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PREGNANCY AND LACTATION:
DYNAFIL is not indicated for use in women.
dynafil 25 mg
DYNAFIL was not found to be carcinogenic, teratogenic, embryotoxic or fetotoxic in animal studies.
Single 100 mg oral doses of sildenafil did not impair sperm motility or morphology.
dynafil 50 mg
DOSAGE AND DIRECTIONS FOR USE:

dynafil 100 mg

The recommended oral dose is 50 mg, taken if needed once a day approximately one hour before sexual intercourse. The dose may be increased depending on the efficacy and toleration to 100 mg or decreased SCHEDULING STATUS: S4
to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency PROPRIETARY NAME AND DOSAGE FORM:
DYNAFIL 25 mg film-coated tablets
Elderly and Patients with Impaired Renal or Hepatic Function:
DYNAFIL 50 mg film-coated tablets
In patients with reduced clearance, increased DYNAFIL plasma levels and an increase in the incidence of
DYNAFIL 100 mg film-coated tablets
adverse events may occur. A starting dose of 25 mg should be considered in the following patient groups: COMPOSITION:
• Hepatic impairment (e.g., cirrhosis, 80 %) DYNAFIL 25 mg: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
• Severe renal impairment (creatinine clearance < 30 mL/min, 100 %), DYNAFIL 50 mg: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
• Concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, DYNAFIL 100 mg: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.
DYNAFIL administration is contraindicated in patients who use nitric oxide donors or nitrates in any form
Inactive Ingredients:
as it was shown to potentiate the hypotensive effects of nitrates.
DYNAFIL contains lactose monohydrate.
Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, opadry blue and povidone.
Children:
DYNAFIL is not indicated for use in children.
PHARMACOLOGICAL CLASSIFICATION:
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
PHARMACOLOGICAL ACTION:
Blood and the lymphatic system disorders:
Sildenafil increases blood flow to the penis, in response to sexual stimulation and thereby restores Less frequent: Anaemia and leukopenia Immune system disorders:
Sildenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor an enzyme responsible for degrading cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. Sildenafil facilitates the effect of Metabolism and nutrition disorders:
nitric oxide on the corpus cavernosum tissue during sexual stimulation with increased cGMP levels, the Less frequent: Thirst, oedema, gout, unstable diabetes, hyperglycaemia, peripheral oedema, smooth muscle is relaxed and blood flows into the corpus cavernosum producing an erection. Without hyperuricaemia, hypoglycaemic reaction and hyponatraemia.
sexual stimulation, sildenafil has no effect on erections. Psychiatric disorders:
Pharmacokinetic properties:
Absorption:
Nervous system disorders:
Sildenafil is rapidly absorbed after an oral dose with a bioavailability of about 40 %. Peak plasma Frequent: Insomnia, headache, dizziness concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted Less frequent: Ataxia, hypertonia, neuralgia, neuropathy, paraesthesia, tremor, vertigo, somnolence, state. The oral pharmacokinetics of sildenafil is proportional over the recommended dose range abnormal dreams, decreased reflexes and hypoaesthesia.
A high fat meal reduces absorption of sildenafil as shown by reducing the maximum plasma Eye disorders:
Less frequent: Abnormal vision, predominantly colour tinge to vision, but also increased perception of light max) by 29 % and delaying time to peak concentration (Tmax) by 60 minutes.
Distribution:
or blurred vision, bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular The mean steady state volume of distribution (Vss) for sildenafil is 105 liters. Sildenafil and its major pressure, retinal vascular disease or bleeding, vitreous detachment/traction and paramacular oedema. circulating N-desmethyl metabolite exhibit very high percentage (96 %) plasma protein binding, Conjunctivitis, photophobia, eye haemorrhage, cataract, dry eyes and eye pain, ocular redness, mydriasis.
independent of total drug concentrations.
The following have been reported but frequencies are unknown: Less than 0,001 % of sildenafil remained in the semen of healthy volunteers at 90 minutes after dosing. Diplopia, temporary vision loss/decreased vision.
