Sildojub 25 mg Film-Coated Tablets

SILDOJUB is used for the treatment of erection problems in men. SILDOJUB IS NOT AN APHRODISIAC.

Do not take Sildojub:

• If you are hypersensitive (allergic) to sildenafil or to any of the other ingredients of Sildojub (see WHAT SILDOJUB CONTAINS).
• If you have a heart, severe liver or kidney disorder.
• If you are taking medicine such as nitrates or nitric oxide donors for high blood pressure or heart problems (such as chest pain). Please inform your doctor.

Take special care with Sildojub:

• If you had a heart attack, stroke or other life-threatening heart problems within the last 6 months.
• If you have high or low blood pressure.
• If you have any heart disorders such as angina (chest pain).
• If you have eye disorders (such as retinitis pigmentosa). Please consult your doctor before taking Sildojub.
• If you are an elderly patient. Follow the dose precisely as prescribed to you.
• If you have a stomach ulcer or a bleeding disorder.
• If you are taking other medications for erection problems or any other diseases. Please consult your doctor or pharmacist before taking Sildojub.
• You should seek immediate medical assistance in the event of an erection that persists longer than 4 hours after taking Sildojub. Painful erections lasting longer than 6 hours (priapism) should be treated immediately, as damage to your penis and permanent loss of potency could result.
• Sildojub should be used with caution if you have an anatomical deformation of your penis. Please consult your doctor.
• If you have ever had loss of vision due to an eye condition known as non-arteritic anterior ischaemic optic neuropathy (NAION).
• You should contact your doctor if you suffer any hearing loss while you are taking Sildojub.
• Sildojub offers no protection against sexually transmitted diseases. You should use protective measures necessary to guard against sexually transmitted diseases, including the human immunodeficiency virus (HIV/AIDS).
• A large-scale study found evidence of an increased risk of retinal detachment with regular use of PDE5 inhibitors like Sildojub. If you experience symptoms of retinal detachment (flashes of light, black spots, a curtain-like shadow in your vision or a limited field of vision), see an ophthalmologist immediately.

Taking Sildojub with food and drink:

Sildojub can be taken with or without food. However, you may find that Sildojub takes longer to start working if you take it with a fatty meal.

Pregnancy and breastfeeding:

Do not use Sildojub if you are female.

Driving and using machinery:

Sildojub can lead to dizziness and influence your vision, therefore you should exercise caution before driving a vehicle, operating hazardous machinery or performing hazardous tasks.

Important information about some of the ingredients of Sildojub:

Sildojub contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars (you cannot digest some sugars), contact your doctor before taking Sildojub.

Taking other medicines with Sildojub:

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). Medicines known to interact with Sildojub are:

• Ketoconazole or itraconazole (used to treat fungal infections).
• Cimetidine (used to treat ulcers).
• Erythromycin (used to treat bacterial infections).
• Saquinavir, ritonavir and other HIV medicines (used to treat HIV infection).
• Rifampicin (used to treat tuberculosis (TB)).
• Nitrates or nitric oxide donors (used to treat chest pain (angina)).
• Antihypertensive medication (used to treat high blood pressure).
• Doxazosin or alpha-blockers (used to treat high blood pressure or an enlarged prostate).

The dose of Sildojub will be different for different patients depending on the seriousness of the problem and the effectiveness and tolerability of Sildojub.

Do not take more Sildojub than was prescribed to you and do not take Sildojub more frequently.

Adults: The recommended dose is one 50 mg tablet per day one hour before sexual intercourse. The maximum recommended dose is 100 mg. The recommended dosing frequency is once per day.

Elderly and patients with liver or kidney disorders: Your doctor may recommend a lower starting dose of one 25 mg tablet per day, to be taken one hour before sexual intercourse.

If you take more Sildojub than you should: In the event of overdosage, consult your doctor of pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

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

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

• Swelling of your hands, feet, ankles, face, mouth or throat, which may cause difficulty in swallowing or breathing.
• Skin rash, hives or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Sildojub. 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 (angina).
• Changes in the way your heart beats (such as beating faster than normal or skipping beats).
• Heart attack (chest pain or tightness, pain in your arm or body, shortness of breath).
• Heart problems or abnormal readings on an electrocardiogram (ECG) when tests are done.
• Seizures (fits).
• Migraine (severe debilitating headache, nausea, vomiting, impaired vision).
• Loss of vision due to an eye condition known as non-arteritic anterior ischaemic optic neuropathy (NAION).
• Bleeding, swelling or build-up of pressure around your eyes.
• Low blood pressure when you stand up (light-headedness or dizziness).
• Shortness of breath or difficulty breathing (asthma).
• Signs of recurrent infections such as fever or sore throat.
• Stroke (severe headache, muscle weakness on one side of your body, loss of coordination or balance, difficulty speaking or swallowing).
• Cellulitis (bacterial skin infection causing rapid swelling, pain, redness and tenderness in the area affected).
• Urinating frequently or leaking urine involuntarily.
• Blood in your urine.
• Bladder infection (pain and burning while passing urine, frequent small amounts of urine).

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

Tell your doctor as soon as possible if you notice any of the following:

The following side effects occur more frequently:

• Difficulty sleeping.
• Feeling anxious.
• Headache or dizziness.
• Problems with seeing colours.
• Eye irritation, pain or redness.
• Sensitivity of your eyes to bright light.
• Vertigo (spinning feeling).
• Nose bleeds.
• Nasal congestion.
• Indigestion (heartburn), diarrhoea, nausea or vomiting.
• Flushing or redness of your skin.

The following side effects occur less frequently:

• Anaemia (unusual weakness, tiredness and pallor of your skin).
• Thirst.
• Gout or high levels of uric acid in your blood (painful, swollen and stiff joints).
• High blood sugar levels (increased thirst, frequent urination).
• High levels of sodium in your blood (tiredness, weakness, irritability).

Feeling depressed.

Abnormal dreams.

Inability to get an orgasm during sexual intercourse.

Lack of coordination or muscle control.

Muscle spasms.

Pain or burning feeling along your nerves, nerve damage (weakness, numbness or pain).

Paraesthesia (burning or tingling sensation of your skin).

Tremor (involuntary shaking).

Drowsiness.

Loss of feeling on your skin.

Abnormal/blurred vision, bloodshot eyes (redness).

Inflammation of your eyes (pink eyes).

Cataracts (loss of vision).

Dry or burning eyes.

Double vision or loss of vision.

Tinnitus (ringing in your ears), deafness or ear pain.

High blood pressure.

Low blood pressure (light-headedness or dizziness).

Throat infection (sore throat), sinus infection (blocked or runny nose, headache), lung infection (coughing, fever, increased phlegm), hoarse voice or loss of your voice.

Increased sputum/phlegm.

Increased coughing.

Pain of your stomach area.

Inflammation of your tongue (swollen, red or tender).

Difficulty swallowing.

Inflammation of your stomach (nausea, vomiting or diarrhoea).

Inflammation of the tube that carries your food to your stomach (heartburn, pain or nausea).

Inflammation of the inside of your mouth or gums (red, swollen gums, cheeks, or palate).

Dry mouth.

Increased sweating.

Skin ulcerations.

Sensitivity of your skin to sunlight.

Arthritis (painful, stiff joints).

Joint pain or muscle pain.

Rupture or inflammation of your tendons.

Muscle weakness.

Back or bone pain.

Enlarged breast tissue, abnormal ejaculation or swollen genitals.

Prostate problems.

Weakness, overall pain or discomfort.

Accidental falling and/or injury.

Swelling of your legs and feet due to water retention.

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, pharmacist or nurse. 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 SILDOJUB.

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