DINAMIS 5 mg Film-Coated Tablets

Зміст інструкції

1. Dinamis 5 mg film-coated tablets
   1. What is Dinamis and what is it 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
2. Dinamis 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Dinamis and what is it 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. Package Contents and Other Information

Dinamis 5 mg film-coated tablets

Tadalafil
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 Dinamis is and what it is used for
• 2. What you need to know before you take 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 is Dinamis and what is it used for

Dinamis contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
Dinamis 5 mg is a treatment for men with:

• erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection suitable for sexual intercourse. Dinamis has been shown to significantly improve the ability to achieve an erection suitable for sexual intercourse. After sexual stimulation Dinamis helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this 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 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.
• 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 to urinate, a feeling of not emptying the bladder completely, and a more frequent need to urinate, even at night. Dinamis improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. Dinamis has been shown to improve these urinary symptoms within 1-2 weeks of 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 are unsure, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low or uncontrolled high blood pressure.
• you have previously experienced a loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION), a condition described as “an eye stroke”.
• 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 increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions
Talk to your doctor before taking Dinamis.
You should be aware that sexual activity carries a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart problem, tell your doctor.
As benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform checks for prostate cancer before starting treatment with Dinamis for benign prostatic hyperplasia. Dinamis does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of bone marrow).
• leukaemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious 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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, stop taking Dinamis and contact your doctor immediately.
A decrease or sudden 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 a sudden decrease 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 the age of 18 years.

Other medicines and Dinamis
Tell 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 can be affected by Dinamis or they themselves can affect how Dinamis 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.

Dinamiswith food and drink and alcohol
Information on the effects of alcohol is given in section 3.
Grapefruit juice can affect how Dinamis works and should be taken with caution. Ask your doctor for further information.

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

Driving and using machines
Some men taking Dinamis during clinical studies reported dizziness. Carefully check how you react to the tablets before driving or using machines.

Dinamiscontainslactoseand sodium
If you have been diagnosed with 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 following exactly the instructions of your doctor. 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. The tablets can be taken independently of food intake.
Drinking alcohol may temporarily cause a decrease in your blood pressure.
If you have taken or intend to take Dinamis, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher) as this may increase the
risk of dizziness when you stand up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet to be taken once a day at approximately the
same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to
Dinamis. This dose will be given to you with a 2.5 mg tablet.
Do not take Dinamis more than once a day.
When taken once a day, Dinamis allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. Daily administration of Dinamis may be useful for men who anticipate having
sexual activity two or more times a week.
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 would if you were not taking medication for
erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

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

If you take more Dinamisthan you should
Contact your doctor. Side effects as described in section 4 may occur.

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 a
missed tablet. You should not take Dinamis more than once a day.
If you have any further questions on 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 usually mild to moderate in nature.

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

• allergic reactions, including skin rashes (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 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 (may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, hot flushes on the face, nasal congestion, digestive disorders

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach pain,
• feeling unwell, malaise (vomiting), reflux,
• blurred vision, eye soreness, difficulty breathing, blood in the urine, prolonged erection, feeling of a strong 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, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and urticaria (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking Dinamis, heart attacks and strokes have been reported.
Most 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 Dinamis. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that change the 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
who were taking Dinamis. Diarrhea has been reported more frequently in men over 65 years of age
who were taking Dinamis.

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 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 which is stated on the box and 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 Dinamis contains

• The active ingredient is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose (E468), sodium lauryl sulfate and magnesium stearate (E470b). The tablet coating contains hypromellose, lactose monohydrate, 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 colour, oval in shape,
10 mm x 6.0 mm in diameter, with “5” imprinted on one side and smooth on the other.

Packs
Dinamis 5 mg is available in packs containing blisters of 14, 28 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following designations:
SE: Dinamis
IT: Dinamis

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

Tadalafil
Generic medicine

Read this leaflet carefully before you start to take 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 may 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 Dinamis is and what it is used for
• 2. What you need to know before you take 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 is Dinamis and what is it for

Dinamis is a treatment for men with erectile dysfunction. This condition occurs when
a man is unable to achieve or maintain an erection adequate for sexual intercourse.
Dinamis has been shown to significantly improve the ability to achieve an erection adequate for
sexual intercourse.
Dinamis contains the active substance tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation Dinamis helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result of this 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 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 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, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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 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 Dinamis.
You should be aware that sexual activity carries a potential risk for patients with heart disease, as 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 deformity of the penis.
• a serious liver problem.
• a serious 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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, stop taking Dinamis and contact your doctor immediately.
A decrease or sudden loss of hearing has been observed in some patients treated with tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience a sudden decrease 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 the age of 18 years.

Other medicines and Dinamis
Tell 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 can be affected by Dinamis or they themselves can affect how Dinamis 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.

Dinamiswith food and drink and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how Dinamis works and should be taken with caution. Ask your doctor for further information.

Fertility
In dogs treated with the drug, 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 Dinamis during clinical studies have reported dizziness. Carefully check how you react to the tablets before driving or using machinery.

Dinamiscontainslactose and sodium
If your doctor has told you that you have an intolerance to some 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 following exactly the instructions of your doctor. If you have any doubts, ask 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 independently of food intake.

The recommended initial doseis one 10 mg tablet before sexual activity.
If the effect of this dosage is too weak, your doctor may increase the dose to 20 mg. Dinamis
tablets are for oral use.
You can take the 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 indicated before
planned sexual activity and is not recommended for continuous daily use.
It is important to note that Dinamis 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 alcohol 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 Dinamis, 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 Dinamisthan you should
Contact your doctor. Side 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 everyone will experience them. These effects are usually mild to moderate in nature.

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

• allergic reactions, including skin rashes (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 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 (may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon (may affect up to 1 in 100 people)
dizziness, stomach pain, feeling unwell, malaise (vomiting), reflux, blurred vision, eye soreness, difficulty breathing, presence of blood in the urine, prolonged erection, feeling of a strong 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, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin surface), bleeding of the penis, presence of blood in the semen and increased sweating.

Rarely, in men taking Dinamis, heart attacks and strokes have been reported. Most 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 Dinamis. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter 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 effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 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 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 Dinamis contains

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

Description of the appearance of Dinamis and package contents
Dinamis 10 mg
Dinamis 10 mg is a film-coated tablet of light yellow color, 11 mm x 6.6 mm in
diameter, oval in shape, with “10” imprinted on one side and smooth on the other side.
Dinamis 10 mg is available in packs containing blister packs of 4 tablets.
Dinamis 20 mg
Dinamis 20 mg is a film-coated tablet of light yellow color, oval in shape, 12 mm x 7.4
mm in diameter, marked “20” on one side and smooth on the other side.
Dinamis 10 mg is available in packs containing blister packs of 2, 4 and 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
SE: Dinamis
IT: Dinamis