TADALAFIL QUALIGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Qualigen 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Tadalafil Qualigen is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

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

It is important to note that Tadalafil Qualigen is not effective if there is no sexual stimulation. You and your partner will still need to use foreplay to get an erection.

2. What you need to know before you take Tadalafil Qualigen

Do not take Tadalafil Qualigen if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Qualigen has been shown to increase the effects of these medicines.

• you have a severe heart or liver problem.

• you have recently had a heart attack (within the last 90 days).

• you have had a stroke (including a 'mini-stroke' or transient ischaemic attack) within the last 6 months.

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

• you have ever had loss of vision 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking Tadalafil Qualigen.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

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

• sickle cell anaemia (a disease of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukaemia (cancer of the blood cells).
• any deformation of your penis.
• a severe liver problem.
• a severe kidney problem.

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

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland) with or without preservation of the neurovascular bundles.

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

Tadalafil Qualigen is not intended for use by women.

Children and adolescents

Tadalafil Qualigen should not be used in children and 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 take any other medicines.

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

Some medicines may be affected by Tadalafil Qualigen or may affect how well Tadalafil Qualigen works. Tell 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 for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines 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 medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Qualigen with food and drink

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

Pregnancy, breastfeeding, and fertility

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Qualigen contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Tadalafil Qualigen

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended doseis 10 mg of tadalafil before sexual activity. However, you have been given the dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

Not all recommended doses are possible with 20 mg tablets; tadalafil may also be available as 2.5, 5, and 10 mg tablets. Not all pack sizes may be marketed.

When you take Tadalafil Qualigen, you may be able to have sexual intercourse from at least 30 minutes after taking the tablet.

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

Do not take Tadalafil Qualigen more than once a day. Doses of 10 and 20 mg should be taken before anticipated sexual activity and are not recommended for continuous daily use.

It is important to note that Tadalafil Qualigen is not effective if there is no sexual stimulation. You and your partner will still need to use foreplay to get an erection.

Drinking too much alcohol can reduce 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 when standing up.

The score line is not intended for breaking the tablet.

If you take more Tadalafil Qualigen than you should

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

In case of overdose or accidental ingestion, contact the Toxicological Information Service, Tel. 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

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

4. Possible side effects

Like all medicines, Tadalafil Qualigen can cause side effects, although not everybody gets them. These effects are normally mild to moderate.

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

• allergic reactions including skin rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• Priapism, a prolonged and possibly painful erection after taking Tadalafil (rare). If you have an erection that lasts for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

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

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, blood in the semen, and increased sweating.

Additionally, the following rare side effects have been reported:

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

In men over 75 years old treated with Tadalafil, the most frequently reported adverse event was dizziness. In men over 65 years old treated with Tadalafil, the most frequently reported adverse event was diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after “EXP.”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should 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 pack and other information

Composition of Tadalafil Qualigen

• Active substanceis tadalafil. Each tablet contains 20 mg of tadalafil.
• Other ingredientsare: Tablet core: lactose monohydrate, croscarmellose sodium, laurilsulfate sodium, Povidone K30 (E-1201), poloxamer type 188, colloidal anhydrous silica, microcrystalline cellulose (E-460i), and magnesium stearate (E-572).

Coating: poly (vinyl alcohol), macrogol (E-1521), titanium dioxide (E171), talc, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance and packaging

Tadalafil Qualigen 20 mg is a pale pink, oblong, biconvex film-coated tablet with a score line.

Tadalafil Qualigen 20 mg is available in blister packs containing 4, 8, and 12 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 Gdański

Poland

or

Pharmacare Premium Ltd.,

HHF003 Hal Far Industrial Estate,

Hal Far Birzebbugia, BBG 3000,

Malta

or

Pharmaceutical Works Polpharma SA

2, Metalowca Street 39-460 Nowa Dęba

Poland

Date of last revision of this leaflet: October 2023

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