Serockfil

Italy
Brand name Serockfil
Form tablets, film-coated
Active substance / Dosage
SILDENAFIL
Prescription type Prescription only
ATC code
G04BE03
Registration number 049519
Manufacturer ADAMED PHARMA S.A.

Table of Contents

Package leaflet: Information for the patient

SEROCKFIL

25 mg film-coated tablets
Sildenafil
Generic medicine
Read this entire leaflet carefully before you start 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 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, inform your doctor, pharmacist, or nurse. See section 4.

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

1. What SEROCKFIL is and what it is used for

SEROCKFIL 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 flow into the penis during sexual stimulation. SEROCKFIL will help you achieve an erection
only if you are sexually stimulated.
SEROCKFIL 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 SEROCKFIL

Do not take SEROCKFIL
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 angina pectoris attacks (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 due to blood clots). PDE5 inhibitors, such as SEROCKFIL, 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

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 SEROCKFIL:

  • if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer)
  • 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 activity
  • 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 SEROCKFIL and contact your doctor immediately.

You must not use SEROCKFIL together with other oral or local treatments for erectile dysfunction.
You must not use SEROCKFIL together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take SEROCKFIL if you do not have erectile dysfunction.
You must not take SEROCKFIL 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
SEROCKFIL must not be given to individuals under 18 years of age.
Other medicines and SEROCKFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SEROCKFIL 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 SEROCKFIL and when you took it. Do not take SEROCKFIL together with other medicines unless your doctor has specifically authorized it.
You must not take SEROCKFIL if you are taking medicines called nitrates, because combining 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”).
You must not take SEROCKFIL 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 SEROCKFIL (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking SEROCKFIL together with alpha-blockers. This is more likely to occur within 4 hours after taking SEROCKFIL. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with SEROCKFIL. Your doctor may start you on a lower dose of SEROCKFIL (25 mg).
If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), inform your doctor or pharmacist.
SEROCKFIL with food, drinks and alcohol
SEROCKFIL can be taken with or without food. However, you may notice that the onset of SEROCKFIL’s effect is 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 using SEROCKFIL.
Pregnancy, breastfeeding and fertility
SEROCKFIL is not indicated for use in women.
Driving and using machines
SEROCKFIL may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to SEROCKFIL.
SEROCKFIL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
SEROCKFIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take SEROCKFIL

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
Do not take SEROCKFIL more than once a day.
Do not take SEROCKFIL film-coated tablets in combination with Viagra or other products containing sildenafil.
You should take SEROCKFIL approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of SEROCKFIL is too strong or too weak, consult your doctor or pharmacist.
SEROCKFIL will help you achieve an erection only if you are sexually stimulated. The time required for SEROCKFIL to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of SEROCKFIL may take longer if you have just eaten a heavy meal.
If SEROCKFIL 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 SEROCKFIL 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 how to use 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 SEROCKFIL are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking SEROCKFIL and contact your doctor immediately:

  • Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
  • Chest pain – occurs uncommonly: If this 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 skin peeling and swelling, mouth blisters, blisters in the genital area or around the eyes, fever.
    • Seizures or convulsions – occur rarely.

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, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, eye redness, eye pain, light flashes, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested sinuses, nasal mucosal inflammation (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include 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 certain areas of the brain, throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, eye or eyelid swelling, appearance of spots or floaters 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, nasal mucosal swelling, irritability, and 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 already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of SEROCKFIL.

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 address:
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 SEROCKFIL

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 medicines 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 SEROCKFIL contains

  • The active substance 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 “SEROCKFIL contains sodium”), magnesium stearate.
    Coating: hypromellose, titanium dioxide (E171), monohydrate lactose (see section 2 “SEROCKFIL contains lactose”), triacetin, indigo carmine (E132).

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

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