Tadalafil Tablets 5mg

Tadalafil Tablets 2.5mg
Tadalafil Tablets 5mg
Tadalafil Tablets 10mg
Tadalafil Tablets 20mg

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

What is in this leaflet:

  1. What Tadalafil is and what it is used for
  2. What you need to know before you take Tadalafil
  3. How to take Tadalafil
  4. Possible side effects
  5. How to store Tadalafil
  6. Contents of the pack and other information


Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil is used to treat adult men with:

Erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to obtain a hard erect penis suitable for sexual activity. Following sexual stimulation Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would you were not taking a medicine for erectile dysfunction.


DonottakeTadalafil if you:

  • are allergic to tadalafil or any of the other ingredients of this medicine(listed in section6).
  • are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (?nitrates?) used in the treatment of angina pectoris (?chest pain?). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
  • have serious heart disease or recently had a heart attack within the last 90days.
  • have recently had a stroke within the last 6 months.
  • have low blood pressure or uncontrolled high blood pressure.
  • ever had a loss of vision because of Non-art er it can terrorism chemic optic neuropathy(NAION), a condition described as ?stroke of the eye?.
  • are taking Riociguat. This drug is used to treat pulmonary arterial hypertension(i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking Riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:

  • sickle cell anaemia (an abnormality of red blood cells).
  • multiple myeloma (cancer of the bone marrow).
  • leukaemia (cancer of the blood cells).
  • any deformation of your penis or unwanted or persistent erection lasting more than 4 hours
  • a serious liver problem.
  • a severe kidney problem.

It is not known if Tadalafil is effective in patients who have had:

  • pelvic surgery.
  • removal of all or part of the prostate gland in which nerves of the prostate are cut(radical- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision, stop taking Tadalafil and contact your doctor immediately.

Decreasedorsuddenhearinglosshasbeennotedinsomepatientstakingtadalafil.Althoughitisnot known if the even it is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil and contact your doctor immediately.

Tadalafil should not be used as a treatment of erectile dysfunction by women because these are health problems are specific to men.

Children and adolescents

Tadalafil is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Tadalafil if you are already taking nitrates.

Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work. Tell your doctor or pharmacist if you are already taking:

  • an alpha blocker(used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
  • other medicines to treat high blood pressure.
  • Rio cut.
  • a5-alpha-reductase inhibitor(used to treat benign prostatic hyperplasia).
  • medicines such as to ask ketoconazole tablets(to treat fungal infections)and protease inhibitors for the treatment of AIDS or HIV infection.
  • phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
  • rifampicin, erythromycin, clarithromycin itraconazole.
  • other treatments for erectile dysfunction.

Tadalafil with drink and alcohol

Information on the effect of alcoholism section 3.Grape fruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to your doctor for further information.

Pregnancy, breastfeeding and Fertility Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take tadalafil when pregnant, unless it is strictly necessary and you have discussed this with your doctor.


Do not breastfeed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.


When dogs are treated there was reduced sperm development in the testes. Are duction in sperm was sawed in some men? These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil contains lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicine.


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablet whole with some water. The tablets can be taken with or without food.

To treat erectile dysfunction

There commended starting dose is one10mg tablet be for sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20mg. Tadalafil tablets are for oral use.

You may take a Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective up to36 hours after taking the tablet.

Do not take Tadalafil more than once a day. Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking alcohol may affect your ability to get an erection and may temporarily to lower your blood pressure. If you have taken or are planning Otake Tadalafil, avoid excessive drinking (blood level of 0.08% or greater), since this may increase there is of dizziness when standing up.

If you take more Tadalafil than you should

If you or anyone else take more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience side effects describe din section4.

If you forget to take Tadalafil

Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

  • allergic reactions including rashes (frequency uncommon).
  • chest pain-do not use nitrates but seek immediate medical assistance(frequency uncommon).
  • priapism, a prolonged and possibly painful erection after taking Tadalafil (frequency rare). If you have such an erection,whichlastscontinuouslyformorethan4hours you should contact a doctor immediately.
  • sudden loss of vision(frequency rare). Other side effects have been reported:

Common (may affect up to 1 in 10 people)

  • headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 people)

  • dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, fast heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1,000 people)

  • fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives(itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of the semen had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil that were not seen in clinical trials. These include:

  • migraine, swelling of the face, a serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorder s affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.

The side effects of dizziness have been reported more frequently in men over 75 years of age taking Tadalafil. Diarrhoea has been reported more frequently in men over 65 years so far taking Tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


What Tadalafil contains

  • The active substance is tadalafil.

Each film-coated tablet contains 5mg tadalafil.

  • The other ingredients are:

Tablet core:

Lactose monohydrate, Croscarmellose sodium, Hypromellose, cellulose microcrystalline, Sorbitan stearate and Magnesium stearate


Lactose monohydrate,Hypromellose,Titaniumdioxide,Triacetin,TalcandIronoxide yellow.

Contents of the pack

Tadalafil is available in PVC/PE/PVdC clear Aluminium blister. Pack size: 4, 14, 28, 30 tablets.

Not all pack sizes may be marketed.

7. Manufactured in India By
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)