TADALAFIL ARISTO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aristo 5 mg Film-Coated Tablets EFG

Read the entire 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Tadalafil Aristo and what is it used for

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

Tadalafil Aristo is used for the treatment of adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Aristo has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

After sexual stimulation, Tadalafil Aristo works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is an improved erection.

Tadalafil Aristo will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Aristo 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.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a feeling that your bladder is not completely empty, needing to urinate more often, or more often during the night. Tadalafil Aristo improves blood flow and relaxes the muscles in the prostate and the bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil Aristo has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before you take Tadalafil Aristo

Do not take Tadalafil Aristo 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 to treat angina pectoris (“chest pain”). It has been shown that Tadalafil Aristo increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor;

• you have a severe heart or liver problem;

• you 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 had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;

• 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 5 inhibitors, such as Tadalafil Aristo, have shown that they 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 taking Tadalafil Aristo.

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.

As benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before you start taking Tadalafil Aristo for benign prostatic hyperplasia. Tadalafil Aristo does not treat prostate cancer.

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 Aristo is effective in patients who have:

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

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

A decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil Aristo and contact your doctor immediately.

Tadalafil Aristo is not intended for use by women.

Children and adolescents

Tadalafil Aristo should not be used in children and adolescents under 18 years.

Using Tadalafil Aristo 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 Aristo if you are already taking nitrates.

Some medicines may be affected by Tadalafil Aristo or may affect how well Tadalafil Aristo works. Tell your doctor or pharmacist if you are using:

• 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 Aristo with food and drink

Information about the effect of alcohol is in section 3 “How to take Tadalafil Aristo”. Grapefruit juice may affect how Tadalafil Aristo 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. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking Tadalafil Aristo during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Aristo contains lactose

Each film-coated tablet contains 63 mg of lactose (as monohydrate).

If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Tadalafil Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially sodium-free.

3. How to take Tadalafil Aristo

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

The tablet can be split into equal doses.

Consuming large amounts of alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Aristo, avoid excessive alcohol consumption (blood alcohol level of 0.08 % or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Aristo. This will be done by taking half of a 5 mg tablet.

Do not take Tadalafil Aristo more than once a day.

Tadalafil Aristo taken daily will allow you to get an erection at any time during the 24 hours of the day, provided that you are sexually stimulated. Tadalafil Aristo taken daily may be useful in men who anticipate having sexual activity twice or more per week.

It is important to note that Tadalafil Aristo 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.

For the treatment of benign prostatic hyperplasia

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

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

Do not take Tadalafil Aristo more than once a day.

If you take more Tadalafil Aristo than you should

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

If you forget to take Tadalafil Aristo

Take your dose as soon as you remember, but do not take a double dose to make up for a forgotten dose. Do not take Tadalafil Aristo more than once a day.

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 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);
• prolonged and possibly painful erections after taking Tadalafil Aristo (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 decreased vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or 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 also been reported rarely in men taking Tadalafil Aristo. Most of these men had pre-existing heart problems.

Decreased or loss of vision, partial, temporary, or permanent, in one or both eyes has been rarely reported.

Some additional rare side effects have been reportedin men taking Tadalafil Aristo that were not seen in clinical trials, including:

• 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 decreased 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 package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System 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 Aristo

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

Composition of Tadalafil Aristo 5 mg

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:

Tablet core: