Patient Information Leaflet: Information for the User

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

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

Contents of this leaflet:

What Sesara is and what it is used for
What you need to know before taking Sesara
How to take Sesara
Possible side effects
How to store Sesara
Contents of the pack and other information

1. What Sesara is and what it is used for

Sesara contains the active substance tadalafil, which belongs to a 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 is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, Sesara helps relax the blood vessels in the penis, allowing blood to flow into 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 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. 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 sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the 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 as early as 1–2 weeks after 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 to 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. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Sesara 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.
if you have a serious heart condition or have recently had a heart attack (within the last 90 days).
if you have had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as "stroke of the eye".
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). PDE5 inhibitors such as Sesara have been shown to increase the blood pressure-lowering 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 Sesara.
If you are being treated for erectile dysfunction or benign prostatic hyperplasia: be aware that
sexual activity poses 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 soft capsules, inform your doctor if you have:

a red blood cell disorder (sickle cell anemia).
malignant bone marrow tumor (multiple myeloma).
malignant blood cell tumor (leukemia).
any deformity of the penis, or unwanted or prolonged 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 similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat 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 with damage to the nerves of the prostate (nerve-sparing radical prostatectomy).

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If you experience sudden decrease or loss of vision, stop taking Sesara 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 decrease or loss of hearing, stop taking Sesara and contact your doctor immediately.
Sesara is not intended for use by women for the treatment of erectile dysfunction or
benign prostatic hyperplasia, as these are health issues specific to men.
Children and adolescents
Sesara is not intended for use in children and adolescents under 18 years of age.
Other medicines and Sesara
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Sesara if you are already taking nitrates.
Some medicines may interact with Sesara or may affect how Sesara 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).
protease inhibitors for the treatment of AIDS or HIV infection (ritonavir).
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin (used to treat bacterial infections).
medicines such as ketoconazole or itraconazole tablets (used to treat fungal infections).
other treatments for erectile dysfunction (PDE5 inhibitors).

Sesara with food and alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Sesara, avoid excessive alcohol consumption (more than 5 units of alcohol, blood alcohol level equal to or above 0.08%) as this may increase the risk of dizziness when standing up.
Grapefruit juice may affect how Sesara 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. It is unlikely that these effects would lead to infertility.
Driving and using machines
Dizziness has been reported. Carefully assess how you react to the soft capsules before driving or operating machinery.
Sesara contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 soy, do not use this medicine. It also contains macrogol glycerol ricinoleate, which may cause stomach upset and diarrhea.

3. How to take Sesara

Take Sesara exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Swallow the soft capsule whole with water. The soft capsules can be taken
regardless of food intake.

For the treatment of erectile dysfunction

Flexible dosing, as needed: Sesara 10 mg and 20 mg; the recommended starting dose is one 10 mg capsule taken 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 may take one capsule of Sesara 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 intended to be used prior to anticipated sexual activity and is not
recommended for daily continuous use.

Once-daily dosing: Sesara 5 mg; the recommended dose is one 5 mg soft capsule taken once daily 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 provided as tadalafil 2.5 mg. When taken once daily, Sesara 5 mg allows you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period following administration. Daily administration of Sesara may be beneficial for men who anticipate having sexual activity two or more times per week. It is important to note that Sesara does not work in the absence of 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 soft capsule taken once daily at approximately the same time of day.
If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg soft capsule taken once daily.
Do not take Sesara more than once a day.

If you take more Sesara than you should
If you or someone else takes more Sesara than prescribed, inform your doctor or go immediately to a hospital, taking the medicine pack with you. Adverse 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, provided that more than 8 hours have not passed since the scheduled time; however, do not take a double dose to make up for the forgotten capsule. You must not take Sesara more than once a day.

If you have any questions about the use of 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 intensity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

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 help (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 lasting more than 4 hours, you must 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, listed below, categorized by indication:

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

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, indigestion.
Uncommon (may affect up to 1 in 100 people)
dizziness, stomach ache, feeling unwell, malaise (vomiting), reflux, blurred vision, eye pain, breathing difficulty, blood in urine, prolonged erection, sensation of rapid heartbeat, increased heart rate, high blood pressure, low blood pressure, epistaxis (nosebleed), tinnitus (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, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red and bruised-looking skin rashes), penile haemorrhage, blood in 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, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death. Dizziness is the most frequently reported side effect in men aged over 75 years taking tadalafil. Diarrhoea has been reported more frequently in men aged over 65 years 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. This includes any possible side effects not mentioned in this leaflet. You can also report side effects directly via 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Store in the original blister to protect it from moisture.
Do not dispose of any medicine 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 Sesara contains

The active substance is tadalafil. Each soft capsule contains 5, 10 or 20 mg of tadalafil.
The other components are: Capsule contents: soybean oil, glycerol monocaprylocaprate, macrogol glycerol ricinoleate, macrogol lauric glycerides, poloxamer, butylhydroxyanisole. Capsule shell: gelatin, glycerol, titanium dioxide (E171).

Description of the appearance of Sesara and package contents
The 5 mg soft capsules are white/yellow in colour, size 2, oval-shaped. The capsule length is approximately 9.6 mm and the width approximately 6.4 mm.
The 10 mg soft capsules are white/yellow in colour, size 5, oval-shaped. The capsule length is approximately 12.7 mm and the width approximately 7.5 mm.
The 20 mg soft capsules are white/yellow in colour, size 10, oval-shaped. The capsule length is approximately 14.7 mm and the width 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 EEA Member States under the following names:
Portugal: Sesara
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