TADALAFIL TEVA-RATIOPHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Teva-ratiopharm 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tadalafil Teva-ratiopharm and what is it used for
2. What you need to know before you take Tadalafil Teva-ratiopharm
3. How to take Tadalafil Teva-ratiopharm
4. Possible side effects
5. Storing Tadalafil Teva-ratiopharm
6. Contents of the pack and other information

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

Tadalafil Teva-ratiopharm contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

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

• Erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

It is important to note that tadalafil is not effective if there is no sexual stimulation.You and your partner will still need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to pass urine, a feeling that your bladder is not completely empty, needing to pass urine more often, or more often during the night. Tadalafil improves blood flow to the prostate and relaxes the muscles in the prostate and the bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in a short period of time, such as 1-2 weeks after starting treatment.

2. What you need to know before you take Tadalafil Teva-ratiopharm

Do not take Tadalafil Teva-ratiopharm if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• you have a severe heart condition or have had a recent heart attack (within the last 90 days).
• you have had a recent stroke (within the last 6 months).
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine 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 blood clots). Phosphodiesterase 5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Tadalafil Teva-ratiopharm.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before you start taking Tadalafil Teva-ratiopharm for benign prostatic hyperplasia. Tadalafil Teva-ratiopharm does not treat prostate cancer.

Before taking Tadalafil Teva-ratiopharm, tell your doctor if you:

• have sickle cell anemia (a disorder of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukemia (cancer of the blood cells).
• have any deformation of the penis.
• have severe liver problems.
• have severe kidney problems.

It is not known if tadalafil is effective in patients who have:

• undergone pelvic surgery.
• had a prostatectomy (removal of the prostate gland).

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

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

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil Teva-ratiopharm should not be used in children and adolescents under 18 years.

Taking Tadalafil Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Tadalafil Teva-ratiopharm if you are already taking nitrates (see “Do not take Tadalafil Teva-ratiopharm”)

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Tell your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines for high blood pressure.
• riociguat
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Teva-ratiopharm with food and drink

Information about the effect of alcohol is in section 3. Grapefruit juice may affect how well tadalafil works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Teva-ratiopharm contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Tadalafil Teva-ratiopharm

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The tablets are for oral use only in men. Swallow the tablet whole with some water. The tablets can be taken with or without food.

Drinking too much alcohol can temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil 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 taken once a day, at approximately the same time. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Teva-ratiopharm. This will be done by taking a 2.5 mg tablet.

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

Tadalafil Teva-ratiopharm taken daily may be useful in men who anticipate having sexual activity at least twice a week.

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

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet taken once a day, at approximately the same time.

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

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

If you take more Tadalafil Teva-ratiopharm than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Tadalafil Teva-ratiopharm

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take Tadalafil Teva-ratiopharm more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• dizziness,
• stomach pain,
• nausea,
• vomiting,
• reflux,
• blurred vision,
• eye pain,
• difficulty breathing,
• 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(may affect up to 1 in 1,000 people)

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

• bleeding from the penis,

• blood in the semen,

• increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart conditions.

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

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

• migraine,
• swelling of 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 pectoris,
• sudden cardiac death,
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tadalafil Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of TadalafilTeva-ratiopharm

• The active ingredient is tadalafil.

Each film-coated tablet contains 5 mg of tadalafil.

• The other ingredients are lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone, and sodium stearyl fumarate.

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

Appearance of the product and container contents

Tadalafil Teva-ratiopharm 5 mg are film-coated tablets of ochre to yellow color, oval, 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.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

Alcobendas, 28108 Madrid (Spain)

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 under the following names:

Germany: Tadalafil AbZ 5 mg Filmtabletten

Spain: Tadalafilo Teva-ratiopharm 5 mg film-coated tablets EFG

Portugal: Tadalafil ratiopharm 5 mg film-coated tablets

Date of the last revision of thisleaflet: November 2023

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

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