Tadalafil Almus

Patient Information Leaflet

Tadalafil Almus 5 mg film-coated tablets

Generic Medicine
Please 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 give it to others, 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 Almus is and what it is used for
  2. What you need to know before taking Tadalafil Almus
  3. How to take Tadalafil Almus
  4. Possible side effects
  5. How to store Tadalafil Almus
  6. Contents of the pack and other information

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

Tadalafil Almus contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors.
Tadalafil Almus 5 mg 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 Almus has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, Tadalafil Almus helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil Almus will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Almus for the treatment of erectile dysfunction 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.
• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and increased frequency of urination, including during the night. Tadalafil Almus improves blood flow and relaxes the smooth muscle of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Almus

Do not take Tadalafil Almus if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (or
  “chest pain”). It has been shown that Tadalafil Almus increases the effect of these
  medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.

• you have 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 previously 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 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 Almus.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will carry out tests for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells),
• multiple myeloma (a malignant tumour of the bone marrow),
• leukaemia (a malignant tumour of blood cells),
• any deformity of the penis,
• severe liver problems,
• severe kidney problems.

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

• pelvic surgery,
• removal of all or part of the prostate gland where the nerves to the prostate have been cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Almus, stop taking Tadalafil Almus and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether the event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Almus and contact your doctor immediately.
Tadalafil Almus is not intended for use by women.

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

Other medicines and Tadalafil Almus
Inform your doctor if you are taking, have recently taken, or might take any other
medicine.
Do not take Tadalafil Almus if you are already taking nitrates.
Some medicines may be affected by Tadalafil Almus or may themselves affect how
Tadalafil Almus 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 fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection,
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

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

Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced 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 Almus contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Tadalafil Almus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Tadalafil Almus

Take this medicine exactly as your doctor has instructed you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Almus tablets are for oral use and are intended only for men. Swallow the tablet whole with water. Tablets can be taken regardless of food intake.
Consuming alcoholic beverages may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Almus, avoid excessive alcohol consumption (blood alcohol level equal to or above 0.08%) as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Almus. This dose will be provided as a 2.5 mg tablet. Do not take Tadalafil Almus more than once a day.
When taken once daily, Tadalafil Almus allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period. Daily administration of Tadalafil Almus may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Almus does 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.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day.
If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take Tadalafil Almus more than once a day.

If you take more Tadalafil Almus than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil Almus
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. You must not take Tadalafil Almus more than once a day.

If you have any questions 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 everyone experiences them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the medicine and seek immediate medical help:

• allergic reactions, including skin rashes (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), distorted central vision, blurred or fuzzy vision, or sudden decrease in vision (frequency not known).

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

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (seen in 1–10 patients out of 1,000)

• dizziness, stomach ache, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (seen in 1–10 patients out of 10,000)

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

Rarely, 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.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have 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 and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted central vision, blurred, fuzzy vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea 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 https://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 Almus

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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Tadalafil Almus contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose (see also “Tadalafil Almus contains lactose” in section 2), maize starch, pregelatinized starch (maize), crospovidone, sodium lauryl sulfate (see also “Tadalafil Almus contains sodium” in section 2), and magnesium stearate. Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Tadalafil Almus and contents of the pack

Tadalafil Almus 5 mg film-coated tablets are oval-shaped, cream to light yellow in colour, with a length of 10.0 mm ± 0.2 mm and a width of 5.5 mm ± 0.2 mm. Available in blister packs containing 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Almus S.r.l.
Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas SA
Rua De Tapada Grande 2,
Abrunheira, Sintra, 2710 – 228
Portugal

This medicinal product is authorized in other European Economic Area (EEA) Member States under the following names:
Portugal: Tadalafil Pentafarma Especialidades
Spain: Tadalafilo Almus 5 mg comprimidos recubiertos con película EFG
France: Tadalafil Almus 5 mg, comprimé pelliculé

