Leaflet: information for the user

Tadalafilo Combix 5 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, 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.

Tadalafilo Combix contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Combix 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get or keep a firm erection that is suitable for a satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis that is suitable for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Combix

• If you are allergic to tadalafilo or any of the other components of this medication (listed in section6).
• 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 pectoris (“chest pain”). Tadalafilo 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 disease 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 disease described as “eye infarction”.
• If you are taking riociguat. This medication 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 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 intercourse carries a possible risk for patients with heart problems, due to the additional effort it imposes on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer check before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

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

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

It is not known if tadalafilo is effective in patients who have undergone:

• pelvic surgery.
• surgery 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 tadalafilo if you are already using nitrates.

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. 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.
• an inhibitor of 5-alpha reductase (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 Combix with beverages and alcohol

Information about the effect of alcohol can be found in section 3. Grapefruit juice may affect the proper functioning of tadalafilo 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 tadalafilo 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 an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Consuming 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 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 one 2.5 mg tablet.

Do not take tadalafil more than once a day.

Daily tadalafil administration allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil administration may be useful for men who anticipate engaging in sexual activity two or more times a week.

It is essential to inform you that tadalafil is not effective without sexual stimulation. Thereforeyou andyour partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

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

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

Do not take tadalafil more than once a day.

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 the missed doses. Do not take tadalafil 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 can 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 (rare).
• chest pain. Do not use nitrates but seek medical help immediately (rare).
• prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(can affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Rare(can 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.

Very Rare(can 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), 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 commonly reported side effect was dizziness. In men over 65 years old taking tadalafil, the most commonly reported side effect was diarrhea.

Rarely, cases of partial or permanent loss of vision 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 of 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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tadalafilo Combix Composition

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• 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 15 CP, lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin, and talc (E553b).

Product appearance and container content

Yellow-coated tablets with a yellow film coating, oval, biconvex, with beveled edges, engraved with “897” on one face and smooth on the other.

PVC/PVDC-Aluminum blisters.

Containers of 28 tablets.

Only some container sizes may 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

The 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.