Tadalafil Pmcs

Package Leaflet: Information for the Patient

Tadalafil PMCS, 5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Tadalafil PMCS and what is it used for

Tadalafil PMCS is a medicine used for the treatment of adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain a hard erection sufficient for satisfactory sexual activity. Tadalafil PMCS has been shown to significantly improve the ability to achieve a hard erection sufficient for satisfactory sexual activity.

Tadalafil PMCS belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil PMCS helps the blood vessels in the penis to relax and expand, allowing more blood to flow into the penis. As a result, the erection is improved. Tadalafil PMCS does not help patients who do not have erectile dysfunction.

It is important to note that Tadalafil PMCS does not work without sexual stimulation.

The patient and his partner should engage in foreplay, just as they would when not taking an erectile dysfunction medicine.

2. Important information before taking Tadalafil PMCS

When not to take Tadalafil PMCS:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking organic nitrates or nitric oxide donors, such as amyl nitrite. This group of medicines is used in the treatment of angina pectoris (chest pain). Tadalafil PMCS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have severe heart disease or have had a heart attack within the last 90 days.
• if you have had a stroke within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• if you are taking riociguat. This medicine is used to treat pulmonary 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadalafil PMCS, increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil PMCS, discuss your condition with your doctor.

It should be noted that sexual activity carries a risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, inform your doctor.

Before taking the medicine, tell your doctor if you have any of the following:

• sickle cell anaemia (a condition where the red blood cells are abnormally shaped).
• multiple myeloma (a cancer of the bone marrow).
• leukaemia (a cancer of the blood cells).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

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

• undergone pelvic surgery.
• had their prostate removed (prostatectomy) and the nerves surrounding the prostate are cut (radical prostatectomy without nerve-sparing).

If you experience sudden loss of vision or loss of vision in one eye during treatment with tadalafil, stop taking Tadalafil PMCS and contact your doctor immediately.

In some patients taking tadalafil, a sudden decrease or loss of hearing has been reported. Although it is not known whether this event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil PMCS and contact your doctor immediately.

Tadalafil PMCS is not intended for use by women.

Children and adolescents

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

Tadalafil PMCS with other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.

Do not take Tadalafil PMCS if you are taking nitrates.

Tadalafil PMCS may affect the way some medicines work, or some medicines may affect the way Tadalafil PMCS works. Tell your doctor or pharmacist if you are taking any of the following:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate gland).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate gland).
• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (medicines used to treat epilepsy).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil PMCS with food and drink

Information about the effect of alcohol is given in section 3.

Grapefruit juice may affect the efficacy of Tadalafil PMCS, and therefore, caution should be exercised when consuming it.

For more information, ask your doctor.

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes.

A decrease in sperm count has been observed in some men.

It is unlikely that this will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness.

Therefore, you should be aware of how you react to the tablets before driving or operating machinery.

Tadalafil PMCS 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.

The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Tadalafil PMCS

This medicine should always be taken exactly as directed by your doctor.

If you are unsure, consult your doctor or pharmacist.

Tadalafil PMCS tablets are for oral use only in men.

Swallow the tablet whole with a small amount of water.

The tablets can be taken with or without food.

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

Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil PMCS (2.5 mg tablets are available).

Do not take Tadalafil PMCS more than once a day.

Taking Tadalafil PMCS once a day may be useful for men who anticipate having sexual activity twice a week or more frequently.

Taking Tadalafil PMCS once a day allows for spontaneous erections in response to sexual stimulation at any time between doses.

It is important to note that Tadalafil PMCS does not work without sexual stimulation.

The patient and his partner should engage in foreplay, just as they would when not taking an erectile dysfunction medicine.

Consuming large amounts of alcohol may decrease your ability to get an erection and may also temporarily lower your blood pressure.

If you have taken or are planning to take Tadalafil PMCS, do not drink large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more Tadalafil PMCS than you should

Inform your doctor.

Side effects may occur (see section 4).

Forgetting a dose of Tadalafil PMCS

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet.

Do not take Tadalafil PMCS 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.

If you experience any of the following side effects, stop taking Tadalafil PMCS and contact your doctor immediately:

• allergic reactions, including skin rash (uncommon).
• chest pain - do not take nitrates, but seek medical help immediately (uncommon).
• priapism, prolonged and possibly painful erections after taking Tadalafil PMCS (rare). If you have an erection that lasts more than 4 hours, contact your doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision in one eye (frequency not known).

Other reported side effects:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, hives (itchy, red welts on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Heart attack and stroke have been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease.

There have been reports of rare cases of partial, temporary, or permanent loss of vision in one eye.

Men taking tadalafil have reported the following additional rare side effectsthat were not observed in clinical trials:

• migraine, swelling of the face, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders causing blood to flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted vision, blurred vision, or loss of vision in one eye (frequency not known). Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

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

Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil PMCS

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

No special precautions for storage are necessary.

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

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil PMCS contains

The active substance is tadalafil.

• Tadalafil PMCS, 5 mg, film-coated tablets: each tablet contains 5 mg of tadalafil.
• Other ingredients are:
• tablet core: lactose monohydrate, microcrystalline cellulose, povidone 25, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate.
• tablet coating: Opadry yellow 0Y-32823 (hypromellose 6cp, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), iron oxide red (E172).

What Tadalafil PMCS looks like and contents of the pack

Tadalafil PMCS, 5 mg, film-coated tablets: yellow, round, biconvex, film-coated tablet, 6 mm in diameter.

The medicine is available in the following packs: blisters (PVC/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium) in a cardboard box.

Pack sizes: 30 film-coated tablets.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Tadalafil PMCS

Estonia: Tadalafil PMCS 5 mg

Lithuania: Tadalafil PMCS 5 mg film-coated tablets

Latvia: Tadalafil PMCS 5 mg coated tablets

Poland: Tadalafil PMCS

Slovakia: Tadalafil PMCS 5 mg

Sweden: Tadalafil PMCS 5 mg film-coated tablets

Date of last revision of the package leaflet:16.05.2024