Brand name Vizarsin

Form tablets, film-coated

Active substance / Dosage

SILDENAFIL

Prescription type Prescription only

ATC code

G04BE03

Registration number 042288

Manufacturer KRKA D.D. NOVO MESTO

Table of Contents

Package leaflet: Information for the patient
Vizarsin 25 mg film-coated tablets
1. What Vizarsin is and what it is used for
2. What you should know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Package contents and other information
Patient Information Leaflet
Vizarsin 50 mg film-coated tablets
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Package contents and other information
Package leaflet: information for the patient
Vizarsin 100 mg film-coated tablets
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Package contents and other information
Patient Information Leaflet
Vizarsin 25 mg orodispersible tablets
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information
Patient information leaflet
Vizarsin 50 mg orodispersible tablets
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Package contents and other information
Patient Information Leaflet
Vizarsin 100 mg orodispersible tablets
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Package contents and other information

Package leaflet: Information for the patient

Vizarsin 25 mg film-coated tablets

sildenafil
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 or pharmacist.
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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will help you achieve an erection only if you are sexually stimulated.
Vizarsin 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 suitable for sexual intercourse.

2. What you should know before taking Vizarsin

Do not take Vizarsin
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
decrease in blood pressure. Inform your doctor if you are taking any of these
medicines, which are often used to relieve angina pectoris (or “chest pain”). If you have any doubts, consult your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous decrease
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 Vizarsin, 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 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 due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vizarsin:
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 coagulation disorders (such as hemophilia).
if you experience a sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.
You must not use Vizarsin together with other oral or topical treatments for erectile dysfunction.
You must not use Vizarsin together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Vizarsin if you do not have erectile dysfunction.
You must not take Vizarsin 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
Vizarsin must not be administered to individuals under 18 years of age.

Other medicines and Vizarsin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Vizarsin tablets may interact with certain medicines, especially those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Vizarsin and when it was taken. Do not take Vizarsin with other medicines unless authorized by your doctor.
Do not take Vizarsin 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 (or “chest pain”).
Do not take Vizarsin 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 you the lowest dose of Vizarsin (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Vizarsin together with alpha-blockers. This is more likely to occur within 4 hours after taking Vizarsin. To reduce the possibility of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Vizarsin. Your doctor may start you on a lower dose of Vizarsin (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Vizarsin with food, drinks and alcohol
Vizarsin can be taken with or without food. However, you may notice that the onset of Vizarsin's effect may be 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 Vizarsin.

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

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

Vizarsin contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Vizarsin

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.
Vizarsin must not be taken more than once a day.
You should take Vizarsin approximately one hour before planned sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of Vizarsin is too strong or too weak, consult your doctor or
pharmacist.
Vizarsin will help you achieve an erection only if you are sexually stimulated. The time required for
Vizarsin to take effect may vary from person to person, but generally ranges from half an hour to
one hour. The effect of Vizarsin may take longer if you have just consumed a heavy meal.
If Vizarsin 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 Vizarsin 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 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects reported in association with the use of Vizarsin are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking Vizarsin and contact your doctor immediately:

Allergic reaction – occurs uncommonly (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 uncommonly: 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 1000 people). If this type of erection lasts 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, blisters in the mouth, genital area or 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, 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 sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested sinuses, nasal mucosal inflammation (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 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, 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, presence of blood in semen, dry nose, nasal mucosal swelling, irritability, sudden decrease or loss of hearing.

Since marketing, 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 conditions before taking this medicine. It is not possible to determine whether these events are directly related to the use of Vizarsin.

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 through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vizarsin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
“EXP:”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Vizarsin contains

The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
The other components are:
Core: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, hypromellose (E464), magnesium stearate (E470b).
Coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518). See section 2 “Vizarsin contains lactose and sodium”.

Description of the appearance of Vizarsin and contents of the pack
Vizarsin 25 mg film-coated tablets are white, oblong, with “25” engraved on one side.
Vizarsin 25 mg film-coated tablets are available in packs containing 1 film-coated tablet in a blister, and also in packs containing 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien
Τηλ: + 30 2100101613 Tel: + 43 (0)1 66 24 300

España Polska
KERN PHARMA, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 93 700 25 25 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 100 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
Τηλ: + 357 24 651 882

Latvija United Kingdom (Northern Ireland)
KRKA Latvija SIA KRKA Pharma Dublin, Ltd.
Tel: + 371 6 733 86 10 Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient Information Leaflet

Vizarsin 50 mg film-coated tablets

sildenafil
Please 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 or pharmacist.
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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will help you achieve an erection
only if you are sexually stimulated.
Vizarsin 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
suitable for sexual intercourse.

2. What you need to know before taking Vizarsin

Do not take Vizarsin
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
decrease in blood pressure. Inform your doctor if you are taking any of these
medicines, which are often used to relieve attacks of angina pectoris (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 decrease 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 Vizarsin, 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 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 or pharmacist before taking Vizarsin:
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 should 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 Vizarsin and contact your doctor immediately.
You must not use Vizarsin together with other oral or topical treatments for erectile dysfunction.
You must not use Vizarsin together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Vizarsin if you do not have erectile dysfunction.
You must not take Vizarsin 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
Vizarsin must not be administered to individuals under 18 years of age.

Other medicines and Vizarsin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Vizarsin 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 Vizarsin and when you took it. Do not take Vizarsin with other medicines unless your doctor has authorized it.
You must not take Vizarsin 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”).
You must not take Vizarsin 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 you the lowest dose of Vizarsin (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 Vizarsin together with alpha-blockers. This is most likely to occur within 4 hours after taking Vizarsin. To reduce the likelihood of these symptoms, you should already be on a stable dose of the alpha-blocker before starting treatment with Vizarsin. Your doctor may start you on a lower dose of Vizarsin (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Vizarsin with food, drinks and alcohol
Vizarsin can be taken with or without food. However, you may notice that the onset of Vizarsin's effect may be 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 Vizarsin.

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

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

Vizarsin contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Vizarsin

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
Vizarsin must not be taken more than once a day.
You should take Vizarsin approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Vizarsin is too strong or too weak, consult your doctor or pharmacist.
Vizarsin will help you achieve an erection only if you are sexually stimulated. The time required for Vizarsin to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of Vizarsin may take longer if you have just consumed a substantial meal.
If Vizarsin 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 Vizarsin than you should:
You may experience 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 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 or pharmacist.

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 Vizarsin are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking Vizarsin 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, 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 swelling, 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 (nosebleed), 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 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, change in the white colour of the sclera (part of the eye), penile bleeding, presence of blood in semen, dry nose, swelling of the nasal mucosa, irritability, and sudden decrease or loss of hearing.

Since marketing authorization, 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 conditions before taking this medicine. It is not possible to determine whether these events are directly related to the use of Vizarsin.

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 listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vizarsin

Keep this medicine out of the sight and reach of children.
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.
This medicine requires no special storage conditions.
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 Vizarsin contains

The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
The other components are:
Core: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, hypromellose (E464), magnesium stearate (E470b).
Coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518). See section 2 “Vizarsin contains lactose and sodium”.

Description of the appearance of Vizarsin and contents of the pack
Vizarsin 50 mg film-coated tablets are white, oblong, with “50” engraved on one side.
Vizarsin 50 mg film-coated tablets are available in packs containing 1 film-coated tablet in a blister, as well as in packs of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet(s) in perforated unit-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: