SEROCKFIL 25 mg Film-Coated Tablets

Зміст інструкції

1. SEROCKFIL
   1. What is SEROCKFIL and what is it 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

SEROCKFIL

25 mg film-coated tablets
Sildenafil
Generic medicine

Read this leaflet carefully before 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, 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 SEROCKFIL is and what it is used for
2 What you need to know before you take 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 is SEROCKFIL and what is it used for

SEROCKFIL 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. SEROCKFIL will only help you to achieve an
erection if you are sexually stimulated.
SEROCKFIL 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 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 can cause a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines that are often used to relieve angina attacks (or “chest pain”). If you are unsure, ask your doctor or pharmacist

if you are taking one 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 SEROCKFIL, 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 hereditary eye disease (such as retinitis pigmentosa)

• if you have previously experienced loss of vision caused by a 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 (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 heart problems. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual activity
• 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 SEROCKFIL and contact your doctor immediately.

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

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

Children and adolescents
SEROCKFIL should not be given to anyone under the age of 18.

Other medicines and SEROCKFIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
SEROCKFIL tablets can interfere with some medicines, especially those used for the
treatment of chest pain. If you should experience a medical emergency, you must inform your doctor, your
pharmacist or your nurse that you have taken SEROCKFIL and when you took it. Do not take SEROCKFIL
together with other medicines unless your doctor has authorized it.
Do not take SEROCKFIL 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 that are often used to relieve angina attacks (or “chest pain”).
Do not take SEROCKFIL if you are using one 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 SEROCKFIL at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when they have
taken SEROCKFIL together with alpha-blockers. This is more likely to happen within 4 hours
of taking SEROCKFIL. To reduce the possibility of these symptoms appearing, you should be on
a regular dose of the 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 for the treatment of heart failure), tell 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 the effect of
SEROCKFIL may be slower if you take it after having a substantial meal.
Drinking alcohol can temporarily impair the ability to achieve an erection. To
get 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 can cause dizziness and can alter your vision. Before driving and using machines you should
be aware of how you react to SEROCKFIL.

SEROCKFIL contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.

SEROCKFIL should not be taken more than once a day.
Do not take the SEROCKFIL film-coated tablets in combination with Viagra or other products
containing sildenafil.
You should take SEROCKFIL approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes 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 be delayed if you have recently
consumed a heavy meal.
If SEROCKFIL 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 SEROCKFIL than you should:
You may notice an increase in unwanted 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, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

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

• Allergic reaction - occurs with a frequency of uncommon(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 with a frequency of uncommon: If it occurs during or after sexual activity:
• 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 people). If this type of erection persists uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction 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.

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 to vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100 people): 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, obstructed 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 warmth and fatigue.

Rare(may affect up to 1 in 1000 people): 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 seminal fluid, dry nose,
swelling of the nasal mucosa, irritability and sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported after marketing. 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 SEROCKFIL.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, 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 SEROCKFIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 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 SEROCKFIL 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 “SEROCKFIL contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “SEROCKFIL contains lactose”), triacetin, indigo carmine (E132).

Description of the appearance of SEROCKFIL and contents of the pack
SEROCKFIL 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 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