Citax 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Citax 20 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Citax is and what it is used for

2. What you need to know before taking Citax

3. How to take Citax

4. Possible side effects

5. Storage of Citax

6. Contents of the pack and other information

1. What Citax is and what it is used for

Citax is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Citax has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Citax

Do not take Citax

• If you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any organic nitrates or nitric oxide donors such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• If you have severe heart disease or have recently had a heart attack (within the last 90 days).
• If you have recently had a stroke (within the last 6 months).
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as "stroke of the eye".
• 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). PDE5 inhibitors such as tadalafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting this medicine.

Be aware that sexual activity carries a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• Sickle cell anemia (an abnormality of red blood cells).
• Multiple myeloma (a cancer of the bone marrow).
• Leukemia (a cancer of blood cells).
• Any penile deformity.
• Severe liver problems.
• Severe kidney problems.

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

• Pelvic surgery.
• Surgery involving total or partial removal of the prostate with nerve bundles severed (radical prostatectomy without nerve-sparing).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed 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 whether this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Taking Citax with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take tadalafil if you are already using nitrates.

Some medicines may interact with tadalafil or affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

• 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 treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Citax with food, drink and alcohol

Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the way tadalafil works and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm count. These effects are unlikely to result in infertility.

Driving and use of machines

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

Citax contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Citax

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is one 10 mg tablet taken prior to sexual activity. However, you have been prescribed a dose of one 20 mg tablet because your doctor has decided that the recommended 10 mg dose is too weak for you.

When you take tadalafil, you may initiate sexual activity at least 30 minutes after taking the tablet.

Tadalafil may remain effective for up to 36 hours after taking the tablet.

You must not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg tablets are to be taken prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection and 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 upon standing.

If you take more Citax than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915620420, stating the medication and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

You may experience adverse effects described in section 4.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:

• Allergic reactions, including rashes (uncommon).
• Chest pain – do not use nitrates but seek immediate medical help (uncommon).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency), distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Common (observed in 1 to 10 out of every 100 patients)

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

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

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

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

• Fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red, itchy welts on the skin surface), bleeding from the penis, presence of blood in semen, and increased sweating.

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

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

Some additional rare adverse effects have been reported in men taking tadalafil that were not observed during clinical trials. These include:

• Migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• Distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citax

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citax

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:
• Tablet core: monohydrate lactose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose and magnesium stearate.
• Coating: Opadry II Yellow 32K12884 containing monohydrate lactose, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172) and triacetin (E-1518).

Appearance of the product and contents of the pack

Yellow, round, film-coated tablets, scored on one side and marked with "20" on the other.

The score line is not intended to divide the tablet into equal doses.

This medicine is available in blister packs containing 4, 8 and 12 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: October 2023

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