Safilo 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Safilo 5mg film-coated tablets EFG

Tadalafil

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

1. What Safilo is and what it is used for

Tadalafil is used to treat adult men with erectile dysfunction. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfying sexual activity. Tadalafil has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping to relax the blood vessels in your 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 should engage in stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Safilo

Do not take Safilo 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 nitrate 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 nitrates or are unsure, inform 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

Talk to your doctor before starting to take tadalafil.

Be aware that sexual activity involves a possible 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:

• pelvic surgery.
• total or partial prostate resection with nerve-sparing prostatectomy (radical prostatectomy without nerve preservation).

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 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 or adolescents under 18 years of age.

Use of Safilo with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 using:

• An alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• Other medicines to treat high blood pressure.
• Riociguat.
• A 5-α-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 Safilo with food and alcohol

Information about 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

A decrease in sperm production by the testes was observed in treated dogs. Some men have shown reduced sperm count. These effects are unlikely to result in 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.

Safilo contains lactose.

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

3. How to take Safilo

Follow exactly the instructions for using 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 with some water. Tablets may 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 (a blood alcohol concentration of 0.08% or higher), as it may increase the risk of dizziness upon standing.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg depending on your response to tadalafil, in which case you will take a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Daily administration of tadalafil allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation is present. Daily tadalafil may be beneficial for men who expect to have sexual activity two or more times per week.

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 achieve an erection.

For the treatment of benign prostatic hyperplasia

The recommended 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.

Do not take tadalafil more than once a day.

If you take more Safilo than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested. You may experience adverse effects described in section 4.

If you forget to take Safilo

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

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 immediate medical help:

• Allergic reactions, including rashes (uncommon).
• Chest pain: do not use nitrates, but seek immediate medical attention (uncommon).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience an erection lasting more than 4 continuous hours, you must contact a doctor immediately.
• Sudden vision loss (rare frequency), distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects have been reported:

Common (observed in 1–10 out of every 100 patients)

• Headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

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

• Dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the 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 (observed in 1–10 out of every 10,000 patients)

• Fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden partial or complete hearing loss, hives (red, itchy welts on the skin), penile bleeding, blood in the 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 problems before taking this medicine.

Rare cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.

Additional rare adverse effects not reported during clinical trials have been observed in men taking tadalafil. 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 arrest.
• Distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

The adverse effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Safilo Storage

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Safilo

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

Tablet core: monohydrate lactose (see end of section 2), low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460), sodium lauryl sulfate (E-487), magnesium stearate (E-470b).

Coating: monohydrate lactose, hypromellose (E-464), triacetin (E-1518), titanium dioxide (E-171), yellow iron oxide (E-172), talc (E-553b).

Appearance of the product and pack contents

Safilo 5 mg is a film-coated tablet, yellow in colour, 8.00 mm × 4.20 mm, oval-shaped, engraved on one side with the code "T5" and smooth on the other.

Safilo 5 mg is available in blisters containing 4, 14, 28, 30, 84 and 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS Q PHARMA S.L.
C/Moratín, nº 15, Emtlo. Oficinas 6-7
03008 Alicante
Spain

Manufacturer:

Misom Labs Limited, Malta
Malta Life Science Park
LS2.01.06, Industrial Estate, San Gwann
SGN 3000, Malta

Date of the most recent revision of this leaflet: May/2020

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/.