CITAX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citax 10 mg film-coated tablets EFG

Tadalafil

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

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

Contents of the package leaflet:

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 Storage of Citax

1. Package contents and further information

1. What is Citax and what is it used for

Citax is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Citax has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. 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 an improvement in 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. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

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 nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or heart attack within the last 90 days.
• 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 “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). Phosphodiesterase type 5 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

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, tell your doctor.

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

• Sickle cell anemia (a disorder of the 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 a surgical procedure in which the prostate was partially or completely removed and the nerves of the prostate 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, 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 by 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 the way tadalafil works. Tell your doctor or pharmacist if you are using:

• An alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• Other medicines for high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat an enlarged prostate).
• 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 the way tadalafil works and should be taken with caution. Consult your doctor for further 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 affect fertility.

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The recommended 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 for oral use.

When you take tadalafil, you can attempt sexual activity at any time from 30 minutes after taking the tablet.

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

Do not take tadalafil more than once a day. Tadalafil 10 and 20 mg will be taken before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just 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 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 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 Toxicology Information Service, telephone 915620420, stating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, 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 usually mild to moderate.

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

• Allergic reactions, including skin 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), distorted, blurred, central blurred vision, or sudden 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 transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin), 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 decreased or loss of vision, partial, transient, or permanent in one or both eyes have been reported.

Additional rare side effectshave been reported in men taking tadalafil that were not seen in 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, blurred, central blurred vision, or sudden loss of vision (frequency not known).

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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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. Storage 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 packaging after “EXP”. The expiry date refers to the last day of the month shown.

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. Package contents and further information

Composition of Citax

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other ingredients are:
• Core of the tablet: lactose monohydrate, hydroxypropylcellulose, croscarmellose sodium, laurilsulfate sodium, 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 package contents

Yellow, round, film-coated tablets, scored on one side and marked with a “10” on the other.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

This medicine is available in blister packs of 4 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 package leaflet: October 2023

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