SAFILO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Safilo 5mg film-coated tablets EFG

Tadalafil

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 package leaflet:

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

1. What is Safilo and what is it used for

Tadalafil is used to treat adult men with erectile dysfunction. 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.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase 5 inhibitors.

Following 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 you do not have sexual stimulation.

2. What you need to know before you take Safilo

Do not take Safilo 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”). Tadalafil has been shown to increase the effects of these medicines.
• you have a severe heart or liver problem.
• you have recently had a stroke or heart attack within the last 90 days.
• 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 “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 shown an increase in the hypotensive effect of this medicine.

Warnings and precautions

Before taking tadalafil, tell your doctor if you have:

• sickle cell anemia (a disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the 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 total or partial removal of the prostate gland (prostatectomy), where the prostate nerves have been spared.

If you experience sudden loss of vision or your vision is distorted, stop taking tadalafil and contact your doctor immediately.

A sudden loss of hearing has been reported in some patients taking tadalafil. Although it is not known if this event is directly related to tadalafil, if you experience sudden 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.

Using Safilo with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use 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 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 (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 Safilo with food and drink

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.

Safilo contains lactose

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

3. How to take Safilo

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

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

Consuming large amounts of alcohol may temporarily reduce 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 this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet taken once a day, at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg, based on your response to tadalafil, which would be one 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil administered daily allows you to obtain an erection at any time during the 24 hours of the day, provided that you have sexual stimulation. Tadalafil administered daily may be useful for men who anticipate having sexual activity twice or more per week.

It is important to note that tadalafil is not effective if there is no sexual stimulation.

For the treatment of benign prostatic hyperplasia

The recommended dose is one 5 mg tablet taken once a day, at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.

Do not take tadalafil more than once a day.

If you take more Safilo than you should

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken. You may experience side 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 forgotten doses. Do not take tadalafil 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 attention immediately (uncommon).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you experience this erection that lasts for more than 4 hours, contact your doctor immediately.
• Sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side effects have been reported:

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

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

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

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the 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(seen in 1-10 in every 10,000 patients)

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden 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 been reported rarely in men taking tadalafil. Most of these men had pre-existing heart conditions.

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

Additional rare side effects have been reported in men taking tadalafil 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, some disorders affecting blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac arrest.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

The side 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 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Safilo

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 Safilo contains

• The active substanceis tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare:

Core of the tablet: lactose monohydrate (see the end of section 2), hypromellose (E-464), hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460), sodium lauryl sulfate (E-487), magnesium stearate (E-470b).

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

Appearance of the product and pack size

Safilo 5 mg is a film-coated tablet, yellow in color, 8.00 mm x 4.20 mm, oval, engraved on one side with the inscription «T5» and smooth on the other.

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

Not all 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 last revision of this leaflet: May/2020

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