TADALAFIL ALTER 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Alter 5 mg Orodispersible Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 Tadalafil Alter and what is it used for
2. What you need to know before you take Tadalafil Alter
3. How to take Tadalafil Alter
4. Possible side effects
5. Storage of Tadalafil Alter
6. Contents of the pack and other information

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

Tadalafil Alter contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil 5 mg 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 feeling like you need to urinate during the night. Tadalafil improves blood flow 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 Tadalafil Alter

Do not take Tadalafil Alter

• 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 are taking any form of nitrate or are unsure, tell your doctor.
• 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 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

Talk to your doctor before taking Tadalafil Alter.

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.

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).

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

A sudden decrease or loss of hearing has been reported in some patients taking tadalafil. Although it is not known if this 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

Tadalafil should not be used in children and adolescents under 18 years.

Taking Tadalafil Alter 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 (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Alter with drinks 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. Talk to your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm 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.

Tadalafil Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Tadalafil Alter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Tadalafil Alter contains aspartame

This medicine contains 2.04 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly).

3. How to take Tadalafil Alter

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

Tadalafil orodispersible tablets are for oral use only in men. They should be taken as a single dose and can be taken with or without food. The orodispersible tablet should be placed on the tongue where it will dissolve and can be swallowed without water.

Consuming alcohol 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 this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet taken once a day, approximately at 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 will allow you to get an erection, at any time during the 24 hours of the day, as long as you are sexually stimulated. Tadalafil taken daily may be useful for 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 each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet taken once a day, approximately at the same time.

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

Do not take tadalafil more than once a day.

If you take more Tadalafil Alter than you should

Talk to your doctor. You may experience side effects as described in section 4.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Tadalafil Alter

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 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 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 have an erection that lasts for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or affected vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in 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, prolonged erection, palpitations, rapid heartbeat, 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 1,000 people)

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, 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 in one or both eyes.

Additional rare side effects have been reportedin men taking tadalafil that were not seen in clinical trials, including:

• migraine, facial swelling, 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, and sudden cardiac death.
• distorted, blurred, or affected 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Alter

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

Store below 30°C. Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Alter

• The active substanceis tadalafil. Each orodispersible tablet contains 5 mg of tadalafil.
• The other ingredientsare:

Lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, aspartame (E-951), ethyl vanillin, magnesium stearate.

Appearance and packaging

White to off-white, flat, uncoated orodispersible tablets, approximately 7 mm in diameter.

Tadalafil Alter 5 mg is available in PCTFE/PVC-Aluminum blisters in a pack containing 28 orodispersible tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this package leaflet:June 2024

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/.