Alneo 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Alneo 10 mg film-coated tablets EFG

Alneo 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, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Alneo is and what it is used for

Tadalafil 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. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

Alneo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing 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 warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Alneo

Do not take Alneo

• 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. 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 type of nitrate or are unsure, tell your doctor.
• if you have a 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 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 effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take Alneo.

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 deformity of the penis.
• severe liver problems.
• severe kidney problems.

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

• pelvic surgery.
• prostate surgery in which the prostate has been partially or totally removed and the nerves to the prostate have been severed (radical prostatectomy without nerve-sparing).

If you experience a 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 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

Tadalafil must not be used in children or 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 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 Alneo with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well tadalafil works and should be used 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. It is unlikely that these effects would lead to infertility.

Driving and using 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.

Alneo contains lactose

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

Alneo contains sodium

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

3. How to take Alneo

Follow exactly the administration instructions for this medicine as indicated 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. Tadalafil tablets may be taken with or without food.

The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil tablets are administered orally.

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

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

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

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 the same level of sexual 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 Alneo than you should

Contact your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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 will experience 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 vision loss (rare frequency), distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Frequent (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 pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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 transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin rashes), bleeding from the penis, blood in semen, and increased sweating.

Rare cases of myocardial infarction (heart attack) and stroke have also been reported 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, in one or both eyes have been reported.

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, and sudden cardiac death.
• distorted, dimmed, 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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alneo

Store below 30°C. Keep the container tightly closed to protect from moisture. Keep the container in the outer carton to protect from light. Keep out of the reach and sight of children. Do not use after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month. After first opening, the product remains stable for 6 months. After this period, discard any remaining product.

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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alneo

• The active substance is tadalafil.

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

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

• The other components are:

Tablet core: lactose monohydrate (see section 2, Alneo contains lactose), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

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

Appearance of the product and contents of the pack

Alneo 10 mg: Yellow, round, biconvex, film-coated tablets, with a score line on one side and smooth on the other, 8 mm in diameter. The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

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

Alneo 10 mg is available in blisters containing 4 tablets.

Alneo 20 mg is available in blisters containing 2, 4 or 8 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: August 2023

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