Tadalafil Pmcs

Package Leaflet: Information for the Patient

Tadalafil PMCS, 10 mg, Film-Coated Tablets

Tadalafil PMCS, 20 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 any not listed in this leaflet, please tell 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 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 to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil PMCS does not help patients who have no erectile dysfunction.

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

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 other 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 have severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in 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 effects of this medicine.

Warnings and precautions

Before taking Tadalafil PMCS, you should discuss this 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, you should tell your doctor.

Before taking Tadalafil PMCS, you should tell your doctor if you have any of the following:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• 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 (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of hearing while taking tadalafil, 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 and 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, and some medicines may affect the way Tadalafil PMCS works.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia).
• certain antibiotics (such as ketoconazole), and certain antiviral medicines (such as ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil PMCS with food and drink

Information on 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 grapefruit juice.

For more information, ask your doctor.

Fertility

When given to dogs, a decrease in sperm production was observed. Decreased sperm count has been observed in some men. It is unlikely to 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 (23 mg) of sodium 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 not sure, ask your doctor or pharmacist.

The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. If this dose is too weak, your doctor may increase the dose to 20 mg.

Tadalafil PMCS tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.

Tadalafil PMCS can be taken at least 30 minutes before planned sexual activity. Tadalafil PMCS may still be effective up to 36 hours after taking the tablet.

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

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

Consuming large amounts of alcohol may decrease your ability to get an erection and may temporarily lower your blood pressure. If you have taken Tadalafil PMCS or plan to take it, you should 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.

Take more Tadalafil PMCS than prescribed

Inform your doctor. Adverse reactions (see section 4) may occur. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadalafil PMCS can cause side effects, although not everybody gets them.

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

• allergic reactions, including skin rash (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• prolonged and possibly painful erections after taking Tadalafil PMCS (rare). If you experience this, contact your doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (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 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 rarely reported 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 vision loss or blindness in one or both eyes.

Men taking tadalafil have reported the following additional rare side effects:

• migraine, swelling of the face, severe allergic reactions causing swelling of the face and throat, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Dizziness has been reported more frequently in men over 75 years old taking tadalafil. Diarrhea has been reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Adverse reactions can be reported to the Department of Drug Safety, Office for Registration 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. Adverse reactions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil PMCS contains

The active substance is tadalafil.

• Tadalafil PMCS, 10 mg, film-coated tablets: each tablet contains 10 mg of tadalafil.
• Tadalafil PMCS, 20 mg, film-coated tablets: each tablet contains 20 mg of tadalafil. The 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, yellow iron oxide (E172), red iron oxide (E172).

What Tadalafil PMCS looks like and contents of the pack

Tadalafil PMCS, 10 mg: yellow, round, biconvex, film-coated tablet with a line on one side and smooth on the other, 8 mm in diameter.

The tablet can be divided into equal doses.

Tadalafil PMCS, 20 mg: yellow, oval, biconvex, film-coated tablet with a line on both sides, 15 mm long and 6 mm wide.

The tablet can be divided into equal doses.

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

Pack sizes:

Tadalafil PMCS, 10 mg: 4 film-coated tablets.

Tadalafil PMCS, 20 mg: 2 or 4 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 10 mg, Tadalafil PMCS 20 mg

Lithuania: Tadalafil PMCS 10 mg film-coated tablets, Tadalafil PMCS 20 mg film-coated tablets

Latvia: Tadalafil PMCS 10 mg coated tablets, Tadalafil PMCS 20 mg coated tablets

Poland: Tadalafil PMCS

Slovakia: Tadalafil PMCS 10 mg, Tadalafil PMCS 20 mg

Sweden: Tadalafil PMCS 10 mg film-coated tablets, Tadalafil PMCS 20 mg film-coated tablets

Date of last revision of the package leaflet:16.05.2024