TADALAFIL TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Teva-ratiopharm 10 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. Storage of Tadalafil Teva-ratiopharm
6. Contents of the pack and other information

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

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. 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 obtain a hard erect penis suitable for sexual activity.

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

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).
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem.
• if you have recently had a stroke or heart attack.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
• if 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

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

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

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

• have sickle cell anaemia (an abnormality of red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukaemia (cancer of the blood cells).
• have any deformation of your penis.
• have a serious liver or kidney problem.

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 sudden decrease or loss of vision or hearing, stop taking tadalafil and contact your doctor immediately.

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

Tadalafil is not intended for use by women.

Children and adolescents

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

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 will work. Tell your doctor or pharmacist if you are taking:

• an alpha blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).
• certain medicines for fungal infections (e.g., ketoconazole) and some medicines for HIV and AIDS.
• phenobarbital, phenytoin, and carbamazepine (medicines for epilepsy).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Teva-ratiopharm with food and drink

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well tadalafil will work 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. These effects are unlikely to lead to a lack of fertility.

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, contact them 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.

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

The recommended doseis one 10 mg tablet taken at least 30 minutes before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Teva-ratiopharm tablets are for oral use.

When taking Tadalafil Teva-ratiopharm, you may initiate sexual activity at any time between 30 minutes to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. Tadalafil Teva-ratiopharm 10 and 20 mg will be used before anticipated sexual activity and is not recommended for continuous daily use.

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.

Consuming large amounts of alcohol may reduce your ability to get an erection and 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 this may increase the risk of dizziness when standing up.

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 leaflet of the medicine to the healthcare professional.

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, a prolonged erection that can be painful and may require medical attention (rare). If you have an erection that lasts more than 4 hours, seek medical help immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or 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 erection,
• palpitations, rapid heartbeat, 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 decrease or loss of hearing and hives (red itchy patches on the skin),

• penile bleeding,

• blood in semen,

• increased sweating.

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

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

Additional rare side effects have been reportedin men taking tadalafil that were not seen 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 affecting blood flow to the eyes,
• irregular heartbeats,
• angina pectoris,
• sudden cardiac death
• distorted, blurred, or decreased 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 diarrhoea.

Reporting of side effects:

If you get 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 Medicines Agency's website: https://www.notificaram.es. By reporting side 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 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. Contents of the pack and other information

Composition of Tadalafil Teva-ratiopharm

• The active substance is tadalafil.

Each film-coated tablet contains 10 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 and packaging

Tadalafil Teva-ratiopharm 10 mg film-coated tablets are yellow to ochre, oval, and debossed with "10" on one side and plain on the other. Length: 11.1 mm, width: 6.4 mm.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Tadalafil AbZ 10 mg Filmtabletten

Spain: Tadalafilo Teva-ratiopharm 10 mg comprimidos recubiertos con película EFG

Portugal: Tadalafil ratiopharm 10 mg comprimidos revestidos por película

Date of last revision of this leaflet: November 2023

Detailed and up-to-date information on this medicine 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 up-to-date information about 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