Tadalacon tadalafil 10 mg. 12 tablets

What you need to know before you take Tadalafil

1. What Tadalafil is and what it is used for

Tadalafil is used to treat adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a hard, erect penis suitable for sexual activity.

Tadalafil contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. After sexual stimulation, Tadalafil works by helping the blood vessels in your penis to relax and allow blood to flow into the penis. The result 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 if you were not taking erectile dysfunction medicine.

2. What you need to know before you take Tadalafil

Do not take Tadalafil if:

you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

you are taking any type of organic nitrate or nitric oxide donors such as amyl nitrite. These are a group of medicines (“nitrates”) used to treat 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 not sure, talk to your doctor. you have a serious heart condition or have had a recent heart attack in the last 90 days.

you have had a recent stroke in the last 6 months.

you have low blood pressure or uncontrolled high blood pressure.

you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) - a condition described as a “stroke of the eye”.

you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors such as tadalafil have been shown to increase the blood pressure lowering effect of this medicine. If you are taking riociguat or are not sure, tell your doctor.

Warnings and precautions

Talk to your doctor before taking tadalafil.

Please note that sexual activity carries possible risks for patients with heart disease, as it puts extra strain on the heart. If you have heart problems, you should tell your doctor.

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

sickle cell anemia (an abnormality of red blood cells);

multiple myeloma (cancer of the bone marrow);

leukemia (cancer of the blood cells);

any deformity of the penis;

a serious liver problem;

a serious kidney problem.

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

pelvic surgery;

removal of all or part of the prostate gland, in which the nerves to 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.

Decreased hearing or sudden loss of hearing has been reported in some patients taking tadalafil. Although it is not known whether the condition is directly related to tadalafil, if you experience hearing loss or sudden hearing loss, stop taking Tadalafil and contact your doctor immediately.

Tadalafil is not intended for use by women.

Children and adolescents

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

Other medicines and Tadalafil

Tell your doctor 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; riociguat;

a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia);

medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;

phenobarbital, phenytoin and carbamazepine (anticonvulsants);

rifampicin, erythromycin, clarithromycin or itraconazole;

other treatments for erectile dysfunction.

Tadalafil with food, drink and alcohol

Information on the effects of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil works and should be avoided.

Take special care with this medicine. Talk to your doctor for more information.

Pregnancy, breast-feeding and fertility

Fertility

Reduced sperm production in the testicles has been observed in dogs treated with this medicine. Reduced sperm production has also been observed in some men. It is unlikely that these effects will lead to loss of fertility.

Driving and using machines

In clinical studies, some men taking tadalafil have reported feeling dizzy. Check carefully how you tolerate the tablets before driving or using machines.

Tadalafil contains lactose

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

3. How to take Tadalafil

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Tadalafil tablets are for oral use, for men only. Swallow the tablet whole with some water. You can take the tablets with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil tablets are for oral use.

You can take a Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective for up to 36 hours after taking the tablet.

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

It is important to note that Tadalafil does not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking erectile dysfunction medication.

Alcohol use can affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or above) as this may increase the risk of dizziness when standing up.

If you have taken more Tadalafil than you should

Tell your doctor. You may experience side effects listed in section 4.

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

4. Possible side effects

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

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

allergic reactions, including rashes (frequency - uncommon);

chest pain - do not use nitrates, but seek medical help immediately (frequency - uncommon);

priapism, a prolonged and painful erection after taking Tadalafil (frequency - rare). If you have such an erection that lasts for more than 4 hours, you should contact your doctor immediately;

sudden loss of vision (frequency - rare).

Other reported side effects:

Common: (may affect up to 1 in 10 people)

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

Uncommon: (may affect up to 1 in 100 people)

dizziness, abdominal pain, nausea, vomiting, heartburn, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, feeling of a pounding heart, rapid heartbeat, increased blood pressure, decreased blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles and tiredness.

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

weakness, fits and temporary memory loss, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, blood in the semen and

increased sweating.

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

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

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

migraine, facial swelling, serious allergic reaction that causes swelling of the face or throat, serious skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.

The side effect dizziness has been reported more often in men over 75 years of age taking tadalafil. Diarrhoea has been reported more often in men over 65 years of age taking tadalafil.

5. How to store Tadalafil

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister and 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.

6. Contents of the pack and other information

What Tadalafil 10 mg film-coated tablets contain

The active substance is tadalafil.

Each film-coated tablet contains 10 mg tadalafil.

The other ingredients are:

Tablet core:

Anhydrous lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropylmethyl cellulose, polysorbate 80 and magnesium stearate.

Film coating:

Lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172) and black iron oxide (E172).

What Tadalafil 20 mg film-coated tablets contain

The active substance is tadalafil.

Each film-coated tablet contains 20 mg tadalafil.

The other ingredients are:

Tablet core:

Anhydrous lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80 and magnesium stearate.

Film coating:

Lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172).

What Tadalafil 10 mg and 20 mg film-coated tablets look like and contents of the pack

Tadalafil 10 mg film-coated tablets

Light yellow, oblong, biconvex, film-coated tablet, debossed with “T 10” on one side and plain on the other side.

Tadalafil 20 mg film-coated tablets

Yellow, oblong, biconvex, film-coated tablet, debossed with “T 20” on one side and plain on the other side.

Tadalafil film-coated tablets are available in PVC/PVDC aluminium blisters.

Pack sizes: 4,12 tablets.