Tadalafil Teva-Ratiopharm 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Teva-ratiopharm 5 mg film-coated tablets EFG

Read the entire 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, and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Tadalafilo Teva-ratiopharm contains the active substance tadalafil, 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 occurs when a man cannot achieve or maintain a firm erection suitable for sexual activity. Tadalafil has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

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

It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should stimulate each other in the same way 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 occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as little as 1-2 weeks after starting treatment.

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

Do not take Tadalafil Teva-ratiopharm if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (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 medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor (see section "Taking Tadalafil Teva-ratiopharm with other medicines").
• you have severe heart disease or have recently had a heart attack within the last 90 days.
• you have recently had a stroke within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil Teva-ratiopharm.

Be aware that sexual activity involves a possible risk for patients with heart problems due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer screening before starting treatment with Tadalafil Teva-ratiopharm for benign prostatic hyperplasia. Tadalafil Teva-ratiopharm does not treat prostate cancer.

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

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether tadalafil is effective in patients who have undergone:

• pelvic surgery.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

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

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Taking Tadalafil Teva-ratiopharm with other medicines

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

Do not take Tadalafil Teva-ratiopharm if you are already using nitrates (see "Do not take Tadalafil Teva-ratiopharm").

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Inform 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 treating high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for treating AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Teva-ratiopharm with food and alcohol

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

Fertility

In treated dogs, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm count. It is unlikely that these effects would lead to infertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Teva-ratiopharm contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Tadalafil Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Alcohol consumption may 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

Recommended dose: One 5 mg tablet once daily, at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Teva-ratiopharm. This adjustment will be made by taking a 2.5 mg tablet.

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

Daily administration of Tadalafil Teva-ratiopharm may be beneficial for men who anticipate having sexual activity two or more times per week.

Daily administration of Tadalafil Teva-ratiopharm allows you to achieve an erection at any time during the 24-hour period, provided that sexual stimulation occurs.

It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

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

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

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

If you take more Tadalafil Teva-ratiopharm than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Tadalafil Teva-ratiopharm

Take the missed 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. These effects are generally mild to moderate in intensity.

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

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

Other adverse effects that have been reported:

Frequent (may affect up to 1 in 10 people)

• headache,
• back pain,
• muscle pain,
• pain in arms and legs,
• facial 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,
• presence of blood in urine,
• prolonged erection,
• palpitations, rapid pulse, high blood pressure, low blood pressure,
• nosebleeds 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 partial or complete hearing loss, and urticaria (red, itchy welts on the skin),

• bleeding in the penis,

• presence of blood in semen,

• increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had existing heart problems before taking this medicine.

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

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

• migraine,
• facial swelling,
• severe allergic reaction causing swelling of the face or throat,
• severe skin rashes,
• certain disorders affecting blood flow to the eyes,
• irregular heartbeats,
• angina,
• sudden cardiac death,
• distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

The most frequently reported adverse effect in men over 75 years of age taking tadalafil has been dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect has been diarrhoea.

Reporting of adverse effects:

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

5. Storage of Tadalafil Teva-ratiopharm

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

Do 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 indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Teva-ratiopharm

• The active substance is tadalafil.

Each film-coated tablet contains 5 mg of tadalafil.

• The other components are monohydrate lactose, 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 contents of the container

Tadalafilo Teva-ratiopharm 5 mg are film-coated tablets, ochre to yellow in colour, oval-shaped, marked 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.

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

Only certain 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 European Economic Area member states under the following names:

Germany: Tadalafil AbZ 5 mg Filmtabletten

Spain: Tadalafilo Teva-ratiopharm 5 mg comprimidos recubiertos con película EFG

Portugal: Tadalafil ratiopharm 5 mg comprimidos revestidos por película

Date of the latest revision of this leaflet: November 2023

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

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