Prospecto: Information for the user

Citax 10 mg film-coated tablets EFG

Tadalafil

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What Citax is and for what it is used

2.What you need to know before starting to take Citax

3.How to take Citax

4.Possible adverse effects

5Storage of Citax

6.Contents of the package and additional information

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

This medication contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafilo acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not be effective 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 you would without taking a medication for erectile dysfunction.

Do not take Citax

-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”). 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 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 tadalafil, 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 this medication.

Be aware that sexual intercourse carries 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.

Tadalafil is not known to be effective in patients who have undergone:

• Surgeries in the pelvic area.
• 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 sudden decrease or loss of vision or your vision is distorted or blurred while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

This medication should not be used in children or adolescents under 18 years old.

Taking Citax with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 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 Citax with food, drink, 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. A decrease in sperm count has been observed in some men. 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.

Citax contains lactose

This medication 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.

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.

Recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil tablets are taken orally.

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

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

You should not take tadalafil more than once a day. Tadalafil 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 tadalafil 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 plan 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.

If you take more Citax than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

You may experience adverse effects described in section 4.

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).
• Priapism, a 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(observed in 1 to 10 of every 100 patients)

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

Infrequent(observed in 1 to 10 of every 1,000 patients)

• Dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, 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(observed in 1 to 10 of every 10,000 patients)

• Loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red patches on the skin that itch), bleeding in the penis, blood in the semen and increased sweating.

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

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).

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.

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: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.

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.

This medication does not require special storage conditions.

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.

Composition of Citax

-The active ingredient is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.

-The other components are:

-Tablet core: lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, and magnesium stearate.

-Coating: Opadry II Yellow 32K12884 containing lactose monohydrate, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172), and triacetin (E-1518).

Appearance of the product and contents of the packaging

Film-coated tablets of yellow color, round, scored on one face and marked with a “10” on the other.

The score is not for splitting the tablet.

This medication is available in blister packs containing 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: October 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/