SILDEHEXAL SF

Posology Use in adults The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased up to 100 mg (two orodispersible films 50 mg can be taken at once), or decreased to 25 mg.

The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. 2). Elderly (≥ 65 years old) Dosage adjustments are not required in elderly patients. Renal impairment The dosing recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min).

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased to 50 mg, 75 mg, and 100 mg (two orodispersible films 50 mg can be taken at once) as necessary.

g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and tolerability , the dose may be increased to 50 mg, 75 mg, and 100 mg (two orodispersible films can be taken at once) as necessary. Paediatric population Sildenafil is not indicated for individuals below 18 years of age.

5). In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. 5). Method of administration SildeHEXAL SF orodispersible films are for oral use and are taken without water.

If desired SildeHEXAL SF may also be used with water.

Instructions on handling SildeHEXAL SF Important:

Do not handle the orodispersible film with wet hands! a) Take the sachet, locate the arrow mark at one of the shorter sides and hold the sachet with this side facing up. The sachet is not sealed here. b) Gently peel both parts of the sachet apart at the arrow mark.

Now you can hold each between your thumb and your index finger using one hand for each part. c) Carefully tear both parts of the sachet into opposite directions until they are separated. The orodispersible film is now visible and placed on one of the separated sachet parts.

d) Take the orodispersible film with dry fingers out of the sachet and put it in your mouth directly on your tongue. It will dissolve rapidly, so that it can be easily swallowed.

Summary of the safety profile The safety profile of sildenafil is based on 9570 patients in 74 double-blind placebo- controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.

Tabulated list of adverse reactions In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1:

Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through postmarketing surveillance. System Organ Class Very common (≥ 1/10) Common (≥ 1/100 and < 1/10) Uncommon (≥ 1/1000 and <1/100) Rare (≥ 1/10000 and <1/1000) Infections and infestations Rhinitis Immune system disorders Hypersensitivit y Nervous system disorders Headache Dizziness Somnolence, Hypoaesthesia Cerebrovascular accident, Transient ischaemic attack, Seizure,* Seizure recurrence, * Syncope Eye disorders Visual colour distortions**, Visual disturbance, Vision blurred Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion,* Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia, Visual acuity reduced, Myopia, Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal System Organ Class Very common (≥ 1/10) Common (≥ 1/100 and <1/10) Uncommon (≥ 1/1000 and <1/100) Rare (≥ 1/10000 and <1/1000) Ear and labyrinth disorders Vertigo, Tinnitus Deafness Cardiac disorders Tachycardia, Palpitations Sudden cardiac death,* Myocardial infarction, Ventricular arrhythmia,* Atrial fibrillation, Unstable angina Vascular disorders Flushing, Hot flush Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Nasal congestion Epistaxis, Sinus congestion Throat tightness, Nasal oedema, Nasal dryness Gastrointestinal disorders Nausea, Dyspepsia Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, Dry mouth Hypoaesthesia oral Skin and subcutaneous tissue disorders Rash Stevens-Johnson Syndrome (SJS),* Toxic Epidermal Necrolysis (TEN)* Musculoskeletal and connective tissue disorders Myalgia, Pain in extremity Renal and urinary disorders Haematuria System Organ Class ) Very common (≥ 1/10) Common (≥ 1/100 and <1/10) Uncommon (≥ 1/1000 and <1/100) Rare (≥ 1/10000 and <1/1000) Reproductive system and breast disorders Penile haemorrhage, Priapism,* Haematospermia, Erection increased General disorders and administration site conditions Chest pain, Fatigue, Feeling hot Irritability Investigations Heart rate increased *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Cardiovascular risk factors Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

1). Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity.

g. aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. 3). Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of SildeHEXAL SF.

Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of SildeHEXAL SF without sexual activity.

It is not possible to determine whether these events are related directly to these factors or to other factors. Priapism Agents for the treatment of erectile dysfunction, including sildenafil, 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).

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied.

Therefore the use of such combinations is not recommended. 8). 8). 3). 5). 5). This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.

2). In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.

There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.

Women SildeHEXAL SF is not indicated for use by women.

1. 1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated. 5). g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).

4). The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).