Tadalafil Almus 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tadalafil Almus 5 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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.

Package leaflet contents

1. What Tadalafil Almus is and what it is used for
2. What you need to know before taking 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 Tadalafilo Almus is and what it is used for

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

Tadalafilo Almus 5 mg is used in adult men for:

• Erectile dysfunction. This occurs when a man cannot 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.

Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow 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 in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges over time. Symptoms include difficulty starting urination, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before starting to take Tadalafil Almus

Do not take Tadalafil Almus if:

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

• you are taking any type of 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.

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

• you have recently had a stroke (within the last 6 months).

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

• you have ever experienced vision loss due to non-arteritic anterior ischemic 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 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

Consult your doctor before starting to take tadalafil.

Be aware that sexual activity poses 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.

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will examine you for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

• sickle cell anemia (an abnormality of the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any penile deformity.
• severe liver problems.
• severe kidney problems.

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

• surgery in the pelvic area.
• surgical procedures involving total or partial removal of the prostate with cutting of the prostate nerves (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or diminished while taking Tadalafil Almus, 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 event 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 and adolescents under 18 years of age.

Other medicines and Tadalafil Almus

Inform 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 may 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 treating 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 the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Almus with food and alcohol

Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of tadalafil and should be consumed with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects would cause infertility.

Driving and operating machinery

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Almus contains lactose

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

Tadalafil Almus contains sodium

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

3. How to take Tadalafil Almus

Follow exactly the instructions for use of this medicine given 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. The tablets can be taken with or without food.

Alcohol consumption 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.

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For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg, depending on your response to tadalafil. This will be achieved by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation occurs. Daily tadalafil may be beneficial for men who anticipate having sexual activity two or more times per week.

It is important to warn you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day.

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

You must not take tadalafil more than once a day.

If you take more Tadalafilo Almus than you should

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

If you forget to take Tadalafil Almus

Take your dose as soon as you remember. However, do not take a double dose to make up for the missed dose. You must not take tadalafil more than once a day.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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 may 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 medical help immediately:

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

Other adverse effects that have been reported:

Frequent (observed in 1 to 10 out of every 100 patients)

• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (observed in 1 to 10 out of every 1,000 patients)

• 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 hands, feet or ankles, and feeling tired.

Rare (observed in 1 to 10 out of every 10,000 patients)

• fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart conditions before taking this medicine.

Rare cases of decreased or lost vision, partial, transient or permanent, in one or both eyes have also 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 heartbeat, angina, and sudden cardiac death.
  • distorted vision, dimmed vision, 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these are possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Almus

Keep this medicine out of sight and reach of children.

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Almus

• The active substance is tadalafil.

Each tablet contains 5 mg of tadalafil.

• The other components are:

Tablet core: monohydrate lactose (see section 2 “Tadalafilo Almus contains lactose”), corn starch, pregelatinized corn starch, crospovidone, sodium lauryl sulfate (see also “Tadalafilo Almus contains sodium” in section 2), and magnesium stearate.

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

Appearance of the product and contents of the container

Tadalafilo Almus 5 mg film-coated tablets EFG are oblong, cream to light yellow tablets, 10.0 mm ± 0.2 mm in length and 5.5 mm ± 0.2 mm in width.

Tadalafilo Almus 5 mg is available in blister packs containing 28 or 84 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturing Responsible Party:

Atlantic Pharma – Produções Farmacêuticas SA

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710 – 228

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

EN: Tadalafil Pentafarma Especialidades

Instructions for Use

Active substance: Tadalafil

Presentation: Film-coated tablets of 20 mg.

Indications: Treatment of erectile dysfunction in adult men.

Dosage and administration:

• The recommended dose is 10 mg taken prior to anticipated sexual activity.
• The maximum recommended dosing frequency is once per day.
• In patients taking concomitant alpha-blockers, caution is advised due to potential hypotensive effects.
• No adjustment of dose is required in elderly patients (≥65 years).
• In patients with mild or moderate hepatic impairment, the starting dose should be 10 mg.
• Tadalafil is not recommended in patients with severe hepatic impairment.
• The effect of tadalafil may last up to 36 hours.

Contraindications:

• Hypersensitivity to the active substance or to any of the excipients.
• Concomitant use with nitric oxide donors, organic nitrates, or nitrites.
• Concomitant use with other PDE5 inhibitors.
• Severe cardiovascular disorders (unstable angina, severe heart failure, recent myocardial infarction or stroke).
• Severe hypotension (blood pressure <90/50 mmHg).
• Hereditary degenerative retinal disorders (e.g., retinitis pigmentosa).
• Non-arteritic anterior ischemic optic neuropathy (NAION) in one eye.

Special warnings and precautions for use:

• Sexual activity involves cardiac risk; therefore, treatment should not be used in men for whom sexual activity is inadvisable.
• In case of sudden vision loss, discontinue use and seek immediate medical attention.
• Priapism or prolonged erection (>4 hours) requires immediate medical intervention.
• Use with caution in patients with anatomical penile deformities or conditions predisposing to priapism.
• Caution is advised when administered with CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
• Avoid consumption of large amounts of alcohol, which may increase adverse effects such as dizziness, headache, and hypotension.

Adverse reactions: Common: headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, pharyngitis. Uncommon: dizziness, nausea, blurred vision. Rare: priapism, sudden hearing loss, NAION.

Overdose: Symptoms: severe hypotension, syncope, prolonged erection. Treatment: supportive and symptomatic; hemodialysis is not effective due to high protein binding.

Pharmacological properties: Tadalafil is a selective inhibitor of phosphodiesterase type 5 (PDE5), which increases cyclic guanosine monophosphate (cGMP) levels in the corpus cavernosum, promoting smooth muscle relaxation and blood flow, thus facilitating erection in response to sexual stimulation.

Storage conditions: Store below 30°C, in the original packaging, protected from moisture.

Manufacturer: Pentafarma Especialidades São Paulo, Brazil

Registration number: [Insert registration number]

Expiration date: [Month/Year]

Keep out of reach of children.

Do not use after expiration date.

**This medicine is subject to additional monitoring.** Help to identify new safety information: report any suspected adverse reactions. How to report adverse reactions: Contact the national pharmacovigilance system or your healthcare provider.

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For medical use only.

EN: Tadalafil Almus 5 mg film-coated tablets EFG

FR: Tadalafil Almus 5 mg, film-coated tablet

IT: Tadalafil Almus

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

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