QIZERZ 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Qizerz 20 mg 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 Pack

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

1. What is Qizerz and what is it used for

Qizerz contains the active substance tadalafil.

Qizerz is indicated for the treatment of pulmonary arterial hypertension in adults and in children from 2 years of age.

It belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5) that work by helping to relax the blood vessels around your lungs, improving blood flow in the lungs. The result is an improved ability to perform physical activity.

2. What you need to know before you take Qizerz

Do not take Qizerz if:

• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• you are taking any form of nitrates, such as amyl nitrite, which are used to relieve chest pain. Qizerz can increase the effects of these medicines. If you are taking any form of nitrate or are unsure, consult your doctor,
• you have previously experienced loss of vision, a condition described as "eye infarction" (non-arteritic anterior ischemic optic neuropathy, NAION),
• you have had a heart attack in the last 3 months,
• you have low blood pressure,
• 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 that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Qizerz.

Before taking the tablets, inform your doctor if you have:

• any heart problems other than pulmonary hypertension,
• blood pressure problems,
• any inherited eye disease,
• a red blood cell disorder (sickle cell anemia),
• bone marrow cancer (multiple myeloma),
• blood cell cancer (leukemia),
• any penile deformity, or unexpected and unwanted erections lasting more than 4 hours,
• a severe liver problem,
• a severe kidney problem.

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred while taking Qizerz, stop taking Qizerz and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if this reaction is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Children and adolescents

Tadalafil is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.

Other medicines and Qizerz

Tell your doctor if you are taking, have recently taken, or might take any other medicines. DO NOT take these tablets if you are being treated with nitrates.

Some medicines may be affected by tadalafil or may affect the proper functioning of tadalafil. Tell your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension),
• nitrates (for chest pain),
• alpha-blockers for high blood pressure or prostate problems,
• riociguat,
• rifampicin (for bacterial infections),
• ketoconazole tablets (for fungal infections),
• ritonavir (for HIV treatment),
• tablets for the treatment of erectile dysfunction (PDE5 inhibitors).

Taking Qizerz with alcohol

Consuming alcohol can temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (more than 5 units of alcohol), as it may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not take tadalafil during pregnancy, unless it is strictly necessary and you have discussed it with your doctor.

Do not breastfeed while taking these tablets, as it is not known if the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

There have been reports of dizziness. Check carefully how you react to the medicines before driving or using machines.

Qizerz contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Qizerz

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Qizerz is available in the form of 20 mg film-coated tablets. Swallow the tablets whole with a glass of water. The tablets can be taken with or without food.

Pulmonary arterial hypertension in adults

The usual doseis two 20 mg tablets taken once a day. You should take the two tablets at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (from 2 years of age) who weigh at least 40 kg

The recommended dose is two 20 mg tablets taken once a day. You should take the two tablets at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (from 2 years of age) who weigh less than 40 kg

The recommended dose is one 20 mg tablet taken once a day. If you have mild to moderate liver or kidney problems, your doctor may advise you to take 10 mg once a day.

Other pharmaceutical forms of this medicine may be more suitable for children; consult your doctor or pharmacist.

If you take more Qizerz than you should

If you have taken more tablets than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. You may experience any of the side effects described in section 4.

If you forget to take Qizerz

Take your doses as soon as you remember if it is within 8 hours of the time you should have taken your dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Qizerz

Do not stop taking your tablets unless your doctor has advised you to do so.

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 side effects are generally 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 (frequent, may affect up to 1 in 10 people),
• chest pain, do not use nitrates but seek medical help immediately (frequent, may affect up to 1 in 10 people),
• priapism, a prolonged and possibly painful erection after taking tadalafil (uncommon, may affect up to 1 in 100 people). If you experience this type of erection, with a continuous duration of more than 4 hours, you should contact a doctor immediately,
• sudden loss of vision (rare, may affect up to 1 in 1,000 people), distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known)

The following side effects have been reported very frequently in patients taking tadalafil (may affect more than 1 in 10 people):

• headache, flushing, nasal congestion (stuffy nose), nausea, indigestion (including abdominal pain and discomfort), muscle aches, back pain, and limb pain (including limb discomfort).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeats, and fainting.

Uncommon(may affect up to 1 in 100 people)

• seizures, transient memory loss, hives, excessive sweating, bleeding from the penis, presence of blood in the semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death, and ringing in the ears.

PDE5 inhibitorsare also used for the treatment of erectile dysfunction in men. The following side effects have been rarely reported:

• decrease or loss of vision of one or both eyes, and severe allergic reaction that causes swelling of the face or throat.

There have also been reports of sudden decrease or loss of hearing.

Some side effects have been reported in men who were taking tadalafil for the treatment of erectile dysfunction. These side effects have not been seen during clinical trials for pulmonary arterial hypertension, and therefore are of unknown frequency:

• swelling of the eyelids, eye pain, red eyes, heart attack, and stroke.

Some additional rare side effectshave been reported in men taking tadalafil that were not reported during clinical trials. These include:

• distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Most men who reported cases of rapid heartbeat, irregular heartbeats, heart attack, stroke, and sudden cardiac death had some heart problems before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

Reporting of side effects

If you experience 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Qizerz

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 packaging and on the blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Qizerz

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are lactose monohydrate, sodium lauryl sulfate, povidone K-12, crospovidone (type B), stearic acid fumarate, and sodium in the core; polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc, yellow iron oxide (E172) in the coating.

Appearance and packaging

Film-coated tablet, oval, yellow to ochre, approximately 15 x 9 mm. One side marked with "20". The other side of the tablet with two notches. The tablet can be divided into two or four equal parts.

The film-coated tablets are packaged in aluminum OPA/aluminum/PVC blisters, PVC/ACLAR/PVC/aluminum blisters, or PVC/ACLAR/PVdC/PVC/aluminum blisters and inserted into a cardboard box.

Package sizes: 4x1, 8x1, 12x1, 14x1, 24x1, 28x1, 36x1, 56x1, and 112x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

or

TEVA Pharma, S.L.U.

Polígono Industrial

Malpica, C/C, nº4

50016, Zaragoza

Spain

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

Germany: Tadal - 1 A Pharma PAH 20 mg Filmtabletten

Netherlands: QIZERZ 20 mg, filmomhulde tabletten

Date of last revision of this leaflet:June 2024.

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