INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SILDOJUB (film coated tablets)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

SILDOJUB (film coated tablets)

Sildojub 25 mg (film coated tablets)
Sildojub 50 mg (film coated tablets)
Sildojub 100 mg (film coated tablets)

COMPOSITION
Active ingredient:
Sildojub 25 mg
: Each film coated tablet contains sildenafil citrate equivalent to 25 mg
sildenafil.
Sildojub 50 mg: Each film coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
Sildojub 100 mg: Each film coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.
Inactive ingredients:
Anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and Opadry Blue (containing hypromellose, lactose monohydrate, titanium dioxide, triacetin and FD&C Blue).
Contains sugar: lactose monohydrate.

PHARMACOLOGICAL CLASSIFICATION
A 7.1.5 Vasodilators –peripheral

PHARMACOLOGICAL ACTION
Pharmacodynamic properties:
Sildenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor, an enzyme responsible for degrading cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. Sildenafil enhances the effect of nitric oxide (NO) on the corpus cavernosum tissue during sexual stimulation, resulting in increased cGMP levels, causing the smooth muscle to relax, allowing blood flow into the corpus cavernosum producing an erection. Without sexual stimulation, sildenafil has no effect on erections. Sildenafil increases blood flow to the penis, in response to sexual stimulation and thereby restores impaired erectile function.
Pharmacokinetic properties:
Absorption
:
Sildenafil is well absorbed after an oral dose with a mean absolute bioavailability of about 40%. Peak plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The oral pharmacokinetics of sildenafil is proportional over the recommended dose range (25 - 100 mg). A high fat meal reduces absorption of sildenafil as shown by a mean reduction in the maximum plasma concentration (Cmax) of 29% and a mean delay in the time to peak concentration (Tmax) of 60 minutes.
Distribution:
The mean steady state volume of distribution (Vss) for sildenafil is 105 litres. Sildenafil and its major circulating N-desmethyl metabolite, exhibit high (96%) plasma protein binding, independent of total medicine concentrations. Less than 0,0002% of sildenafil remained in the semen of healthy volunteers at 90 minutes after dosing.
Metabolism:
Hepatic metabolism of sildenafil is predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) microsomal isoenzymes. Sildenafil is converted by N-demethylation to an active metabolite with a PDE selectivity profile similar to sildenafil. The terminal half-life of the N-desmethyl metabolite is approximately 4 hours.
Elimination:
Sildenafil is excreted as metabolites mainly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Pharmacokinetics in special patient groups:
Elderly
:
Healthy elderly volunteers, 65 years or over, cleared sildenafil less effectively from the plasma than did normal healthy volunteers, 18 to 45 years of age, as shown by a 40% increase of AUC in older adults.
Renal insufficiency:
Sildenafil clearance was reduced in volunteers with severe renal impairment, with creatinine clearance values of CLcr <30 mL/min, resulting in increases in AUC (100%) and C
max (88%) compared to age-matched volunteers with no renal impairment (see DOSAGE AND DIRECTIONS FOR USE). The pharmacokinetics of sildenafil were not altered in persons with mild to moderate renal impairment.
Hepatic insufficiency:
Sildenafil clearance was reduced in volunteers with hepatic cirrhosis (Child-Pugh A and B), resulting in increases in AUC by 84% and C
max by 47% compared to age-matched volunteers with no hepatic impairment (see DOSAGE AND DIRECTIONS FOR USE).

INDICATIONS
Sildojub
is indicated only for the treatment of erectile dysfunction.
SILDOJUB IS NOT AN APHRODISIAC.

CONTRAINDICATIONS
Known hypersensitivity to sildenafil or to any of the other components of Sildojub (see COMPOSITION ).
Consistent with its known effects on the nitric oxide/cGMP pathway (see PHARMACOLOGICAL ACTION), sildenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates, and its co- administration with nitric oxide donors or nitrates in any form, either regularly or intermittently, is therefore contraindicated. Doctors should discuss the contraindication of Sildojub with concurrent organic nitrates.
Severe hepatic impairment (e.g. cirrhosis).
Severe renal impairment (e.g. creatinine clearance <30 mL/min).
Concomitant use of Sildojub with potent cytochrome P450 3A4 inhibitors (e.g. cimetidine, erythromycin, ritonavir, saquinavir, ketoconazole, itraconazole) is contraindicated (see INTERACTIONS).

