Tadalafil polpharma

Package leaflet: Information for the patient

Tadalafil Polpharma, 20 mg 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, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Tadalafil Polpharma 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 Polpharma has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.
Tadalafil Polpharma contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation, Tadalafil Polpharma helps widen the blood vessels of the penis, allowing blood flow into the penis.
This results in improved erection. Tadalafil Polpharma does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil Polpharma does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would when the patient is not taking medication for erectile dysfunction.

2. Important information before using Tadalafil Polpharma

When not to use Tadalafil Polpharma

• 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, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that Tadalafil Polpharma 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 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 is a medicine 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 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 Tadalafil Polpharma, patients should discuss this with their doctor.
Patients should remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if any of the following conditions apply:

• sickle cell anemia (abnormally shaped 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 Polpharma is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland with nerve-sparing techniques (radical prostatectomy without nerve-sparing).

If sudden vision loss, sudden decrease in vision, or distorted or dimmed vision occurs during treatment with Tadalafil Polpharma, the patient should stop taking Tadalafil Polpharma and contact their doctor immediately.
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 tadalafil use, if hearing loss or sudden decrease in hearing occurs, the patient should stop taking Tadalafil Polpharma and contact their doctor immediately.
Tadalafil Polpharma is not intended for use in women.
Children and adolescents
Tadalafil Polpharma is not intended for use in children and adolescents under 18 years of age.
Tadalafil Polpharma and other medicines
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tadalafil Polpharma must not be taken if the patient is using nitrates.
Tadalafil Polpharma may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Polpharma. The patient should tell their doctor or pharmacist if they are taking:

• alpha-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 to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Polpharma, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Polpharma, and therefore caution should be exercised when consuming it. For further information, the patient should consult their doctor.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and using machines
In some men participating in clinical trials, dizziness was reported during treatment with tadalafil. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Polpharma contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Polpharma

This medicine should always be taken as instructed by the doctor. In case of any doubts, consult
your doctor or pharmacist.
Tadalafil Polpharma tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water. The tablets may be taken
regardless of meals.
The recommended starting dose is one 10 mg tablet, taken prior to planned sexual activity.
If the 10 mg dose does not produce the desired effect, the doctor may increase the dose to 20 mg.
The medicine should be taken at least 30 minutes before planned sexual activity. The medicine
may remain effective for up to 36 hours after taking the tablet.
The maximum frequency of dosing is once per day.
Tadalafil Polpharma 10 mg and 20 mg is intended for use prior to planned sexual activity.
Regular, daily use of the medicine is not recommended.
It is important to be aware that Tadalafil Polpharma 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.
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 Polpharma, he should not consume large amounts of alcohol (blood alcohol
concentration of 0.08% or higher), as this may increase the risk of experiencing
dizziness upon standing.
Use of a higher than recommended dose of Tadalafil Polpharma
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missed dose of Tadalafil Polpharma
Take the missed dose as soon as remembered, but do not take a double dose to make up for
the missed tablet. Do not take Tadalafil Polpharma more frequently than once per day.
If you have any further doubts concerning 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 rash (uncommon).
• chest pain – do not take nitrates, seek immediate medical help (uncommon).
• priapism – prolonged and possibly painful erection after taking Tadalafil Polpharma (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 dim central vision, or sudden worsening of vision (frequency not known).

Other adverse reactions reported:
Common (observed in 1 to 10 out of 100 patients)

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

Uncommon (observed in 1 to 10 out of 1,000 patients)

• dizziness, abdominal pain, nausea, vomiting, gastroesophageal reflux, 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 of fatigue.

Rare (observed in 1 to 10 out of 10,000 patients)

• fainting, convulsions and 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 tadalafil treatment.
There have been reports of rare cases of partial, transient or permanent vision loss or vision impairment occurring in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions have been reported that 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 characterized by blood flow into the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred or dim central vision, or sudden worsening of vision (frequency not known).

Adverse reaction: 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 of adverse reactions
If any adverse effects 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 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tadalafil Polpharma

No special storage instructions are required for this medicinal product.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the stated month.
The label on the packaging shows EXP followed by the expiry date, and Lot/LOT followed by the batch number.
Medicines must 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 packaging and other information

What Tadalafil Polpharma contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are:
  Tablet core: lactose monohydrate, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate;
  Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

What Tadalafil Polpharma looks like and contents of the pack
Light pink, elongated, biconvex film-coated tablets with a division line on one side;
length 14.9–15.4 mm, width 7.1–7.6 mm. The division line on the tablet is not intended for breaking the tablet.
The medicine is available in blisters made of PVC/PVDC/Aluminium, packed in a cardboard carton.
Pack sizes:
2, 4, 8 or 12 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer/Importer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
Pharmacare Premium Ltd,
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000, Malta
POLPHARMA S.A. Pharmaceutical Works
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba