Package Leaflet Tadalafil

● Read the entire package insert carefully before taking this medicine.
● Keep this package insert. You may need it again.
● Consult your doctor or pharmacist if you have additional questions.

This medicine has been prescribed for you only. Do not pass it on to anyone else. It may harm them even if they have the same symptoms as you.

In this leaflet:

1. What is Tadalafil and what is it used for?
2. What you should know before using Tadalafil
3. How Tadalafil is taken
4. Possible side effects
5. How to store Tadalafil
6. Additional information

What is tadalafil and what is it used for

Tadalafil comes as light yellow film-coated tablets. They are almond-shaped and marked "C 10" on one side. These tablets are available in strip packs containing 4 tablets.

Tadalafil is for the treatment of men with erectile dysfunction. Thisis when a man cannot get an erection or maintain an erection long enough for successful sexual intercourse.

Tadalafil belongs to the group of drugs called thiefosfodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil helps the blood vessels in the penis relax, allowing the blood to flow into your penis. This results in an improvement in yourerection. Tadalafil will not work if you do not have erectile dysfunction.

It is important to know that Tadalafil does not work in the absence of a sexual stimulus. You and your partner should know that foreplay is necessary, just as you would if you were not taking a medication for erectile dysfunction.

What you should know before using tadalafil

Do not use Tadalafil:

● If you are taking medicines that contain organic nitrates or give off nitric oxide, such as amyl nitrite. These drugs are used to treat angina pectoris (chest pain).Tadalafil has been shown to potentiate the effects of these drugs. Tell your doctor if you are taking a medicine containing nitrate, or if you are not sure.
● if you have serious heart problems or have recently had a heart attack.
● if you have recently had a stroke.
● if you have low blood pressure or high blood pressure that is not controlled.
● if you are hypersensitive (allergic) to tadalafil or any of the other ingredients of Tadalafil.

Take care with tadalafil:

Sexual activity has a possible risk for patients with heart problems because it requires an extra effort from your heart. If you have a heart condition, you should tell your doctor.
The following are reasons why Tadalafil may not be suitable for you. Tell your doctor if any of these reasons apply to you before taking this medicine:
● You have sickle cell anemia (an abnormality of the red blood cells),multiple myeloma (bone marrow cancer), leukemia (blood cell cancer) or a malformation of your penis.
● You have liver or kidney problems.

Using Tadalafil with other medicines:

In general, you should tell your doctor or pharmacist if you are taking or have recently taken other medicines because they may affect each other's symptoms. This is especially important if you are taking nitrates because you should not use Tadalafil if you are taking these medicines.

You should not use Tadalafil with other medicines to treat erectile dysfunction.

Tadalafil is not intended for use by women or children under 18 years of age.

Driving and operating machinery:

Because dizziness has been reported in men who used Tadalafil inclinical studies, you should be aware of your reaction to Tadalafil before driving or operating machinery.

Information for men who cannot tolerate lactose, one of Tadalafil's excipients,:

Tadalafil contains lactose and should not be used by patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or impaired uptake of glucose-galactose

How is Tadalafil taken

When taking Tadalafil, follow your doctor's instructions carefully. If in doubt, consult your doctor or your pharmacist.

The usual dose is an 10 mg tablet for desexual activity. If the effect of this dose is too low, your doctor may increase the dose to 20 mg. Tadalafil tablets should be taken by mouth. Swallow the tablet whole with some water. You can take Tadalafil with or without food.

You can take a Tadalafil tablet at any time from 30 minutes to 12 hours before sexual activity. Tadalafil may still be effective up to24 after taking the tablet. It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner should have samentot foreplay, just as if you were not using a drug for erectile dysfunction.

You should NOT use Tadalafil more often than once a day. Daily use of Tadalafil is strongly discouraged.

If you have used more Tadalafil than you should:

Consult your doctor

Possible side effects

Like all drugs, Tadalafil can have side effects. These side effects are usually mild to moderate in nature.

The most common side effects are headache and upset digestion. Less commonly reported side effects are back pain,muscle pain, nasal congestion, facial flushing and dizziness.Swollen eyelids, eye pain and red eyes have sometimes been reported.

If you have any of these side effects and if they are bothersome or serious or if they do not go away, contact your doctor.

Hypersensitivity reactions (including skin rashes) may occur.

In rare cases, it is possible that a prolonged and sometimes painful erection may occur after using Tadalafil. If you have such an erection lasting more than 4 hours, contact your doctor immediately.

If you experience chest pain during or after sexual activity, do not use nitrates and seek medical attention immediately.

If you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Heart attack, stroke and irregular heartbeat have been rarely reported in men who used Tadalafil. Most but not all men were known to have heart problems before taking the drug. It is not possible to determine whether these side effects are directly related to the use of Tadalafil.

In one animal species, effects were seen that could possibly indicate impairment of fertility. Follow-up studies in humans suggest that this effect is unlikely in humans.

How to store Tadalafil

Keep out of the reach and sight of children.

Store in the original packaging.

Do not use after the expiration date indicated on the package and blister.

Additional Information

For any information regarding this drug, contact the local representative of the marketing authorization holder.


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