Patient Information Leaflet

Qizerz 20 mg Film-Coated Tablets EFG

tadalafil

Read this leaflet carefully before you start taking this medicine, as 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. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.

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

1. What Qizerz is and what it is used for

2. What you need to know before you start taking Qizerz

3. How to take Qizerz

4. Possible side effects

5. Storage of Qizerz

6. Contents of the pack and additional information

Qizerz contains the active ingredient tadalafilo.

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

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

Do not take Qizerz if:

• you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• you are taking any type of nitrates such as amyl nitrite, which are administered to relieve "chest pain". Qizerz may increase the effects of these medications. If you are taking any type of nitrates or are unsure, consult your doctor,
• you have previously experienced vision loss, a condition described as "eye stroke" (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 medication 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 clots). PDE5 inhibitors, such as tadalafil, have shown to increase the hypotensive effect of this medication. 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 problem other than pulmonary hypertension,
• problems with your blood pressure,
• any hereditary eye disease,
• an abnormality of red blood cells (sickle cell anemia),
• multiple myeloma (bone marrow cancer),
• leukemia (blood cell cancer),
• any deformity of your penis, or unexpected and unwanted erections that last more than 4 hours,
• severe liver disease,
• severe kidney disease.

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

Decreased or sudden 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 decreased or sudden loss of hearing, stop taking tadalafil and immediately contact your doctor.

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 medications and Qizerz

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.Do not take these tablets if you are being treated with nitrates.

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

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

Qizerz and alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (above 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, or think you may be pregnant, consult your doctor before using this medication. Do not take tadalafil during pregnancy unless it is strictly necessary and you have discussed this with your doctor.

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

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Dizziness has been reported. Check carefully how you react to the medication before driving or operating machinery.

Qizerz contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

Qizerz is available in the form of 20 mg 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 any mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet a day.

Pulmonary arterial hypertension in children (2 years of age or older) weighing 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 any mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet a day.

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

Other pharmaceutical forms of this medication 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 medication and the amount used.You may experience any of the adverse 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 when you should have taken your dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Qizerz

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

-allergic reactions, including skin rashes (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),

-prolonged and possibly painful erection after taking tadalafil (rare, 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 must contact a doctor immediately,

-sudden loss of vision (rare, may affect up to 1 in 1,000 people), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency)

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 pain, 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, nasal bleeding, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeat and fainting.

Rare(may affect up to 1 in 100 people)

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

Phosphodiesterase type 5 inhibitors are also used to treat erectile dysfunction in men. Rarely reported side effects include:

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

There have also been cases of sudden hearing loss.

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

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

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

• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging and in the blisterafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Qizerz

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are lactose monohydrate, sodium lauryl sulfate, povidone K-12, crospovidone (type B), stearate 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 packaging

Coated tablet, oval in shape, yellow to yellow-brown in color, approximately 15 x 9 mm. One side marked with “20”. The other side of the tablet has two grooves. The tablet can be divided into halves and/or quarters.

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 with the following names:

Germany: Tadal - 1 A Pharma PAH 20 mg Filmtabletten

Netherlands: QIZERZ 20 mg, filmomhulde tabletten

Last review date of this leaflet: June 2024.

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