Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets)

Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets)
© The Swiss Pharmacy

Tadali Superb (Tadalafil and Dapoxetine Tablets) is a
combination medication containing Tadalafil 20mg
and Dapoxetine 60mg in a single tablet.
Tadali Superb is used for the treatment of male erectile
dysfunction as well as treatment of premature
ejaculation in men at the same time.

Tadali Superb Tablets are
manufactured by Alpha-Pharma
Healthcare Limited, India in the
strength of 80 mg (Tadalafil 20 mg
and Dapoxetine 60 mg).

Chemical Structure - Tadalafil

Chemical Structure - Dapoxetine Hydrochloride

The active ingredients
contained in Tadali
Superb tablets are
Tadalafil and
Dapoxetine
Hydrochloride.
Each Tadali Superb
tablet contains 20 mg of
Tadalafil and 60 mg of
Dapoxetine.

Uses of Tadali Superb 80 mg tablets:
The medical effect produced by Tadali Superb tablets is due to it's two components:
Tadalafil and Dapoxetine Hydrochloride.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used to treat men who have erectile
dysfunction (also called sexual impotence). Erectile dysfunction is a condition where the
penis does not harden and expand when a man is sexually excited, or when he cannot
keep an erection.
Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in
adult men aged 18 to 64 years. Dapoxetine Hydrochloride should only be prescribed to
patients who meet all the following criteria:
An intravaginal ejaculatory latency time (IELT) of less than two minutes; and persistent
or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after
penetration and before the patient wishes; and marked personal distress or
interpersonal difficulty as a consequence of PE; and poor control over ejaculation as well
as a history of premature ejaculation in the majority of intercourse attempts over the
prior 6 months.
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Recommended Adult Dosage
The dose of Tadali Superb Tablets (Tadalafil and
Dapoxetine Tablets) is orally one tablet once a day,
with or without meals.
The tablet has to be administered one to three hours
before sexual activity.
Do not take more than 1 tablet in any 24 hour period. i.e.
At least 24 hours should pass before you take the next
dose.

Contraindications
➔
Tadali Superb is contraindicated in patients with a known hypersensitivity to
Tadalafil , Dapoxetine Hydrochloride or any component of the tablet.
➔
Administration of Tadali Superb to patients using any form of organic nitrate
is contraindicated. Tadalafil was shown to potentiate the hypotensive effect of
nitrates.
➔
Administration of this medicine to patients with significant pathological
cardiac conditions is contraindicated.
➔
A history of mania or severe depression.
➔
Concomitant treatment with thioridazine, or within 14 days of discontinuing
treatment with Thioridazine. Similarly, Thioridazine should not be administered
within 7 days after Tadali Superb has been discontinued.

Contraindications
➔
Concomitant treatment of potent CYP3A4 inhibitors such as
Ketoconazole, Itraconazole, Ritonavir, Saquinavir, Telithromycin,
Nefazadone, Nelfinavir, Atazanavir, etc..
➔
Moderate and severe hepatic impairment.
➔
Do not use Tadali Superb in patients who are using a GC
stimulator, such as Riociguat. Tadalafil may potentiate the
hypotensive effects of GC stimulators.

Storage Instructions
Tadali Superb Tablets (Tadalafil and Dapoxetine
Hydrochloride Tablets) have to be stored at
controlled room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Patients should not use Tadali Superb if sex is inadvisable due to
cardiovascular status
Use of Tadali Superb with alpha blockers, antihypertensives or
substantial amounts of alcohol (5 units or greater) may lead to
hypotension
Tadali Superb is not recommended in combination with alpha blockers
for the treatment of BPH because efficacy of the combination has not
been adequately studied and because of the risk of blood pressure
lowering. Caution is advised when Tadali Superb is used as a
treatment for ED in men taking alpha blockers.
Tadali Superb is not suitable and should not be used if taking potent
inhibitors of CYP3A4.

Warnings
Patients should seek emergency treatment if an erection lasts for more
than 4 hours. Use Tadali Superb with caution in patients predisposed
to priapism.
Patients should stop Tadali Superb and seek medical care if a sudden
loss of vision occurs in one or both eyes, which could be a sign of Non
Arteritic Ischemic Optic Neuropathy (NAION).
Discuss increased risk of NAION in patients with history of NAION.
Patients should stop Tadali Superb and seek prompt medical attention
in the event of sudden decrease or loss of hearing.

Warnings
Dapoxetine, a constituent of Tadali Superb is only indicated in men
with Premature Ejaculation who meet all the criteria listed listed earlier.
Dapoxetine should not be prescribed to men who have not been
diagnosed with Premature Ejaculation.
Before treatment initiation, a careful medical examination including
history of orthostatic events should be performed by the physician. An
orthostatic test should be performed before initiating therapy (blood
pressure and pulse rate, supine and standing).
In case of a history of documented or suspected orthostatic reaction,
treatment with Tadali Superb should be avoided.