WARNINGS AND SPECIAL PRECAUTIONS
There is a potential of cardiac risk with sexual activity in patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including Sildojub, should generally not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status
.
A thorough medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment.
Sildojub has systemic vasodilatory properties that resulted in transient decrease in supine blood pressure in healthy volunteers. Medical practitioners should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.
Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (such as aortic stenosis or hypertrophic obstructive cardiomyopathy), or those with the syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Concomitant administration of Sildojub to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see INTERACTIONS ). In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating Sildojub treatment. Doctors should advise patients what to do in the event of postural hypotensive symptoms.
Sildojub should be prescribed with caution in the following patients:
Patients who have suffered a myocardial infarction, stroke or life-threatening dysrhythmia within the last 6 months.
Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110).
Patients with cardiac failure or coronary artery disease, causing unstable angina.
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Patients should seek immediate medical assistance in the event of an erection that persists longer than 4 hours. Priapism (painful erections lasting longer than 6 hours) should be treated immediately, as penile tissue damage and permanent loss of potency could result.
Sildojub should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Combinations of Sildojub with other treatments for erectile dysfunction is not recommended as the safety and efficacy of such combinations have not been studied.
Sildojub should be administered with caution to patients with bleeding disorders or active peptic ulceration.
Sildojub has no effect on bleeding time, including during co-administration with aspirin.
Non-arteritic anterior ischaemic optic neuropathy (NAION) with some loss of vision or irreversible blindness has been reported with the use of selective phosphodiesterase type-5 inhibitors including sildenafil (contained in Sildojub). NAION appears to be a class effect of these medicines. Most of these patients had risk factors such as low cup to disc ratio (“crowded disk”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidaemia and smoking. Sildojub should not be given to these patients.
A sudden or bilateral decrease or loss of hearing (sensorineural deafness), with or without associated vestibular symptoms has been reported with the use of PDE5 inhibitors, including Sildojub. There is insufficient information regarding the reversibility of the hearing loss and the role of underlying risk factors for hearing loss in individual subjects.

Information for patients:
The use of Sildojub offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the human immunodeficiency virus (HIV/AIDS), should be considered.
Precautions against unwanted pregnancy should be taken.
Effects on ability to drive and use machines:
Sildojub
can lead to dizziness and altered vision and patients should be aware how they react to Sildojub and exercise caution before driving a vehicle, operating hazardous machinery or performing hazardous tasks.
Lactose monohydrate: Sildojub contains lactose monohydrate (see COMPOSITION). Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take Sildojub.

INTERACTIONS
Effects of other medicines on Sildojub
:
In vivo studies:
A 100 mg single dose of Sildojub co-administered with erythromycin 500 mg twice daily, resulted in a 182% increase in sildenafil systemic exposure (AUC) at steady state. However, with co-administration of sildenafil with azithromycin (500 mg daily for three days), no evidence was found of an effect on the AUC or other kinetic parameters of sildenafil.
Co-administration of a 100 mg single dose of Sildojub with saquinavir (1 200 mg three times daily) or ritonavir (500 mg twice daily) resulted respectively in a 210% and 1 000% increase in the AUC of sildenafil. (Sildojub had no effect on either the saquinavir or ritonavir pharmacokinetics).
Inhibitors of cytochrome P450 (CYP) isoforms 3A4 (major route of sildenafil) and 2C9 (minor route of sildenafil) isoenzymes may reduce sildenafil clearance which include the following: Cimetidine, erythromycin, itraconazole, ketoconazole and HIV-protease inhibitors, such as saquinavir.
Inducers of cytochrome P450 (CYP) isoform 3A4 may increase the metabolism and clearance of sildenafil, such as rifampicin. Ritonavir increases the plasma concentration of sildenafil significantly and such combinations should not be given (see CONTRAINDICATIONS). No effect of concomitant medication on sildenafil pharmacokinetics acting as CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates) has been noted.
Effects of Sildojub on other medicines:
Sildenafil may potentiate the hypotensive effect of acute and chronic nitrates. Therefore, the concomitant use of Sildojub and nitrates or nitric oxide donors is contraindicated (see CONTRAINDICATIONS).
Concomitant use of Sildojub and other antihypertensive medicines may potentiate the antihypertensive effect of these medicines. Symptomatic postural hypotension has been reported in patients who receive concomitant therapy with doxazosin and Sildojub. This includes reports of dizziness and light-headedness, but not syncope.
Sildojub did not potentiate the increase in bleeding time caused by aspirin. No significant interactions were shown between Sildojub and tolbutamide (250 mg) or warfarin (40 mg), both being metabolised by CYP2C9 isoenzyme. Sildojub did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dL.
Symptomatic hypotension may occur when Sildojub is administered concomitantly with alpha-blockers (see WARNINGS AND SPECIAL PRECAUTIONS).