Metabolism:
Ear and labyrinth disorders:
Hepatic metabolism of sildenafil is predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) Less frequent: Tinnitus, deafness, ear pain.
microsomal isoenzymes. Sildenafil is converted by N-demethylation to an active metabolite with a PDE Cardiac disorders:
selectivity profile similar to sildenafil. The terminal half-lives of sildenafil and the N-desmethyl metabolite Less frequent: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage and transient ischaemic attack (see “WARNINGS
Elimination:
for further important cardiovascular information), angina pectoris, AV block, migraine, tachycardia, Sildenafil is excreted as metabolites mainly in the faeces (approximately 80 % of administered oral dose) palpitation, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy have also been and to a lesser extent in the urine (approximately 13 % of administered oral dose).
Pharmacokinetics in Special Patient Groups:
Vascular disorders:
Elderly:
Less frequent: Serious cardiovascular events, including hypertension, hypotension, syncope and postural Healthy elderly volunteers 65 years or over cleared sildenafil less effectively from the plasma than did healthy volunteers 18 to 45 years of age as shown by a 40 % increase of AUC in older adults.
Respiratory, thoracic and mediastinal disorders:
Renal Insufficiency:
Frequent: Nasal congestion, dyspnoea.
Sildenafil clearance was reduced in volunteers with severe renal impairment with creatinine clearance Less frequent: Asthma, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
values of CLcr ≤30 mL/min, resulting in increases in AUC (100 %) and Cmax (88 %) compared to Gastrointestinal disorders:
age-matched volunteers with no renal impairment (see “DOSAGE AND DIRECTIONS FOR USE”). The
pharmacokinetic of sildenafil were not altered in persons with mild to moderate renal impairment.
Less frequent: Vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, oesophagitis, stomatitis, Hepatic Insufficiency:
dry mouth, rectal haemorrhage, gingivitis, abdominal pain.
Sildenafil clearance was reduced in volunteers with hepatic cirrhosis (Child-Pugh A and B), resulting Hepato-biliary disorders:
max by 47 % compared to age-matched volunteers with no hepatic impairment (see “DOSAGE AND DIRECTIONS FOR USE”).
Less frequent: Liver function tests abnormal.
Skin and subcutaneous tissue disorders:
INDICATIONS:
DYNAFIL is indicated only for the treatment of erectile dysfunction.
Less frequent: Urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative DYNAFIL IS NOT AN APHRODISIAC.
dermatitis, photosensitivity reaction.
CONTRA-INDICATIONS:
Musculoskeletal, connective tissue and bone disorders:
• Use of DYNAFIL is contraindicated in patients with a known hypersensitivity to any component of
Less frequent: Arthritis, arthrosis, tendon rupture, and tendosynovitis, pain, myasthenia, synovitis.
• Consistent with its known effects on the nitric oxide / cGMP pathway (see “PHARMACOLOGICAL
Renal and urinary disorders:
ACTION”), DYNAFIL was shown to potentiate the hypotensive effects of nitrates, and its co-
Less frequent: Cystitis, nocturia, urinary frequency, urinary incontinence, haematuria.
administration with nitric oxide donors or nitrates in any form is therefore contraindicated. Doctors Reproductive system and breast disorders:
should discuss the contra-indication of DYNAFIL with concurrent organic nitrates.
Less frequent: Priapism (prolonged erection), breast enlargement, abnormal ejaculation, genital oedema, In the following patients: age >65, hepatic impairment (e.g. cirrhosis), severe renal impairment (e.g. creatine clearance <30 mL/min) and concomitant use of potent cytochrome P450 3A4 inhibitors (e.g. erythromycin); plasma levels of sildenafil, at 24 hours post dose, have been found to be 3 to 8 times General disorders and administrative site conditions:
higher than those seen in healthy volunteers. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co- Less frequent: Face oedema, shock, asthenia, pain, chills, chest pain.
Injury and poisoning:
• Ritonavir increases the plasma concentration of sildenafil significantly and such combinations should Less frequent: Accidental fall, accidental injury.
Special Precautions:
WARNINGS:
Effects on Ability to Drive and Use Machines:
There is a potential for cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. DYNAFIL can lead to dizziness and altered vision and patients should be aware how they react to
Therefore, treatments for erectile dysfunction, including DYNAFIL, should not be generally used in men for
DYNAFIL and exercise caution before driving, operating hazardous machinery or performing hazardous
whom sexual activity is inadvisable because of their underlying cardiovascular status.
