ALNEO 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Alneo 10 mg film-coated tablets EFG

Alneo 20 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 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 package leaflet

1. What is Alneo and what is it used for
2. What you need to know before you take Alneo
3. How to take Alneo
4. Possible side effects
5. Storage of Alneo
6. Contents of the pack and other information

1. What is Alneo 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.

Alneo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil acts by helping to relax the blood vessels in your penis, allowing the flow of blood into the penis. The result is improved erectile function. Tadalafil will not help 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 Alneo

Do not take Alneo

• 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 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 shown an increase in the hypotensive effect of this medicine.

Warnings and precautions

Talk to your doctor before taking Alneo.

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:

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

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

A sudden 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 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 Alneo 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 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 (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (medicines for epilepsy).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Alneo 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 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.

Alneo 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.

Alneo contains sodium

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

3. How to take Alneo

Follow exactly the instructions of your doctor. If you are not sure, talk to your doctor or pharmacist.

The 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.

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. The tadalafil tablets are taken by mouth.

When you take tadalafil, you can attempt sexual intercourse at any time from 30 minutes up to 36 hours 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 this may increase the risk of dizziness when standing up.

If you take more Alneo than you should

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

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

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 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 vision, blurred vision, or sudden loss of 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 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 been reported 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.

Some 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.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known)

In men over 75 years of age taking tadalafil, the most frequently reported adverse reaction was dizziness. In men over 65 years of age taking 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alneo

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

This medicine does not require any special storage conditions.

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

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 other information

Composition of Alneo

• The active substanceis tadalafil.

Alneo 10 mg: Each tablet contains 10 mg of tadalafil.

Alneo 20 mg: Each tablet contains 20 mg of tadalafil.

• The other ingredientsare:

Core of the tablet: lactose monohydrate (see section 2, Alneo contains lactose), croscarmellose sodium, hypromellose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Coating: hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Alneo 10 mg: Film-coated tablets, yellow, round, biconvex, scored on one side and smooth on the other, 8 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Alneo 20 mg: Film-coated tablets, yellow, round, biconvex, with a cross engraved on one side and smooth on the other, 11 mm.

Alneo 10 mg is available in blister packs in packs of 4 tablets.

Alneo 20 mg is available in blister packs in packs of 2, 4, or 8 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:August 2023

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