Tadalafil Qualigen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Qualigen 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tadalafilo Qualigen is and what it is used for
2. What you need to know before taking Tadalafilo Qualigen
3. How to take Tadalafilo Qualigen
4. Possible adverse effects
5. How to store Tadalafilo Qualigen
6. Contents of the pack and other information

1. What Tadalafilo Qualigen is and what it is used for

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

Tadalafilo Qualigen contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafilo Qualigen works by helping to relax the blood vessels in your penis, allowing blood to flow into the penile tissue. The result is improved erectile function. Tadalafilo Qualigen will not help you if you do not have erectile dysfunction.

It is important to warn you that Tadalafilo Qualigen is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Qualigen

Do not take Tadalafil Qualigen if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (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 medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil Qualigen has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.

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

• you have recently had a stroke, within the last 6 months.

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".

• you are taking riociguat. This medicine is used to treat pulmonary arterial 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, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take Tadalafil Qualigen.

Be aware that sexual activity involves a possible risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known whether Tadalafil Qualigen is effective in patients who have undergone:

• pelvic surgery.
• a surgical procedure in which the prostate has been completely or partially removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision or if your vision becomes distorted or dimmed while taking Tadalafil Qualigen, stop taking Tadalafil Qualigen and contact your doctor immediately.

Tadalafil Qualigen is not intended for use in women.

Children and adolescents

Tadalafil Qualigen must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafil Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Some medicines may be affected by Tadalafil Qualigen or may affect how well Tadalafil Qualigen works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Qualigen with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well Tadalafil Qualigen works and should be taken with caution. Consult your doctor for further information.

Pregnancy, breastfeeding, and fertility

Fertility

A decrease in sperm production by the testes was observed in treated dogs. A reduction in sperm has been observed in some men. It is unlikely that these effects would result in infertility.

Driving and use of machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Qualigen contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially "sodium-free".

3. How to take Tadalafil Qualigen

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafil Qualigen tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.

The recommended starting dose is 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 tadalafil.

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

When taking Tadalafil Qualigen, you may initiate sexual activity at least 30 minutes after taking the tablet.

Tadalafil Qualigen may remain effective for up to 36 hours after taking the tablet.

You must not take Tadalafil Qualigen more than once a day. Doses of 10 and 20 mg are to be used before anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn you that Tadalafil Qualigen is not effective without sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Qualigen, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness upon standing.

The score line should not be used to split the tablet.

If you take more Tadalafil 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 Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

4. Possible adverse effects

Like all medicines, Tadalafil can cause adverse effects, although not everyone experiences them. These effects are usually mild to moderate in intensity.

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

• allergic reactions including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• Priapism, prolonged and possibly painful erection after taking Tadalafil (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted central vision, dim, blurred vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Frequent (observed in 1 to 10 out of every 100 patients)

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

Uncommon (observed in 1 to 10 out 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 pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin rashes), bleeding from the penis, blood in the semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking Tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Rare cases of decreased or lost vision, partial, temporary or
permanent, in one or both eyes have also been reported.

Some additional rare adverse effects have been reported in men taking Tadalafil that were not observed 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 heartbeats, angina, and sudden cardiac death.
• distorted central vision, dim, blurred vision, or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving Tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving Tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Qualigen

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

Do not use this medicine after the expiry date stated on the carton and blister after "EXP:". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Tadalafil Qualigen

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other components are:
  Tablet core: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, povidone K30 (E-1201), poloxamer 188, colloidal anhydrous silica, microcrystalline cellulose (E-460i), magnesium stearate (E-572).

Film 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 contents of the container

Tadalafil Qualigen 10 mg is a pale orange, oblong, biconvex tablet with a score line.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain

Manufacturer

Pharmaceutical Works Polpharma SA
19 Pelplinska Street
83-200 Starogard 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

Date of the most recent review of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/