PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ZAKFIL 50 mg film-coated tablets
ZAKFIL 100 mg film-coated tablets
Equivalent medicine
Please 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 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What ZAKFIL is and what it is used for

ZAKFIL contains the active substance sildenafil, which belongs to a class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps relax blood vessels in the penis,
allowing increased blood flow to the penis during sexual stimulation. ZAKFIL will help you
achieve an erection only if you are sexually stimulated.
ZAKFIL 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 ZAKFIL

Do not take ZAKFIL

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. Inform 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, consult your doctor or pharmacist;
if you are taking 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 due to blood clots). PDE5 inhibitors such as Zakfil 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

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

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

You must not use ZAKFIL together with other oral or local treatments for erectile dysfunction.
You must not use ZAKFIL together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take ZAKFIL if you do not have erectile dysfunction.
You must not take ZAKFIL 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
ZAKFIL must not be administered to individuals under 18 years of age.

Other medicines and ZAKFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ZAKFIL 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 ZAKFIL and when you took it.
Do not take ZAKFIL with other medicines unless authorized by your doctor.
Do not take ZAKFIL if you are taking medicines called nitrates, because combining these medicines can 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 attacks (or “chest pain”).
Do not take ZAKFIL if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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, such as medicines used to treat HIV, your doctor may initially prescribe the lowest dose of ZAKFIL (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 down or standing up quickly. Some patients have reported these symptoms when taking ZAKFIL together with alpha-blockers. This is most likely to occur within 4 hours after taking ZAKFIL. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting ZAKFIL treatment. Your doctor may start you on a lower dose of ZAKFIL (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

ZAKFIL with food, drinks, and alcohol
ZAKFIL can be taken with or without food. However, you may notice that the onset of ZAKFIL’s effect may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your 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 ZAKFIL.

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

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

ZAKFIL contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking ZAKFIL.

3. How to take ZAKFIL

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
ZAKFIL must not be taken more than once a day.
Do not take Zakfil with other medicines containing sildenafil.
You should take ZAKFIL approximately one hour before planned sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of ZAKFIL is too strong or too weak, consult your doctor or pharmacist.
ZAKFIL will help you achieve an erection only if you are sexually stimulated. The time needed for
ZAKFIL to take effect varies from person to person, but generally ranges from half an hour to one
hour. The effect of ZAKFIL may take longer if you have just eaten a heavy meal.
If ZAKFIL 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 ZAKFIL 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 ZAKFIL are usually mild to moderate in severity and short-lived.

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

Allergic reaction – occurs with uncommon frequency (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 uncommon frequency:
If it occurs during or after sexual intercourse:

Sit semi-upright 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, blisters in the mouth, 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, enhanced colour 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, somnolence, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or stuffy nose, nasal mucosal inflammation (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 certain areas of the brain, sensation of throat tightness, numb mouth, bleeding from 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, change 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 conditions before using this medicine. It is not possible to determine whether these events are directly related to the use of ZAKFIL.

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 website www.agenziafarmaco.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 ZAKFIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ZAKFIL contains

The active substance is sildenafil. Each tablet contains 50 mg or 100 mg of sildenafil (as citrate salt).
The other components are:
Core: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate
Coating: Hypromellose, lactose, triacetin, potassium sorbate, titanium dioxide (E171), aluminium lake containing indigo carmine (E132).

Description of the appearance of ZAKFIL and pack contents
ZAKFIL 50 mg film-coated tablets
ZAKFIL tablets are film-coated, blue, rhomboidal, biconvex tablets, marked with "50" on one side.
ZAKFIL 100 mg film-coated tablets
The tablets are film-coated, blue, rhomboidal, biconvex tablets, marked with "100" on one side.
The tablets are available in PVC/PVDC/Al blisters containing 4 or 8 tablets.
Marketing Authorization Holder
Dymalife Pharmaceutical S.r.l., Via Bagnulo, 95, Piano di Sorrento, 80063 (NA), Italy
Manufacturers

Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de’ Stampi - 20089 Rozzano (MI)
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore