TAZZLE 10MG TABLET 15'S

Introduction About TAZZLE

TAZZLE contains Tadalafil which belongs to the group of medicines called
Phosphodiesterase type 5 (PDE 5) inhibitors. It helps in relaxing the blood
vessels and allows more blood flow to the penis. It is also used for pulmonary
arterial hypertension (PAH).

Avoid consuming alcohol or grapefruit juice while taking TAZZLE as it may lead
to unwanted side effects. Before taking TAZZLE, inform your doctor if you have
any liver, kidney or heart problems. You must also inform your doctor if you
have any deformity in your penis or have undergone surgical removal of the whole
or a part of the prostate gland. TAZZLE is not recommended for use in patients
with severely low or high blood pressure and in patients who recently had a
stroke. It is also not suitable for use in pregnant or breastfeeding women
unless considered necessary by the physician.

The most common side effects of taking TAZZLE are flushing, headache, dizziness,
blurred vision and muscle pain. Consult your doctor if any of these side effects
troubles you. You must also inform your doctor if you experience any pain after
taking TAZZLE.

Uses Of TAZZLE

It is used:

• To improve blood flow and oxygen supply to the penis
• For Pulmonary Arterial Hypertension (PAH)

How TAZZLE Works

TAZZLE works by blocking the effects of certain enzymes (PDE5) which limits
blood flow to the penis. Therefore, it relaxes the blood vessels supplying the
penis and improves blood flow and oxygen supply. For Pulomonary arterial
hypertension, TAZZLE relaxes the blood vessels supplying the lungs which enable
the blood to flow more smoothly within them with less pressure, leading to
reduction in the signs of pulmonary arterial hypertension.

How to use TAZZLE

Take TAZZLE as advised by your physician. Swallow the medicine with a glass of
water. Do not crush or chew the medicine. Your doctor will decide the correct
dose and duration of therapy for you depending on your age, body weight and
disease condition.

Side Effects Of TAZZLE

Common

• Headache
• Back pain, muscle pain
• Pain in arms and legs
• Flushing of the face
• Nasal congestion
• Indigestion
• Swelling of the face
• Uterine bleeding
• Nausea, indigestion, stomach pain, acidity

Uncommon

• Dizziness
• Vomiting
• Blurred vision, eye pain
• Difficulty in breathing
• Blood in urine
• Palpitation (racing heartbeat)
• Changes in blood pressure (high/low)
• Nasal bleeds
• Tinnitus (ringing in ears)
• Tiredness

Rare

• Bleeding from penis
• Blood in semen

Stop taking TAZZLE and contact your doctor immediately if you experience any of
the following side effects:

• Severe allergic reaction (such as wheeziness, difficulty in breathing or dizziness, swelling of the face, lips, eyelids or throat)
• Priapism
• Chest pain
• Sudden decline or loss of vision
• Decreased hearing or sudden hearing loss

How To Manage Side Effects

!### Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines completely while you are feeling dizzy. Do not consume excessive
alcohol, as it could aggravate your dizziness. Consult your doctor if your
dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

!### Nausea And Vomiting

Take TAZZLE with or just after meals. Stick to simple meals. Avoid eating
oil-rich or spicy foods. Consult your doctor if your symptom worsens.

Warning & Precautions

!### Pregnancy

Monitoring requiredTAZZLE is not recommended for use in pregnant women unless considered necessary
by the physician. Therefore, consult your doctor before taking it.

!### Breastfeeding

ContraindicatedTAZZLE is not recommended for use in breastfeeding women. Therefore, consult
your doctor before taking it.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you experience dizziness or blurred
vision after taking TAZZLE.

!### Alcohol

Consult your doctorAvoid consum

!### Kidney

Use with CautionTAZZLE should be used with caution in patients with kidney problems. Therefore,
consult your doctor before taking it.

!### Liver

Use with CautionTAZZLE should be used with caution in patients with liver problems. Therefore,
consult your doctor before taking it.

!### Allergy

ContraindicatedDo not take TAZZLE if you are allergic to Tadalafil.

!### Lungs

Use with CautionTAZZLE should be used with caution in patients with pulmonary arterial
hypertension. Therefore, consult your doctor before taking it.

!### Heart Disease

Consult your doctorTAZZLE is not recommended for use in patients with severe heart diseases. It
should be used with caution in patients with other heart diseases. Therefore,
consult your doctor before taking it.

!### Use In Pediatrics

ContraindicatedTAZZLE is not recommended for use in children and adolescents (aged below 18
years). Therefore, consult your doctor before taking it.

!### Use In Geriatrics

Use with CautionTAZZLE should be used with caution in elderly patients. Therefore, consult your
doctor before taking it.

