Tadalafil Alter

Package leaflet: Information for the user

Tadalafil Alter 20 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tadalafil Alter is and what it is used for

Tadalafil Alter is a treatment for adult men with erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse.
Tadalafil Alter contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil will not benefit you if you do not have erectile dysfunction.
It is important to note that tadalafil has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Alter

Do not take Tadalafil Alter

• if you are allergic to tadalafil or to 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. These are a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor;
• if you have a severe heart disease or have had a heart attack within the last 90 days;
• if you have recently had a stroke within the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye";
• 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 secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions

Talk to your doctor before taking Tadalafil Alter.

Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.

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

• sickle cell anemia (an abnormality of red blood cells);
• multiple myeloma (a malignant tumor of the bone marrow);
• leukemia (a malignant tumor of blood cells);
• any deformity of the penis;
• severe liver problems;
• severe kidney problems.

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

• pelvic surgery;
• removal of all or part of the prostate gland with nerve damage (nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Alter and contact your doctor immediately.

In some patients treated with tadalafil, reduced or sudden hearing impairment has been observed. 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 and contact your doctor immediately.

Tadalafil Alter is not intended for use by women.

Children and adolescents

Tadalafil Alter is not intended for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Alter

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

Do not take Tadalafil Alter if you are already taking nitrates.

Some medicines may be affected by Tadalafil Alter or may themselves affect how Tadalafil Alter works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems 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 treating 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.

Tadalafil Alter with food and alcohol

Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Alter works and should be consumed with caution. Consult your doctor for further information.

Fertility

In treated dogs, reduced sperm development in the testes has been observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.

Driving and using machines

Some men taking tadalafil in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Alter contains lactose

If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Alter

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil tablets are for oral use and for men only. Swallow the tablet whole with water. Tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet taken before sexual activity. However, you have been prescribed a dose of one 20 mg tablet, as your doctor has decided that the recommended 10 mg dose is too low for you.
You may take the tadalafil tablet at least 30 minutes before sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg is intended to be used as needed before anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take tadalafil, 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 Alter than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

• allergic reactions, including skin rash (uncommon frequency);
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency);
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately;
• sudden loss of vision (rare frequency).

Other side effects reported include:
Common (observed in 1 to 10 patients out of 100)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.
  Uncommon (observed in 1 to 10 patients out of 1,000)

• dizziness, stomach discomfort, nausea, malaise (vomiting), acid reflux, blurred vision, eye discomfort, difficulty breathing, blood in the urine, prolonged erection, sensation of pounding heartbeat, rapid heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling of fatigue.
  Rare (observed in 1 to 10 patients out of 10,000)

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Rare cases of heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rare cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have also been reported.
Some additional rare side effects, not observed during clinical studies, have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Tadalafil Alter

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Alter contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Coating film: hypromellose, glycerol triacetate, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Tadalafil Alter and contents of the pack
Tadalafil Alter 20 mg are yellow, round, biconvex film-coated tablets, marked with a cross on one side and flat on the other side.
Tadalafil Alter 20 mg is available in blisters in packs containing 2, 4 and 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratori Alter s.r.l., via Egadi 7, 20144 Milano
Manufacturer:
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Tadalafil Alter 20 mg, comprimé pelliculé
Italy: Tadalafil Alter
Spain: Tadalafilo Alter 20 mg comprimidos recubiertos con película EFG
November 2017