Tadilex 5 mg. 28 tablets

€55
Tax included

TadiLEX contains the active substance tadalafil, which belongs to the group of medicinal products called phosphodiesterase type 5 inhibitors.

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What TadiLEX is and what it is used for

TadiLEX contains the active substance tadalafil, which belongs to the group of medicinal products called phosphodiesterase type 5 inhibitors.

TadiLEX 5 mg is used to treat adult men with:

erectile dysfunction. It is a condition in which a man cannot reach or maintain a hard, erect penis suitable for sexual activity. TadiLEX shows a significant improvement in the ability to obtain a hard, erect penis suitable for sexual activity.

After sexual stimulation, TadiLEX works by helping the blood vessels in your penis to relax and allow blood to flow into your penis. The result of this is improved erectile function. TadiLEX will not help you if you do not have erectile dysfunction. It is important to note that TadiLEX for the treatment of erectile dysfunction 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 medication.

urinary symptoms associated with a commonly seen condition called benign prostatic hyperplasia (enlargement). This is a condition in which the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling like the bladder is not completely empty, and needing to urinate more often at night. TadiLEX improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia (enlargement). TadiLEX has been shown to improve these urinary symptoms as early as 1-2 weeks after the start of treatment.

2. What you need to know before you take TadiLBKS

Do not take TadiLBX if:

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

you take some kind of organic nitrate or nitric oxide donors like amyl nitrite. These are a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). TadiLEX has been shown to increase the effects of these drugs. If you are taking any form of nitrates or are not sure, tell your doctor;

you have serious heart disease or have had a recent heart attack in the past 90 days;

you have had a recent stroke (stroke) in the last 6 months;

you have low blood pressure or uncontrolled high blood pressure;

have ever had vision loss as a result of non-arterial anterior ischemic optic neuropathy (NAION) - a condition described as a 'stroke to the eye';

you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (ie, high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie, high blood pressure in the lungs as a result of blood clots). PDE5 inhibitors, such as TadiLEX, have been shown to enhance 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 TadiLEX.

Note that sexual activity carries possible risks for patients with heart disease because it puts extra strain on your 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 (tumor of the bone marrow);

leukemia (tumor of blood cells);

any deformity of the penis;

serious liver problem;

serious kidney problem.

It is not known whether TadiLEX is effective in patients who have:

pelvic surgery;

removal of all or part of the prostate gland in which the prostate nerves are severed (radical, non-nerve-sparing prostatectomy).

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

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

TadiLEX is not intended for use by women.

Children and adolescents

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

Other medicines and TadiLEX

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

Do not take TadiLEX if you are already taking nitrates.

Some medicines may be affected by TadiLEX or they may affect how well TadiLEX 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 (enlargement));

other medicines to treat high blood pressure;

riociguat;

inhibitor

Pregnancy

There are limited data on the use of TadiLEX in pregnant women. As a precautionary measure, it is preferable to avoid the use of TadiLEX during pregnancy.

Breastfeeding

Available animal data show passage of TadiLEX into milk. A risk to the infant cannot be ruled out. TadiLEX should not be used during breast-feeding.

Fertility

Decreased sperm production in the testes has been observed in treated dogs. A decrease in sperm is seen in some men. These effects are unlikely to result in a lack of fertility.

Driving and using machines

In clinical trials, some men taking TadiLEX reported experiencing dizziness. Check carefully how you tolerate the tablets before driving or using machines.

TadiLEX contains lactose:

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

3. How to take TadiLEX

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

TadiLEX tablets are for oral use only in men. Swallow the tablet whole with a little water. You can take the tablets with or without food.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once daily at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to TadiLEX.

Do not take TadiLEX more than once a day.

Taking TadiLEX once a day may benefit men who have sexual activity two or more times a week.

When you take TadiLEX once a day, it allows you to get an erection when you are stimulated at any time, 24 hours a day.

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

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

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet taken once daily at approximately the same time of day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

Do not take TadiLEX more than once a day.

If you have taken more than the required dose of TadiLEX

Contact your doctor. You may experience unwanted effects described in point 4.

If you forget to take TadnLEX

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

If you have any further questions related to 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.

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

allergic reactions, including rashes (frequency - uncommon);

pain in the chest area - do not use nitrates, but immediately seek medical help (frequency - infrequent);

priapism, prolonged and possibly painful erection after taking TadiLEX (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 side effects reported:

Common: (seen in 1 to 10 out of every 100 patients)

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

Uncommon: (seen in 1 to 10 out of every 1,000 patients)

dizziness, abdominal pain, nausea, vomiting, heartburn, blurred vision, eye pain, difficulty breathing, presence of blood in the urine, prolonged erection, feeling of a strong heartbeat, rapid heart rate, increased blood pressure, decreased blood pressure, nosebleeds, tinnitus, swelling of the hands, feet or ankles, and fatigue.

Rare: (seen in 1 to 10 out of every 10,000 patients)

weakness, fainting and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red spots on the surface of the skin), bleeding from the penis, presence of blood in the semen, and increased sweating.

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

Rarely, partial

5. How to store TadiLEX

Keep out of the reach of children. To be stored below 25°C in the original packaging.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What TadiLEX contains

The active substance is: tadalafil (itadalafil). One film-coated tablet contains 5 mg tadalafil.

The other ingredients are:

Tablet core: lactose monohydrate, L-hydroxypropyl cellulose - LH I, L-hydroxy propyl cellulose - EF, croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose pH 102, magnesium stearate.

Film coating Opadray II TAN 85G27001 containing: lecithin, yellow iron oxide, titanium dioxide, red iron oxide, polyvinyl alcohol - partially hydrolyzed, talc, black iron oxide, polyethylene glycol.

What TadiLEX 5 mg looks like and what the pack contains

TadiLEX 5 mg film-coated tablets are pale orange, biconvex, drop-shaped, film-coated tablets, debossed with "5" on one side.

One blister contains 14 film-coated tablets.

Package size: 28 film-coated tablets (1 package/ 2 blisters).

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