08/06/2021
MEGAFIL
DESCRIPTION
Tadalafil (MEGAFIL) an oral treatment for erectile dysfunction is a
selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific
phosphodiesterase type 5 (PDE5) .Pe**le er****ons during sexual
stimulation is caused by increased pe**le blood flow resulting from the
relaxation of pe**le arteries and corpus cavernosal smooth muscle.
This response is mediated by the release of nitric oxide (NO) from
nerve terminals and endothelial cells, which stimulates the synthesis of
cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle
relaxation and increased blood flow into the corpus cavernosum. The
inhibition of phosphodiesterase type 5 (PDE5) enhances erectile
function by increasing the amount of cGMP. Tadalafil inhibits PDE5.
Because sexual stimulation is required to initiate the local release of
nitric oxide, the inhibition of PDE5 by Tadalafil has no effect in the
absence of sexual stimulation.
The effect of PDE5 inhibition on cGMP concentration in the corpus
cavernosum and pulmonary arteries is also observed in the smooth
muscle of the prostate, the bladder and their vascular supply. The
mechanism for reducing BPH symptoms has not been established.
COMPOSITION
MEGAFIL 5 : Each film-coated tablet contains Tadalafil INN 5 mg.
MEGAFIL 10 : Each film-coated tablet contains Tadalafil INN 10 mg.
MEGAFIL 20 : Each film-coated tablet contains Tadalafil INN 20 mg.
INDICATIONS
MEGAFIL (Tadalafil) is indicated for the treatment of-
Erectile dysfunction.
Benign Prostatic Hyperplasia
Erectile Dysfunction and Benign Prostatic Hyperplasia
DOSAGE AND ADMINISTRATION
Erectile dysfunction:
The recommended starting dose of MEGAFIL (Tadalafil) in most
patients is 10 mg, taken 30 minutes before sexual activity. The dose
may be increased to 20 mg or decreased to 5 mg, based on individual
efficacy and tolerability. The maximum recommended dosing frequency
is once per day in most patients.
MEGAFIL (Tadalafil) may be taken without regard to food.
Benign Prostatic Hyperplasia:
The recommended dose of Tadalafil for once daily use is 5 mg, taken
at approximately the same time every day.
Erectile Dysfunction and Benign Prostatic Hyperplasia:
The recommended dose of Tadalafil for once daily use is 5 mg, taken
at approximately the same time every day, without regard to timing of
sexual activity.
OR AS DIRECTED BY THE PHYSICIAN.
SIDE-EFFECTS
The side-effects of Tadalafil as mild or moderate in severity include
dyspepsia, headache, flushing, dizziness, visual disturbances, raised
intra-ocular pressure, nasal congestion, back pain and myalgia.
Hypersensitivity reactions (including rash), priapism, and painful red
eyes have been reported.
CONTRAINDICATIONS
Tadalafil is contra-indicated in patients receiving nitrates or in patients
in whom vasodilation or sexual activity are inadvisable. In the absence
of information, manufacturers contra-indicate this drug in hypotension,
recent stroke, unstable angina, myocardial infarction, moderate heart
failure, uncontrolled arrhythmias and uncontrolled hypertension.
PRECAUTIONS
Tadalafil should be used with caution in cardiovascular disease,
anatomical deformation of the p***s (e.g. angulation, cavernosal
fibrosis, Peyronie's disease), and in those with a predisposition to
prolonged er****on (e.g. in sickle-cell anaemia, multiple myeloma, or
leukaemia). In hepatic impairment and in mild renal impairment
maximum dose is 10 mg.
Use in children and adolescents
Tadalafil is not indicated for individuals below 18 years of age.
Use in Pregnancy & Lactation
Tadalafil is not indicated for use in women.
DRUG INTERACTIONS
Nitrates and Nicorandil: Tadalafil significantly enhances hypotensive
effect of Nitrates and Nicorandil (avoid concomitant use)
Alpha-blockers: Enhanced hypotensive effect when Tadalafil is given
with alpha-blockers (avoid concomitant use).
Plasma concentration of Tadalafil is possibly increased by Saquinavir,
Clarithromycin, Erythromycin, Itraconazole, and Grapefruit juice.
Plasma concentration of Tadalafil is increased by Ketoconazole and
Ritonavir and reduced by Rifampicin.
SUPPLY
MEGAFIL 5: Each box contains 5x4 tablets in blister strips.
MEGAFIL 10: Each box contains 5x4 tablets in blister strips.
MEGAFIL 20: Each box contains 5x2 tablets in blister strips.
Store in a cool & dry place, protected from light.
Keep all medicines out of reach of children.
* Further information is available on request.
FOR HEALTH, VIGOUR AND HAPPINESS
