpha-blocker before starting treatment with SELADIK. Your doctor may start you on a lower dose of SELADIK (25 mg).
If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), inform your doctor or pharmacist.

SELADIK with food, drinks, and alcohol
SELADIK can be taken with or without food. However, you may notice that the onset of SELADIK’s effect is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using SELADIK.

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

Driving and using machines
SELADIK may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to SELADIK.

SELADIK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

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

3. How to take SELADIK

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.
SELADIK must not be taken more than once a day.
Do not take SELADIK film-coated tablets in combination with Viagra or other
medicines containing sildenafil.
You should take SELADIK approximately one hour before anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of SELADIK is too strong or too weak, consult your doctor or
pharmacist.
SELADIK will help you achieve an erection only if you are sexually stimulated. The time required
for SELADIK to take effect varies from person to person, but generally ranges from
half an hour to one hour. The effect of SELADIK may take longer if you have just consumed a heavy meal.
If SELADIK 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 SELADIK than you should
You may experience an increase in the frequency and severity of side effects.
Doses higher than 100 mg do not increase efficacy.
Do not take more tablets than 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The adverse reactions reported in association with the use of SELADIK are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious adverse reactions, stop taking
SELADIK and contact your doctor immediately:
Allergic reaction – 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 or throat.
Chest pain – occurs with uncommon frequency.
If this occurs during or after sexual intercourse:

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 this type of erection persists continuously 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 skin peeling and swelling, blisters in the mouth, genital area or around the eyes, fever.
Seizures or convulsions – occur rarely.
Other adverse reactions:
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 a sudden feeling of warmth in the upper body), indigestion, increased colour brightness in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, light flashes, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensitivity, vertigo, tinnitus, 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 (including heartburn), blood in urine, pain in arms or legs, epistaxis, feeling of warmth 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, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, eye or eyelid swelling, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.
From post-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 reactions 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 SELADIK.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store SELADIK

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 blister after EXP.
The expiry date refers to the last day of the 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 SELADIK contains

The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
The other ingredients are:
- Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “SELADIK contains sodium”), magnesium stearate.
- Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “SELADIK contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

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