TADALAFIL PMCS

Package leaflet: Information for the patient

Tadalafil PMCS, 5 mg, film-coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

Tadalafil PMCS is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil PMCS has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse.
Tadalafil PMCS belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil PMCS helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil PMCS does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil PMCS does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

2. Important information before taking Tadalafil PMCS

When not to take Tadalafil PMCS:

• if the patient is allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This group of medicines (‘nitrates’) is used in the treatment of angina pectoris (‘chest pain’). It has been shown that Tadalafil PMCS enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
• if the patient has severe heart disease or has recently had a heart attack (within the last 90 days).
• if the patient has recently had a stroke (within the last 6 months).
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as “eye stroke”.
• if the patient is 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 lung pressure caused by blood clots). PDE5 inhibitors, such as Tadalafil PMCS, have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil PMCS, patients should discuss this with their doctor.
Patients should be aware that sexual activity involves some risk in individuals with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking Tadalafil PMCS, the patient should inform their doctor if any of the following conditions apply:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (a bone marrow cancer).
• leukemia (a blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

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

• after pelvic surgery.
• after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (non-nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs during treatment with tadalafil, or if vision becomes distorted or dimmed, the patient should stop taking Tadalafil PMCS and contact their doctor immediately.
In some patients taking tadalafil, hearing deterioration or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing deterioration or sudden hearing loss occurs, the patient should stop taking Tadalafil PMCS and contact their doctor immediately.
Tadalafil PMCS is not intended for use in women.
Children and adolescents
Tadalafil PMCS is not intended for use in children and adolescents under 18 years of age.
Tadalafil PMCS and other medicines
The patient should inform their doctor about all medicines currently taken or recently taken, as well as any medicines they plan to take.
Tadalafil PMCS must not be taken if the patient is using nitrates.
Tadalafil PMCS may affect the action of certain medicines, or other medicines may affect the action of Tadalafil PMCS. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
• medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil PMCS, food and alcohol
Information regarding the effects of alcohol is provided in section 3.
Grapefruit juice may affect the effectiveness of Tadalafil PMCS, and caution should therefore be exercised when consuming it.
For further information, the patient should consult their doctor.
Fertility
When Tadalafil PMCS was administered to dogs, a reduction in sperm production in the testes was observed.
A reduction in sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
During clinical trials, dizziness was reported in some men taking tadalafil. Therefore, patients should assess their individual response to the tablets before deciding to drive or operate machinery.
Tadalafil PMCS contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning that the medicine is considered “sodium-free”.

3. How to take Tadalafil PMCS

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
Tadalafil PMCS tablets are intended for oral use only in men. The tablets should be swallowed whole with a small amount of water. Tadalafil PMCS tablets may be taken with or without food.
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. The physician may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil PMCS (2.5 mg tablets are available for sale).
Do not take Tadalafil PMCS more often than once a day.
Daily administration of Tadalafil PMCS may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Tadalafil PMCS once daily allows achieving an erection following sexual stimulation at any time within 24 hours.
It is important to be aware that Tadalafil PMCS does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil PMCS, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking more Tadalafil PMCS than recommended
Inform the doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Tadalafil PMCS
Take the missed dose as soon as remembered, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil PMCS more often than once a day.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the
medicine and seek immediate medical advice:

• allergic reactions, including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a prolonged and possibly painful erection after taking Tadalafil PMCS (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
Common (may occur in up to 1 in 10 people)

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

Uncommon (may occur in no more than 1 in 100 people)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (may occur in no more than 1 in 1,000 people)

• fainting, convulsions and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin eruptions), bleeding from the penis, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse
reactions have been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterised by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown). The adverse reaction: dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions
of the 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil PMCS

Keep this medicine out of sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the carton following: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 5 mg film-coated tablets: each tablet contains 5 mg of tadalafil. The other ingredients are:
• Tablet core: monohydrate lactose, microcrystalline cellulose, povidone 25, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate.
• Tablet coating: Opadry yellow 0Y-32823 (hypromellose 6cp, titanium dioxide (E171), polyethylene glycol 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 with a diameter of 6 mm.
The medicine is available in the following pack sizes: blisters (PVC/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium) in a cardboard box.
Pack size: 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Tadalafil PMCS
Estonia: Tadalafil PMCS 5 mg
Lithuania: Tadalafil PMCS 5 mg plėvele dengtos tabletės
Latvia: Tadalafil PMCS 5 mg apvalkotās tabletes
Poland: Tadalafil PMCS
Slovakia: Tadalafil PMCS 5 mg
Sweden: Tadalafil PMCS 5 mg filmdragerade tabletter