Tadali Superb Tablets

Tadali Superb (Tadalafil and Dapoxetine Tablets) manufactured by Alpha-Pharma Healthcare, India is a medicine which is used for the treatment of erectile dysfunction (ED) and premature ejaculation in adult men at the same time.

1. Tadali Superb Tablets
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Tadali Superb Tablets, a combination of Tadalafil 20mg
and Dapoxetine 60mg, is a new combination medicine
manufactured by Alpha-Pharma Healthcare, India used
for the treatment of male erectile dysfunction when at the
same time treatment of premature ejaculation is also
desirable in adults 18 years and above.

2. Tadali Superb Tablets
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Tadali Superb Tablets are
manufactured by Alpha-Pharma
Healthcare, India.
(Website: www.alpha-pharma.com)

3. Tadalafil and Dapoxetine Tablets – Brand Names
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Tadalafil and Dapoxetine tablets are
available as Tadali Superb, Super
Tadalis tablets and Super Tadarise
tablets .

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

5. Chemical Structure
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The structure of Tadalafil is given below:

6. Chemical Structure
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The structure of Dapoxetine is given below:

7. Uses of Tadali Superb Tablets
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Tadali Superb tablets are used for the treatment
of male erectile dysfunction as well as treatment of
premature ejaculation at the same time in men 18
years and greater.
Tadalafil is an oral treatment for male sexual
function problems (impotence or erectile
dysfunction-ED). Along with sexual stimulation,
Tadalafil works by increasing blood flow to the
penis to help a man get and keep an erection.
Dapoxetine Hydrochloride, is a selective
serotonin reuptake inhibitor (SSRI) is used to treat
persistent or recurrent ejaculation with minimal
sexual stimulation before, on, or shortly after
penetration and before the patient wishes.

8. Tadali Superb Dosage

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➢Take one Tadali Superb tablet one to three
hours before sexual activity with at least one
full glass of water.
➢Do not take more than 1 tablet in any 24
hour period. At least 24 hours must pass since
your last dose.
The dosage of Tadali Superb tablets (Tadalafil
and Dapoxetine Hydrochloride) is given below:

9. Storage Instructions

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Tadali Superb tablets (Tadalafil and
Dapoxetine 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.

10. Warnings

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Tadali Superb (Tadalafil and Dapoxetine HCl
Tablets) must not be used by patients if sexual
activity is not advisable for them due to their
cardiovascular status.
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 must stop taking Tadali Superb and seek
medical care in case a sudden loss of vision occurs
in one or both eyes, which could be a sign of non
arteritic anterior ischemic optic neuropathy (NAION).
Patients should stop Tadali Superb and seek
immediate medical attention in the event of sudden
decrease or loss of hearing.

11. Warnings

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Caution is advised when Tadali Superb is co-administered with
alpha-blockers or anti-hypertensives. Concomitant use may
lead to hypotension.
Decreased blood pressure, syncope, and prolonged erection
may occur at higher Tadalafil exposures. In patients taking
strong CYP inhibitors, such as ritonavir, Tadalafil exposure is
increased.
Dizziness, disturbance in attention, syncope, blurred vision and
somnolence have been reported in subjects receiving
Dapoxetine, a constituent of Tadali Superb.
Patients must be advised not to use Tadali Superb in
combination with recreational drugs like Amyl Nitrite and Butyl
Nitrite.
Recreational drugs with serotonergic activity such as
ketamine, methylenedioxy-methamphetamine (MDMA) and
lysergic acid diethylamide (LSD) can lead to potentially serious
reactions if combined with Tadali Superb.

12. Warnings

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Use of this medicine with alpha-blockers,
antihypertensives or substantial amounts of alcohol (5
units or more) may lead to hypotension.
Combining alcohol with Tadali Superb may increase
alcohol-related neurocognitive effects and may also
enhance neurocardiogenic adverse events such as
syncope, thereby increasing the risk of accidental
injury.
Substantial consumption of alcohol increases the
potential for orthostatic signs and symptoms, including
increase in heart rate, decrease in standing blood
pressure, dizziness, and headache.
Hence, patients must be advised to avoid alcohol
while taking Tadali Superb.