PREGNANCY AND LACTATION
Sildojub
is not indicated for use in women.
Sildenafil was not found to be teratogenic, embryotoxic or foetotoxic in animal studies. Single 100 mg oral doses of sildenafil does not impair sperm motility or morphology.

DOSAGE AND DIRECTIONS FOR USE
Adults
:
The recommended oral dose is 50 mg, taken as needed once daily, approximately one hour before sexual intercourse. The dose may be increased to 100 mg or decreased to 25 mg, depending on the efficacy and tolerance. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once daily.
Elderly and patients with impaired renal or hepatic function:
In patients with reduced clearance, increased Sildojub plasma levels and an increase in the incidence of adverse events may occur. A starting dose of 25 mg should be considered.
Sildojub administration is contraindicated in patients who use nitric oxide donors or nitrates in any form, as it was shown to potentiate the hypotensive effects of nitrates (see CONTRAINDICATIONS).
Children:
Sildojub is not indicated for use in children.

SIDE EFFECTS
Infections and infestations:
Less frequent: Infection, herpes simplex, cellulitis
Blood and the lymphatic system disorders:
Less frequent: Anaemia and leucopenia
Immune system disorders:
Less frequent: Allergic reaction, hypersensitivity reaction
Metabolism and nutrition disorders:
Less frequent: Thirst, gout, unstable diabetes, hyperglycaemia, hyperuricaemia, hypoglycaemic reaction and hypernatraemia
Psychiatric disorders:
Frequent: Insomnia, anxiety
Less frequent: Depression, abnormal dreams, anorgasmia
Nervous system disorders:
Frequent: Headache, dizziness
Less frequent: Ataxia, hypertonia, neuralgia, neuropathy, paraesthesia, tremor, somnolence, decreased reflexes, hypaesthesia, migraine, seizures
Eye disorders:
Frequent: Cyanopsia, eye irritation, eye pain, ocular redness, photophobia, chromatopsia (mild and transient, predominantly colour tinge to vision)
Less frequent: Abnormal vision (increased perception of light, blurred vision), bloodshot appearance, ocular burning, ocular swelling or pressure, increased intraocular pressure, retinal vascular disease or bleeding, vitreous detachment/traction and paramacular oedema, conjunctivitis, eye haemorrhage, cataract, dry eyes, non-arteritic anterior ischaemic optic neuropathy (NAION)
Frequency unknown: Diplopia, temporary vision loss, decreased vision
Ear and labyrinth disorders:
Frequent: Vertigo
Less frequent: Tinnitus, deafness, ear pain
Cardiac disorders:
Frequent: Palpitations
Less frequent: Serious cardiovascular events, myocardial infarction, sudden cardiac death, ventricular dysrhythmia, angina pectoris, AV block, tachycardia, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy
Vascular disorders:
Frequent: Epistaxis
Less frequent: Cerebrovascular haemorrhage, transient ischaemic attack, hypertension (see WARNINGS AND SPECIAL PRECAUTIONS), hypotension, postural hypotension, vasodilatation (flushing), shock
Respiratory, thoracic and mediastinal disorders:
Frequent: Nasal congestion, dyspnoea
Less frequent: Asthma, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough, respiratory disorder, respiratory tract infection
Gastrointestinal disorders:
Frequent: Dyspepsia, diarrhoea, nausea, vomiting
Less frequent: Abdominal pain, glossitis, colitis, dysphagia, gastritis, gastroenteritis, oesophagitis, stomatitis, dry mouth, rectal haemorrhage, gingivitis
Skin and subcutaneous tissue disorders:
Frequent: Flushing, erythema
Less frequent: Urticaria, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, rash, photosensitivity reaction
Musculoskeletal, connective tissue and bone disorders:
Less frequent: Arthritis, arthrosis, tendon rupture, tenosynovitis, myasthenia, synovitis, arthralgia, back pain, bone pain, myalgia
Renal and urinary disorders:
Less frequent: Cystitis, nocturia, urinary frequency, urinary incontinence, haematuria
Reproductive system and breast disorders:
Less frequent: Priapism (prolonged erection), breast enlargement, abnormal ejaculation, genital oedema, prostatic disorder
General disorders and administrative site conditions:
Frequent: Pyrexia (fever)
Less frequent: Facial oedema, asthenia, pain, chills, accidental fall, chest pain, accidental injury, oedema, peripheral oedema, syncope
Investigations:
Less frequent: Abnormal liver function tests, abnormal electrocardiogram (ECG)

