Quator

Leaflet accompanying the packaging: patient information

Quator, 2.5 mg, film-coated tablets

Quator, 5 mg, film-coated tablets

Quator, 10 mg, film-coated tablets

Quator, 20 mg, film-coated tablets

Tadalafil
For medicinal products dispensed on a doctor's prescription:

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

For medicinal products available without a prescription:You should carefully read the contents of this leaflet
before taking the medicine, as it contains important information for the patient.
The medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Quator and what is it used for
• 2. Important information before taking Quator
• 3. How to take Quator
• 4. Possible side effects
• 5. How to store Quator
• 6. Contents of the packaging and other information

1. What is Quator and what is it used for

Quator contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Quator 2.5 mg, 5 mg, 10 mg, and 20 mgis a medicine used to treat adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that Quator significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
After sexual stimulation, Quator helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection of the penis is improved. Quator does not help patients who do not have erectile dysfunction.
It is important to note that Quator does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.
Quator 5 mgis used to treat adult men with symptoms of benign prostatic hyperplasia (enlargement of the prostate gland).
This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, a feeling of not emptying the bladder, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the prostate and bladder muscles, which can help alleviate the symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms after 1-2 weeks of treatment.
Quator 20 mgis used to treat pulmonary arterial hypertensionin adults. It causes the blood vessels in the lungs to widen and improves blood flow in the lungs. As a result, the body's ability to perform physical activity is improved.

2. Important information before taking Quator

When not to take Quator

• if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking organic nitrates or other donors of nitric oxide, such as amyl nitrite. Nitrates are a group of medicines used to treat angina pectoris (chest pain). It has been shown that tadalafil enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
• if the patient has severe heart disease or has had a heart attack in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke"
• if the patient is taking riociguat. This is a medicine used to treat pulmonary 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Quator, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting treatment with Quator, the patient should discuss it with their doctor.
Treatment of erectile dysfunction: it should be remembered that sexual activity is associated with a certain risk in patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Treatment of benign prostatic hyperplasia: benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform an examination to rule out prostate cancer before starting treatment with Quator for symptoms of benign prostatic hyperplasia. Quator is not used to treat prostate cancer.
Before taking the tablets, the patient should inform their doctor if they have any of the following:

• sickle cell anemia (abnormal shape of red blood cells),
• multiple myeloma (a type of bone marrow cancer),
• leukemia (a type of blood cell cancer),
• any deformation of the penis or unwanted and prolonged erections lasting more than 4 hours,
• severe liver disease,
• severe kidney disease,
• any inherited eye diseases,
• heart disease other than pulmonary hypertension,
• abnormal blood pressure.

It is not known whether Quator is effective in patients:

• who have had surgical procedures in the pelvic area,
• who have had a complete or partial removal of the prostate gland, during which the nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If sudden vision loss or sudden blindness occurs, the patient should stop taking Quator and immediately contact their doctor.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss occurs, the patient should stop taking Quator and immediately contact their doctor.

Quator should not be used to treat erectile dysfunction or benign prostatic hyperplasia in women, as these are conditions that only occur in men.

Children and adolescents

Quator is not intended for use in children and adolescents under 18 years of age.

Quator and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those they plan to take.
Do nottake Quator if the patient is taking nitrates.
Quator may affect the action of some medicines or other medicines may affect the action of Quator. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia),
• other medicines used to treat high blood pressure,
• nitrates (taken for chest pain)
• riociguat,
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia),
• protease inhibitors used to treat AIDS or HIV infection (ritonavir),
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines),
• rifampicin, erythromycin, or clarithromycin (antibiotics),
• medicines such as ketoconazole or itraconazole (used to treat fungal infections),
• bosentan (another medicine used to treat pulmonary arterial hypertension),
• other treatments for erectile dysfunction (phosphodiesterase type 5 inhibitors).

Taking Quator with food and alcohol

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Quator, so caution should be exercised when consuming it. For more information, the patient should consult their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Quator should not be taken during pregnancy, unless it is absolutely necessary and has been agreed with the treating doctor.
Quator should not be taken during breastfeeding, as it is not known whether the medicine passes into breast milk. Before taking any medicine during pregnancy or breastfeeding, the patient should consult their doctor or pharmacist.
In animal studies, a decrease in sperm production in the testes was observed. A decrease in sperm concentration has been observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Dizziness has been reported. The patient should be aware of their reaction to the medicine before driving or operating machinery.

Quator contains lactose and sodium

If the doctor has previously determined that the patient has an intolerance to some sugars, they should contact their doctor before starting treatment with Quator.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Quator

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The tablets should be swallowed whole with a small amount of water. Quator 20 mg tablets can be divided into equal doses.
The tablets can be taken with or without food.

Treatment of erectile dysfunction

• Flexible dosing, as needed:The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. If this dose is not sufficient, the doctor may increase the dose to 20 mg. Quator tablets are intended for oral use. Quator can be taken at least 30 minutes before planned sexual activity. Quator may still be effective up to 36 hours after taking the tablet. Quator should not be taken more than once a day. Quator 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take Quator on a regular, daily basis.
• Daily dosing:The recommended dose is one 5 mg tablet, taken once a day, at approximately the same time every day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Quator. In this case, the patient should take a 2.5 mg tablet. Taking Quator once a day allows for an erection to be achieved after sexual stimulation at any time during the 24-hour period. Taking Quator once a day may be beneficial for men who intend to engage in sexual activity twice a week or more.

