Tadalafil Film-Coated Tablets

TADALAFIL BIOTECH contains the active substance tadalafil. TADALAFIL BIOTECH is a treatment for men with erectile disfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, TADALAFIL BIOTECH works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is an improved erection. TADALAFIL BIOTECH will not help you if you do not have erectile dysfunction. It is important to note that tadalafil for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking any medicines for erectile dysfunction.

Do not take TADALAFIL BIOTECH:

• If you are hypersensitive (allergic) to tadalafil or any of the other ingredients of TADALAFIL BIOTECH (listed in section 6).
• If you are taking any form of a group of medicines called nitrates. These are used in the treatment of angina.
• If you have a serious heart disease or had a heart attack within the last 90 days.
• If you had a stroke within the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have severe hepatic (liver) insufficiency (Child-Pugh Class C).
• If you have ever had loss of vision because of a condition called non-arteritic anterior ischemic optic neuropathy (NAION), also described as “stroke of the eye”. This may or may not have been connected to taking a medicine like TADALAFIL BIOTECH.
• If you have previously experienced loss of hearing in one or both ears, with or without symptoms like vertigo and dizziness.

Warnings and precautions

Tell your doctor if you have a history of heart disease. Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. Take special care with TADALAFIL BIOTECH:

• If you are taking medicines to control your blood pressure as the dosage of these medicines might have to be adjusted to prevent your blood pressure from dropping too low.
• If you notice any symptoms or feel any discomfort when you begin sexual activity, stop immediately and report the incident to your doctor.
• And let your doctor know immediately If you experience sudden loss of vision or any change in vision.
• And let your doctor know immediately if you experience a sudden loss of hearing or decrease in ability to hear. You may experience dizziness and ringing in your ears with this loss of hearing.
• If you have kidney or liver disease.
• If you experience prolonged erections (4 hours or more) while taking tadalafil. If this is not treated immediately it can lead to permanent damage and loss of potency.
• If you have any malformations of the penis.
• If you suffer from a type of anaemia called sickle cell anaemia or any type of cancer.
• If you are taking other medication for erectile dysfunction as TADALAFIL BIOTECH should not be taken with certain other medicines (see section “Other medicines and TADALAFIL BIOTECH” below).

It is not known if TADALAFIL BIOTECH is effective in patients who have had:

• Pelvic surgery.
• Removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve sparing prostatectomy).

Children and adolescents

TADALAFIL BIOTECH is not intended for use by children and adolescents under the age of 18.

Do not share medicines prescribed for you with any other person. Always take TADALAFIL BIOTECH exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. The maximum dose is 20 mg a day. You should not take TADALAFIL BIOTECH more than once in a day. TADALAFIL BIOTECH 20 mg may be taken up to 36 hours or as early as 16 minutes prior to when you want to engage in sexual activity. Swallow the tablet whole with a glass of water. If you have the impression that the effect of TADALAFIL BIOTECH is too strong or too weak, tell your doctor or pharmacist.

If you take more TADALAFIL BIOTECH than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. You may experience headache, discomfort in your stomach, back or muscle pain and an erection that lasts longer than 4 hours.

If you forget to take TADALAFIL BIOTECH

If you forget to take TADALAFIL BIOTECH, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

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

• Difficulty breathing
• Severe skin rash or itching
• Swollen tongue or lips

These are all very serious side effects. If you have them, you may have had a serious reaction to TADALAFIL BIOTECH. 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:

• chest pain;
• an erection that lasts longer than 4 hours;
• sudden loss of vision.

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:

• headache;
• reddening of the face (flushing);
• stuffy nose;
• discomfort in your stomach;
• back pain, pain in your muscles or any part of your body.

Less frequent side effects:

• dizziness;
• loss of consciousness or numbness on one side of the body;
• fainting, severe headache (migraine), sudden memory loss;
• blurred vision or loss of vision, eye pain, swelling of eyelids, redness or itching of the eye;
• ringing in ears, loss of hearing;
• changes in heart rhythm, chest pain or feeling of pressure in chest;
• low or high blood pressure;
• difficulty breathing, nose bleeds;
• stomach pain, nausea, vomiting, heartburn or burning sensation in your throat;
• rash, sweating;
• blood in urine;
• prolonged erections, blood in the sperm or bleeding from the penis;
• tiredness, swelling of the legs or face.

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. 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 TADALAFIL BIOTECH.

• 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 blister or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).