Tadalafil 5 mg. 28 tablets

1. What Tadalafil is and what it is used for

Tadalafil 5 mg film-coated tablets contain the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil 5 mg film-coated tablets are 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 5 mg has been shown to significantly improve the ability to achieve a hard, erect penis suitable for sexual activity.

After sexual stimulation, Tadalafil 5 mg works by helping the blood vessels in your penis to relax and allow blood to flow into your penis. The result is improved erectile function.

Tadalafil 5 mg will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil 5 mg 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 common condition called benign prostatic hyperplasia (enlargement).

This is a condition in which the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a feeling that the bladder is not completely emptying, and the need to urinate more often, even at night. Tadalafil 5 mg improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia (enlargement). Tadalafil 5 mg has been shown to improve these urinary symptoms as early as 2 weeks after starting treatment.

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);

if 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 nitrates or are not sure, tell your doctor;

if you have a serious heart condition or have had a recent heart attack in the last 90 days;

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

if you have low blood pressure or uncontrolled high blood pressure;

if 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 caused by 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 your heart. If you have heart problems, you should tell your doctor.

Since benign Prostatic hyperplasia (enlargement) and prostate cancer may have similar symptoms, your doctor will check you for prostate cancer before you start treatment with Tadalafil for benign prostatic hyperplasia (enlargement). Tadalafil does not treat prostate cancer.

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

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

multiple myeloma (a tumor of the bone marrow);

leukemia (a tumor 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:

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 or your vision is distorted, blurred while taking Tadalafil, stop taking Tadalafil 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 Tadalafil and contact your doctor.

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.

us.

Other medicines and Tadalafil STADA

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

Do not take Tadalafil STADA if you are already taking nitrates.

Some medicines may be affected by Tadalafil STADA or they may affect how well Tadalafil STADA 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 (to treat fungal infections) and protease inhibitors to treat AIDS or HIV infection;

phenobarbital, phenytoin and carbamazepine (anticonvulsants);

rifampicin, erythromycin, clarithromycin or itraconazole;

other treatments for erectile dysfunction.

Taking Tadalafil STADA with drink and alcohol

Information on the effects of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil STADA works and should be taken with caution. Talk to your doctor for more information.

Fertility

Reduced sperm production in the testicles has been observed in dogs treated with Tadalafil STADA. A reduction in sperm has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

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

Tadalafil STADA contains lactose

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

Tadalafil STADA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

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.

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

Do not take Tadalafil more than once a day.

Drinking alcohol can temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil STADA, avoid excessive alcohol consumption (e.g. more than 900 ml of beer or 350 ml of wine) as this may increase the risk of dizziness when you stand up.

For the treatment of erectile dysfunction

Dosage

The recommended dose is one 5 mg tablet taken once a day at about the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil STADA. It will be given as a 2.5 mg tablet.

Not all dosing recommendations are possible using the 5 mg tablet; tadalafil may also be available as 2.5, 10 and 20 mg tablets. Not all strengths may be marketed.

Please note

Tadalafil STADA taken once a day allows you to get an erection when stimulated at any time 24 hours a day. Taking Tadalafil STADA once a day may be beneficial for men who are sexually active two or more times a week.

It is important to note that Tadalafil STADA 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 medicine.

Drinking alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia (enlargement)

Dosage

The dose is one 5 mg tablet taken once a day at about the same time of day.

If you have benign prostatic hyperplasia (enlargement) and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

If you take more Tadalafil STADA than you should

Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil STADA

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 STADA more than once a day. 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 and seek medical help immediately (frequency - uncommon);

a prolonged and possibly painful erection after taking Tadalafil STADA (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), distorted, blurred, blurred central vision or sudden decrease in vision (frequency unknown).

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;

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;

a feeling of pounding heartbeat;

rapid heartbeat;

increased blood pressure;

decreased blood pressure;

nosebleed;

ringing in the ears;

swelling of the hands, feet or ankles;

tiredness.

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

weakness;

fits;

temporary memory loss;

swelling of the eyelids;

redness of the eyes;

sudden decrease or loss of hearing;

hives (itchy red spots on the surface of the skin);

bleeding from the penis, blood in the semen;

increased sweating.

Rarely, heart attack, stroke have been reported in men using Tadalafil STADA. 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 have been reported in men taking Tadalafil STADA that have not been seen in clinical trials. These include:

migraine;

facial swelling;

serious allergic reaction causing swelling of the face or throat;

serious skin rashes;

certain disorders affecting blood flow to the eyes;

irregular

n pulse;

angina;

sudden cardiac death;

distorted, blurred, blurred central vision or sudden decrease in vision (frequency unknown).

Dizziness has been reported more often in men over 75 years of age taking tadalafil. Diarrhea has been reported more often in men over 65 years of age taking tadalafil.

5. How to store Tadalafil

Keep out of the reach of children.

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

This medicinal product does not require any special storage conditions.

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

6. Contents of the pack and other information

What Tadalafil contains

The active substance is tadalafil

Each film-coated tablet contains 5 mg tadalafil.

The other ingredients (excipients) are:

Tablet core Lactose monohydrate Croscarmellose sodium Sodium laurilsulfate (E487) Hydroxypropyl cellulose

Polysorbate 80 Microcrystalline cellulose Magnesium stearate

Film coating:

Hypromellose

Lactose monohydrate

Titanium dioxide (E171)

Triacetin

Talc

Yellow iron oxide (E 172)

What Tadalafil looks like and contents of the pack

Light yellow, round, biconvex, film-coated tablets with a diameter of 6.1 ± 0.2 mm.

Available in PVC/PCTFE/PVC/Aluminium blister packs.

Pack sizes of 14x1, 28x1, 30x1, 56x1 and 84x1 film-coated tablets.

Not all pack sizes may be marketed.