TADALAFIL ALMUS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Almus 10 mg film-coated 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 Almus and what is it used for
2. What you need to know before you take Tadalafil Almus
3. How to take Tadalafil Almus
4. Possible side effects
5. Storage of Tadalafil Almus
6. Contents of the pack and other information

1. What is Tadalafil Almus 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 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 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. You and your partner will still 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 Almus

Do not take Tadalafil Almus if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• 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.

• you have a severe heart or liver problem.

• you have recently had a heart attack (within the last 90 days).

• you have had a stroke (including a ‘mini-stroke’ or transient ischaemic attack) within the last 6 months.

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• 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 due to 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.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on your 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 your 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 prostatectomy (removal of the prostate gland) or have been treated for prostate cancer.

If you experience sudden decrease or loss of vision or your vision is distorted, 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 these events are 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.

Other medicines and Tadalafil Almus

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 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 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 Almus 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 produce a lack of 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 Almus contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Tadalafil Almus contains sodium

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

3. How to take Tadalafil Almus

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended doseis one 10 mg tablet taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Almus tablets are for oral use.

When you take tadalafil, you may still be able to have sexual intercourse from at least 30 minutes up to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. Tadalafil 10 and 20 mg is intended for use 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. You and your partner will still need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking too much alcohol can reduce 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 drinking of alcohol (blood alcohol level of 0.08 % or greater), as it may increase the risk of dizziness when standing up.

If you take more Tadalafil Almus than you should

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

In case of overdose, contact your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the medicine pack with you.

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 taking 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 loss of vision (frequency not known).

Other side effects that have been reported include:

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 ache, feeling sick, being sick, 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 the hands, feet or ankles and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• fainting, seizures, temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, presence of blood in the semen and increased sweating.

Myocardial infarction and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems.

Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Additional rare side effects have been reportedin men taking tadalafil that were not seen in clinical trials. These include:

• migraine, swelling of the face, severe allergic reaction which causes 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 vision, blurred vision, or loss of vision (frequency not known).

In men over 75 years old treated with tadalafil, the most frequently reported adverse event was dizziness. In men over 65 years old treated with tadalafil, the most frequently reported adverse event was diarrhoea.

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 of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Almus

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

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. Contents of the pack and other information

What Tadalafil Almus contains

• The active substance is tadalafil.

Each tablet contains 10 mg of tadalafil.

• The other ingredients are:

Core of the tablet: lactose monohydrate (see section 2 “Tadalafil Almus contains lactose”), maize starch, pregelatinised maize starch, crospovidone, sodium lauryl sulfate (see also “Tadalafil Almus contains sodium” in section 2) and magnesium stearate.

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

Appearance and packaging

Tadalafil Almus 10 mg film-coated tablets EFG are oblong tablets, yellow in colour, 10.0 mm ± 0.2 mm in length and 5.5 mm ± 0.2 mm in width.

Tadalafil Almus 10 mg film-coated tablets EFG are available in blister packs containing 4 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

PT: Tadalafil Pentafarma Especialidades

ES: Tadalafilo Almus 10 mg film-coated tablets EFG

FR: Tadalafil Almus 10 mg, film-coated tablet

IT: Tadalafil Almus

Date of last revision of this leaflet:December 2023

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/