SESARA 5 mg Miękkie Kapsułki

Treść ulotki

1. Sesara 5 mg, soft capsules, 10 mg, soft capsules, 20 mg, soft capsules
   1. What is Sesara and what is it used for
   2. What you need to know before taking Sesara
   3. How to take Sesara
   4. Possible side effects
   5. How to store Sesara
   6. Contents of the pack and other information

Sesara 5 mg, soft capsules, 10 mg, soft capsules, 20 mg, soft capsules

Tadalafil
Generic medicine

Read this leaflet carefully before you start 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 Sesara is and what it is used for
• 2. What you need to know before you take Sesara
• 3. How to take Sesara
• 4. Possible side effects
• 5. How to store Sesara
• 6. Contents of the pack and other information

1. What is Sesara and what is it used for

Sesara contains the active ingredient tadalafil, which belongs to the class of medicines
called phosphodiesterase type 5 inhibitors.
Sesara 5 mg, 10 mg and 20 mg is a treatment for adult men with erectile dysfunction

• This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation, Sesara helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Sesara 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. Sesara 5 mg is a treatment for adult men with 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 feeling of not emptying the bladder completely, and a more frequent need to urinate, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

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2. What you need to know before taking Sesara

Do not take Sesara:

• 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 (or “chest pain”). It has been shown that Sesara 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 recently, within the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have previously experienced 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 Sesara, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking Sesara.
If you are being treated for erectile dysfunction or benign prostatic hyperplasia: be aware that
sexual activity involves a potential risk for patients with heart disease, because
it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the soft capsules, tell your doctor if you have:

• an abnormality of red blood cells (sickle cell anemia).
• cancer of the bone marrow (multiple myeloma).
• cancer of the blood cells (leukemia).
• any deformity of the penis, or unwanted or persistent erections lasting more than 4 hours
• a serious liver problem.
• a serious kidney problem.
• heart problems other than pulmonary hypertension.
• blood pressure problems.
• any hereditary eye disease.

If you are being treated for benign prostatic hyperplasia: since benign prostatic hyperplasia and prostate
cancer can have the same symptoms, your doctor will perform checks for prostate cancer
before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not cure
prostate cancer.
It is not known whether Sesara 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 nerve sparing).

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

Sesara is not indicated for use by women for the treatment of erectile dysfunction or
benign prostatic hyperplasia, as these are health problems specific to men.
Children and adolescents
Sesara is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Sesara
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

Do not takeSesara if you are already taking nitrates.
Some medicines can be affected by Sesara or they themselves can affect how
Sesara 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).
• protease inhibitors for the treatment of AIDS or HIV infection (ritonavir).
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin (for treating bacterial infections);
• medicines such as ketoconazole or itraconazole tablets (for treating fungal infections).
• other treatments for erectile dysfunction (PDE5 inhibitors).

Sesara with drinks and alcohol
Drinking alcohol can temporarily cause a decrease in your blood pressure. If you have taken or intend to take Sesara, avoid excessive alcohol consumption (more than 5 units of alcohol, blood alcohol level of 0.08% or higher) as this may
increase the risk of dizziness when you get up.
Grapefruit juice can affect how Sesara works and should be taken with
caution. Ask your doctor for further information.

Fertility
In dogs treated, a reduction in sperm development in the testicles was observed. In some
men, a decrease in sperm count has been observed. It is unlikely that these effects will cause
infertility.

Driving and using machines
Dizziness has been reported. Carefully check how you react to the soft capsules before driving or
using machines.

Sesara contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.
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Sesara contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

Sesara contains refined soybean oil.If you are allergic to peanuts or soybeans, do not use this
medicine. It also contains macrogolglycerol ricinoleatewhich can cause stomach upset and
diarrhea.

3. How to take Sesara

Take Sesara following your doctor’s instructions exactly. If you have any doubts, ask your doctor or
pharmacist.
Swallow the soft capsule whole with water. The soft capsules can be taken
independently of food intake.

For the treatment of erectile dysfunction

• Flexible dose, as needed: Sesara 10 mg and 20 mg; the recommended starting dose is one 10 mg capsule before sexual activity. If the effect of the recommended 10 mg dose is too weak, your doctor may increase the dose to 20 mg. You can take one Sesara capsule at least 30 minutes before sexual activity.

