Dynafil 50 mg Tablets

DYNAFIL contains the active substance sildenafil and belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) 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. DYNAFIL will only help you to get an erection if you are sexually stimulated. DYNAFIL is a treatment for 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. Dynafil will not increase your sex drive. DYNAFIL IS NOT AN APHRODISIAC.

Do not take DYNAFIL:

• if you are hypersensitive (allergic) to sildenafil or any of the other ingredients of DYNAFIL (see section 6)
• if you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease 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 nitrate), as the combination may also lead to a potentially dangerous decrease in your blood pressure
• if you have a severe liver or kidney disorder and are not receiving dialysis
• if you use erythromycin (antibiotic), ritonavir, saquinavir (for HIV infections), ketoconazole and itraconazole (treatment for fungal infections)
• if you are taking riociguat, a medicine 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). When taken with DYNAFIL, the blood pressure lowering effects of riociguat are increased, if you are taking riociguate, or are unsure, talk to your doctor
• if you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION), a medical condition where the optic nerve is damaged due to loss of blood supply.

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection: Take special care DYNAFIL:

• if you have had a heart attack or stroke or other life-threatening heart problems within the last 6 months, or have been told by a doctor that you are at risk of having a cardiac event
• if you have high or low blood pressure
• if you have any heart disorders such as angina. Your doctor will advise you as to whether your heart can take the additional strain of having sex
• if you have an eye disorder called retinitis pigmentosa (a hereditary disease, causing loss of vision)
• 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) or are taking any other medicines for erectile dysfunction
• if you are taking medication known as alpha-blockers for hypertension (high blood pressure) or prostrate problems
• if you currently have a stomach ulcer, or a bleeding disorder (such as haemophilia)
• if you have a hearing problem or suddenly develop a hearing problem (symptoms may include dizziness, ringing in the ears or loss of balance) whilst taking DYNAFIL
• if you have eye disorders or experience sudden decrease or loss of vision. If the latter happens, stop taking DYNAFIL and contact your doctor immediately
• if you suffer from any vision loss or a condition called ischaemic optic neuropathy as the use of DYNAFIL may worsen your condition
• if you are taking a medicine called ritonavir (used in the treatment of HIV) as this may affect the way DYNAFIL works.
• if you have certain rare inherited eye diseases (such as retinitis pigmentosa).

You should not take DYNAFIL if you are a woman.

Do not share medicines prescribed for you with any other person. Always take DYNAFIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose of DYNAFIL will be different for different patients and may depend on the seriousness of your disorder and whether or not you are taking other medicines. You should not take DYNAFIL more than once a day.

Adults: The recommended dose is one 50 mg tablet per day when needed one hour before sexual intercourse. This dose may be increased to 100 mg or decreased to 25 mg by your doctor. DYNAFIL 25mg is discontinued and the available tablets are not scored or breakable, a 25 mg dose cannot be achieved by splitting these tablets. Another medicine should be used to achieve the 25 mg dose. Swallow the tablet whole with a glass of water. Your doctor will tell you how long your treatment with DYNAFIL will last.

If you have the impression that the effect of DYNAFIL is too strong or too weak, tell your doctor or pharmacist.

If you take more DYNAFIL than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

Taking a dose higher than 100 mg does not increase the effect of DYNAFIL. However, it will result in an increase in side effects and their severity.

DYNAFIL can have side effects. Not all side effects reported for DYNAFIL are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using DYNAFIL, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using DYNAFIL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, 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 allergic reaction to DYNAFIL. 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:

• rapid heartbeat, high or low blood pressure, increased heart rate, severe pain in chest, impairment in conduction between chambers, heart failure, heart disease
• swelling in any part of the body
• prolonged or painful erections
• sudden loss or decrease of vision
• sudden loss of hearing
• unstable diabetes
• seizures
• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• sleep disturbances including insomnia
• headache, dizziness, fever, flushing of the skin
• flu-like symptoms including throat infection, blocked or stuffy nose
• indigestion
• abnormal vision including blurred vision and colour tinge to vision.

Less frequent side effects:

• bladder infections, passing too little urine or more urine than is normal for you, excessive urination at night
• respiratory tract infection, fluid-filled sores on the mouth or genitals, infection of the voice box, throat infection, bronchitis, sinusitis
• abnormal blood test results including anaemia and abnormal liver test results
• dry mouth, thirst, gout, blood sugar levels that swing quickly from high to low, too much sugar in the blood, too much salt in the blood
• depression, abnormal dreams (nightmares)
• migraine, feeling sleepy
• damage to the nerves of your legs and arms (such as numbness), pins and needles sensation
• light sensitivity, eye infection
• 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, eye pain, dry eye
• ear pain, ringing in the ears
• asthma, cough, increased phlegm (mucous) dry or swollen nasal passages
• nausea, vomiting, diarrhoea, abdominal pain, gastric reflux, inflammation of the stomach and intestines, inflammation of the gums, reduced sensitivity in the mouth, inflammation of the tongue, food pipe, colon or mouth
• bleeding from the rectum, traces of blood in your urine
• abnormal sweating, rash, itching or other skin reactions
• muscle, tendon, joint and back pain or inflammation, arthritis, bone pain, tendon rupture, joint disease
• muscle weakness, poor muscle coordination, tremors
• nose bleeds, shock
• breast enlargement in men, prostrate disorder, abnormal ejaculation, difficulty in achieving orgasm, genital swelling, presence of blood in semen
• general pain, chest pain, chills, feeling hot, irritability
• accidental injury and falls.

The following side effects have been reported but the frequency for them to occur is not known:

• increased brightness of light, appearance of light flashes, inflammation of membrane of the eye, swelling of the eye, eye strain, double vision, yellow or red tinge in vision, burning of the eye, watering of the eyes, bleeding in the eye, pressure in the eye, detachment of the liquid in the eye from the inner lining of the eye, damage of the optic nerve associated with loss of vision or blindness, glaucoma
• heart attack, sudden cardiac 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 are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of DYNAFIL. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Do not remove from outer carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).