Quator should not be taken more than once a day
It is important to note that Quator does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Quator or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of symptoms of benign prostatic hyperplasia

The dose is one 5 mg tablet, taken once a day, at approximately the same time every day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
Quator should not be taken more than once a day.

Treatment of pulmonary arterial hypertension

The usual dose is two 20 mg tablets, taken once a day. Both tablets should be taken at the same time, one after the other. In cases of mild or moderate liver or kidney impairment, the doctor may recommend taking only one 20 mg tablet per day.

Taking a higher dose of Quator than recommended

If the patient or another person has taken more tablets than recommended, they should immediately inform their doctor or go to the hospital, taking the medicine or packaging with them.
Side effects may occur, as described in section 4.

Missing a dose of Quator

The patient should take the dose as soon as they remember, unless it is less than 8 hours before the time the dose is due to be taken. The patient should not take a double dose to make up for a missed dose. Quator should not be taken more than once a day.

Stopping treatment with Quator

The patient should not stop taking Quator without consulting their treating doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Quator can cause side effects, although not everybody gets them.
These side effects are usually mild to moderate.

If the patient experiences any of the following side effects, they should stop taking Quator and seek medical help immediately.

• allergic reactions, including rash (frequent, may occur less often than in 1 in 10 people).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (frequent, may occur less often than in 1 in 10 people).
• priapism, prolonged and possibly painful erections after taking Quator (uncommon, may occur less often than in 1 in 100 people). If such an erection occurs and lasts continuously for more than 4 hours, the patient should seek medical help immediately.
• sudden vision loss (rare, may occur less often than in 1 in 1000 people).

Other reported side effects, grouped by indication:

Side effects related to the treatment of erectile dysfunction or benign prostatic hyperplasia

Common (may occur less often than in 1 in 10 people)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and indigestion.

Uncommon (may occur less often than in 1 in 100 people)

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, and swelling of hands, feet, or ankles, and feeling tired.

Feeling tired.

Rare (may occur less often than in 1 in 1000 people)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.
• Heart attack and stroke have been rarely reported in men taking Quator. Most of them had heart problems before starting treatment with this medicine.
• Partial, transient, or permanent decrease in vision or loss of vision in one or both eyes.

In men taking Quator, a few rare additional side effectshave been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Side effects related to the treatment of pulmonary arterial hypertension

Very common (may occur in more than 1 in 10 patients)

• headache, flushing, nasal congestion, nausea, indigestion (including abdominal pain or stomach upset), muscle pain, back pain, and limb pain (including pain in the limbs).

Common (may occur less often than in 1 in 10 people)

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

Uncommon (may occur in 1 in 100 patients)

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

Most men who reported symptoms of rapid heartbeat, irregular heartbeat, heart attack, stroke, and sudden cardiac death had heart problems before starting treatment with tadalafil. It cannot be determined with certainty whether these events were directly related to the use of tadalafil (see above "Side effects related to the treatment of erectile dysfunction or benign prostatic hyperplasia")

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Quator

The medicine should be stored out of sight and reach of children.
Quator should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Quator contains

The active substance of Quator is tadalafil.
Quator, 2.5 mg
Each film-coated tablet contains 2.5 mg of tadalafil.
Quator, 5 mg
Each film-coated tablet contains 5 mg of tadalafil.
Quator, 10 mg
Each film-coated tablet contains 10 mg of tadalafil.
Quator, 20 mg
Each film-coated tablet contains 20 mg of tadalafil.
The other ingredients of the medicine are: lactose monohydrate, spray-dried, sodium lauryl sulfate, povidone K-12, crospovidone type B, sodium stearyl fumarate. Tablet coating:polyvinyl alcohol, partially hydrolyzed, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E 172).

What Quator looks like and contents of the pack

Quator, 2.5 mg
Round film-coated tablets, yellow to ochre in color, with a diameter of approximately 5 mm, with the inscription "2.5" on one side and smooth on the other side.
Quator, 5 mg
Oval film-coated tablets, yellow to ochre in color, with dimensions of approximately 8 x 4 mm, with the inscription "5" on one side and smooth on the other side.
Quator, 10 mg
Oval film-coated tablets, yellow to ochre in color, with dimensions of approximately 11 x 6 mm, with the inscription "10" on one side and smooth on the other side.
Quator, 20 mg
Oval film-coated tablets, yellow to ochre in color, with dimensions of approximately 15 x 9 mm, with the inscription "20" on one side and two notches on the other side.
The film-coated tablets are packaged in blisters of aluminum/OPA/aluminum/PVC, PVC/ACLAR/PVC/aluminum, or PVC/ACLAR/PVDC/PVC/aluminum, in a cardboard box.
Pack sizes:
Quator, 2.5 mg
4x1, 8x1 film-coated tablets
Quator, 5 mg
28x1 film-coated tablets
Quator, 10 mg
2x1, 4x1 film-coated tablets
Quator, 20 mg
4x1 film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer/Importer:
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
TEVA Pharma, S.L.U.
Polígono Industrial Malpica, C/C, nº4
50016 Zaragoza
Spain

For more information about Quator, the patient should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 48 22 209 70 00
Date of last revision of the leaflet:09/2022
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