• A thorough medical history and physical examination should be undertaken to diagnose erectile KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
dysfunction, determine potential underlying causes, and identify appropriate treatment.
In studies with healthy volunteers, of single doses up to 800mg, adverse events were similar to those • DYNAFIL has systemic vasodilatory properties that resulted in transient decreases in supine
seen at lower doses but incidence rates were increased.
blood pressure in healthy volunteers. Physicians should carefully consider whether their patients with Supportive measures should be adopted as required, in the event of an overdose. Renal dialysis is not underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in • There is no controlled clinical data on the safety or efficacy of DYNAFIL in the following groups; if
prescribed this should be done with caution: IDENTIFICATION:
• Patients who have suffered a myocardial infarction, stroke or life-threatening arrhythmia within the DYNAFIL 25 mg: Blue, elliptical, biconvex, 10,0 x 5,0 mm film-coated tablets, with SL25 engraved on
• Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110).
DYNAFIL 50 mg: Blue, elliptical, biconvex, 13,0 x 6,5 mm film-coated tablets, with SL50 engraved on
• 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 DYNAFIL 100 mg: Blue, elliptical, biconvex, 17,0 x 8,5 mm film-coated tablets, with SL100 engraved on
• Patients should seek immediate medical assistance in the event of an erection that persists longer PRESENTATION:
than 4 hours. Priapism (painful erections longer than 6 hours) should be treated immediately, as DYNAFIL 25 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister
penile tissue damage and permanent loss of potency could result.
strips, containing 2 or 4 tablets each. Each outer carton contains 1 blister strip. • DYNAFIL should be used with caution in patients with anatomical deformation of the penis (such
DYNAFIL 50 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister
as angulation, cavernosal fibrosis or Peyronie’s disease) or in patients who have conditions which may strips, containing 2 or 4 tablets each. Each outer carton contains 1 blister strip.
predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
DYNAFIL 100 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister
DYNAFIL should not be used in men for whom sexual activity is inadvisable.
strips, containing 2 or 4 tablets each. Each outer carton contains 1or 2 blister strips.
• Combinations of DYNAFIL with other treatments for erectile dysfunction is not recommended as the
safety and efficacy of such combinations have not been studied.
STORAGE INSTRUCTIONS:
• Drug interactions between DYNAFIL and other antihypertensive medications have not been
• There is no safety information on the administration of DYNAFIL to patients with bleeding disorders
Do not remove from outer carton until required for use.
or peptic ulceration, DYNAFIL should therefore be administered with caution to these patients.
DYNAFIL has no effect on bleeding time, including during co-administration with aspirin.
DYNAFIL can cause deafness and temporary loss of vision (see “SIDE-EFFECTS”).
REGISTRATION NUMBERS:
DYNAFIL contains lactose and should not be given in patients with rare hereditary problems, or a
DYNAFIL 25 mg: 42/7.1.5/1070 *
history of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
DYNAFIL 50 mg: 42/7.1.5/1071
DYNAFIL 100 mg: 42/7.1.5/1072
INTERACTIONS:
Effects of other medicines on DYNAFIL :
NAME AND BUSINESS ADDRESS OF APPLICANT:
Inhibitors of cytochrome P450 (CYP) isoforms 3A4 (major route of sildenafil) and 2C9 (minor route
of sildenafil) may reduce sildenafil clearance include the following:
Cimetidine, erythromycin, itraconazole, ketoconazole, mibefradil, HIV-protease inhibitors such as Inducers of cytochrome P450 (CYP) isoform 3A4 may increase the metabolism and clearance of sildenafil Ritonavir increases the plasma concentration of sildenafil significantly and such combinations should not DATE OF PUBLICATION OF THIS PACKAGE INSERT:
No effect of concomitant medication on sildenafil pharmacokinetics acting as CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, ACE inhibitors, * Not all dosage strengths are available yet in South Africa.
calcium channel blockers, beta-adrenoreceptor antagonists.
Effects of DYNAFIL on other medicines:
Sildenafil may potentiate the hypotensive effect of acute and chronic nitrates. Therefore, the concomitant use of DYNAFIL and nitrates or nitric oxide donors is contra-indicated (see “CONTRA-INDICATIONS”).
Concomitant use of DYNAFIL and other antihypertensive medicines may potentiate the antihypertensive
effect of these medicines. A mean additional reduction in supine blood pressure (systolic, 8 mmHg; diastolic, 7 mmHg) was observed in concomitant use of sildenafil and amlodipine.
DYNAFIL did not potentiate the increase in bleeding time caused by aspirin. No significant interactions
were shown between DYNAFIL and tolbutamide (250 mg) or warfarin (40 mg), both being metabolised by
Effekte van DYNAFIL op ander geneesmiddels:
Sildenafiel kan die hipotensiewe effek van akute en chroniese nitrate versterk. Die gesamentlike gebruik dynafil 25 mg
van DYNAFIL en nitrate of stikstofoksiedskenkers is dus teenaangedui (sien “KONTRA-INDIKASIES”).
Die gesamentlike gebruik van DYNAFIL en ander anti-hipertensiewe medikasie kan die anti-
dynafil 50 mg
hipertensiewe effek van hierdie medikasie versterk. ‘n Gemiddelde addisionele vermindering in die rugliggende bloeddruk (sistolies, 8 mmHg; diastolies, 7 mmHg) is waargeneem met die gelyktydige
dynafil 100 mg
gebruik van DYNAFIL en amlodipien.
SKEDULERINGSTATUS:
versterk nie die verhoging in bloedingstyd wat veroorsaak word deur aspirien nie. Geen noemenswaardige interaksies word aangedui tussen DYNAFIL en tolbutamied (250 mg) of warfarien
EIENDOMSNAAM EN DOSEERVORM:
(40 mg) nie en beide word gemetaboliseer deur CYP2C9 iso-ensiem.
DYNAFIL 25 mg filmbedekte tablette
SWANGERSKAP EN BORSVOEDING:
DYNAFIL 50 mg filmbedekte tablette
DYNAFIL 100 mg
is nie bedoel vir gebruik in vrouens nie. DYNAFIL het geen karsinogeniese, teratogeniese, embriotoksiese of fetotoksiese effekte getoon in
SAMESTELLING:
dierestudies nie. ‘n Enkel mondelikse dosering van 100 mg sildenafiel het nie spermbeweeglikheid of DYNAFIL 25 mg: Elke filmbedekte tablet bevat sildenafielsitraat, gelykstaande aan 25 mg sildenafiel.
DYNAFIL 50 mg: Elke filmbedekte tablet bevat sildenafielsitraat, gelykstaande aan 50 mg sildenafiel.
DOSIS EN GEBRUIKSAANWYSINGS:
DYNAFIL 100 mg: Elke filmbedekte tablet bevat sildenafielsitraat, gelykstaande aan 100 mg sildenafiel.
Volwassenes:
Onaktiewe Bestanddele:
Die voorgestelde mondelikse dosis is 50 mg, geneem soos benodig een keer per dag, ongeveer een uur DYNAFIL tablette bevat laktose.
voor seksuele aktiwiteit. Die dosis kan verhoog word tot 100 mg, afhangende van die doeltreffendheid Magnesiumstearaat, mikrokristallyne sellulose, natrium-kruisgekoppeldekarmellose, opadry blou, en verdraagsaamheid, of verlaag word na 25 mg. Die maksimum aanbevole dosis is 100 mg en die gebruiksinterval is eenmalige daaglikse dosering.
Gebruik by bejaardes en by pasiënte met belemmerde nier- of hepatiese funksie:
FARMAKOLOGIESE KLASSIFIKASIE:
By pasiëente met verminderde opruiming, kan verhoogde DYNAFIL plasmavlakke voorkom en dus ‘n
verhoging in die voorkoms van newe-effekte. ‘n Aanvangsdosis van 25 mg moet oorweeg word by die FARMAKOLOGIESE WERKING:
• Ouderdom > 65 (40 % verhoging in AOK) Farmakodinamika:
• Hepatiese inkorting (bv. sirrose, 80 %) Sildenafiel herstel belemmerde erektiele funksie deur die bloedvloei na die penis te verhoog, met • Ernstige nierinkorting (kreatinienopriuming < 30 ml/min., 100 %) gevolglike natuurlike respons op seksuele stimulering. • Gesamentlike gebruik met kragtige sitochroom P450 3A4 inhibeerders (eritromisien, ketokonasool, Sildenafiel is ‘n selektiewe fosfodiësterase tipe 5 (PDE5) inhibeerder, wat verantwoordelik is vir die afbreking van sikliese guanosienmonofosfaat (cGMP) in die corpus cavernosum. Sildenafiel versterk die Dit is aangetoon dat DYNAFIL die hipotensiewe effek van nitrate potensieer, dus word die toediening van
ontspanningseffek van stikstofmonoksied op die weefsel van die corpus cavernosum gedurende seksuele hierdie middel aan pasïente wat stikstofoksiedskenkers of nitrate in enige vorm gebruik, teenaangedui. stimulasie. Dit het verhoogde cGMP-vlakke tot gevolg, wat gladdespier verslapping veroorsaak en lei tot Kinders:
die toevloeiing van bloed na die corpus cavernosum, wat lei to ‘n ereksie. Sildenafiel veroorsaak nie ‘n DYNAFIL word nie aangedui vir gebruik by kinders nie.