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptomatic or supportive measures should be adopted as required, in the event of an overdose. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

IDENTIFICATION
Sildojub
25 mg: Blue, oval shaped, biconvex, film coated tablets, plain on one side and debossed with “B9” on the other side.
Sildojub 50 mg: Blue, oval shaped, biconvex, film coated tablets, plain on one side and debossed with “C1” on the other side.
Sildojub 100 mg: Blue, oval shaped, biconvex film coated tablets, plain on one side and debossed with “436” on the other side.

PRESENTATION
Sildojub
25 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.
Sildojub 50 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.
Sildojub 100 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.

STORAGE INSTRUCTIONS
Store at or below 25°C.
Do not remove blister strips from outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
Sildojub
25 mg: 45/7.1.5/0735
Sildojub 50 mg: 45/7.1.5/0736
Sildojub 100 mg: 45/7.1.5/0737

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
LeBasi Pharmaceuticals CC
Jankra Building, 2nd Floor
3 OR Tambo Street
Potchefstroom
2531

MARKETED BY
Forrester Pharma (Pty) Ltd
13 Pasita Street
Rosen Heights
Rosen Park
Bellville, 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT
27 November 2014


PATIENT INFORMATION LEAFLET

SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
Sildojub
25 mg (film coated tablets)
Sildojub 50 mg (film coated tablets)
Sildojub 100 mg (film coated tablets)

Please read this leaflet carefully before taking Sildojub
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or your pharmacist.

Sildojub has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

1. WHAT SILDOJUB CONTAINS
Active ingredient:
Sildojub
25 mg: Each film coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
Sildojub 50 mg: Each film coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
Sildojub 100 mg: Each film coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.
The other ingredients are anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and Opadry Blue (containing hypromellose, lactose monohydrate, titanium dioxide, triacetin and FD&C Blue).
Contains sugar: lactose monohydrate.

2. WHAT SILDOJUB IS USED FOR
Sildojub
is used for the treatment of erection problems in men.
SILDOJUB IS NOT AN APHRODISIAC.

3. BEFORE YOU TAKE SILDOJUB
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. Your doctor will examine you and determine the cause of your disorder before starting treatment with Sildojub.
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).
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).

4. HOW TO TAKE SILDOJUB
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 Sildojubthan was prescribed to you and do not take Sildojubmore 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.

5. POSSIBLE SIDE EFFECTS
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.
Fainting.
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 involuntary.
Blood in your urine.
Bladder infection (pain and burning while passing urine, frequent small amounts of urine).
Prolonged or painful erection.
Unstable diabetes (uncontrolled sugar levels in your body). #
Sudden drop in your blood sugar (confusion, disorientation or dizziness).
Bleeding of your rectum (presence of blood when you pass stools, pain or discomfort).
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.

6. STORAGE AND DISPOSING 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).

7. PRESENTATION OF SILDOJUB
Sildojub
25 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.
Sildojub 50 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.
Sildojub 100 mg: Aluminium foil/transparent PVC film blister strips containing 2 or 4 tablets packed into an outer carton. Pack sizes: 2, 4 or 12 tablets.

8. IDENTIFICATION OF SILDOJUB
Sildojub
25 mg: Blue, oval shaped, biconvex, film coated tablets, plain on one side and debossed with “B9” on the other side.
Sildojub 50 mg: Blue, oval shaped, biconvex, film coated tablets, plain on one side and debossed with “C1” on the other side.
Sildojub 100 mg: Blue, oval shaped, biconvex film coated tablets, plain on one side and debossed with “436” on the other side.

9. REGISTRATION NUMBERS
Sildojub
25 mg: 45/7.1.5/0735
Sildojub 50 mg: 45/7.1.5/0736
Sildojub 100 mg: 45/7.1.5/0737

10. NAME AND ADDRESS OF REGISTRATION HOLDER
LeBasi Pharmaceuticals CC
Jankra Building, 2nd Floor
3 OR Tambo Street
Potchefstroom
2531

11. MARKETED BY
Forrester Pharma (Pty) Ltd
13 Pasita Street
Rosen Heights
Rosen Park
Bellville,
7530

12. DATE OF PUBLICATION
27 November 2014

New addition to this site: December 2016
Source: Pharmaceutical Industry

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