Tadalafil Teva-Ratiopharm 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Teva-ratiopharm 20 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 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 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 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 is indicated for the treatment of erectile dysfunction in adult men.

This condition occurs when a man is unable to achieve or maintain a firm erection suitable for sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Tadalafilo Teva-ratiopharm contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafilo 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 must engage in stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

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 a 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 you start taking Tadalafil Teva-ratiopharm.

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

Before taking the tablets, 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 severe liver problem.
• a severe 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 preservation of neurovascular bundles).

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

Tell 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 treatment of fungal infections) and protease inhibitors for 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 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 taken with caution. Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testes was observed. In some men, a reduction in sperm has been observed. These effects are unlikely to cause 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 told you that you have an intolerance to certain sugars, consult 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 in doubt, consult your doctor or pharmacist again.

Tadalafil Teva-ratiopharm tablets are for oral use only in men.

Daily administration

The recommended dose is 5 mg (corresponding to one quarter of a tablet) once daily, taken 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 will be achieved 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 suitable for men who expect to have sexual activity two or more times per week. Daily use allows you to achieve an erection at any time during the 24-hour period, provided there is sexual stimulation.

On-demand administration

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

After taking the dose, you may initiate sexual activity at least 30 minutes later. Tadalafil may remain effective up to 36 hours after dosing.

Do not take 10 mg or 20 mg doses of tadalafil more than once a day. These doses are to be used prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to note that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same level of sexual stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to have 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 upon standing.

Method of administration

Depending on the dosing regimen (daily or on-demand), tablets may be divided into four equal parts (for daily use) or into halves (for on-demand use).

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

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

Divide the tablet into four equal doses (each containing 5 mg of tadalafil for daily administration).

Tablet splitting into halves (with 10 mg tadalafil for on-demand treatment)

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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Tadalafilo Teva-ratiopharm

If you take tadalafil once daily, take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. You must not take Tadalafilo 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 experiences them. These effects are usually mild to moderate in intensity.

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

• 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). 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), distorted, diminished, central blurred 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,
• blood in the urine,
• prolonged erection,
• palpitations, rapid pulse, high blood pressure, low blood pressure,
• nosebleeds and tinnitus,
• swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1,000 people)

• fainting,

• seizures,

• temporary memory loss,

• eyelid swelling, red eyes, sudden partial or complete hearing loss, and urticaria (red, itchy welts on the skin),

• bleeding in the penis,

• blood in the semen,

• increased sweating.

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

Rarely, cases of decreased or lost vision, 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, diminished, central blurred 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 Medicinal Products: 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 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 unused medicines and their packaging at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 20 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 pack

Tadalafil Teva-ratiopharm 20 mg are film-coated tablets, ochre to yellow in colour, oval-shaped. One side of the tablet has a double score line, and on the other side is printed "20". Length: 15.0 mm, width: 9.0 mm. The tablet may be divided into two or four equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
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 (EEA) member states under the following names:

Germany: Tadalafil AbZ 20 mg Filmtabletten
Spain: Tadalafilo Teva-ratiopharm 20 mg comprimidos recubiertos con película EFG
Portugal: Tadalafil ratiopharm 20 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 Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80045/P_80045.html