TADALAFIL QILU 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Qilu 20mg 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 pack and other information

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. Storage of Tadalafil Qilu
6. Contents of the pack and other information

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

Tadalafil Qilu 20 mg film-coated tablets are 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.

The active ingredient, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors. 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. Tadalafil Qilu will not help you if you do not have erectile dysfunction.

It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

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 to treat angina pectoris (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any of these medicines or are unsure, tell your doctor.
• if you have 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 a rare condition that affects the blood supply to the optic nerve.
• if you are taking riociguat. This medicine is used to treat high blood pressure in the lungs (pulmonary hypertension) and chronic thromboembolic pulmonary hypertension. PDE5 inhibitors, such as tadalafil, have been shown to increase the effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Qilu, consult your doctor.

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 condition, tell your doctor.

Before taking these tablets, tell your doctor if you:

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

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

• pelvic surgery.
• removal of the prostate gland (prostatectomy) or other surgeries that have affected the nerves that control erection.

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

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

Tadalafil Qilu is not intended for use by women.

Children and adolescents

Tadalafil Qilu is not intended for use by 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 increase the risk of side effects. Tell your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• 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 how this medicine works, so you should take it with caution. If you have any questions, ask your doctor.

Fertility

When treated with tadalafil, dogs have been reported to have reduced sperm development in the testes. In some men, a decrease in the number of sperm has been 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 20mg 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.

The use of Tadalafil 20 mg film-coated tablets is intended only for men. Swallow the tablet with a little water. These tablets can be taken with or without food.

The recommended dose isone 10 mg tablet before sexual activity. However, if you have been prescribed the 20 mg dose, it is because your doctor has decided that the recommended dose of 10 mg is too weak.

You can take Tadalafil 20 mg at least 30 minutes before sexual activity.

Tadalafil may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil 20 mg more than once a day. The use of Tadalafil 10 mg and 20 mg is intended before planned sexual activity and is not recommended for continuous daily use.

It is important to note that this medicine will not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking too much alcohol can reduce your ability to get an erection and 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 when standing up.

If you take more Tadalafil Qilu than you should

In case of overdose or accidental ingestion, contact 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 the side effects described in section 4.

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 experience this erection that lasts more than 4 hours continuously, 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 dizziness.
• vomiting (emesis).
• reflux.
• blurred vision, eye pain.
• difficulty breathing.
• blood in urine.
• prolonged erections.
• strong heartbeat.
• rapid heartbeat.
• high blood pressure.
• low blood pressure.
• nasal bleeding.
• 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 and temporary memory loss.
• swelling of the eyelids.
• red eyes.
• sudden decrease or loss of hearing.
• hives (red and itchy rash on the skin surface).
• penile bleeding.
• blood in semen and increased sweating.
• there have also been reports of rare cases of heart attack and stroke in men taking tadalafil. Most of these men had known heart problems before taking this medicine.
• 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, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rash, some disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris and sudden cardiac arrest.

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 to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 that month.

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 20 mg 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, dark yellow film-coated tablets, with the inscription «20» on one face and the other face is smooth.

Tadalafil Qilu 20 mg film-coated tablets are available in PCTFE/PVC/aluminum blisters.

Presentation: 1, 2, 4, 5, 7, 8, 12, 14, 15, 28, 30 and 56 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/