Leaflet: information for the user

Tadalafilo Teva-ratiopharm 10 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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

Tadalafilo is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm, adequate erection for sexual activity. Tadalafilohas demonstrated a significant improvement in the ability to obtain a lasting, adequate erection of the penis for sexual activity.

TadalafiloTeva-ratiopharm contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors.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 inform you that tadalafilo is not effective without sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not take TadalafiloTeva-ratiopharm if:

• You are allergic to tadalafilo or any of the other components 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”). Tadalafilo 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 TadalafiloTeva-ratiopharm with other medications”).
• You have a serious heart disease 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 disease described as “eye infarction”.
• You are taking riociguat. This medication is 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 clots). PDE5 inhibitors, such as tadalafilo, 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 TadalafiloTeva-ratiopharm.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional effort it puts on the heart. If you have a heart problem, consult your doctor.

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

- Sickle cell anemia (a red blood cell abnormality).

- Multiple myeloma (bone marrow cancer).

- Leukemia (blood cell cancer).

- Any penile deformity.

- A severe liver problem.

- A severe kidney problem.

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

- Surgery in the pelvic area.

- 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 visionor your vision is distorted, blurred while taking tadalafilo, stop taking tadalafilo and contact your doctor immediately.

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

Tadalafilo is not intended for use in women.

Children and adolescents

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

Taking TadalafiloTeva-ratiopharm with other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

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

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. 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
• An inhibitor of 5-alpha reductase (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 TadalafiloTeva-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 tadalafilo and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, 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 tadalafilo during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

TadalafiloTeva-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 (1mmol) per film-coated tablet; this is, essentially “sodium-free”.

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

The recommended initial dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafilo Teva-ratiopharm tablets are for oral administration.

You can initiate sexual activity at least 30 minutes after taking Tadalafilo Teva-ratiopharm. Tadalafilo may still be effective up to 36 hours after taking the tablet.

You should not take tadalafilo more than once a day. Tadalafilo Teva- ratiopharm 10 and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

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 have an erection and 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.

If you take more Tadalafilo Teva- 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.

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 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(can 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(can 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(can affect up to 1 in 1,000 people)

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

• bleeding in the penis,

• blood in the semen,

• increased sweating.

It has also been reported that heart attack and stroke can occur 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,
• 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 about 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 blisterpack after 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 medications you no longerneed.This will help protect the environment.

Tadalafil Teva-ratiopharm Composition

• The active ingredient is tadalafil.

Each film-coated tablet contains 10 mg of tadalafil.

• The other components are lactose monohydrate, sodium laurilsulfate, povidone, crospovidone, and sodium stearate fumarate.

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

Tadalafil Teva-ratiopharm 10 mg are film-coated, yellow to brown tablets, oval in shape, with "10" printed on one face and flat on the other. Length of 11.1 mm and width of 6.4 mm.

Tadalafil Teva-ratiopharm 10 mg film-coated tablets EFG are available in blisters of 4, 18, or 28 film-coated tablets or in perforated single-dose blisters of 4x1 or 24x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer responsible

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 medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Tadalafil AbZ 10 mg Filmtabletten

Spain: Tadalafilo Teva-ratiopharm 10 mg film-coated tablets EFG

Portugal: Tadalafil ratiopharm 10 mg film-coated tablets

Last review date of this leaflet: November 2023

For detailed and updated information on this medicine, please visit 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 medicine 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/80042/P_80042.html