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 medical prescription:

You should carefully read the contents of the 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 and should not be passed 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 side effects 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 the 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 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 side effects 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 their 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 for the treatment of 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 erectile dysfunction medication.
Quator 5 mgis used to treat adult men with symptoms of benign prostatic hyperplasia (BPH).
This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, a feeling of not completely emptying the bladder, and a need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the prostate and bladder muscles, which may alleviate the symptoms of BPH. 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 engage in 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 nitric oxide donors, 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 a 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 PDE5 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 may have the same symptoms, so the doctor will perform an examination to rule out prostate cancer before starting treatment with Quator for the symptoms of BPH. 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 anaemia (abnormal shape of red blood cells),
• multiple myeloma (bone marrow cancer),
• leukaemia (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 pelvic surgery,
• who have had their prostate removed (radical prostatectomy without nerve sparing).

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

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 the age of 18.

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 way some medicines work or other medicines may affect the way Quator works. 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 BPH),
• other medicines used to treat high blood pressure,
• nitrates (taken for chest pain)
• riociguat,
• 5-alpha reductase inhibitors (used to treat BPH),
• protease inhibitors used to treat AIDS or HIV infection (ritonavir),
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines),
• rifampicin, erythromycin, or clarithromycin (medicines used to treat bacterial infections),
• 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 (PDE5 inhibitors).

Taking Quator with food and alcohol

Information on 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 baby, 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 patient's doctor.
Quator should not be taken while 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, tadalafil has been shown to reduce sperm production in the testes. 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 how they react to Quator before driving or operating machinery.

Quator contains lactose and sodium

If the patient's doctor has previously told them that they have an intolerance to some sugars, they should consult their doctor before taking 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 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 continuous, daily basis.
• Daily dosing:The recommended dose is one 5 mg tablet, taken once a day, at approximately the same time each 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 have sexual activity twice a week or more often.

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 their partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.
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 level 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 each day. If the patient has BPH and erectile dysfunction, the dose of 5 mg once a 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 once a day.

Taking a higher dose of Quator than recommended

If the patient or someone else 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. 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

Quator should not be stopped without consulting the patient's 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 any of the following side effects occur, the patient should stop taking Quator and seek medical help immediately.

• allergic reactions, including skin 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 associated with the treatment of erectile dysfunction or benign prostatic hyperplasia

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

Fatigue.

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

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, hives, penile bleeding, blood in the 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, 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 associated with the treatment of pulmonary arterial hypertension

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

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

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

• blurred vision, low blood pressure, nosebleeds, vomiting, 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, penile bleeding, blood in the semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death, and ringing in the ears.

Most men who reported symptoms such as 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 associated with the treatment of erectile dysfunction or benign prostatic hyperplasia")

Reporting side effects

If the patient experiences any side effects, including any side effects 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 Monitoring of the 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.
By reporting side effects, more information can be gathered 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 they no longer need. 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, anhydrous, 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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