TADALAFIL 5 mg Film-Coated Tablets

Зміст інструкції

1. Tadalafil Alter 20 mg film-coated tablets
   1. What is Tadalafil Alter and what is it 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

Tadalafil Alter 20 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Tadalafil Alter and what is it 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 achieve an erection sufficient for sexual intercourse.
Tadalafil Alter contains the active ingredient tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. Tadalafil will not be helpful if you do not have erectile dysfunction.
It is important to note that tadalafil has no effect if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication 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 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 for the treatment of 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, tell your doctor;
• if you have a serious heart condition or have had a heart attack in the last 90 days;
• if you have recently had a stroke in the last 6 months;
• if you have low or uncontrolled high blood pressure;
• if you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;
• 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). It has been shown
that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are
taking riociguat or have any doubts, tell 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 a heart
condition, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells);
• multiple myeloma (a cancerous tumor of the bone marrow);
• leukemia (a cancerous tumor of the blood cells);
• any deformation 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;
• removal of all or part of the prostate gland where the nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Alter and
contact your doctor immediately.
Decreased or sudden impairment of hearing has been observed in some patients treated with tadalafil. Although it is not known whether the event is directly related to tadalafil, if you experience a
decrease or sudden loss of hearing, stop taking tadalafil and contact your
doctor immediately.
Tadalafil Alter is not indicated for use by women.

Children and adolescents
Tadalafil Alter is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Alter
Tell 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 can be affected by Tadalafil Alter or they themselves can affect the
way Tadalafil Alter works. Tell your doctor or pharmacist if you are already taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia);
• other medicines to treat high blood pressure;
• riociguat;
• a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (to treat 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 drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can
affect how Tadalafil Alter works and should be taken with caution. Ask your
doctor for more information.

Fertility
In dogs treated, a reduction in sperm development in the testicles was observed. A decrease in sperm count has been observed in some
men. These effects are unlikely to cause
infertility.

Driving and operating machinery
Some men taking tadalafil during clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machinery.

Tadalafil Alter contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Tadalafil Alter

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Tadalafil tablets are for oral use and only for men. Swallow the tablet whole with
water. The tablets can be taken with or without food.

The recommended initial doseis one 10 mg tablet before sexual activity. However, you have
been given a dose of a 20 mg tablet because your doctor has decided that the recommended dose of
10 mg is too low.
You can 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 indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that tadalafil does not work if there is no 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.
Drinking alcoholic beverages may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
to take tadalafil, avoid excessive alcohol consumption (blood alcohol level
of 0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more Tadalafil Alter than you should
Contact your doctor. Adverse effects as described in section 4 may occur.
If you have any doubts about 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 normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical attention:

• allergic reactions, including skin rashes (uncommon frequency);
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency);
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately;
• sudden loss of vision (rare frequency).

Other side effects have been reported:

Common(observed in 1 - 10 patients per 100)

• headache, back pain, muscle aches, pain in the arms and legs, hot flushes on the face, nasal congestion and indigestion. Uncommon(observed in 1 - 10 patients per 1,000)
• dizziness, stomach pain, nausea, feeling unwell (vomiting), reflux, blurred vision, eye soreness, difficulty breathing, blood in urine, prolonged erection, pounding sensation of heartbeat, a fast heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired. Rare(observed in 1 - 10 patients per 10,000)
• fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin surface), bleeding of the penis, blood in semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. The
majority of these subjects had heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of
vision in one or both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials
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, some disorders that alter blood flow 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more 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 which is stated on the package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Alter contains

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172).

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Laboratori Alter s.r.l., via Egadi 7, 20144 Milan

Manufacturer:
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

This medicinal product is authorised in the member states of the European Economic Area with the
following denominations:
France: Tadalafil Alter 20 mg, film-coated tablet
Italy: Tadalafil Alter
Spain: Tadalafilo Alter 20 mg film-coated tablets EFG
November 2017