Tadalafil Teva

Leaflet accompanying the packaging: information for the user

Tadalafil Teva,

10 mg, coated tablets

Tadalafil

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.
• In case of 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.
• 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.

Table of contents of the leaflet

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

1. What is Tadalafil Teva and what is it used for

Tadalafil Teva is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that Tadalafil Teva significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Tadalafil Teva contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Teva helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil Teva does not help patients who do not have erectile dysfunction.

It is important to be aware that Tadalafil Teva does not work without sexual stimulation.

The patient and his partner should arrange foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.

2. Important information before taking Tadalafil Teva

When NOT to take Tadalafil Teva

• 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 in any form 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 Teva enhances the effect of these medicines. If the patient is taking nitrates in any form, or is unsure, they should inform their doctor (see section Tadalafil Teva and other medicines).

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If the patient is taking nitrates in any form or is unsure, they should inform their doctor (see section Tadalafil Teva and other medicines).

• 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 phosphodiesterase type 5 inhibitors, such as Tadalafil Teva, 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 taking Tadalafil Teva, the patient should consult their doctor.
The patient should remember that sexual activity carries a degree of risk for patients with heart disease, as it puts extra strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking Tadalafil Teva, the patient should inform their doctor if they have any of the following:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformity of the penis.
• severe liver disease.
• severe kidney disease.

It is not known whether Tadalafil Teva is effective in patients who have:

• had pelvic surgery.
• had their prostate removed (radical prostatectomy without nerve sparing).

If the patient experiences sudden worsening of vision or sudden loss of vision or distorted vision while taking tadalafil, they should STOPtaking Tadalafil Teva and seek medical help 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 the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Tadalafil Teva and seek medical help immediately.
Tadalafil Teva is not intended for use in women.

Children and adolescents

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

Tadalafil Teva and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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The patient should NOTtake Tadalafil Teva if they are taking nitrates (see section "When NOT to take Tadalafil Teva").
Tadalafil Teva may affect the way some medicines work, or other medicines may affect the way Tadalafil Teva works. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat an enlarged prostate).
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Teva with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Teva, and therefore, caution should be exercised when consuming it. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed.
A decrease in sperm count has been observed in some men. It is unlikely to lead to infertility.

Driving and using machines

In some men taking Tadalafil Teva during clinical trials, dizziness was reported, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Tadalafil Teva contains lactose and sodium

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Tadalafil Teva

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Tadalafil Teva tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
The recommended starting doseis one 10 mg tablet, taken before planned sexual activity. If this dose is not effective, the doctor may increase the dose to 20 mg. Tadalafil Teva tablets are for oral use.
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Tadalafil Teva can be taken at least 30 minutes before planned sexual activity.
Tadalafil Teva may still be effective up to 36 hours after taking the tablet.
The patient should not take Tadalafil Teva more than once a day. Tadalafil Teva 10 mg and 20 mg is intended for use before planned sexual activity and is not recommended for continuous, daily use.
It is important to be aware that Tadalafil Teva does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Teva or plans to take it, they should not consume large amounts of alcohol (blood alcohol level 0.08% or above), as this may increase the risk of dizziness when standing up.

Taking more Tadalafil Teva than prescribed

The patient should inform their doctor. Side effects may occur, as described in section 4.
If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.

If the patient experiences any of the following side effects, they should STOPtaking Tadalafil Teva and seek medical help immediately:

• allergic reactions, including rashes (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Tadalafil Teva (rare). If such an erection occurs and lasts for more than 4 hours, the patient should seek medical help immediately.
• sudden loss of vision (rare), distorted, blurred, or decreased vision (frequency not known).

Other reported side effects:
Common(seen in 1 to 10 in 100 patients)

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

Uncommon(seen in 1 to 10 in 1000 patients)

• dizziness,
• stomach pain,
• nausea, 4
• vomiting,
• gastroesophageal reflux disease,
• blurred vision,
• eye pain,
• difficulty breathing,
• penile bleeding,
• blood in urine,
• prolonged erections,
• palpitations, rapid heartbeat, high blood pressure, low blood pressure,
• nasal bleeding and ringing in the ears,
• swelling of hands, feet, or ankles and feeling tired.

Rare(seen in 1 to 10 in 10,000 patients)

• fainting,
• seizures,
• temporary memory loss,
• swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, and hives (itchy, red bumps on the skin),
• penile bleeding,
• blood in semen,
• increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Teva. Most of them had heart problems before taking this medicine.
There have been reports of rare cases of partial, temporary, or permanent loss of vision or blindness in one or both eyes.
In men taking Tadalafil Teva, a few additional rare side effectshave been reported, which were not observed during clinical trials. These include:

• migraine,
• facial swelling,
• severe allergic reactions causing swelling of the face and throat,
• severe skin rashes,
• eye disorders,
• irregular heartbeat,
• angina pectoris,
• sudden cardiac deaths,
• distorted, blurred, or decreased vision or sudden worsening of vision (frequency not known). The side effect dizziness was reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhea was reported more frequently in men over 65 years of age taking Tadalafil Teva.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Tadalafil Teva

The medicine should be stored out of the sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
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 use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Teva contains

The active substance is tadalafil.
Each tablet contains 10 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, sodium lauryl sulfate, povidone K12, crospovidone, sodium stearyl fumarate
Coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172)

What Tadalafil Teva looks like and contents of the pack

Tadalafil Teva 10 mg is an oval, yellow to ochre-colored, coated tablet with "10" engraved on one side. The other side of the tablet is smooth. The length of the tablet is 11.1 mm; the width is 6.4 mm.
The tablets are available in blisters containing 4, 12, 18, or 28 coated tablets or perforated blisters containing 4x1 or 24x1 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: +48 22 345 93 00

Manufacturer/Importer:

TEVA Gyógyszergyár Zrt.
(TEVA Pharmaceutical Works Private Limited Company)
Pallagi út 13
4042 Debrecen,
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica,
50016 Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Strasse 3,
89143 Blaubeuren
Germany
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb, Croatia
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Date of last revision of the leaflet:February 2024