TADALAFIL COMBIX 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Combix 5 mg film-coated tablets

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Tadalafil Combix contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Combix 5 mg is used for the treatment of adult men with:

• erectile dysfunction. 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.

After sexual stimulation, tadalafil works 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 will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil is not effective if there is no sexual stimulation.

• symptoms of benign prostatic hyperplasia. This is when the prostate gland is enlarged and can cause problems with passing urine. Symptoms include difficulty starting to pass urine, a feeling that your bladder is not completely empty, needing to pass urine more often, or more often during the night. Tadalafil improves blood flow and relaxes the muscles in the prostate and the bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

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

Do not take Tadalafil Combix

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem.
• if you have recently had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke".
• if 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). Phosphodiesterase 5 inhibitors, such as Tadalafil Combix, 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 Combix.

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

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before you start taking tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

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

It is not known if tadalafil is effective in patients who have:

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland).

If you experience sudden loss of vision or your vision is distorted, blurred, or diminished while taking Tadalafil Combix, stop taking Tadalafil Combix and contact your doctor immediately.

Tadalafil Combix is not intended for use by women.

Children and adolescents

Tadalafil Combix should not be used in children and adolescents under 18 years of age.

Using Tadalafil Combix with other medicines

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

Do not take tadalafil if you are already taking nitrates.

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Tell 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 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 Combix with food and drink

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects will 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 Combix contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Combix

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist.

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

Consuming large amounts of alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, 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 taken once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafil taken daily may be useful for men who anticipate having sexual activity twice or more per week.

It is important to note that tadalafil is not effective if there is no 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.

Consuming large amounts of alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

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

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

Do not take tadalafil more than once a day.

If you take more Tadalafil Combix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tadalafil Combix

Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses. Do not take tadalafil more than once a day.

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

4. Possible side effects

Like all medicines, this medicine 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 taking the medicine and seek medical help immediately:

• allergic reactions including rash (uncommon).
• chest pain. Do not use nitrates but seek medical help immediately (uncommon).
• prolonged and possibly painful erections after taking tadalafil (rare). If you experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or diminished vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

Additionally, the following rare side effects have been reported in men taking tadalafil:

• 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 pectoris, and sudden cardiac death.
• distorted, blurred, or diminished vision (frequency not known).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tadalafil Combix

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 Combix

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), hypromellose (E463), croscarmellose sodium, and magnesium stearate (E470b).

Tablet coating: Opadry II Yellow 32K520080 (hypromellose 15 CP, lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin, and talc (E553b).

Appearance and packaging

Yellow, oval, biconvex, film-coated tablets with beveled edges, engraved with "897" on one face and plain on the other.

PVC/PVDC-Aluminum blisters.

Packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Idifarma Desarrollo Farmacéutico, S.L.

Polígono Mocholí

C/ Noáin 1

31110 Noáin (Navarra)

Spain

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of last revision of this package leaflet: November 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.