TADALAFIL ALTER 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Alter 10 mg Orodispersible Tablets EFG

Tadalafil Alter 20 mg Orodispersible Tablets EFG

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

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 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. Tadalafil has been shown to significantly improve the ability to obtain a hard erect penis suitable for sexual activity.

Tadalafil Alter contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil acts to help relax the blood vessels in your penis, 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 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 in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem.
• if you have recently 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 “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

Consult 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.

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

• sickle cell anaemia (a disease of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukaemia (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:

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland).

If you experience 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 reported in some patients taking tadalafil. Although it is not known if this 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 by women.

Children and adolescents

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

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 (anticonvulsant 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. 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. These effects are unlikely to 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.

Tadalafil Alter 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.

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

Tadalafil Alter 10 mg contains 4.08 mg of aspartame in each tablet.

Tadalafil Alter 20 mg contains 8.16 mg of aspartame in each tablet.

Aspartame contains 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

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

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.

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.

10 mg dose: the score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

When you take tadalafil, you may be able to have sexual intercourse from at least 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 used 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 Tadalafil Alter than you should

Consult your doctor. You may experience side effects described in section 4.

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

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 in nature.

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 vision, blurred vision, or sudden decrease in 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 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(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 sudden loss of vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials, including:

• 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, and sudden cardiac death.
• distorted, blurred, or sudden decrease in vision (frequency not known).

In men over 75 years of age treated with tadalafil, the most frequently reported adverse reaction was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse reaction 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: 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 packaging to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy’s SIGRE collection point. If you are unsure, consult your pharmacist on how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Alter

• The active substanceis tadalafil.

Tadalafil Alter 10 mg: each orodispersible tablet contains 10 mg of tadalafil.

Tadalafil Alter 20 mg: each orodispersible tablet contains 20 mg of tadalafil.

• The other ingredientsare:

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

Appearance and packaging

Tadalafil Alter 10 mg: white to off-white, round, biconvex orodispersible tablets with a non-functional score line on one side, approximately 8 mm in diameter.

Tadalafil Alter 20 mg: white to off-white, round, biconvex orodispersible tablets without a score line, approximately 11 mm in diameter.

Tadalafil Alter 10 mg is available in PCTFE/PVC-Aluminum blisters in packs of 4 orodispersible tablets.

Tadalafil Alter 20 mg is available in PCTFE/PVC-Aluminum blisters in packs of 4 and 8 orodispersible tablets.

Marketing authorisation holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this 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/.