Tadali Tablets (Generic Tadalafil Tablets)

Tadali Tablets (Generic Tadalafil Tablets)
© The Swiss Pharmacy

Tadali (Generic Tadalafil Tablets) is a PDE5 inhibitor
prescribed for the treatment of erectile dysfunction (ED),
also known as impotence, in men 18 years and above. This
is when a man cannot get, or maintain, a hard erect penis
suitable for sexual activity.
It is also approved by the US FDA for treating the signs
and symptoms of benign prostatic hyperplasia (BPH) as
well as a combination of BPH and erectile dysfunction
when the conditions coincide. This medicine is also used
for the treatment of pulmonary arterial hypertension.

Tadali Tablets are manufactured by
Alpha Pharma Healthcare Private limited,
India in the strength of 20 mg.

Chemical Structure - Tadalafil

The active ingredient present in Tadali
tablets is Tadalafil.
Each Tadali tablet contains 20 mg of
Tadalafil.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9531_Tadalafil-Tablets.html

Uses of Tadali 20 mg tablets:
Tadali (Generic Tadalafil Tablets) is used to treat men who have erectile
dysfunction (also called sexual impotence). Tadalafil belongs to a group
of medicines called phosphodiesterase 5 (PDE5) inhibitors. These
medicines prevent an enzyme called phosphodiesterase type-5 from
working too quickly. The penis is one of the areas where this enzyme
works.
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. When a man is sexually stimulated, his body's normal response
is to increase blood flow to his penis to produce an erection.

Uses of Tadali 20 mg tablets:
By controlling the enzyme, Tadalafil helps to maintain an erection
after the penis is stroked by increasing blood flow to the penis.
Without physical action to the penis, such as that occurring during
sexual intercourse, tadalafil will not work to cause an erection.
Tadalafil is also used to treat men who have signs and symptoms of
benign prostatic hyperplasia (BPH). BPH is caused by an enlarged
prostate.

Recommended Adult Dosage
The dose of Tadali Tablets (Generic Tadalafil Tablets) for the treatment
of various indications is given below. The maximum dose frequency is
once per day (The next dose can be taken only after 24 hours have passed
since the previous dose.)
Adult men For The Treatment Of Erectile Dysfunction (ED):
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without food. In those patients in whom
Tadalafil 10 mg does not produce an adequate effect, 20 mg could be
tried. It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day. Tadalafil 10 and 20 mg is
intended for use prior to anticipated sexual activity and it is not
recommended for continuous daily use.

of various indications is given below.
Adult men For The Treatment Of Erectile Dysfunction (ED) (Once Daily
Dose): In patients who anticipate a frequent use of Generic Tadalafil
tablets (i.e., at least twice weekly) a once daily regimen. with the lowest
doses of Generic Tadalafil might be considered suitable, based on patient
choice and the physician’s judgement. In such patients the recommended
dose is 5 mg taken once a day at approximately the same time of day. The
dose may be decreased to 2.5 mg once a day based on individual
tolerability.
Elderly Men: Dose adjustments are not required in elderly patients.

of various indications is given below.
Men With Renal Impairment: Dose adjustments are not required in patients with
mild to moderate renal impairment. For patients with severe renal impairment 10
mg is the maximum recommended dose. Once-a-day dosing of Tadalafil tablets is
not recommended in patients with severe renal impairment.
Men With Hepatic Impairment: The recommended dose of is 10 mg taken prior
to anticipated sexual activity and with or without food. There is limited clinical
data on the safety of Tadalafil tablets in patients with severe hepatic impairment
(Child-Pugh Class C). In case Tadali tablets are prescribed, a careful individual
benefit/risk evaluation must be undertaken by the prescribing doctor.
Men With Diabetes: Dose adjustments are not required in diabetic patients.

Contraindications
Tadali tablets are contraindicated in persons with a hypersensitivity (allergy) to
Tadalafil or any of the other ingredients of this medicine. During clinical studies,
Tadalafil was shown to augment the hypotensive effects of nitrates. Therefore,
administration of Tadali tablets to patients who are using any form of organic nitrate
is contraindicated.
Tadali tablets, must not be used in men with cardiac disease for whom sexual activity is
inadvisable. Physicians should consider the potential cardiac risk of sexual activity in
patients with pre-existing cardiovascular disease.
Tadali tablets are contraindicated in patients who have loss of vision in one eye
because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of
whether this episode was in connection or not with previous PDE5 inhibitor exposure.
The co-administration of PDE5 inhibitors, including Tadalafil tablets(Tadali), with
guanylate cyclase stimulators, such as Riociguat, is contraindicated as it may potentially
lead to symptomatic hypotension.

