SELDEK 25 mg Tabletki Powlekane

Treść ulotki

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

SELDEK

25 mg film-coated tablets
Sildenafil
Generic medicine

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

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

1. What is SELDEK and what is it used for

SELDEK contains the active ingredient sildenafil which belongs to the class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing blood flow to the penis when it is sexually stimulated. SELDEK will only help you to achieve an erection if you are sexually stimulated.
SELDEK is a treatment for adult men who experience erectile dysfunction, sometimes called impotence. This condition occurs when a man cannot achieve or maintain an erection suitable for sexual intercourse.

2. What you need to know before taking SELDEK

Do not take SELDEK
if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in
section 6)

• if you are taking medicines called nitrates, because this combination can cause a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines which are often used to relieve angina attacks (or “chest pain”). If you are unsure 1/7

about it, ask your doctor or pharmacist
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite
(“poppers”), because this combination can also cause a dangerous drop in blood
pressure

• 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 SELDEK, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor

if you have a serious problem with your heart or liver
if you have recently had a stroke or heart attack, or if you have low blood pressure
if you have a rare inherited eye disease (such as retinitis pigmentosa)
if you have previously experienced loss of vision caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking SELDEK:

• if you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow)
• if you have a deformity of the penis or Peyronie's disease
• if you have problems with your heart. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual intercourse
• if you currently have a stomach ulcer, or problems with blood clotting (such as hemophilia)
• if you experience a sudden decrease or loss of vision, stop taking SELDEK and contact your doctor immediately.

You must not use SELDEK together with other oral or topical treatments for erectile dysfunction.
You must not use SELDEK together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You must not take SELDEK if you do not have erectile dysfunction.
You must not take SELDEK if you are a woman.

Special precautions for patients with kidney or liver problems
If you have problems with your kidneys or liver, you must tell your doctor. Your doctor may decide to give you
a lower dose.

Children and adolescents
SELDEK must not be given to anyone under the age of 18.

Other medicines and SELDEK
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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
SELDEK tablets can interfere with some medicines, particularly those used for the
treatment of chest pain. If you should experience a medical emergency, you must inform your doctor, the
pharmacist or the nurse that you have taken SELDEK and when you took it. Do not take SELDEK together with
other medicines unless your doctor has authorized it.
You must not take SELDEK if you are taking medicines called nitrates because the combination of
these medicines can cause a dangerous drop in blood pressure. Tell your doctor, pharmacist or
nurse if you are taking any of these medicines which are often used to relieve angina attacks (or “chest pain”).
You must not take SELDEK if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”) because this combination can also cause a dangerous drop
in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the treatment
of HIV, your doctor may initially prescribe SELDEK at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when they have
taken SELDEK together with alpha-blockers. This is more likely to happen within 4 hours
of taking SELDEK. To reduce the possibility of these symptoms, you should be on a regular dose of the alpha-blocker before starting treatment with SELDEK. Your doctor may
start you on a lower dose of SELDEK (25 mg).
If you are taking medicines containing sacubitril with valsartan (used for the treatment of heart failure), tell your doctor or pharmacist.

SELDEK with food, drinks and alcohol
SELDEK can be taken with or without food. However, you may notice that the onset of the effect of
SELDEK may be slower if you take it after having a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To
get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of
alcohol before using SELDEK.

Pregnancy, breastfeeding and fertility
SELDEK is not indicated for use in women.

Driving and using machines
SELDEK can cause dizziness and can alter your vision. Before driving and using machines you should be
aware of how you react to SELDEK.

SELDEK contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
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SELDEK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially “sodium
free”.

3. How to take SELDEK

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended starting dose is 50 mg.

SELDEK should not be taken more than once a day.
Do not take the film-coated tablets of SELDEK in combination with Viagra or other products containing
sildenafil.
You should take SELDEK approximately one hour before the anticipated sexual activity. Swallow the tablet whole
with a glass of water.
If you feel that the effect of SELDEK is too strong or too weak, consult your doctor or
pharmacist.
SELDEK will only help you to achieve an erection if you are sexually stimulated. The time it takes for
SELDEK to take effect varies from person to person, but generally ranges from half an hour to an hour.
The effect of SELDEK may be delayed if you have just consumed
a substantial meal.
If SELDEK does not help you to achieve an erection, or if the erection does not last long enough to
complete sexual intercourse, inform your doctor.

If you take more SELDEK than you should
You may notice an increase in undesirable effects and the severity of these effects. Doses greater than 100 mg
do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than those prescribed, contact your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported in association with the use of SELDEK are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop taking SELDEK
and contact your doctor immediately:

• allergic reaction - occurs with a frequency of uncommon(may affect up to 1 in 4/7

100).
Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the
eyelids, face, lips or throat.

• Chest pain - occurs with a frequency of uncommon: If it occurs during or after sexual intercourse:
• assume a semi-sitting position and try to relax
• do not use nitratesto treat chest pain
• prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000). If this type of erection persists uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - occur rarely.

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• Other side effects:

Very common(may affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, flushing, hot flushes (symptoms
include a sudden feeling of warmth in the upper body), indigestion, increased
intensity of colors in vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100): vomiting, rash, eye irritation,
red eyes, eye pain, flashes of light, increased perception of light, sensitivity to light,
tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears,
dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms
include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs,
nosebleeds, feeling of heat and fatigue.

Rare(may affect up to 1 in 1000): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, feeling of constriction
in the throat, numb mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or corpuscles
in the visual field, seeing halos around lights, dilation of the pupils, alteration of the white color
of the sclera (part of the eye), bleeding of the penis, presence of blood in the semen, dry nose,
swelling of the nasal mucosa, irritability and sudden or loss of hearing.
Cases of unstable angina (a heart condition) and sudden death have been reported following post-marketing experience. It should be noted that most men who experienced
these side effects, but not all, had heart problems before using this medicine. It is not
possible to determine whether these events are directly related to the use of SELDEK.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly through the
national reporting system at
https://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 SELDEK

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 blister after EXP.
The expiry date refers to the last day of that month.
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.
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6. Contents of the pack and other information

What SELDEK contains

• The active ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
• The other ingredients are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “SELDEK contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “SELDEK contains lactose”), triacetin, indigo carmine (E132).

Description of the appearance of SELDEK and contents of the pack
SELDEK tablets are film-coated, blue in colour, rounded, biconvex with the number “25” imprinted on one side.
The tablets are available in blisters in packs of 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milano, Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
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