Sesara may still be effective up to 36 hours after taking the soft capsule.
Sesara 10 mg and 20 mg is indicated for use before planned sexual activity and is not
recommended for continuous daily use.

• Once-daily dosage: Sesara 5 mg; the recommended dose is one 5 mg soft capsule 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 Sesara. This dose will be given with 2.5 mg of tadalafil. When taken once a day, Sesara 5 mg allows you to achieve an erection, if there is sexual stimulation, at any time of the day within 24 hours. Daily administration of Sesara 5 mg may be useful for men who anticipate having sexual activity two or more times a week. It is important to note that Sesara 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 medication for erectile dysfunction. Drinking alcoholic beverages may interfere with your ability to achieve an erection.

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

If you take moreSesara than you should
If you or others take more Sesara than you should, inform your doctor or go to the hospital immediately, bringing
the package of the medicine with you. Side effects described in
section 4 may occur.

If you forget to take Sesara
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Take your dose as soon as you remember if no more than 8 hours have passed since the scheduled
time for taking it, but do not take a double dose to make up for a missed
capsule. You should not take Sesara more than once a day.
If you have any questions about using 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 you experience any of the following side effects, stop using the medicine and seek
immediate medical assistance:

• allergic reactions, including skin rashes (common frequency, may affect up to 1 in 10 people).
• chest pain - do not use nitrates but seek immediate medical assistance (common frequency, may affect up to 1 in 10 people).
• priapism, a prolonged and sometimes painful erection after taking tadalafil (uncommon frequency, may affect up to 1 in 100 people). 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, may affect up to 1 in 1,000 people). Other side effects have been reported, which are listed below, broken down by indication:

Side effects in erectile dysfunction or benign prostatic hyperplasia
Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion, digestive disorders. Uncommon(may affect up to 1 in 100 people)
• dizziness, stomach discomfort, feeling unwell, feeling sick (vomiting), reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, feeling of a fast-beating heart, high heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of 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, decreased or sudden loss of hearing, hives (red and itchy raised areas on the skin), bleeding of the penis, blood in semen and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking tadalafil.
Most of these subjects had pre-existing heart problems 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 and throat, severe skin reactions, some disorders that change blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death. Dizziness is the most frequently reported side effect in men over the age of 75 years taking tadalafil. Diarrhoea was reported more
  frequently in men over 65 years of age taking tadalafil.

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superior to 75 years who were taking tadalafil. Diarrhoea was reported more
frequently in men over 65 years of age who were taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. This includes all possible side effects not listed
in this leaflet. You can also report side effects directly through
the national reporting system at:
https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store Sesara

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.
Do not use this medicine if you notice that the package is damaged or shows signs of
tampering.
Store in the original blister pack to protect it from moisture.
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. Contents of the pack and other information

What Sesara contains

• The activesubstance is tadalafil. Each soft capsule contains 5, 10 or 20 mg of tadalafil.
• The other ingredientsare: Capsule contents: soybean oil, glycerol monocaprylocaprate, macrogolglycerol ricinoleate, macrogol laurates, poloxamer, butylated hydroxyanisole. Capsule shell: gelatin, glycerol, titanium dioxide (E171).

Description of the appearance of Sesara and contents of the pack
The 5 mg soft capsules are white/yellow in colour, size 2, oval in shape. The
capsule length is approximately 9.6 mm and the width is approximately 6.4 mm.
The 10 mg soft capsules are white/yellow in colour, size 5, oval in shape. The
capsule length is approximately 12.7 mm and the width is approximately 7.5 mm.
The 20 mg soft capsules are white/yellow in colour, size 10, oval in shape. The
capsule length is approximately 14.7 mm and the width is approximately 9.3 mm.
Available in PVC/PE/PVDC/Al blisters in packs of 4, 8, 28 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Lampugnani Farmaceutici S.p.A.
Via Gramsci 4
20014 Nerviano (MI)
Italy
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Manufacturer
GAP S.A.
46, Agissilaou str.,
173 41 Agios Dimitrios, Attiki,
Greece

This medicinal product is authorised in the Member States of the EEA with the following
names:
Portugal: Sesara
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