Storage Instructions
Tadali Tablets (Generic Tadalafil 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 tablets if sex is inadvisable due to
cardiovascular status.
Use of Tadali tablets with alpha-blockers, antihypertensives or substantial
amounts of alcohol (greater than 5 units) may lead to hypotension.
Tadali tablets are 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 is used as a treatment for ED in men taking
alpha-blockers.
If taking potent inhibitors of CYP3A4, dose should be adjusted: Tadalafil
for use as needed: less than 10 mg every 72 hours. For once daily use:
dose not to exceed 2.5 mg.

Warnings
Patients should seek emergency treatment if an erection lasts for greater than 4
hours. Use Tadali tablets with caution in patients predisposed to priapism.
Patients should stop Tadali tablets and seek medical care if a sudden loss of
vision occurs in one or both eyes, which could be a sign of non-arteritic anterior
ischemic optic neuropathy (NAION). Tadali tablets must be used with caution,
and only when the anticipated benefits outweigh the risks, in patients with a
history of NAION. Patients with a "crowded" optic disc may also be at an increased
risk of NAION.
Patients should stop Tadali tablets and seek prompt medical attention in the
event of sudden decrease or loss of hearing.
Prior to initiating treatment with Tadali tablets for Benign Prostatic Hyperplasia
(BPH), consideration should be given to other urological conditions that may
cause similar symptoms.

Possible Side Effects
Most common Tadalafil Tablets (Tadali Tablets) side effects with an
incidence rate of 2% or more include headache, dyspepsia, back pain,
myalgia, nasal congestion, flushing, and pain in limb.
The following side effects occurred with a frequency of less than 2% in
controlled clinical trials of Tadalafil tablets for once daily use or use as
needed:
Body as a Whole — asthenia, face edema, fatigue, pain
Cardiovascular — angina pectoris, chest pain, hypotension, myocardial
infarction, postural hypotension, palpitations, syncope, tachycardia.

The following side effects occurred with a frequency of less than 2% in
controlled clinical trials of Tadalafil tablets for once daily use or use as needed:
Digestive — abnormal liver function tests, dry mouth, dysphagia,
esophagitis, gastritis, GGTP increased, loose stools, nausea, upper
abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal
hemorrhage, rectal hemorrhage.
Musculoskeletal — arthralgia, neck pain
Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence,
vertigo
Renal and Urinary — renal impairment
Respiratory — dyspnea, epistaxis, pharyngitis
Skin and Appendages — pruritus, rash, sweating

The following side effects occurred with a frequency of less than
2% in controlled clinical trials of Tadalafil tablets for once daily
use or use as needed:
Ophthalmologic — blurred vision, changes in color vision,
conjunctivitis (including conjunctival hyperemia), eye pain,
lacrimation increase, swelling of eyelids Otologic — sudden
decrease or loss of hearing, tinnitus Urogenital — erection
increased, spontaneous penile erection

Overdosage
Single doses of Tadalafil (Tadali Tablets) up to 500 mg 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 Tadalafil overdose, standard supportive measures must be adopted as
required. Hemodialysis contributes negligibly to Tadalafil elimination.

Tadali Tablets during Pregnancy
Tadalafil (Tadali Tablets) is classified by the US FDA as Pregnancy
Category B.
Generic Tadalafil (Tadali tablets) is not indicated for use in women. There
are no adequate and well controlled studies of Tadalafil tablets use in
pregnant women to inform any drug-associated risks for adverse
developmental outcomes.
During animal reproduction studies, no adverse developmental effects
were observed with oral administration of Tadalafil to pregnant rats or
mice during organogenesis at exposures up to 11 times the maximum
recommended human dose (MRHD) of 20mg/day.

Tadali Tablets are manufactured by Alpha
Pharma Healthcare Private limited, India.

Tadali Tablets (Generic Tadalafil Tablets)

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