Patient Information Leaflet

Tadalafil Almus 10 mg film-coated tablets, 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Tadalafil Almus is and what it is used for
  2. What you need to know before taking Tadalafil Almus
  3. How to take Tadalafil Almus
  4. Possible side effects
  5. How to store Tadalafil Almus
  6. Contents of the pack and other information

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

Tadalafil Almus is a treatment for men with erectile dysfunction.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil Almus has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse.
Tadalafil Almus contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors.
Following sexual stimulation, Tadalafil Almus helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil Almus will not benefit you if you do not have erectile dysfunction.
It is important to note that Tadalafil Almus 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 Almus

Do not take Tadalafil Almus if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Almus increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.

• you have a severe heart disease or have had a heart attack recently, 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 previously 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 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 Almus. 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,
• a serious liver problem,
• a serious kidney problem.

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

• pelvic surgery,
• removal of all or part of the prostate gland where the nerves to the prostate have been cut (nerve-sparing radical prostatectomy). If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Almus, stop taking Tadalafil Almus and contact your doctor immediately. In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if sudden decrease or loss of hearing occurs, stop taking Tadalafil Almus and contact your doctor immediately.

Tadalafil Almus is not intended for use by women.

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

Other medicines and Tadalafil Almus
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Tadalafil Almus if you are already taking nitrates.
Some medicines may be affected by Tadalafil Almus or may themselves affect how Tadalafil Almus works. Inform 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 for treating 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 Almus with beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Almus works and should be consumed with caution. Consult your doctor for further information.

Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced 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 monitor how you react to the tablets before driving or operating machinery.

Tadalafil Almus contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

Tadalafil Almus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tadalafil Almus

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Almus tablets are for oral use and only for men. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended starting dose is one 10 mg tablet before sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil Almus tablets are for oral use.
You can take the Tadalafil Almus tablet at least 30 minutes before sexual activity. Tadalafil Almus may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Almus more than once a day. Tadalafil Almus 10 mg and 20 mg is intended to be used before anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Almus 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 Almus, 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 Almus than you should
Contact your doctor. You may experience side effects described in section 4.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild to moderate in severity.
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 take nitrates but seek immediate medical help (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Almus (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), distorted central vision, blurred, hazy vision or sudden decrease in vision (frequency not known).

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

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion and digestive disturbances.

Uncommon (seen in 1 to 10 out of 1,000 patients)

• dizziness, stomach discomfort, feeling unwell, malaise (vomiting), acid reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 out of 10,000 patients)

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

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

Some additional rare adverse reactions 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 and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred, hazy vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tadalafil Almus

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 Almus contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are: Tablet core: monohydrate lactose (see also “Tadalafil Almus contains lactose” in section 2), maize starch, pregelatinized starch (maize), crospovidone, sodium lauryl sulfate (see also “Tadalafil Almus contains sodium” in section 2) and magnesium stearate. Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of Tadalafil Almus and contents of the pack
Tadalafil Almus 10 mg film-coated tablets are oval-shaped, dark yellow in colour, with a length of 10.0 mm ± 0.2 mm and a width of 5.5 mm ± 0.2 mm. Available in blister packs containing 4 film-coated tablets.

Tadalafil Almus 20 mg film-coated tablets are oval-shaped, dark yellow in colour, with a length of 12.0 mm ± 0.2 mm and a width of 6.5 mm ± 0.2 mm. Available in blister packs containing 4 or 8 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Almus S.r.l.
Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas SA
Rua De Tapada Grande 2,
Abrunheira, Sintra, 2710 – 228
Portugal

This medicinal product is authorized in other European Economic Area (EEA) Member States under the following names:
Portugal: Tadalafil Pentafarma Especialidades
Spain: Tadalafilo Almus 10 mg & 20 mg comprimidos recubiertos con película EFG
France: Tadalafil Almus 10 mg & 20 mg, comprimé pelliculé