13. Warnings

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Possibly prodromal symptoms such as nausea, dizziness /
lightheadedness, and diaphoresis were observed more
commonly among patients treated with Dapoxetine compared
to placebo.
Patients should be cautioned to avoid situations where injury
could result, including driving or operating hazardous
machinery, should syncope or its prodromal symptoms such as
dizziness or lightheadedness occur.
An orthostatic test should be done before starting
treatment with this medicine. In case of a history of
documented or suspected orthostatic reaction, treatment
with Tadali Superb must be avoided.
This medicine 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.

14. Tadali Superb Tablets
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Contraindications
Tadali Superb tablets are contraindicated in
patients with a hypersensitivity to Tadalafil ,
Dapoxetine Hydrochloride or any other
component of this medication.
Administration of Tadali Superb to patients using
nitric oxide donors, such as organic nitrates or
organic nitrites in any form is contraindicated.
Tadali Superb tablets are also contraindicated
in patients with significant cardiac conditions as
well as in patients for whom sexual intercourse is
inadvisable due to cardiovascular risk factors.
This medicine is contraindicated in men with
severe hepatic impairment (decreased liver
function)

15. Tadali Superb Tablets
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Contraindications
Concomitant treatment with monoamine oxidase inhibitors
(MAOIs) or Thioridazine, or within 14 days of discontinuing
treatment with an MAOI or Thioridazine. Similarly, an MAOI
or Thioridazine should not be administered within 7 days
after this medicine has been discontinued is
contraindicated.
Concomitant treatment with serotonin reuptake inhibitors
[selective serotonin reuptake inhibitors (SSRIs), serotonin-
norepinephrine reuptake inhibitors (SNRIs), tricyclic
antidepressants (TCAs)] or other medicinal/herbal products
with serotonergic effectsor within 14 days of discontinuing
treatment with these medicinal/herbal products. Similarly,
these medicinal/herbal products should not be administered
within 7 days after this medicine has been discontinued.

16. Tadali Superb Side Effects
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➢The most common side effects caused
by Dapoxetine with an incidence rate of
5% or more are headache, dizziness,
nausea, dry mouth, diarrhoea, insomnia
and fatigue.
➢Most common side effects with an
incidence rate of 2% or more caused by
Tadalafil include headache, dyspepsia,
back pain, myalgia, nasal congestion,
flushing, and pain in limb.

17. Tadali Superb Overdose
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The overdose effects due to Tadalafil can
include chest pain, nausea, irregular
heartbeat, and feeling light-headed or
fainting.
Symptoms of overdose with Dapoxetine
can include somnolence, gastrointestinal
disturbances such as nausea and
vomiting, tachycardia, tremor, agitation
and dizziness.

18. Tadali Superb Overdose
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In cases of overdose, standard supportive
measures must 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.
Hemodialysis contributes negligibly to
Tadalafil elimination.

19. Tadali Superb During Pregnancy
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Tadalafil has been classified by the US FDA as
Pregnancy Category B.
There are no adequate and well controlled
studies of Tadalafil use in pregnant women.
Animal reproduction studies in rats and mice
revealed no evidence of fetal harm.
Dapoxetine Hydrochloride has been classified
by the US FDA as Pregnancy Category C.
Animal studies do not indicate direct or indirect
harmful effects with respect to fertility, pregnancy
or embryonal/foetal development.
Tadali Superb (Tadalafil and Dapoxetine
Hydrochloride tablets) is not indicated for use by
women.

20. Tadali Superb Tablets
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© Clearsky Pharmacy
Tadali Superb (Tadalafil and Dapoxetine
Tablets) by Alpha-Pharma Healthcare, India.