TADALAFIL TEVA-RATIOPHARM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Teva-ratiopharm 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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 further 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 occurs when a man cannot get or maintain a firm erection, suitable for sexual activity. Tadalafil has shown a significant improvement in the ability to get an erection that lasts long enough 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 acts by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction.

It is important to note that tadalafil is not effective if there is no 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.

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 nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor (see section "Taking Tadalafil Teva-ratiopharm with other medicines").
• you have a severe heart disease or have had a heart attack in the last 90 days.
• you have had a stroke in 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). PDE5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tadalafil Teva-ratiopharm.

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

Before taking the tablets, inform your doctor if you have:

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

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

• surgery in the pelvic area.
• a surgical intervention in which the prostate has been completely or partially removed and in which the prostate nerves have been cut (radical prostatectomy without preservation of neurovascular bundles).

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 observed 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 or 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 using nitrates (see "Do not take Tadalafil Teva-ratiopharm").

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

• an alpha-blocker (used to treat high blood pressure or symptoms of 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 the treatment of fungal infections) and protease inhibitors for the treatment of 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 drinks and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when you take 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 him 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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets of Tadalafil Teva-ratiopharm are for oral administration only in men.

Daily administration

The recommended dose is 5 mg(corresponding to a quarter of a tablet) once a day, approximately at 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 administered daily may be useful in men who anticipate having sexual activity twice a week or more. Tadalafil Teva-ratiopharm administered daily allows you to get an erection at any time during the 24 hours of the day, provided that there is sexual stimulation.

Administration on demand

The initial recommended dose is one 10 mgtablet (corresponding to half a tablet) before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg(one whole tablet).

When you take the dose, you can start sexual activity from at least 30 minutes after taking it. Tadalafil can still be effective up to 36 hours after taking the dose.

Do not take the 10 mg and 20 mg dose of tadalafil more than once a day. They will be used before expected sexual activity and are not recommended for continuous daily use.

It is important to note that tadalafil is not effective if there is no 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.

Consuming alcohol may affect 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 consumption of alcohol (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

Method of administration

Depending on the dosing regimen (daily or on demand), the tablets can be divided into four parts (daily) or into halves (on demand).

Tadalafil Teva-ratiopharm is for oral administration and can be taken with or without food.

Swallow the whole tablet or part of the tablet with a little water.

Division of the tablet into 4 equal doses (with 5 mg of tadalafil for daily administration)

Division of the tablet into halves (with 10 mg tadalafil for administration on demand)

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, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Tadalafil Teva-ratiopharm

If you take tadalafil once a day, 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 generally mild to moderate.

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

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

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache,
• back pain,
• muscle pain,
• 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 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 decrease or loss of hearing, and hives (red itchy patches on the skin),

• bleeding in 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 disease before taking this medicine.

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

Some additional rare side effectshave 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 heartbeats,
• angina pectoris,
• sudden cardiac death,
• distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

The most frequently reported side effect in men over 75 years of age taking tadalafil has been dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect has been diarrhea.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through 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. 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 is the last day of the month shown.

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 Content and Additional Information

Composition of Tadalafilo Teva-ratiopharm

• The active ingredient is tadalafil.

Each film-coated tablet contains 20 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 Content

Tadalafilo Teva-ratiopharm 20 mg are film-coated tablets of ochre to yellow color, oval shape. One side of the tablet has a double score, and the other side is printed with "20". Length: 15.0 mm, width: 9.0 mm. The tablet can be divided into two or four equal doses.

Tadalafilo Teva-ratiopharm 20 mg film-coated tablets EFG are available in blisters of 2, 4, 5, 8, 10, 12, 15, 18, 24, 28, 36, 48 or 56 film-coated tablets or 4x1, 8x1, 12x1 or 24x1 film-coated tablets in perforated unit dose blisters.

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 20 mg Filmtabletten

Spain: Tadalafilo Teva-ratiopharm 20 mg film-coated tablets EFG

Portugal: Tadalafil ratiopharm 20 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/80045/P_80045.html