Dinamis

Package leaflet: Information for the user

Dinamis 5 mg film-coated tablets

Tadalafil
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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Dinamis is and what it is used for

Dinamis contains the active substance tadalafil, which belongs to a class of medicines known as
phosphodiesterase type 5 inhibitors.
Dinamis 5 mg 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. Dinamis has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, Dinamis helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Dinamis will not help you if you do not have erectile dysfunction. It is important to note that Dinamis for the treatment of erectile dysfunction has no effect without 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 a more frequent need to urinate, including during the night. Dinamis improves blood flow and relaxes the smooth muscle of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Dinamis has been shown to improve these urinary symptoms as early as 1–2 weeks after starting treatment.

2. What you need to know before taking Dinamis

Do not take Dinamis 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 nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Dinamis has been shown to increase 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 Dinamis, have been shown to enhance 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 Dinamis.
You should 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 any heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Dinamis for benign prostatic hyperplasia. Dinamis does not treat prostate cancer.
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 blood cell disorder).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

It is not known whether Dinamis 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 severed (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden decrease or loss of vision, stop taking Dinamis 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 you experience sudden reduction or loss of hearing, stop taking Dinamis and contact your doctor immediately.
The use of Dinamis is not indicated in women.
Children and adolescents
The use of Dinamis is not indicated in children and adolescents under 18 years of age.
Other medicines and Dinamis
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Dinamis if you are already taking nitrates.
Some medicines may be affected by Dinamis or may themselves affect how Dinamis 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, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Dinamis with food and drink and alcohol
Information on the effects of alcohol is provided in section 3.
Grapefruit juice may affect how Dinamis 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, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Dinamis in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Dinamis contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Dinamis

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

For the treatment of erectile dysfunction
Recommended dose: One 5 mg 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 Dinamis. This lower dose will be provided as a 2.5 mg tablet.
Do not take Dinamis more than once a day.
When taken once daily, Dinamis allows you to achieve an erection, provided there is sexual stimulation, at any time within 24 hours after dosing. Taking Dinamis once daily may benefit men who anticipate having sexual activity two or more times per week.
It is important to note that Dinamis does not work without 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 alcohol may interfere with your ability to achieve an erection.

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

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

If you forget to take Dinamis
Take your dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Dinamis more than once a day.

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 everyone gets them. These side effects are usually mild to moderate in nature.
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 Dinamis (rare frequency). If you have an erection of this type lasting for more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects reported:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Rarely, heart attacks and strokes have been reported in men taking Dinamis.
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 side effects not observed during clinical studies have been reported in men taking Dinamis. 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.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Dinamis. Diarrhoea has been reported more frequently in men over 65 years of age taking Dinamis.
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 Dinamis

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 in use. This will help protect the environment.

6. Package contents and other information

What Dinamis contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are monohydrate lactose, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose (E468), sodium lauryl sulfate and magnesium stearate (E470b). The tablet coating contains hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin (E1518), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Dinamis and contents of the pack
Dinamis 5 mg is a film-coated tablet (tablet) of light yellow color, oval in shape,
10 mm x 6.0 mm in diameter, with "5" engraved on one side and smooth on the other.
Pack sizes
Dinamis 5 mg is available in packs containing blisters of 14, 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina 1143
00156 Roma
Italy
Manufacturers
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1,
03012 Anagni (FR)
Italy
This medicinal product is authorized in the European Economic Area countries under the
following names:
SE: Dinamis
IT: Dinamis

Package leaflet: Information for the user

Dinamis 10 mg film-coated tablets, 20 mg film-coated tablets

Tadalafil
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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dinamis is and what it is used for

Dinamis 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. Dinamis has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.
Dinamis contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Dinamis helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Dinamis will not help you if you do not have erectile dysfunction.
It is important to note that Dinamis 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 Dinamis

Do not take Dinamis 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. These are a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Dinamis has been shown to increase 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 due to blood clots). PDE5 inhibitors, such as Dinamis, 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 Dinamis.
You should 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 any heart problems, 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 severe liver problem.
• a severe kidney problem.

It is not known whether Dinamis 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, stop taking Dinamis and contact your doctor immediately.
In some patients treated with tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known if this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Dinamis and contact your doctor immediately.
The use of Dinamis is not indicated in women.
Children and adolescents
The use of Dinamis is not indicated in children and adolescents under 18 years of age.
Other medicines and Dinamis
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Dinamis if you are already taking nitrates.
Some medicines may be affected by Dinamis or may themselves affect how Dinamis 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 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.

Dinamis with food and drink and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Dinamis 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 Dinamis during clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Dinamis contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Dinamis

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Dinamis tablets are for oral use and for men only. Swallow the tablet whole with water. Dinamis tablets can be taken regardless of food intake.
The recommended starting dose is one 10 mg tablet taken before sexual activity.
If this dose is not effective enough, your doctor may increase the dose to 20 mg. Dinamis tablets are for oral use.
You can take a Dinamis tablet at least 30 minutes before sexual activity. Dinamis may still be effective up to 36 hours after taking the tablet.
Do not take Dinamis more than once a day. The use of Dinamis 10 mg and 20 mg is intended prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Dinamis 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 cause a drop in your blood pressure. If you have taken or plan to take Dinamis, 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 Dinamis 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 everyone experiences them. These side effects are usually mild to moderate in nature.
If you experience any of the following side effects, stop using the medicine and seek immediate medical assistance:

• allergic reactions, including skin rash (uncommon frequency).
• chest pain – do not use nitrates but seek immediate medical assistance (uncommon frequency).
• Priapism, a prolonged and possibly painful erection after taking Dinamis (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:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)
dizziness, stomach discomfort, feeling unwell, nausea (vomiting), acid reflux,
blurred vision, eye discomfort, breathing difficulties, presence of blood in the
urine, prolonged erection, sensation of strong heartbeat, rapid heartbeat,
high blood pressure, low blood pressure, nosebleeds, ringing in the ears,
swelling of the hands, feet or ankles, and feeling tired.

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

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

Rarely, in men taking Dinamis, 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 side effects not observed during clinical studies have been reported in men taking Dinamis. 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.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Dinamis. Diarrhea has been reported more frequently in men over 65 years of age taking Dinamis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Dinamis

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 required. This will help protect the environment.

6. Package contents and other information

What Dinamis contains

• The active substance is tadalafil. Dinamis 10 mg: each tablet contains 10 mg of tadalafil. Dinamis 20 mg: each tablet contains 20 mg of tadalafil.
• The other components are: monohydrate lactose, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose (E468), sodium lauryl sulfate, magnesium stearate (E470b). The tablet coating contains hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin (E1518), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Dinamis and the contents of the pack
Dinamis 10 mg
Dinamis 10 mg is a film-coated tablet, light yellow in colour, oval-shaped, 11 mm x 6.6 mm in diameter, marked with "10" on one side and smooth on the other.
Dinamis 10 mg is available in packs containing blisters of 4 tablets.

Dinamis 20 mg
Dinamis 20 mg is a film-coated tablet, light yellow in colour, oval-shaped, 12 mm x 7.4 mm in diameter, marked with "20" on one side and smooth on the other.
Dinamis 20 mg is available in packs containing blisters of 2, 4 and 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina 1143
00156 Rome
Italy

Manufacturers
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1,
03012 Anagni (FR)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
SE: Dinamis
IT: Dinamis