ereksie sonder seksuele stimulering nie.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Farmakokinetika:
Newe-effekte:
Absorpsie:
Bloed - en limfatiese sisteemversteurings:
Sildenafiel word vinnig geabsorbeer na ‘n mondelingse dosis en het ‘n biobeskikbaarheid van ongeveer Dikwels: Epistakse (neusbloeding).
40 %. Piekplasmakonsentrasies word binne 30 tot 120 minute (mediaan van 60 minute) na ‘n mondelikse Minder dikwels: Anemie en leukopenie.
dosering in die vastende toestand bereik. Die mondelikse famakokinetika van sildenafiel is eweredig oor Immuunsisteemversteurings:
die aanbevole dosis reikwydte (25-100 mg). Minder dikwels: Allergiese reaksie.
‘n Hoë-vet maaltyd verminder die absorpsie van sildenafiel, met ‘n gemiddelde vertraging in tyd tot Metabolisme- en voedingversteurings:
maks) van 60 minute en ‘n 29 % afname in die maksimum plasmakonsentrasie Minder dikwels: Dors, edeem, jig, onstabiele diabetes, hiperglukemie, perifere edeem, hiperurisemie, Verspreiding:
Die gemiddelde gelykvlak volume van verspreiding (Vss) vir sildenafiel is 105 liter. Sildenafiel en sy Psigiatriese afwykings:
hoof-sirkulerende N-desmetiel metaboliet bind albei ongeveer 96 % aan plasmaproteïene en die proteïenbinding is onafhanklik van die totale geneesmiddelkonsentrasie.
Senuweestelselversteurings:
Negentig minute na die dosis geneem is, was minder as 0,001 % van die sildenafiel in die semen van Dikwels: Slaaploosheid, hoofpyn en duiseligheid.
Minder dikwels: Ataksie, hipertonie, neuralgie, neuropatie, parestesie, tremor, duiseligheid, slaperigheid, Metabolisme:
abnormale drome, verminderde reflekse en hipoëstesie. Hepatiese metabolisme van sildenafiel vind hoofsaaklik plaas deur die CYP3A4 (hoofroete) en CYP2C9 (minder belangrike roete) mikrosomale iso-ensieme. Sildenafiel word deur N-demetilasie na ‘n aktiewe Oogversteurings:
metaboliet met ‘n PDE-selektiewe profiel soortgelyk aan sildenafiel, omgeskakel. Die terminale halfleeftyd Minder dikwels: Abnormale visie, oorwegende kleurtinte in visie, maar ook verhoogde persepsie van lig van sildenafiel en die N-desmetiel metaboliet is ongeveer 4 ure.
of wasige visie, bloedbelope voorkoms, brandende oë, oogswelling/drukking, verhoogde intra-okulêre Eliminasie:
drukking, retinale vaskulêre siekte of bloeding, vitreuse losmaking/traksie en paramakulêre edeem. Sildenafiel word hoofsaaklik as metaboliete in feses (ongeveer 80 % van die toegediende mondelikse Konjunktivitis, fotofobie, oogbloeding, katarakte, droë oë en oogpyn, okulêre rooiheid en midriase.
dosis) en tot ‘n mindere mate in urine (ongeveer 13 % van die toegediende mondelikse dosis) uitgeskei.
Die volgende newe-effekte is aangemeld en die frekwensie is onbekend: Dubbelvisie, tydelike verlies van visie of verminderde visie.
