Leaflet: information for the user

Tadalafilo Teva-ratiopharm 5 mg film-coated tablets

Read 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. Do not give it to others even if they have the same symptoms as you, 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 Tadalafilo Teva-ratiopharm is and what it is used for

2. What you need to know before you start taking Tadalafilo Teva-ratiopharm

3. How to take Tadalafilo Teva-ratiopharm

4. Possible side effects

5. Storage of Tadalafilo Teva-ratiopharm

6. Contents of the pack and additional information

TadalafiloTeva-ratiopharm contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Teva-ratiopharm is indicated in adult men for the treatment of:

- Erectile dysfunction. This is when a man cannot get or keep an erection firm enough for sexual activity. Tadalafilohas shown a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have erectile dysfunction.

It is essential to note that tadalafilo is not effective without sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medication for erectile dysfunction.

- Urinary symptoms associated with a common disease calledbenign prostatic hyperplasia.This is when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Teva-ratiopharm if:

• You are allergic to tadalafil or any of the other ingredients of this medication (listed in section 6).
• You are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor (See section “Taking Tadalafilo Teva-ratiopharm with other medications”).
• You have a serious heart condition or have had a heart attack recently, within the last 90 days.
• You have had a recent stroke, within the last 6 months.
• You have low or uncontrolled high blood pressure.
• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye infarction”.
• 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). Phosphodiesterase type 5 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 Tadalafilo Teva-ratiopharm.

Be aware that sexual activity can pose a possible risk to patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with Tadalafilo Teva-ratiopharm for benign prostatic hyperplasia. Tadalafilo Teva-ratiopharm is not intended to treat prostate cancer.

Before taking Tadalafilo Teva-ratiopharm, inform your doctor if you have:

- Sickle cell anemia (an abnormality of red blood cells).

- Multiple myeloma (bone marrow cancer).

- Leukemia (blood cell cancer).

- Any penile deformity.

- A severe liver problem.

- A severe kidney problem.

Tadalafil is not known to be effective in patients who have undergone:

- Pelvic surgery.

- A surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

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

A decrease or sudden loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a decrease or sudden loss of hearing, stop taking Tadalafilo Teva-ratiopharm and immediately contact your doctor.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafilo Teva-ratiopharm should not be used in children or adolescents under 18 years old.

Taking Tadalafilo Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Tadalafilo Teva-ratiopharm if you are already using nitrates (see “Do not take Tadalafilo Teva-ratiopharm”).

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

• An alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• Other medications to treat high blood pressure.
• Riociguat
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Teva-ratiopharm with beverages and alcohol

The information about the effect of alcohol is found in section 3. Orange juice may affect the proper functioning of tadalafil and should be taken with caution. Consult your doctor for more information.

Fertility

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 machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Teva-ratiopharm contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially “sodium-free”.

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

Tadalafilo Teva-ratiopharm tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Teva-ratiopharm, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafilo Teva-ratiopharm. This will be done by taking one 2.5 mg tablet.

Do not take Tadalafilo Teva-ratiopharm more than once a day.

Tadalafilo Teva-ratiopharm taken daily may be useful in men who anticipate engaging in sexual activity two or more times a week.

Tadalafilo Teva-ratiopharm taken daily allows you to achieve an erection at any time during the 24 hours of the day, as long as there is sexual stimulation.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take Tadalafilo Teva-ratiopharm more than once a day.

If you take more TadalafiloTeva-ratiopharm than you should

Consult your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take TadalafiloTeva-ratiopharm

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Teva-ratiopharm more than once a day.

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 of mild to moderate intensity.

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

• allergic reactions including rashes (rare).
• chest pain - do not use nitrates but seek medical help immediately (rare).
• prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

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

Very rare(may affect up to 1 in 1,000 people)

• loss of consciousness,
• seizures,
• temporary loss of memory,
• swelling of the eyelids, red eyes, sudden loss or decrease in hearing and urticaria (red itchy patches on the skin),

• bleeding in the penis,

• blood in the semen,

• increased sweating.

It has also been reported that rare cases of heart attack and stroke have occurred in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

Very rarely, cases of partial or permanent loss of vision in one or both eyes have been reported.

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

• migraine,
• swelling in the face,
• severe allergic reaction that causes swelling of the face or throat,
• severe skin rashes,
• certain disorders that affect blood flow to the eyes,
• irregular heartbeat,
• angina of the chest,
• sudden cardiac death,
• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

The most common side effect reported in men over 75 years old taking tadalafil has been dizziness. In men over 65 years old taking tadalafil, the most common side effect reported has been diarrhea.

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 the Spanish 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and on the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines 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. Ask your pharmacisthow to dispose ofpackaging and medicationsyou no longer need. This will help protect the environment.

Composition of TadalafilTeva-ratiopharm

• The active ingredient is tadalafil.

Each film-coated tablet contains 5 mg of tadalafil.

• The other componentsare lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone, and sodium stearate.

The film coating of the tablet contains polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, and iron oxide yellow (E172).

Appearance of the product and contents of the package

TadalafilTeva-ratiopharm 5 mg are film-coated, yellow to brown tablets, oval in shape, printed on one side with “5”, and flat on the other side, with a length of 8.1 mm and a width of 4.1 mm.

TadalafilTeva-ratiopharm 5 mg film-coated tablets are available in blisters of 14, 18, 28, 30, or 84 film-coated tablets, or in 28x1 or 98x1 film-coated tablets in a perforated single-dose blister.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

TEVA Pharmaceutical Works Private Limited Company

Debrecen, Pallagi út 13, H-4042

Hungary

or

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex,

BN22 9AG

United Kingdom

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, Krakow 31-546

Poland

or

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

or

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren 89143

Germany

or

Merckle GmbH

Graf-Arco-Str. 3, Ulm 89079

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Tadalafil AbZ 5 mg Filmtabletten

Spain:TadalafiloTeva-ratiopharm 5 mg film-coated tablets EFG

Portugal:Tadalafil ratiopharm 5 mg film-coated tablets

Last revision date of thisleaflet: November 2023

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

You can access detailed and updated information on this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80044/P_80044.html