Makdefil 5 mg

MAKDEFIL and MAKDEFIL 10 mg ODT contains an ingredient called vardenafil hydrochloride, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are prescribed for the treatment of erectile dysfunction in men. This is a condition where men have difficulties in achieving a penile erection hard enough for successful penetrative sex.

Always tell your health care provider if you are taking any other medicine. Your doctor should consider your cardiovascular status, since there is a degree of heart risk associated with sexual activity. MAKDEFIL should not be used in men for whom sexual activity is not recommendable because of their underlying cardiovascular status. If sexual activity is not recommended for you due to some underlying heart condition, do not take MAKDEFIL.

Do not take MAKDEFIL:

• If you are hypersensitive (allergic) to vardenafil or any of the other ingredients of MAKDEFIL (listed in section 6)
• If you are concurrently treated with nitrates or nitric oxide donors.
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischaemic optic neuropathy (NAION).
• If you are suffering from end-stage kidney disease requiring dialysis.
• If you are a woman or a child.
• If you are suffering from sickle cell anaemia, multiple myeloma or leukaemia.
• If you have anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease).
• If you are suffering from hypotension or low blood pressure (resting systolic blood pressure of < 90 mmHg).
• If you are suffering from uncontrolled hypertension or high blood pressure (> 170/110 mmHg).
• If you have a recent history of stroke, life-threatening irregular heart rhythm or heart attack (within last 6 months).
• If you are suffering from uncontrolled cardiac (heart) failure.
• If you suffer from unstable angina (chest pains as a result of lack of oxygen supply to the heart muscles).
• If there is a known hereditary (family related) degenerative eye disorders such as progressive degeneration of the retina.
• If you suffer from bleeding disorders.
• If you suffer from active peptic ulcers.
• If you suffer from severe impairment of liver function.
• If you are currently taking the HIV protease inhibitors indinavir and ritonavir.
• If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
• You suffer from moderate hepatic impairment.
• You have phenylketonuria.
• You have hereditary problems of lactose intolerance.

If you are not at all sure, please consult your doctor.

Warnings and precautions

Talk to your doctor or health care provider before taking MAKDEFIL

Take special care with MAKDEFIL Some loss of vision or blindness that is irreversible has been reported with some medication similar to MAKDEFIL. Should this occur, please consult your doctor immediately. There have been reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of medicines. In the event that your erection persists longer than 4 hours, you should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

A sudden decrease or loss of hearing in one or both ears, with or without ringing in the ears and dizziness has been reported. You should contact your doctor as soon as you become aware of the hearing loss.

Use in children and patients younger than 18 years of age

MAKDEFIL is not to be used in children or adolescents under 18 years.

Other medicines and MAKDEFIL

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) It is especially important to inform your doctor if you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of MAKDEFIL with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare provider for advice.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following medicines:

• Alpha blockers, such as doxazosin, prazosin, phentolamine, used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
• Nitrates (medicines for angina), or nitric oxide donors, such as amyl nitrite.
• Quinidine, procainamide, amiodarone or sotalol used to treat arrythmias.
• Ketoconazole, itraconazole, clarithromycin, erythromycin, used to treat infections.
• Indinavir and ritonavir used for HIV treatment

The safety and efficacy of combinations of MAKDEFIL with other treatments for erectile dysfunction have not been studied, therefore, do not take MAKDEFIL in combinations with other erectile dysfunction medicines, unless if it is directed by your doctor.

MAKDEFIL with food and drink: MAKDEFIL can be taken with or without food. Do not drink grapefruit juice when you use MAKDEFIL. It can interfere with the usual effect of the medicine.

Pregnancy, breastfeeding and fertility

MAKDEFIL is not indicated for use by women.

Driving and using machines

MAKDEFIL may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery. It is not always possible to predict to what extent MAKDEFIL may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which MAKDEFIL affects them.

MAKDEFIL 10 mg ODT contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

MAKDEFIL 10 mg ODT 10 mg contains Aspartame Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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

Take MAKDEFIL by mouth. The usual dose is: The recommended daily dose range is 5 mg, or 10 mg, or 20 mg per day. The recommended starting dose of MAKDEFIL is 10 mg. Based on efficacy and tolerability; your dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg once daily.

MAKDEFIL 10 mg ODT is placed on the tongue and dissolves in the mouth in the presence of saliva. It should be taken immediately after release from the blister. It should be taken by itself without food or liquid in the mouth.

Take MAKDEFIL as needed (approximately one hour) before sexual activity. However, you can take MAKDEFIL anytime from 25 minutes to at least up to 4 to 5 hours before sexual activity. Do not take more than one (1) tablet of MAKDEFIL per day. MAKDEFIL will not give you an instant erection; you will require sexual stimulation, either visual or physical, for an erection to occur after taking MAKDEFIL.

You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

If you have the impression that the effect of MAKDEFIL is too strong or too weak, talk to your doctor or pharmacist.

MAKDEFIL offers no protection against sexually transmitted diseases.

If you have the impression that the effect of MAKDEFIL is too strong or too weak, talk to your doctor or pharmacist.

If you take more MAKDEFIL than you should In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. You may experience severe back pain if you have taken an overdose of MAKDEFIL. In cases of overdose, your doctor or paramedics will take standard supportive measures as dictated by your clinical status.

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

If any of the following happens, stop taking MAKDEFIL 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 MAKDEFIL. You may need urgent medical attention or hospitalization.

If you experience sudden loss of vision while taking MAKDEFIL, you should stop treatment immediately and consult your doctor.

Tell your doctor if you notice any of the following:

Frequent side effects may include:

• headache
• dizziness
• flushing (vasodilation)
• blocked or runny nose
• indigestion (dyspepsia)

Less frequent side effects

• swelling of the skin and mucous tissue including swollen face, lips or throat
• sleep disorder
• “pins and needles” and unpleasant sensation (paraesthesia and dysthesia), sleepiness
• visual disturbances, redness of eyes or watery eyes (ocular hyperaemia),
• sensitivity to light, colour distortion, eye pain and discomfort
• ringing of ears (tinnitus), feeling off balance (vertigo)
• palpitation, rapid heart rate (tachycardia)
• breathlessness (dyspnoea), stuffy nose (sinus congestion)
• nausea, stomach and abdominal pain, dry mouth, diarrhoea, acid reflux, gastritis,
• vomiting
• increase in protein enzymes (transaminases)
• inflammatory skin redness (erythema), rash
• back pain, increase in the enzyme creatine phosphokinase, increased muscle tone and cramping, muscle pain (myalgia)
• increase in erection
• feeling unwell
• conjunctivitis
• allergic reaction
• fainting (syncope) loss of memory (amnesia), seizure
• increase in eye pressure (glaucoma)
• effects on the heart such as angina pectoris, heart attack (myocardial infarction),
• abnormal rapid heart rhythm that originates in the ventricles (ventricular tachyarrhythmias)
• low blood pressure
• prolonged and painful erection (priapism)
• chest pain
• nosebleed

Frequency unknown

• partial, sudden, temporary, or permanent loss in vision in one or both eyes
• sudden decrease or loss of hearing
• cerebral haemorrhage
• Bleeding from the penis, blood in semen (haematospermia)
• Retinal detachment (which may appear as tiny specks through your field of vision).

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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MAKDEFIL.

Store at or below 25 ° C (room temperature). Protect from light. Keep the blisters in the carton until required for use. Keep the HDPE container tightly closed. Store in the original package in order to protect from light and moisture. KEEP OUT OF THE REACH OF CHILDREN. Do not store in a bathroom. Do not use after the expiry date stated on the blister / label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).