Farmakokinetika in spesiale bevolkingsgroepe:
Oor- en labirintversteurings:
Bejaardes:
Minder dikwels: Tinnitus (oorsuising), doofheid, oorpyn.
Gesonde, bejaarde vrywilligers (65 jaar en ouer) het ‘n verminderde doeltreffende opruiming van sildenafiel getoon, met ‘n 40 % groter area onder die kurwe (AOK) in vergelyking met gesonde vrywilligers Kardiale versteurings:
Minder dikwels: Ernstige kardiovaskulêre voorvalle, insluitend miokardiale infarksie, skielike hartdood, ventrikulêre aritmieë, serebrovaskulêre bloeding en verbygaande iskemiese aanvalle Nierontoereikendheid:
(sien “WAARSKUWINGS” vir verdere belangrike kardiovaskulêre inligting), angina pectoris, AV-blok,
Sildenafielopruiming was minder in vrywilligers met erge nierbelemmering (kreatinienopruimingsvlakke skeelhoofpyn, tagikardie, palpitasies, hartstilstand, hartversaking, abnormale elektrokardiogram en van CLcr ≤ 30 ml/min), met gevolglike verhoging in AOK (100 %) en Cmaks (88 %), in vergelyking met vrywillige ouderdomsgenote met geen nierafwyking nie (sien “DOSIS EN GEBRUIKSAANWYSINGS”). Die
Vaskulêre versteurings:
farmakokinetika van sildenafiel is nie gewysig in persone met ligte tot matige nierbelemmering nie.
Minder dikwels: Ernstige kardiovaskulêre gebeurtenisse, insluitend hipertensie, hipotensie, sinkopee Hepatiese ontoereikendheid:
Sildenafielopruiming was minder in vrywilligers met hepatiese sirrose (Child-Pugh A en B), gevolglik het Respiratoriese, torakale en mediastinale versteurings:
die AOK met 84 % en Cmaks met 47 % verhoog, in vergelyking met ouderdomsgenote met geen hepatiese Dikwels: Nasale kongestie, dispnee ontoereikendheid nie (sien “DOSIS EN GEBRUIKSAANWYSINGS”).
Minder dikwels: Asma, laringitis, faringitis, sinusitis, brongitis, verhoogde speekselvorming, verhoogde INDIKASIES:
DYNAFIL word aangedui vir die behandeling van erektiele disfunksie.
Gastro-intestinale versteurings:
HIERDIE PRODUK IS NIE ‘N GESLAGSPRIKKELMIDDEL NIE.
Minder dikwels: Braking, tongontsteking, kolitis, disfagie, gastritis, gastroënteritis, esofagitis, stomatitis, KONTRA-INDIKASIES:
droë mond, rektale bloeding, tandvleisontsteking en abdominale pyn.
• Die gebruik van DYNAFIL word teenaangedui by pasiënte met bekende hipersensitiwiteit van enige
Hepatobiliêre versteurings:
Minder dikwels: Abnormale lewerfunksietoetse.
• In ooreenstemming met sy bekende effekte op die stikstofmonoksied/cGMP-weg, (sien “FARMAKOLOGIESE WERKING”), is dit aangetoon dat DYNAFIL die hipotensiewe effekte van
Vel-en subkutane weefselversteurings:
nitrate potensieer en die gesamentlike toediening daarvan met stikstofmonoksiedskenkers of Dikwels: Blosing en huidrooiheid.
nitrate in enige vorm, is dus teenaangedui. Dokters behoort dit met die pasïente te bespreek dat Minder dikwels: Galbulte, herpes simplex, jeuk, sweet, velswere, kontakdermatitis, afskilferende die gelyktydige gebruik van DYNAFIL met organiese nitrate teenaangedui is. By die volgende
dermatitis en fotosensitiwiteitsreaksie.
pasiënte (ouderdom > 65, lewerinkorting (bv. sirrose), erge nierinkorting (bv. kreatienopruiming Muskuloskeletale, bindweefsel- en beenversteurings:
< 30 ml/min) en gepaardgaande gebruik van kragtige sitochroom P450 3A4 inhibeerders (bv. eritromisien); is waargeneem dat sildenafielplasmavlakke, 24 uur na dosering, 3 tot 8 keer hoër is Minder dikwels: Artritis, gewrigsaandoening, tendonbreuk en tenosinovitis, spierpyn, miastenie en as by gesonde vrywilligers. Alhoewel sildenafielplasmavlakke 24 uur na ‘n dosis heelwat laer is as by piekkonsentrasies, is dit onbekend of nitrate op hierdie tydstip veilig toegedien kan word.
