Tadalafil pmcs

Package leaflet: Information for the patient

Tadalafil PMCS, 10 mg, coated tablets
Tadalafil PMCS, 20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of 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. The active substance in this medicine, tadalafil, has been shown to significantly improve the ability to achieve an erection sufficient 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 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, e.g. amyl nitrite. This group of medicines ("nitrates") is used in the treatment of angina pectoris ("chest pain"). It has been shown that Tadalafil PMCS intensifies 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 had a heart attack (within the last 90 days).
• if the patient has 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 blood pressure in the lungs 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, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients 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 deformity of the penis.
• 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 nerve-sparing techniques (nerve-sparing radical prostatectomy).

If during treatment with tadalafil there is sudden worsening of vision or sudden vision loss, or if vision becomes distorted or dimmed, treatment with Tadalafil PMCS should be stopped immediately and the patient should contact their doctor without delay.
In some patients taking tadalafil, worsening 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 loss or sudden hearing deterioration occurs, treatment with Tadalafil PMCS should be stopped and the patient should 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
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Tadalafil PMCS if you are using nitrates.
Tadalafil PMCS may affect the action of certain medicines or other medicines may affect the action of Tadalafil PMCS. Tell your doctor or pharmacist if you 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 ketoconazole tablets (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 effect of alcohol is provided in section 3.
Grapefruit juice may affect the efficacy of Tadalafil PMCS and therefore caution should be exercised when consuming it.
For further information, consult your doctor.
Fertility
When Tadalafil PMCS was administered to dogs, a reduction in sperm production in the testes was observed.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking tadalafil reported experiencing dizziness. 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 consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadalafil PMCS

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg.

Tadalafil PMCS tablets are intended 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.

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

Do not take Tadalafil PMCS more than once a day. Tadalafil PMCS in doses of 10 mg and 20 mg is intended for use prior to planned sexual intercourse and is not recommended for chronic daily use.

It is important to be aware that Tadalafil PMCS will 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.

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 avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Taking more than the recommended dose of Tadalafil PMCS
Inform your doctor immediately. Adverse effects described in section 4 may occur.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 skin 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, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

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 up to 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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

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

• fainting, convulsions, transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), 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 manifesting as blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or impaired central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Tadalafil PMCS

Keep this medicine out of the 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 after: 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 you no longer use. 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 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: monohydrate lactose, microcrystalline cellulose, povidone 25, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate.
• Tablet coating: Opadry yellow 0Y-32823 (hypromellose 6 cp, titanium dioxide (E171), polyethylene glycol 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 score 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, elongated, biconvex film-coated tablet with a score 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 pack sizes: blister packs (PVC/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium) in a cardboard carton.
Pack sizes:
Tadalafil PMCS 10 mg: 4 film-coated tablets.
Tadalafil PMCS 20 mg: 2 or 4 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 10 mg, Tadalafil PMCS 20 mg
Lithuania: Tadalafil PMCS 10 mg plėvele dengtos tabletės, Tadalafil PMCS 20 mg plėvele dengtos tabletės
Latvia: Tadalafil PMCS 10 mg apvalkotās tabletes, Tadalafil PMCS 20 mg apvalkotās tabletes
Poland: Tadalafil PMCS
Slovakia: Tadalafil PMCS 10 mg, Tadalafil PMCS 20 mg
Sweden: Tadalafil PMCS 10 mg filmdragerade tabletter, Tadalafil PMCS 20 mg filmdragerade tabletter