Leaflet: information for the user

Tadalafilo Combix 20 mg film-coated tablets

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, ask 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.

Tadalafilo Combix 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 Combix has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

Tadalafilo Combixcontains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulationTadalafilo Combixacts by helping to relax the blood vessels of your penis, allowing blood to flow into the penis. The result is an improvement in erectile function.Tadalafilo Combixwill not help if you do not have erectile dysfunction.

It is essential to inform you thatTadalafilo Combixis 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 Combix

• If you are allergic to tadalafil or any of the other components of this medication (listed in section 6).
• If 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 (chest pain). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• If you have a serious heart condition or have had a recent heart attack, within the last 90 days.
• If you have had a recent stroke, within the last 6 months.
• If you have low or uncontrolled high blood pressure.
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction".
• If you are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Tadalafilo Combix, 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 Combix.

Be aware that sexual activity poses a possible risk for patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

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

• Thalassemia (a blood disorder).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cancer).
• Any deformity of the penis.
• A serious liver problem.
• A serious kidney problem.

The effectiveness of tadalafil is not known in patients who have undergone:

• Pelvic surgery.
• A surgical procedure in which the prostate has been completely or partially removed and the nerves of the prostate 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 Combix, stop taking Tadalafilo Combix and immediately contact your doctor.

Tadalafilo Combix is not intended for use in women.

Children and adolescents

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

Use of Tadalafilo Combix with other medications

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

Do not take tadalafil if you are already using nitrates.

Some medications may be affected by tadalafil or may affect the proper functioning of tadalafil. 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 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 Combix with beverages and alcohol

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

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. Some men have experienced a reduction in sperm count. It is unlikely that these effects will cause infertility.

Driving and operating machinery

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

Tadalafilo Combix contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafilo Combix 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. However, you have been given a dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

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

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

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

It is essential to inform you that Tadalafilo Combix 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 Combix, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafilo Combix than you should

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

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

If you forgot to take Tadalafilo Combix

Take your dose as soon as you remember. Do not take a double dose to compensate for missed doses. Do not take tadalafilo 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 and possibly painful erection after taking tadalafil (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, central vision blurred or sudden decrease in vision (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, 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(may affect up to 1 in 1000 people)

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

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

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

Rarely, 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 tadalafil that were not reported during clinical trials. These include:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Tadalafilo Combix Composition

• The active ingredient is tadalafilo. Each tablet contains 20 mg of tadalafilo.
• The other components (excipients) are:

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

Tablet coating:Opadry II Yellow 32K520080 (hypromellose (E464), lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin and talc (E553b)).

Product appearance and packaging contents

Yellow-coated tablets with a yellow film coating, oval, biconvex, with beveled edges, engraved with “899” on one face and smooth on the other.

PVC/PVDC-Aluminum blisters.

Packaging of 2, 4, 8, and 12 tablets. Some packaging sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Combix Laboratories, S.L.U.

C/Badajoz, 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Idifarma Pharmaceutical Development, S.L.

Mocholí Industrial Estate

C/ Noáin 1

31110 Noáin (Navarra)

Spain

or

Netpharmalab Consulting Services

Alcobendas Highway, 22

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: November 2023

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