Qizerz 20 mg film-coated tablets EFG

Package leaflet: Information for the user

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 as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Qizerz is and what it is used for

Qizerz contains the active substance tadalafil.

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

It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors, which work by helping to relax the blood vessels around the lungs, thereby improving blood flow in the lungs. This results in improved ability to exercise.

2. What you need to know before taking Qizerz

Do not take Qizerz if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• you are taking any type of nitrates such as amyl nitrite, which are administered to relieve "chest pain". Qizerz can cause an increase in the effects of these medicines. If you are taking any type of nitrate or are unsure, consult your doctor,
• you have previously experienced loss of vision, a condition described as "eye stroke" (non-arteritic anterior ischemic optic neuropathy, NAION),
• you have had a heart attack within 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Qizerz.

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

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

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking Qizerz, stop taking Qizerz immediately and contact your doctor without delay.

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this reaction is directly related to tadalafil, if you experience 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, as 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 need to 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 how tadalafil works. Inform your doctor or pharmacist if you are taking:

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

Taking Qizerz with alcohol

Drinking 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 this 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 are planning to become pregnant, consult your doctor before using this medicine. Do not take tadalafil during pregnancy unless strictly necessary and only after discussing it with your doctor.

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

In treated dogs, a decrease in sperm production by the testes was observed. In some men, a reduction in sperm has been observed. These effects are unlikely to result in infertility.

Driving and use of machines

Dizziness has been reported. Carefully assess how you react to the medicine before driving or operating machinery.

Qizerz contains lactose and sodium

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

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

3. How to take Qizerz

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Qizerz is available as 20 mg tablets. Swallow the tablets whole with a glass of water. The tablets may be taken with or without food.

Pulmonary arterial hypertension in adults

The usual dose is two tablets of 20 mg taken once daily. You should take both 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 daily.

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

The recommended dose is two tablets of 20 mg taken once daily. You should take both 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 daily.

Pulmonary arterial hypertension in children (from 2 years of age) weighing less than 40 kg
The recommended dose is one 20 mg tablet taken once daily. If you have mild to moderate liver or kidney problems, your doctor may advise you to take 10 mg once daily.

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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken. You may experience any of the adverse effects described in section 4.

If you forget to take Qizerz

Take your dose as soon as you remember, provided it is within 8 hours of the time you were supposed to take it. Do not take a double dose to make up for forgotten doses.

If you stop taking Qizerz

Do not stop taking your tablets unless advised by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These adverse effects are generally of mild to moderate intensity.

If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:

• allergic reactions, including skin rashes (common, may affect up to 1 in 10 people),
• chest pain; do not use nitrates but seek immediate medical help (common, 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 lasting continuously for more than 4 hours, you must contact a doctor immediately,
• sudden vision loss (rare, may affect up to 1 in 1,000 people), distorted vision, dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

The following adverse effects have been reported very commonly 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 pain in the limbs (including limb discomfort).

Other adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• seizures, transient memory loss, hives, excessive sweating, penile bleeding, blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death, and tinnitus (ringing in the ears).

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

• decreased or partial, temporary or permanent vision loss in one or both eyes, and severe allergic reaction causing facial or throat swelling.

In addition, cases of sudden decrease or loss of hearing have been reported.

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

• eyelid swelling, eye pain, red eyes, heart attack, and stroke.

Some additional rare adverse effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

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

Most men who reported cases of rapid pulse, irregular heartbeat, heart attack, stroke, and sudden cardiac death had pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly related to tadalafil.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Qizerz

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. 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 components are monohydrate lactose, sodium lauryl sulfate, povidone K-12, crospovidone (type B), stearic fumarate and sodium in the core; polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc, yellow iron oxide (E172) in the coating.

Appearance of the product and contents of the pack

Film-coated tablet, oval-shaped, ochre to yellow in colour, approximately 15 x 9 mm. Marked with "20" on one side. The other side of the tablet has two score lines. The tablet can be divided into equal halves and/or quarters.

Film-coated tablets are packed in aluminium OPA/aluminium/PVC blisters, PVC/ACLAR/PVC/aluminium blisters, PVC/ACLAR/PVdC/PVC/aluminium blisters or PVC/PVdC-aluminium blisters, and placed in cardboard boxes.

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

Only some pack sizes may be commercially available.

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 medicinal product 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 the latest revision of the package leaflet: June 2024.

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