Leaflet: information for the user

Tadalafilo Qualigen 5 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTadalafilo Qualigenand what it is used for

2. What you need to know before starting to takeTadalafilo Qualigen

3. How to takeTadalafilo Qualigen

4. Possible side effects

5. Storage ofTadalafilo Qualigen

6. Contents of the pack and additional information

Tadalafilo Qualigen contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Qualigen 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, Tadalafilo Qualigen acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo Qualigen will not help if you do not have erectile dysfunction. It is essential to inform you that Tadalafilo Qualigen is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medicine for erectile dysfunction.

-urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo Qualigen improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Qualigen if:

• You are allergic to tadalafilo or any of the other components of this medication (listed in section 6).

• You are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). It has been seen that Tadalafilo Qualigen increases the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.

• You have a serious heart disease or have had a heart attack recently, within the last 90 days.

• You have had a recent stroke, within the last 6 months.

• You have low or uncontrolled high blood pressure.

• You have ever presented vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.

• You are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as tadalafilo, have shown to produce an increase in the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warning and precautions

Consult your doctor before starting to take Tadalafilo Qualigen.

Be aware that sexual relations carry a possible risk in patients with heart problems, due to the additional effort they pose for the same. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with Tadalafilo Qualigen for benign prostatic hyperplasia.

Tadalafilo Qualigen does not treat prostate cancer.

Before taking the tablets, inform your doctor if you have:

• Anemia falciforme (an abnormality of red blood cells).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• A serious liver problem.
• A serious kidney problem.

It is not known if Tadalafilo Qualigen is effective in patients who have undergone:

• Surgery in the pelvic area.
• A surgical intervention in which the prostate has been completely or partially removed and in which the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a decrease or sudden loss of vision or your vision is distorted while taking Tadalafilo Qualigen, stop taking Tadalafilo Qualigen and immediately contact your doctor.

Tadalafilo Qualigen is not intended for use in women.

Children and adolescents

Tadalafilo Qualigen should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Qualigen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Tadalafilo Qualigen if you are already using nitrates.

Some medications may be affected by Tadalafilo Qualigen or may affect the proper functioning of Tadalafilo Qualigen. Inform your doctor or pharmacist if you are using:

• An alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• Other medications to treat high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Qualigen with beverages and alcohol

The information about the effect of alcohol is found in section 3. Orange juice may affect the proper functioning of Tadalafilo Qualigen and should be taken with caution. Consult your doctor for more information.

Pregnancy, breastfeeding, and fertility

Fertility

In treated dogs, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

Some men who took tadalafilo during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Qualigen contains lactose and sodium

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafilo Qualigen tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Qualigen, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafilo Qualigen. This will be done by taking one 2.5 mg tablet.

Not all recommended doses are possible using 5 mg tablets; tadalafilo is also available in 2.5, 10, and 20 mg tablets. Not all doses may be marketed.

Do not take Tadalafilo Qualigen more than once a day.

Tadalafilo Qualigen taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafilo Qualigen taken daily may be useful for men who anticipate maintaining sexual activity two or more times a week.

It is essential to inform you that Tadalafilo Qualigen is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take Tadalafilo Qualigen more than once a day.

If you take more Tadalafilo Qualigen than you should

Consult your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Phone. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tadalafilo Qualigen

Take your dose as soon as you realize it, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Qualigen more than once a day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).
• prolonged erection and possibly painful after taking Tadalafilo Stada (rare frequency). If you experience this type of erection, which may last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted, blurred, or reduced central vision, or sudden vision loss (unknown frequency).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Infrequent(may affect up to 1 in 100 people)

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

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

• syncope, seizures, and transient memory loss, eyelid swelling, red eyes, sudden hearing loss, urticaria (red itchy patches on the skin), penile bleeding, blood in the semen, and increased sweating.

Infarction and stroke have also been reported in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

Rarely, cases of partial or permanent vision loss, temporary or permanent, in one or both eyes have been reported.

Some rare additional side effects have been reported in men taking tadalafilo that were not reported during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted, blurred, or reduced central vision, or sudden vision loss (unknown frequency).

In men over 75 years old taking tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD.:”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Tadalafilo Qualigen

Theactive ingredientis tadalafil. Each tablet contains 5 mg of tadalafil.

Theother componentsare:Tablet core:lactose monohydrate, croscarmellose sodium, povidone K 30(E-1201), poloxamer type 188, colloidal anhydrous silica, microcrystalline cellulose(E-460i), sodium lauryl sulfate, magnesium stearate(E-572).

Coating:poly(vinyl alcohol), macrogol(E-1521), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), talc.

Appearance of the product and content of the container

Tadalafilo Qualigen 5 mg is a pale brown, oblong, biconvex tablet with a notch.

Tadalafilo Qualigen 5 mg is available in blister packs containing 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer

PharmaceuticalWorks Polpharma SA

19 Pelplinska Street

83-200 Starograd Gdanski

Poland

O

Pharmacare Premium Ltd.,

HHF003 Hal Far Industrial Estate,

Hal Far Birzebbugia, BBG 3000,

Malta

O

Pharmaceutical Works Polpharma SA

2, Metalowca Street 39-460 Nowa Deba

Poland

Last review date of this leaflet: October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/