Renale en urinêre versteurings:
• Ritonovir veroorsaak ‘n aansienlike verhoging in die plasmakonsentrasie van sildenafiel, dus kan Minder dikwels: Sistitis, nokturie, urinêre frekwensie, urinêre inkontinensie en hematurie.
hierdie kombinasie nie gegee word nie.
Voortplantingsisteem- en borsversteurings:
WAARSKUWINGS:
Minder dikwels: Priapisme, borsvergroting, abnormale ejakulasie, genitale edeem, anorgasmie.
Daar is ‘n moontlikheid van hartrisiko met seksuele aktiwiteit vir pasiënte met voorafbestaande Algemene versteurings en toestande by die plek van toediening:
hartsiektes. Behandelings vir erektiele disfunksie, insluitend DYNAFIL, moet dus oor die algemeen nie
gebruik word by mans waar seksuele aktiwiteit, vanweë hul bestaande onderliggende kardiovaskulêre Minder dikwels: Edeem in die gesig, skok, astenie, pyn, koue rillings, borskaspyn.
Beserings en vergiftiging:
• ‘n Deeglike mediese geskiedenis en fisiese ondersoek moet onderneem word om erektiele disfunksie Minder dikwels: Toevallige val en toevallige besering.
te diagnoseer, om potensiële onderliggende oorsake en gepaste behandeling te bepaal.
DYNAFIL het sistemiese vaatverwydende eienskappe, wat verbygaande verminderings in rugliggende
Spesiale Voorsorgmaatreëls:
bloeddruk by gesonde vrywilligers tot gevolg gehad het. Dokters moet deeglik besin of pasïente met Effekte op die vermoë om te bestuur en masjinerie te gebruik:
onderliggende hartvatsiekte nadelig deur sodanige vaatverwydende effekte beïnvloed kan word, veral DYNAFIL mag duiseligheid of gewysigde sig veroorsaak en mag gevolglik konsentrasie of motoriese
in kombinasie met seksuele aktiwiteit.
vaardighede belemmer. Pasiënte moet gewaarsku word dat hul vermoë om ‘n voertuig te bestuur of • Daar is nie beheerde kliniese data oor die veiligheid of doeltreffendheid van DYNAFIL in die volgende
gevaarlike masjinerie te hanteer belemmer mag wees wanneer DYNAFIL geneem word.
groepe beskikbaar nie; indien dit voorgeskryf word, moet dit dus met omsigtigheid gedoen word.
• Pasiënte met miokardiale infarksie, beroerte of lewensbedreigende aritmieë in die afgelope 6 BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN:
ln studies met gesonde vrywilligers, met enkeldosisse van tot 800 mg, was die newe-effekte soortgelyk • Pasiënte met rustende hipotensie (BD < 90/50) of hipertensie (BD > 170/110).
aan die newe-effekte waargeneem by laer dosisse, maar die voorkomssyfer was hoër.
• Pasiënte met hartversaking of hartvatsiekte, met gevolglike onstabiele angina.
In gevalle van ‘n oordosis, moet ondersteunende maatreëls soos nodig geneem word. Nierdialise sal nie • Pasiënte met retinitis pigmentosa (‘n minderheid pasiënte het genetiese afwykings van retinale die opruiming verhoog nie, aangesien sildenafiel grotendeels aan plasmaproteïene bind en nie in die urine • Pasiënte moet onmiddellik mediese hulp kry indien ‘n ereksie langer as 4 ure duur. Priapisme (pynlike ereksies wat Ianger as 6 ure duur) moet onmiddellik behandel word, aangesien die IDENTIFIKASIE:
penisweefsel beskadig kan word en permanente verlies aan potensie kan volg.
