Vizarsin
sildenafil
sildenafil
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Vizarsin is and what it is used for
What you need to know before you take Vizarsin
How to take Vizarsin
Possible side effects
How to store Vizarsin
Contents of the pack and other information
Vizarsin contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Vizarsin will only help you to get an erection if you are sexually stimulated.
Vizarsin is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
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, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
- If you are taking riociguat. This drug 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). PDE5 inhibitors, such as Vizarsin have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
If you have a severe 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 certain rare inherited eye diseases (such as retinitis pigmentosa).
If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Talk to your doctor or pharmacist before taking Vizarsin:
If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
If you have a deformity of your penis or Peyronie’s Disease.
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.
If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
If you experience sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.
You should not use Vizarsin with any other oral or local treatments for erectile dysfunction.
You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
You should not take Vizarsin if you do not have erectile dysfunction. You should not take Vizarsin if you are a woman.
Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.
Vizarsin should not be given to individuals under the age of 18.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Vizarsin tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you that you can.
You should not take Vizarsin if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).
You should not take Vizarsin if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Vizarsin.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin.
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of Vizarsin.
Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
Vizarsin can be taken with or without food. However, you may find that Vizarsin takes longer to start working if you take it with a heavy meal.
Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Vizarsin.
Vizarsin is not indicated for use by women.
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin before you drive or use machinery.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended starting dose is 50 mg.
You should not take Vizarsin more than once a day.
You should take Vizarsin about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of Vizarsin is too strong or too weak, talk to your doctor or pharmacist. Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.
If Vizarsin does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more tablets than your doctor tells you to.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of Vizarsin are usually mild to moderate and of a short duration.
An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pains - this occurs uncommonly
If this occurs during or after intercourse:
Get in a semi-sitting position and try to relax.
Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
A sudden decrease or loss of vision - this occurs rarely
Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals
and around the eyes, fever.
Seizures or fits - this occurs rarely Other side effects:
From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were
directly related to Vizarsin.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 box and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium, hypromellose (E464), magnesium stearate (E470b).
Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin
(E1518).
See section 2 “Vizarsin contains lactose and sodium”.
Vizarsin 25 mg film-coated tablets are white, oblong and marked “25” on one side.
Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva
Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E. J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300
KERN PHARMA, S.L. Tel: + 34 93 700 25 25
KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
KRKA - FARMA d.o.o. Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330
KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA Tel: + 371 6 733 86 10
Consilient Health Limited Tel: + 353 (0)1 2057760