Zyforma 25 mg Film-Coated Tablets

ZYFORMA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. ZYFORMA works by relaxing the blood vessels in your penis when you are sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way. ZYFORMA is used to treat erectile dysfunction, sometimes known as impotence, in men. This is when a man cannot get, or keep, a hard, erect penis suitable for sexual activity. ZYFORMA will work only if you are sexually excited. ZYFORMA will not increase your sex drive. ZYFORMA is not for use in women.

Do not take ZYFORMA:

• If you are hypersensitive (allergic) to sildenafil or any of the other ingredients of ZYFORMA (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. Riociquat 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 ZYFORMA have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
• If you are using cimetidine (used to treat ulcers), ketoconazole or itraconazole (used to treat fungal infections), erythromycin or rifampicin (used to treat infections) or ritonavir or saquinavir (used to treat HIV infections).
• If you have severe problems with your heart (such as unstable angina or heart failure).
• If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
• If you have a severe kidney 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).

Warnings and precautions

Take special care with ZYFORMA:

• 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 have a deformity of your penis or Peyronie’s disease.
• 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 currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
• If you experience sudden decrease or loss of vision, stop taking ZYFORMA and contact your doctor immediately.
• You should not use ZYFORMA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
• You should not use ZYFORMA with any other oral or local treatments for erectile dysfunction.
• You should not take ZYFORMA if you do not have erectile dysfunction.

Children and adolescents

ZYFORMA should not be given to individuals under the age of 18.

Other medicines and ZYFORMA

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) ZYFORMA 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 ZYFORMA and when you did. Do not take ZYFORMA with other medicines unless your doctor tells you that you can. You should not take ZYFORMA 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 ZYFORMA 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 ZYFORMA. 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 ZYFORMA with alpha-blockers. This is most likely to happen within 4 hours after taking ZYFORMA. In order to reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start ZYFORMA. Your doctor may start you on a lower dose (25 mg) of ZYFORMA.

Do not share medicines prescribed for you with any other person. Always take ZYFORMA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 50 mg, taken about one hour before sexual activity. This dose may be increased to 100 mg or decreased to 25 mg by your doctor. Swallow the tablet whole with some water. ZYFORMA will only help you to get an erection if you are sexually stimulated. The amount of time ZYFORMA takes to work varies from person to person, but it normally takes between half an hour and one hour. If ZYFORMA 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 should not use ZYFORMA more than once a day. If you have the impression that the effect of ZYFORMA is too strong or too weak, tell your doctor or pharmacist. If you take more ZYFORMA than you should Taking a dose higher than 100 mg does not increase the effect of ZYFORMA. However, it will result in an increase in undesirable effects and their severity. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

ZYFORMA can have side effects. Not all side effects reported for ZYFORMA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZYFORMA, please consult your health care provider for advice. If any of the following happens, stop taking ZYFORMA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ZYFORMA. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Less frequent chest pains,
• prolonged and sometimes painful erections,
• a sudden decrease or loss of vision,
• serious skin reactions (symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever),
• seizures or fits.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent headache, dizziness
• nausea, indigestion,
• facial flushing, hot flush,
• colour tinge to vision, blurred vision, visual disturbance, stuffy nose.

Less frequent:

• vomiting,
• skin rash,
• eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes,
• pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure,
• muscle pain,
• feeling sleepy, reduced sense of touch,
• vertigo, ringing in the ears,
• dry mouth,
• blocked or stuffy sinuses, inflammation of the lining of the nose, nosebleed,
• upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn),
• presence of blood in urine,
• pain in the arms or legs,
• feeling hot, feeling tired,
• fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain,
• feeling of tightening of the throat, numb mouth,
• bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye,
• penile bleeding, presence of blood in semen,
• dry nose, swelling of the inside of the nose, feeling irritable,
• sudden decrease or loss of hearing.

Frequency unknown:

• unstable angina (a heart condition),
• sudden death.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ZYFORMA.

• Store at or below 25 °C.
• Keep the blister strips in the outer carton until required for use.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton/blister.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).