DYNAFIL 25 mg: Blou, elliptiese, bikonvekse, 10,0 x 5,0 mm filmbedekte tablette, met ‘SL25’ aan die een
DYNAFIL moet met omsigtigheid gebruik word by pasiënte met anatomiese vervorming van die penis
(soos hoekvorming, cavernosa fibrose of Peyronie se siekte) of by pasiënte met toestande wat kan lei DYNAFIL 50 mg: Blou, elliptiese, bikonvekse, 13,0 x 6,5 mm filmbedekte tablette, met ‘SL50’ aan die een
tot priapisme (soos sekelselanemie, veelvuldige miëloom of leukemie).
• Middels vir die behandeling van erektiele disfunksie moet nie by mans gebruik word waar seksuele DYNAFIL 100 mg: Blou, elliptiese, bikonvekse, 17,0 x 8,5 mm filmbedekte tablette, met ‘SL100’ aan die
• Die veiligheid en doeltreffendheid van kombinasies van DYNAFIL met ander behandelings vir
AANBIEDING:
erektiele disfunksie is nie nagevors nie. Die gebruik van sodanige kombinasies word dus nie DYNAFIL 25 mg is verpak in harde, silwerkleurige, aluminiumfoelie en deurskynende PVC/PVDC film
stulpstroke, wat 2 of 4 tablette bevat. Elke karton bevat 1 stulpstrook. • Beheerde studies van geneesmiddelinteraksie tussen DYNAFIL en ander antihipertensiewe middels
DYNAFIL 50 mg: is verpak in harde, silwerkleurige, aluminiumfoelie en deurskynende PVC/PVDC film
stulpstroke, wat 2 of 4 tablette bevat. Elke karton bevat 1 stulpstrook.
• Daar is geen veiligheidsinligting oor die toediening van DYNAFIL aan pasiënte met
DYNAFIL 100 mg: is verpak in harde, silwerkleurige, aluminiumfoelie en deurskynende PVC/PVDC film
bloedingsafwykings of peptiese ulkusse nie. DYNAFIL moet dus met omsigtigheid aan hierdie
stulpstroke, wat 2 of 4 tablette bevat. Elke karton bevat 1 of 2 stulpstroke.
DYNAFIL het geen effek op bloedingstye nie, insluitend gedurende die gesamentlike toediening met
BERGINGSINSTRUKSIES:
DYNAFIL kan doofheid en tydelike verlies van visie veroorsaak (sien “NEWE-EFFEKTE”).
DYNAFIL bevat laktose. Pasiënte met seldsame oorerflike probleme of ‘n geskiedenis van galaktose-
Hou die stulpstroke in die karton tot dit benodig word vir gebruik.
onverdraagsaamheid, die Lapp-laktasetekort of glukose-galaktosewanabsorbsie, moet nie DYNAFIL
REGISTRASIENOMMERS:
INTERAKSIES:
DYNAFIL 25 mg: 42/7.1.5/1070 *
Effekte van ander geneesmiddels op DYNAFIL:
DYNAFIL 50 mg: 42/7.1.5/1071
Inhibeerders van sitochroom P450 (CYP) isovorme 3A4 (hoofroete van sildenafiel) en 2C9 (minder
DYNAFIL 100 mg: 42/7.1.5/1072
belangrike roete van sildenafiel) kan die opriuming van sildenafiel verminder en sluit die volgende
in:
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT:
Simetidien, eritromisien, itrakonasool, ketokonasool, mibefradil, MIV-protease inhibeerders, soos bv. Induseerders van sitochroom P450 (CYP) isovorm 3A4, bv. rifampisien, kan verhoging in die metabolisme en opruiming van sildenafiel veroorsaak.
Ritonavir kan die plasmakonsentrasie van sildenafiel aansienlik verhoog en kan dus nie in kombinasie Daar was geen effek op die farmakokinetika van sildenafiel tydens die gesamentlike gebruik met CYP2C9 inhibeerders (bv. tolbutamied en warfarien), CYP2D6 inhibeerders (bv. selektiewe serotonienheropname- DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
inhibeerders, trisikliese antidepressante), tiasied-en verwante diuretika, boog-en kaliumsparende diuretika, ACE-inhibeerders, kalsiumkanaalblokkeerders en beta-adrenoreseptorantagoniste nie.
* Alle produksterktes is nog nie in Suid-Afrika beskikbaar nie.

Source: http://www.ed-ucate.co.za/wp-content/uploads/2013/06/Dynafil-PISept2012.pdf

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