Leaflet: information for the user

Tadalafilo Qualigen 10 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as 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 Tadalafilo Qualigen is and what it is used for

2. What you need to know before you start taking Tadalafilo Qualigen

3. How to take Tadalafilo Qualigen

4. Possible side effects

5. Storage of Tadalafilo Qualigen

6. Contents of the pack and additional informationadditional information

Tadalafilo Qualigen is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm erection, suitable for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

Tadalafilo Qualigen contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafilo Qualigen acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo Qualigen will not be effective 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 you would without taking a medication for erectile dysfunction.

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, in the last 90 days.

• You have had a recent stroke, in 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 increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings 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 with your doctor.

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

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

Tadalafilo Qualigen is not known to be 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 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/AIDS or HIV infection.
• 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 machinery

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

Tadalafilo Qualigen contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, 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 for this medication as indicated by your doctor. If in 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.

Recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg of tadalafilo.

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

You can initiate sexual activity at least 30 minutes after taking Tadalafilo Qualigen.

Tadalafilo Qualigen may still be effective up to 36 hours after taking the tablet.

You should not take Tadalafilo Qualigen more than once a day. 10 and 20 mg doses will be used before expected sexual activity and are not recommended for continuous daily use.

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 achieve an erection and 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.

The notch should not be used to break the tablet.

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, contact the Toxicological Information Service, Tel. 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 have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Tadalafilo 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 medication and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).
• prolonged erection, possibly painful, after taking Tadalafilo (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(observed in 1 to 10 of every 100 patients)

• headache, back pain, muscle pain, arm and leg pain,

flushing of the face, nasal congestion, and indigestion.

Infrequent(observed in 1 to 10 of every 1,000 patients)

• 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, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

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

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

Tadalafilo has also been associated with rare cases of heart attack and stroke in men taking the medication. Most of these men had some pre-existing heart condition before taking this medication.

Rarely reported cases of partial or permanent loss of vision, 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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tadalafilo Qualigen

• Theactive ingredientis tadalafilo. Each tablet contains 10 mg of tadalafilo.
• Theother componentsare:Tablet core: lactose monohydrate, croscarmellose sodium, laurilsulfate of sodium, povidone K30 (E-1201), poloxamer type 188, colloidal anhydrous silica, microcrystalline cellulose (E-460i), magnesium stearate (E-572).

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

Appearance of the product and content of the packaging

Tadalafilo Qualigen 10 mg is a pale orange, oblong, biconvex, and scored tablet.

Tadalafilo Qualigen 10 mg is available in blister packs containing 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Pharmaceutical Works Polpharma SA

19 Pelplinska Street

83-200 Starograd Gdanski

Poland

or

Pharmacare Premium Ltd,

HHF003, Hal Far Industrial Estate

Hal Far Birzebbugia, BBG3000,

Malta

or

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/