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INTRODUCTION

TADAZA is a combination of Dapoxetine and Tadalafil which belongs to the group of medicines called Selective serotonin reuptake inhibitors and Phosphodiesterase type 5 (PDE5) inhibitors respectively. It is used to treat premature ejaculation and erectile dysfunction in adult men.

Premature ejaculation is a common sexual dysfunction that occurs when a man ejaculates sperms very early with less sexual stimulation or before he wants to. Erectile dysfunction (also known as impotence) is a sexual condition where a man cannot sustain a hard erected penis which is required for a normal sexual activity.

Dapoxetine is a selective serotonin reuptake inhibitor. It delays ejaculation (release of semen) by increasing the activity of a particular chemical called serotonin in the brain. This promotes control over ejaculation and helps your body to hold sperms for a longer period. Tadalafil is a PDE5 inhibitor. It improves penile functions by relaxing the blood vessels supplying the penis. Collectively they delay sperm release, improve control over ejaculation and penile erections.

TADAZA is also not suitable for use in healthy men who do not have any sexual problems. Take TADAZA at least one hour before planning to have sex. Avoid taking TADAZA with grapefruit juice.

Before taking TADAZA inform your doctor if you have any previous history of fainting or dizziness due to low blood pressure. You must also inform your doctor if you have epilepsy, lung problems, mental health problems, or bleeding disorders before taking TADAZA as a precaution. TADAZA is not recommended for use in patients with liver or heart problems. It is also not suitable for use in children aged below 18 years.

The most common side effects of taking TADAZA are flushing, headache, dizziness, blurred vision, muscle pain, nausea, tiredness, increased sweating, restlessness and decrease in sex drive. Consult your doctor if any of these side effect troubles you.

Also, inform your doctor immediately if you experience any prolonged painful penile erections without sexual stimulation (priapism) or experience dizziness upon standing up suddenly or if you have sudden mood changes or suicidal thoughts after taking TADAZA.

USES OF TADAZA

It is used in adult men to treat:

  • Premature ejaculation
  • Erectile dysfunction

HOW TADAZA WORKS

TADAZA effectively improves penile functions and delays sperms release in patients with sexual problems. It contains two medicines called as dapoxetine and tadalafil. Dapoxetine delays ejaculation by blocking the reuptake of a chemical messenger called serotonin between the nerve cells. This increases the activity of serotonin within the brain which therefore increase the time taken to release the semen (ejaculate) during sexual intercourse.

Tadalafil improves penile erections by improving the blood supply to the penis. It works by blocking the effects of certain enzymes (PDE5) in the body that limits blood flow to the penis. As a result, it relaxes the blood vessels supplying the penis, improves penile function and makes it stay erected throughout the process of sexual intercourse.

DIRECTIONS FOR USE

Take TADAZA as advised by your physician. Swallow TADAZA with a glass of water. Do not chew or crush the medicine. TADAZA can be taken with or without meals. Take TADAZA at least 30 minutes to 1 hour before planning to have sexual intercourse. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF TADAZA

COMMON

  • dizziness, headache
  • back pain, muscle pain, pain in arms and legs
  • nausea, vomiting
  • feeling irritable, anxious, agitated, or restless
  • sensation of numbness, tingling or prickling
  • increased sweating
  • hot flushes
  • diarrhea, constipation, wind, stomach pain, indigestion
  • problems in sleeping or strange dreams, difficulty in concentration
  • tiredness or sleepiness
  • blocked nose
  • a rise in blood pressure
  • decrease in sex drive
  • ringing in the ears
  • blurred vision, color tinge to vision, visual disturbance
  • dry mouth

UNCOMMON

  • fainting
  • change in mood, feeling overly excited or feelings of paranoia (feeling threatened)
  • feeling confused, disoriented, or unable to think clearly
  • abnormal heartbeat (slow or fast heart rate)
  • feeling depressed or nervous
  • feeling hot, jittery, abnormal, or drunk
  • eye problems (eye irritation, pain or redenss, watery eyes, double vision, abnormal sensation in the eye, seeing light flashes)
  • low blood pressure
  • feeling itchy or cold sweats
  • spinning sensation
  • abnormal taste
  • skin rash
  • reduced sense of touch
  • signs of inflammation of the lining of the nose such as runny nose, sneezing
  • upper abdominal pain
  • signs of gastro-esophageal reflux disease such as heartburn
  • presence of blood in urine or semen
  • pain in the arms or legs
  • nosebleed

RARE

  • penile bleeding
  • dry nose
  • throat tightness, numbness of mouth
  • temporary decrease in blood flow to brain
  • sudden decrease or loss of hearing
  • sudden onset of sleep (Ex. narcolepsy)
  • urge to empty bowel
  • memory loss

Stop taking TADAZA and contact your doctor 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)
  • prolonged or painful erection (priapism)
  • chest pain especially during or after sexual intercourse
  • severe skin reactions (blistering of skin around the mouth, genitals or eyes, severe peeling and swelling of skin along with fever)
  • sudden decline or loss of vision
  • fits or seizures
  • fainting or light headedness while standing
  • mood changes, suicidal thoughts, or a tendency for self-harming

HOW TO MANAGE SIDE EFFECTS

Nausea or Vomiting:

Take TADAZA with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your vomiting 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.

