Tadalafil Tarbis Farma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Tarbis Farma 10 mg film-coated tablets EFG

Read the entire 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 other people, 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 Tadalafilo Tarbis Farma is and what it is used for
2. What you need to know before taking Tadalafilo Tarbis Farma
3. How to take Tadalafilo Tarbis Farma
4. Possible adverse effects
5. How to store Tadalafilo Tarbis Farma
6. Contents of the pack and other information

1. What Tadalafilo Tarbis Farma is and what it is used for

Tadalafilo 10 mg is used for the treatment of adult men with erectile dysfunction. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Tadalafilo Tarbis Farma contains the active substance tadalafil, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors. During sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into the penile tissue. The result is improved erectile function. Tadalafilo 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 should 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 Tadalafilo Tarbis Farma

Do not take Tadalafilo Tarbis Farma 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 group of medicines (“nitrates”) is 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 condition 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

Talk to your doctor before starting to take this medicine.

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.
• a severe liver problem.
• a severe kidney problem.

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

• surgery in the pelvic area.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, stop taking this medicine 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 this medicine 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.

Other medicines and Tadalafilo Tarbis Farma

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 be affected by 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 Tadalafilo Tarbis Farma 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 taken with caution. Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testes was observed. In some men, a reduction in sperm has been observed. It is unlikely that these effects would lead to infertility.

Driving and use of 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.

Tadalafilo Tarbis Farma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Tadalafilo Tarbis Farma contains sodium

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

3. How to take Tadalafil Tarbis Farma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The tablets of this medicine are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.

The recommended starting dose is 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 tablets of this medicine are taken orally.

When you take tadalafil, you may begin sexual activity at least 30 minutes after taking it.

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

You must not take tadalafil more than once a day. Tadalafil Tarbis Farma 10 and 20 mg are intended to be used before 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 kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection. 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.

If you take more Tadalafil Tarbis Farma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. 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 loss of vision (rare frequency), distorted central vision, dim, blurred 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 hands, feet or ankles, and feeling tired.

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

• 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 existing heart problems before taking this medicine.

Rarely, cases of decreased or lost vision, partial, temporary 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 heartbeat, angina, and sudden cardiac death.
• distorted, dim, 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 diarrhoea.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Tarbis Farma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, 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 Tarbis Farma

The active substance is tadalafil.

Each film-coated tablet contains 10 mg of tadalafil.

The other components are:

Tablet core: monohydrate lactose, copovidone, anhydrous colloidal silica, macrogol glycerol hydroxystearate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b).

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, elongated in shape, white in colour, marked with "T16" on one side and "H" on the other.

Blister packs containing 4, 8, 12, 20, 24, 28, 30 and 50 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Tadalafil Amarox 10 mg Filmtabletten

The Netherlands: Tadalafil Amarox 10 mg filmomhulde tabletten

Spain: Tadalafilo Tarbis Farma 10 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: March 2024

Other sources of information

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