CITAX 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citax 5 mg film-coated tablets EFG

Tadalafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack and other information

1. What is Citax and what is it used for
2. What you need to know before you take Citax
3. How to take Citax
4. Possible side effects

5 Conservation of Citax

1. Contents of the pack and further information

1. What is Citax and what is it used for

This medicinal product contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil 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.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to urinate, feeling like you need to urinate more often, or more urgently, or feeling like your bladder is not completely empty. Tadalafil improves blood flow to the prostate and relaxes the muscles in the prostate and 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 Citax

Do not take Citax

• 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 for the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• If you have a severe heart condition or have 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 type 5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine.

Warnings and precautions

Consult your doctor before taking this medicine.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain 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 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 condition that affects red blood cells).
• Multiple myeloma (cancer of the bone marrow).
• Leukemia (cancer of the blood cells).
• Any deformation of the penis.
• A severe liver problem.
• A severe kidney problem.

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

• Had surgery in the pelvic area.
• Had an operation to remove the prostate gland (prostatectomy) and the nerves that control an erection have been damaged.

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

A 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 medicine should not be used in children or adolescents under 18 years.

Taking Citax 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 Citax with food, drink, and alcohol

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.

Citax contains lactose

This medicine 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 Citax

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

Consuming large amounts of alcohol may temporarily reduce 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 per day, taken at approximately 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 in 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 yourselves 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 per day, taken at approximately the same time.

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

Do not take tadalafil more than once a day.

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: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

You may experience side effects described in section 4.

If you forget to take Citax

Take your dose as soon as you remember, but 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 product, 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 using the medicine and seek medical help immediately:

• Allergic reactions, including rash (uncommon).
• Chest pain – do not use nitrates but seek medical help immediately (uncommon).
• Priapism, a 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 should contact a doctor immediately.
• Sudden loss of vision (rare), blurred vision, or loss of vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

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

Rare(seen in 1 to 10 in every 10,000 patients)

• 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.

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

Rarely, cases of partial, temporary, or permanent loss of vision have been reported.

Additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials. These include:

• 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.
• Blurred vision, or loss of vision (frequency not known)

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Citax

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 further information

Composition of Citax

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are:
• Core of the tablet: lactose monohydrate, hydroxypropylcellulose, croscarmellose sodium, laurilsulfate, microcrystalline cellulose, and magnesium stearate.
• Coating: Opadry II Yellow 31K220010 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 pack

Light yellow, round, film-coated tablets, scored on one side and marked with a “5” on the other.

The score line is not intended for breaking the tablet.

This medicine is available in blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: October 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/