TADALAFIL QILU 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Qilu 10mg 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. 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 10 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 significantly improve the ability to get an erection sufficient for satisfactory sexual activity.

The active substance, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil helps to relax the blood vessels in the penis, allowing blood to flow into the penis. The result is an improved erectile function. Tadalafil will not help 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 in the treatment of 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 due to a non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

Consult your doctor before taking Tadalafil Qilu.

You should be aware that sexual activity carries a possible risk to 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 disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukaemia (cancer of the blood cells).
• any deformation of the penis.
• 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) in which the nerve endings of the prostate were cut (radical prostatectomy without nerve sparing).

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

In some patients taking tadalafil, cases of sudden decrease or loss of hearing have been reported. 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.

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.

Use of 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 may be affected by tadalafil. 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.

Use of Tadalafil Qilu with drinks and alcohol

Information about the effect of alcohol is described 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, a reduction in sperm development was seen in dogs. In some men, a reduction 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. Make sure you know how you react to these tablets before driving or using machines.

Tadalafil Qilu 10mg 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

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 10 mg film-coated tablets is indicated in adult men only. Swallow the tablet with a little water. These tablets can be taken with or without food.

The recommended dose isone 10 mg tablet taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil tablets are for oral use.

You may take Tadalafil 10 mg at least 30 minutes before sexual activity.

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

Do not take more than one dose of tadalafil per day. The use of Tadalafil 10 mg and 20 mg is not recommended for continuous daily use.

It is important to note that this medicine 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.

Consuming large amounts of alcohol may decrease your ability to get an erection and may also 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 this 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).
• priapism, 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 dizziness.
• vomiting (emesis).
• reflux.
• blurred vision.
• eye pain.
• difficulty breathing.
• penile haemorrhage.
• presence of blood in urine.
• prolonged erections.
• feeling of strong heartbeat.
• rapid heartbeat.
• high blood pressure.
• low blood pressure.
• nasal haemorrhage.
• ringing in the ears.
• swelling of hands, feet or ankles and feeling of tiredness.

Rare(may affect up to 1 in 1,000 people)

• fainting.
• seizures and transient memory loss.
• swelling of the eyelids.
• red eyes.
• sudden decrease or loss of hearing.
• hives (red and itchy rash on the skin surface).
• penile haemorrhage.
• presence of blood in semen and increased sweating.
• cases of heart attack and stroke have also been reported 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, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rash, some disorders affecting 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. Diarrhoea 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 Pharmacovigilance System for Human Use Medicines: 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 is the last day of the month stated.

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 10 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, yellow film-coated tablets, with the inscription "10" on one face and the other face is smooth.

Tadalafil Qilu 10 mg film-coated tablets are available in PCTFE/PVC/aluminium blisters.

Presentation: 1, 4, 5, 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/