Others

TAZZLE is not recommended for use if you:

• Recently had a stroke (within the last 3 months)
• Have severe low blood pressure
• Have uncontrollably high blood pressure
• Previously had vision loss due to non-arteritic anterior ischaemic o

Before taking TAZZLE, inform your doctor if you:

• Have sickle cell anemia
• Have cancers of the blood (leukemia) or bone marrow (multiple myeloma)
• Have penile deformation
• Had any pelvis surgery in the past
• Had any surgical removal of all or part of the prostate gland (radical non-nerve-sparing prostatectomy)
• Have stomach ulcers or bleeding disorders such as haemophilia
• Have any type of rare inherited eye disease (such as retinitis pigmentosa)

Interactions

A. Drug-Drug Interactions:

Before taking TAZZLE, inform your doctor if you are taking any of the following
medicines such as:

• Bosentan, riociguat (other medicines used for pulmonary arterial hypertension)
• Nitrates or amyl nitrites (used for relieving chest pain) Ex. nitroglycerin, isosorbide dinitrate
• Alpha-blockers (used to manage high blood pressure or benign prostatic hyperplasia) Ex. prazosin, terazosin, tamsulosin
• Other medicines used to manage high blood pressure (such as atenolol, propranolol, enalapril, lisinopril)
• Ketoconazole, itraconazole (used to manage fungal infection)
• Protease inhibitors (used to manage HIV infection) Ex. ritonavir, lopinavir
• Phenobarbital, phenytoin, carbamazepine (medicines used for fits)
• Rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections)
• Other medicines used to improve blood flow to the penis (Ex. sildenafil)

B. Drug-Food Interactions:

Avoid consuming grapefruit juice while taking TAZZLE, as it may increase the
risk of side effects.

Overdosage:

If you or anyone else accidentally took more TAZZLE, consult your doctor or
visit the nearby hospital.

Synopsis

Drug	:	Tadalafil
Pharmacological Category	:	Phosphodiesterase-5 inhibitors
Therapeutic Indication	:	Improve blood flow and oxygen supply to the penis, Pulmonary Arterial Hypertension
Dosage Forms	:	Tablet, Oral disintegrating strips, Granules

More Information

Storage

• Keep TAZZLE out of sight and reach of children
• Store TAZZLE below 30°C

FAQs About TAZZLE

Q: How TAZZLE works?

A: TAZZLE works by blocking the effects of certain enzymes (PDE5) which limits
blood flow to the penis. Therefore, it relaxes the blood vessels supplying the
penis and improves blood flow and oxygen supply. TAZZLE also relaxes the smooth
muscles surrounding the bladder and prostate gland which improves the flow of
urine thereby reducing the unpleasant signs of Benign Prostatic Hyperplasia.

Q: What is the use of TAZZLE?

A: TAZZLE helps in relaxing the blood vessels and allows more blood flow to the
penis. It is also used for urinary symptoms associated with benign prostatic
hyperplasia (prostate enlargement causing painful or frequent urination or
unintentional passing of urine).

Q: Can I take TAZZLE daily?

A: TAZZLE is generally prescribed as one dose per day. However, your doctor will
decide the number of doses per day depending upon your age, body weight and
disease condition. Do not take TAZZLE more than once a day without consulting
your doctor.

Q: What will happen if I consume a high dose of TAZZLE than prescribed by my doctor?

A: Do not consume a higher dose of TAZZLE than the one prescribed by your
doctor, as it may lead to unwanted side effects. Your doctor will decide the
correct dose for you, depending on your age and disease condition.

Q: Is TAZZLE safe?

A: TAZZLE is considered safe at doses prescribed by the physician. However, it
may cause few side effects such as headache dizziness, flushing or muscle pain
in some individuals. Contact your doctor if they bother you.

Q: Can I consume alcohol while taking TAZZLE?

A: Combining TAZZLE with alcohol is not recommended, as both substances can
independently lower blood pressure. It may increase the risk of experiencing
dizziness, lightheadedness, and an increased heart rate. Additionally, alcohol
could also counteract the effects of TAZZLE and makes it less effective. If you
have concerns or questions about consuming alcohol while taking this medicine,
consult your doctor.

Q: What should I do if I miss a dose of TAZZLE?

A: If you miss a dose of TAZZLE, take it as soon as possible. However, if it is
time to take the next dose, skip the missed dose and take the next one at
regular times. Do not take a double dose of TAZZLE to compensate the missed
dose.

Q: Can TAZZLE helps to urinate easily?

A: TAZZLE helps to regulate the flow of urine by relaxing the smooth muscles
surrounding the bladder and prostate. It improves urine flow and reduces pain
and discomfort while passing urine.

Q: Can TAZZLE stop urine?

A: In patients with urinary problems (such as unintentional passing of urine or
frequent urination), TAZZLE regulates the flow of urine by relaxing the smooth
muscles surrounding the bladder and prostate. Therefore, it controls abnormal
urinary symptoms (such as difficulty in passing urine or frequent urination).

Q: Does TAZZLE affect fertility?

A: Studies have shown that TAZZLE is not having any impact on fertility.
However, if this is your concern, check with your doctor.