Warnings
Antidepressants, including SSRIs, increased the risk compared to placebo of
suicidal thinking and suicidality in short-term studies in children and
adolescents with Major Depressive Disorder and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with
antidepressants compared to placebo in adults beyond age 24. In clinical
trials with Dapoxetine, a constituent of Tadali Superb for the treatment of
premature ejaculation, there was no clear indication of treatment-emergent
suicidality in evaluation of possibly suicide-related adverse events.
Patients should avoid operating hazardous machinery, should syncope or its
prodromal symptoms such as dizziness or lightheadedness occur.
The risk of adverse cardiovascular outcomes from syncope (cardiac syncope
and syncope from other causes) is increased in patients with underlying
structural cardiovascular disease.

Warnings
Patients should be advised not to use Tadali Superb in combination
with recreational drugs.
Patients should be advised not to use Tadali Superb in combination
with alcohol. Combining alcohol with dapoxetine may increase alcohol-
related neurocognitive effects and may also enhance neurocardiogenic
adverse events such as syncope, thereby increasing the risk of
accidental injury; therefore, patients should be advised to avoid alcohol
while taking Tadali Superb.
Tadali Superb should be prescribed with caution in patients taking
medicinal products with vasodilatation properties (such as alpha
adrenergic receptor antagonists and nitrates) due to possible reduced
orthostatic tolerance.

Warnings
This medicine is not suitable in patients taking moderate CYP3A4
inhibitors and in patients taking potent CYP2D6 inhibitors since the
Dapoxetine dose is restricted to 30 mg.
Tadali Superb should not be used in patients with a history of
mania/hypomania or bipolar disorder and should be discontinued in
any patient who develops symptoms of these disorders.
Due to the potential of SSRIs to lower the seizure threshold, Tadali
Superb should be discontinued in any patient who develops seizures
and avoided in patients with unstable epilepsy. Patients with controlled
epilepsy should be carefully monitored.
Tadali Superb should not be used in individuals below 18 years of age.

Warnings
Tadali Superb is not indicated for psychiatric disorders and should not
be used in men with these disorders, such as schizophrenia, or in those
suffering with co-morbid depression, as worsening of symptoms
associated with depression cannot be excluded.
There have been reports of bleeding abnormalities with SSRIs. Caution
is advised in patients taking Tadali Superb, particularly in concomitant
use with medicinal products known to affect platelet function or
anticoagulants, as well as in patients with a history of bleeding or
coagulation disorders.
Tadali Superb is not recommended for use in patients with severe
renal impairment and caution is advised in patients with mild or
moderate renal impairment.

Warnings
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should
not take this medicine.
The use of Dapoxetine, a constituent of Tadali Superb has been
associated with ocular effects such as mydriasis and eye pain.
Dapoxetine should be used with caution in patients with raised
intraocular pressure or those at risk of angle closure glaucoma.

Withdrawal Effects
Abrupt discontinuation of chronically administered SSRIs used to treat
chronic depressive disorders has been reported to result in the
following symptoms: dysphoric mood, irritability, agitation, dizziness,
sensory disturbances (e.g., paresthesias such as electric shock
sensations), anxiety, confusion, headache, lethargy, emotional lability,
insomnia and hypomania.

Possible Side Effects
Most common side effects Tadalafil Dapoxetine Combination
tablets (Tadali Superb) are relatively common, such as increased
thirst and a light-headedness following sudden movements - this is
natural, as blood moves into the genital areas.
The common side effects include headache, dyspepsia, back pain,
myalgia, nasal congestion, flushing, nausea, dizziness, diarrhoea,
insomnia,fatigue and pain in limb.

Tadali Superb Tablets Overdosage
Single doses up to 500 mg of Tadalafil have been given to healthy
subjects, and multiple daily doses up to 100 mg have been given to
patients. Adverse events were similar to those seen at lower doses. In
cases of overdose, standard supportive measures should be adopted
as required. Hemodialysis contributes negligibly to Tadalafil
elimination.

Tadali Superb Tablets Overdosage
No case of Dapoxetine overdose has been reported.
There were no unexpected adverse events in a clinical pharmacology
study of Dapoxetine with daily doses up to 240 mg (two 120 mg doses
given 3 hours apart). In general, symptoms of overdose with SSRIs
include serotonin-mediated adverse reactions such as somnolence,
gastrointestinal disturbances such as nausea and vomiting, tachycardia,
tremor, agitation and dizziness.
In cases of overdose, standard supportive measures should be adopted
as required. Due to high protein binding and large volume of distribution
of Dapoxetine Hydrochloride, forced diuresis, dialysis, hemoperfusion
and exchange transfusion are unlikely to be of benefit.
No specific antidotes for Dapoxetine are known.

Tadali Superb Tablets During Pregnancy
Tadali Superb is a combination medication containing Tadalafil and
Dapoxetine Hydrochloride. Tadalafil has been classified by the US FDA
as Pregnancy Category B. Dapoxetine Hydrochloride has been
classified by the US FDA as Pregnancy Category C. Tadali Superb
tablets are not indicated for use by women.
There is no evidence to suggest that Dapoxetine Hydrochloride
exposure has an effect on a partner's pregnancy based on limited
observational data obtained from the clinical trial database. There are
no adequate and well-controlled studies of Tadalafil or Dapoxetine
conducted in pregnant women.

Tadali Superb Tablets (Tadalafil and Dapoxetine
Hydrochloride Tablets) are manufactured by Alpha-
Pharma Healthcare Limited, India.

Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets)

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