Seldek

Italy
Brand name Seldek
Form tablets, film-coated
Active substance / Dosage
SILDENAFIL
Prescription type Prescription only
ATC code
G04BE03
Registration number 049474
Manufacturer ADAMED S.R.L.

Table of Contents

Patient Information Leaflet

SELDEK

25 mg film-coated tablets
Sildenafil
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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including 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 taking 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 SELDEK is and what it is used for

SELDEK contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. SELDEK will help you achieve an erection only if you are sexually stimulated.
SELDEK is a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient 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 may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve attacks of angina pectoris (or “chest pain”). If you have any doubts,
    consult your doctor or pharmacist
    if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may 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). PDE5 inhibitors, such as SELDEK, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor

if you have a serious heart or liver problem
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 sudden vision loss 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 (a blood cell tumor), or multiple myeloma (a bone marrow tumor)
  • if you have a penile deformity or Peyronie’s disease
  • if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual intercourse
  • if you currently have a stomach ulcer or bleeding disorders (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 with any other phosphodiesterase type 5 (PDE5) inhibitors.
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 kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
SELDEK must not be given to individuals under 18 years of age.

Other medicines and SELDEK
2/7
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
SELDEK tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken SELDEK and when it was taken. Do not take SELDEK with other medicines unless your doctor has authorized it.
Do not take SELDEK if you are taking medicines called nitrates, because the combination of these medicines may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or “chest pain”).
Do not take SELDEK if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of SELDEK (25 mg).
Some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking SELDEK together with alpha-blockers. This is more likely to occur within 4 hours after taking SELDEK. To reduce the likelihood of these symptoms, you should already be on a stable dose of an 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 to treat heart failure), inform 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 SELDEK’s effect may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before taking SELDEK.

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

Driving and using machines
SELDEK may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to SELDEK.

SELDEK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
3/7

SELDEK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take SELDEK

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
SELDEK must not be taken more than once a day.
Do not take SELDEK film-coated tablets in combination with Viagra or other products containing sildenafil.
Take SELDEK approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel the effect of SELDEK is too strong or too weak, consult your doctor or pharmacist.
SELDEK will help you achieve an erection only if you are sexually stimulated. The time required for SELDEK to take effect varies from person to person, but generally ranges from half an hour to one hour.
The effect of SELDEK may take longer if you have just consumed a heavy meal.
If SELDEK does not help you 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 experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions 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 experiences them. The side effects reported in association with the use of SELDEK are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking SELDEK
and contact your doctor immediately:

  • Allergic reaction – occurs with uncommon frequency (may affect up to 1 in 4 to 100 people).
    Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

  • Chest pain – occurs with uncommon frequency: If it occurs during or after sexual intercourse:

    • Sit in a semi-upright position and try to relax
    • Do not use nitrates to treat chest pain

  • Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously 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, mouth blisters, genital or eye-area blisters, fever.

  • Seizures or convulsions – occur rarely.

5/7

  • Other side effects:

Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, enhanced intensity of colours in vision, blurred vision, visual disturbances, nasal congestion, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensitivity, vertigo, tinnitus, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, epistaxis, sensation of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or particles in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, sudden decrease or loss of hearing.

From post-marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, of the men who experienced these side effects had pre-existing heart conditions 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
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 stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
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.
6/7

6. Package contents and other information

What SELDEK contains

  • The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
  • The other components 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, rounded, biconvex, with the number “25” engraved on one side.
Tablets are available in blisters in packs of 2 or 4 tablets.
It is possible that not all pack sizes are 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
7/7