TADALAFIL QILU 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Qilu 5mg Film-Coated Tablets EFG

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

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

Tadalafil Qilu 5mg film-coated tablets contain the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil is used to treat adult men with:

• Erectile dysfunction. This is a condition where a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity. Tadalafil has been shown to improve the ability to get an erection in response to sexual stimulation.

After sexual stimulation, tadalafil works by helping the blood vessels in the penis to relax and allow blood to flow into the penis. The result is improved erectile function. This medicine will not help you if you do not have erectile dysfunction. It is important to note that this medicine does not work if there is no sexual stimulation.

• Symptoms of benign prostatic hyperplasia, such as difficulty starting to urinate, a feeling of not completely emptying the bladder, and more frequent need to urinate, even at night. Tadalafil improves blood flow and relaxes the muscles in the prostate and bladder, which helps to improve these symptoms. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

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

Do not take Tadalafil Qilu:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This group of medicines is used in the treatment of angina pectoris (chest pain). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• • if you have ever had loss of vision because of a condition called non-arteritic anterior ischemic optic neuropathy (NAION), which is described as "stroke of the optic nerve".
• if 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 after a blood clot). Phosphodiesterase type 5 inhibitors, such as tadalafil, have been shown to increase the effects of this medicine.

Warnings and precautions

Consult your doctor before taking Tadalafil Qilu.

You should be aware that sexual activity carries a risk for patients with heart disease because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

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

Before taking these tablets, tell your doctor if you have:

• sickle cell anaemia (a condition that affects red blood cells)
• multiple myeloma (cancer of the bone marrow)
• leukaemia (cancer of the blood cells)
• any deformation of the penis
• severe liver problems
• severe kidney problems

It is not known if tadalafil is effective in patients who have:

• pelvic surgery
• total or partial removal of the prostate, in which the nerves of the prostate have been removed (radical prostatectomy without nerve sparing)

If you experience sudden loss of vision, stop taking this medicine and contact your doctor immediately.

In some patients taking tadalafil, cases of sudden loss of hearing have been reported. Although it is not known if these events are directly related to tadalafil, if you experience sudden loss of hearing, stop taking this medicine and contact your doctor immediately.

The use of tadalafil is not indicated in women.

Children and adolescents

The use of tadalafil is not indicated in children and adolescents under 18 years of age.

Using Tadalafil Qilu 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 Qilu if you are already taking nitrates.

Some medicines may affect the way tadalafil works or tadalafil may affect the way they work. Tell your doctor or pharmacist if you are already taking:

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia)
• other medicines used to treat high blood pressure
• riociguat, a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole (for 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

Using Tadalafil Qilu with food and drink

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the way this medicine works, so you should take it with caution. If you need more information, ask your doctor.

Fertility

When treated with tadalafil, reduced development of sperm was seen in some animals. In some men, a decrease in the number of sperm was observed. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking this medicine have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Qilu 5mg film-coated tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Tadalafil Qilu

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

Tadalafil 5mg film-coated tablets are for use in adult men only.

Swallow the tablet with a little water. You can take the tablets with or without food.

Consuming large amounts of alcohol may reduce your ability to get an erection. Drinking too much alcohol can also increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

For the treatment of erectile dysfunction

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

Do not take more than one 5mg tablet per day.

Taking 5mg of tadalafil once a day will enable you to achieve an erection, whenever you are sexually stimulated, at any time of the day. Once-a-day dosing of this medicine may be useful for men who anticipate having sexual activity twice or more per week.

It is important to note that this medicine does not work if there is no sexual stimulation.

For the treatment of benign prostatic hyperplasia

The recommended dose is one 5mg 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 5mg tablet per day.

Do not take more than one 5mg tablet of tadalafil per day.

If you take more Tadalafil Qilu than you should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately. You may experience the side effects described in section 4.

If you forget to take Tadalafil Qilu

Take your dose as soon as you remember, but do not take a double dose to make up for a forgotten dose. You should not take more than one 5mg tablet per 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 usually mild to moderate.

If you experience any of the following side effects, stop taking this medicine and seek medical attention immediately:

• allergic reactions, including skin rash (frequency not known)
• chest pain: do not use nitrates, but seek medical attention immediately (frequency not known)
• prolonged and possibly painful erections after taking tadalafil (rare). If you have an erection that lasts more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare)

Other side effects:

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• dizziness
• stomach pain
• feeling of faintness
• 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 the hands, feet or ankles and feeling tired

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

• fainting
• seizures and temporary memory loss
• swelling of the eyelids
• red eyes
• sudden loss of hearing
• rash (including red and itchy rashes on the skin)
• penile bleeding
• presence of blood in the semen and increased sweating
• there have also been reported cases of heart attack and stroke in men taking tadalafil. Most of these men had pre-existing heart conditions.
• partial, temporary, or permanent decrease or loss of vision in one or both eyes

In some men taking tadalafil, the following rare side effects have been reported, which were not observed in clinical trials:

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, some disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death

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

5. Storing Tadalafil Qilu

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of the month shown.

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 Tadalafil Qilu contains

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

Core of the tablet: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose (E-460), hypromellose-L, laurilsulfate sodium, magnesium stearate (E-572)

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

Appearance and packaging

Round, biconvex, light yellow film-coated tablets, with "5" engraved on one face and the other face plain.

Tadalafil Qilu 5mg film-coated tablets are available in PCTFE/PVC/aluminium blisters.

Pack sizes: 1, 7, 14, 15, 28, and 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40, 8th floor, 28046 - Madrid, Spain

Manufacturer

KYMOS PHARMA SERVICES, S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès), Cerdanyola del Vallès, 08290 - Barcelona, Spain

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22, 28108 - Alcobendas, Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: December 2018

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/