Dizziness:

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 or if you feel dizzy upon standing up suddenly.

Diarrhea:

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-treat diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.

WARNING & PRECAUTIONS

PREGNANCY

TADAZA is not intended for use in women.

BREASTFEEDING

TADAZA is not intended for use in women.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness or blurred vision after taking TADAZA.

ALCOHOL

Avoid consumption of alcohol while taking TADAZA as it may cause dizziness, or sleepiness.

KIDNEY

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

LIVER

TADAZA is not recommended for use in patients with moderate or severe liver diseases. Therefore, consult your doctor before taking it.

ALLERGY

Do not take TADAZA if you are allergic to Dapoxetine or Tadalafil.

LUNGS

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

HEART DISEASE

TADAZA is not recommended for use in patients with heart problems (such as heart failure, low blood pressure, problems with the heart rhythm). Therefore, consult your doctor before taking it.

OTHERS

TADAZA is not recommended for use if you:

  • have a history of fainting
  • have or ever had signs of mania such as feeling overexcited, irritable, or not being able to think clearly
  • have severe depression
  • have recently had a stroke
  • have low blood pressure
  • have signs of retinitis pigmentosa (a rare inherited eye disease) such as decreased vision at night or in low light and loss of side vision

Before taking TADAZA, inform your doctor if you:                                                         

  • have a history of feeling dizzy due to low blood pressure
  • have schizophrenia (a psychiatric disease)
  • have epilepsy
  • have a history of bleeding or blood clotting problems
  • have or at risk of developing glaucoma
  • have sickle cell anemia (an abnormality of red blood cells)
  • have leukemia (cancer of blood cells)
  • have multiple myeloma (cancer of bone marrow)
  • have a deformity of your penis
  • have Peyronie’s disease (development of fibrous scar tissue in the penis that causes painful erection)
  • currently have a stomach ulcer
  • have bleeding problems such as hemophilia
  • are alcoholic
  • had any pelvic surgery or surgery in your prostate gland

Use in pediatrics:

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

Use in geriatrics:

TADAZA is not recommended for use in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug Interaction:

Before taking TADAZA, inform your doctor, if you are taking any of the following:

  • nitrates or amyl nitrites (used for reliving chest pain) Ex. nitroglycerin, isosorbide dinitrite
  • other medicines used to treat prostate problems or blood pressure such as alpha blockers (Ex. silodosin, doxazosin)
  • riociguat (a medicine used to treat increased pressure in the lungs)
  • medicines used to treat depression (Ex. fluoxetine, sertraline, citalopram, escitalopram, amitriptyline, isocarboxazid, selegiline, nefazodone and St. john’s wort)
  • thioridazine (a medicine used to treat a mental disorder called schizophrenia)
  • lithium (a medicine used to treat bipolar disorder)
  • tryptophan (a medicine used to induce sleep)
  • medicines used to treat migraines (Ex. almotriptan, sumatriptan)
  • non-steroidal anti-inflammatory drugs (used to treat pain and inflammation) Ex. ibuprofen and aspirin
  • tramadol (a medicine used to relieve pain)
  • antibiotics (used to treat bacterial infections) Ex. telithromycin, linezolid, erythromycin, and clarithromycin
  • medicines used to treat HIV infection (Ex. ritonavir, saquinavir, nelfinavir, atazanavir amprenavir and fosamprenavir)
  • medicines used to treat fungal infections (such as ketoconazole, itraconazole and fluconazole)
  • warfarin (a medicine used to prevent blood clotting)
  • other medicines used to treat erectile dysfunction (such as sildenafil or vardenafil)
  • medicines used to treat high blood pressure or chest pain (such as verapamil and diltiazem)
  • aprepitant (a medicine which is used to treat nausea)
  • medicines used to reduce anxiety and alter mental stability (Ex. morphine, pethidine, alprazolam, midazolam, clonazepam, MDMA (ecstasy) or lysergic acid diethylamide)

B. Drug-Food Interaction:

Avoid drinking grapefruit juice within 24 hours prior taking TADAZA as it may increase the level of TADAZA in the body.

Overdosage:

If you or anyone else accidentally took more TADAZA, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, and vomiting.

SYNOPSIS

Drug :  

Dapoxetine, Tadalafil

Pharmacological Category :  

Selective serotonin reuptake inhibitors (SSRI), Phosphodiesterase type 5 inhibitors

Therapeutic Indication :  

Premature Ejaculation, Erectile Dysfunction

Dosage Forms :  

Tablet

MORE INFORMATION

  • Keep TADAZA out of reach of children
  • Store TADAZA at room temperature

FAQs ABOUT TADAZA

What TADAZA is used for?

TADAZA is used to treat premature ejaculation and erectile dysfunction in adult men.

How to take TADAZA?

Take TADAZA at least 30 minutes to 1 hour before having sexual intercourse. Swallow the medicine with a glass of water. Do not cursh or chew the medicine.

Can I take TADAZA daily?

TADAZA is generally prescribed as one dose per day. However, your doctor will decide whether you can take this medicine daily or not, depending upon your health condition. Do not take TADAZA more than once a day without consulting your doctor.

How long does it take for TADAZA to start working?

It may take around 30 minutes to 1 hour for TADAZA to start working, therefore take this medicine at least one hour before planning to have sex. This time may vary from person to person depending upon their health condition.

Who can take TADAZA?

TADAZA can be used in adult men with sexual problems. It is not suitable for use in healthy men who does not have any sexual problems or in men who are not sexually stimulated. It is also not advisable for use in children or adolescents (aged below 18 years).

Is TADAZA effective?

Yes. TADAZA effectively improves penile erection (make penis firm) and delays sperm release during sexual intercourse in patients with sexual problems.

Can healthy men consume TADAZA to improve sexual performance?

TADAZA is not an aphrodisiac (sex-stimulating agent). It does not induce sexual thoughts or can improve sexual performance/pleasure in healthy men. It would help you to get an erection only if you are sexually stimulated.

What happens if I consume a high dose of TADAZA than prescribed by my doctor?

Do not consume a higher dose of TADAZA 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. If the prescribed dose, does not help you, contact your doctor.

Can men taking TADAZA father a child?

There is no confirmed proof that TADAZA could affect fertility in men. However, it is better to consult your doctor before taking TADAZA if you are planning to father a child.

Is TADAZA safe?

Yes. TADAZA is safe to use. But inform your doctor immediately if you experience painful prolonged erection or chest pain after taking TADAZA. It can also cause headache dizziness, flushing or muscle pain in some individuals. Contact your doctor if they bother you.

Can I consume alcohol while taking TADAZA?

Avoid consumption of alcohol while taking TADAZA as it could reduce the effectiveness of TADAZA.

How long does the effects of TADAZA would last long?

The effects of TADAZA would normally last long for 4 hours. However, this time may vary from person to person depending upon their age and health condition. Consult your doctor if the effects of TADAZA does not last long until sexual intercourse.

Can TADAZA make you last longer?

Yes. TADAZA delays the release of sperms (ejaculation) in patients suffering from premature ejaculation.

Will taking TADAZA affect my sexual life?

Long term use of TADAZA may negatively impact your sex life. It may cause sexual problems such as decrease in sex drive. Talk to your doctor if you are facing any sexual problems while taking TADAZA.

How TADAZA works?

TADAZA delays the ejaculation (release of semen) by increasing the activity of a particular chemical called serotonin in the brain. This promotes the control over ejaculation and helps your body to hold sperms for a longer period. It also improves penile functions by improving blood supply to the penis.

Can I stop taking TADAZA by my own without consulting doctor?

Do not stop taking TADAZA without consulting your physician, as sudden discontinuation of TADAZA may cause withdrawal symptoms like sleeping problems or dizziness.

Can TADAZA cause bipolar disorder?

TADAZA may cause mood changes in some individuals. Inform your doctor immediately if you experience any sudden changes in mood. Also, it is important to inform you doctor if you already have bipolar disorder as a precaution before starting treatment with TADAZA.

REFERENCES

1. KD. Tripathi. Androgens and Drugs for Erectile Dysfunction & Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 304 & 464.

2. Aykut Bugra Sentürk, Ali Haydar Yilmaz, Basri Çakiroglu, Muhammet Yaytokgil, Cemil Aydin, Musa Ekici, Serdar Aykan, Mustafa Sungur. Combination or alone? Which one is the Best in Premature Ejaculation Treatment? HAYDARPASA NUMUNE MEDICAL JOURNAL. October 2018. [Accessed on 7th July 2022] https://jag.journalagent.com/hnhjournal/pdfs/HNHJ-87699-RESEARCH_ARTICLE-SENTURK.pdf

3. Hamed Mohseni Rad, Telma Zahirian Moghadam, Ali Hosseinkhani and Nima Nima Soluki. Comparison of Dapoxetine /Tadalafil and Paroxetine/Tadalafil Combination Therapies for the Treatment of the Premature Ejaculation: A Randomized Clinical Trial. ScienceDirect. November 2021.[Accessed on 7th July 2022] https://www.researchgate.net/publication/360618767_Comparison_of_Dapoxetine_Tadalafil_and_ParoxetineTadalafil_Combination_Therapies_for_the_Treatment_of_the_Premature_Ejaculation_A_Randomized_Clinical_Trial

4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed 4th March 2022] https://www.medicines.org.uk/emc/files/pil.8636.pdf

5. Menarini - Von Heyden GmbH. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed 4th March 2022] https://www.medicines.org.uk/emc/files/pil.1269.pdf

PRODUCT DETAILS

    Net Qty
    1 N
    Item Weight
    10 g
    Ingredient
    DAPOXETINE HYDROCLORIDE 30MG+TADALAFIL 10MG
    Hsn Code
    30049099
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Tadaza Tablet 4'S

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