TADALAFIL COMBIX 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Combix 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tadalafil Combix and what is it used for
2. What you need to know before taking Tadalafil Combix
3. How to take Tadalafil Combix
4. Possible side effects
5. Storage of Tadalafil Combix
6. Package Contents and Additional Information

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

Tadalafil Combix is indicated for the treatment of erectile dysfunction in adult men. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil Combix has been shown to significantly improve the ability to achieve a lasting erection of the penis suitable for sexual activity.

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

It is essential to warn you that Tadalafil Combix 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 medication for erectile dysfunction.

2. What you need to know before taking Tadalafil Combix

Do not take Tadalafil 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 pectoris ("chest pain"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.
• If you have a severe heart condition or have recently suffered a heart attack, within the last 90 days.
• If you have recently suffered a stroke, within the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever experienced sudden 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 blood clots). Phosphodiesterase type 5 inhibitors, such as Tadalafil Combix, have shown that they 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 Tadalafil Combix.

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it requires for the heart. If you have a heart problem, consult your doctor.

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

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

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

• surgery in the pelvic area.
• a surgical intervention in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

Tadalafil Combix is not intended for use in women.

Children and Adolescents

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

Use of Tadalafil Combix with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, 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 for treating high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Combix with Drinks and Alcohol

Information about the effect of alcohol can be 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 with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and Using Machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully check how you react when taking the tablets before driving or using machines.

Tadalafil Combix contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Tadalafil Combix

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

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

The 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.

When taking Tadalafil Combix, you can initiate sexual activity at least 30 minutes after taking it.

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

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

It is essential to warn you that Tadalafil Combix 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 medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil 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 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. These effects are generally mild to moderate.

If you experience any of the following side effects, stop using the medication 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 erection after taking tadalafil (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, facial 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 the urine, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1000 people)

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

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

In men over 75 years of age treated with tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse effect was diarrhea.

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

Some additional rare side effectshave 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 that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Combix

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of in wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafil Combix

• The active ingredient is tadalafil. Each tablet contains 20 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 (E464), lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin, and talc (E553b)).

Appearance of the Product and Package Contents

Yellow film-coated tablets, 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. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Combix Laboratories, S.L.U.

C/Badajoz, 2. Building 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 Pharmaceutical Development, S.L.

Mocholí Industrial Park

Noáin Street, 1

31110 Noáin (Navarra)

Spain

or

Netpharmalab Consulting Services

Fuencarral Road, 22

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: November 2023

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