Sildenafil Eg Stada: detailed information

Patient Information Leaflet: Information for the User

Sildenafil EG STADA 25 mg chewable tablets, 50 mg chewable tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it may 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

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

1. What Sildenafil EG STADA is and what it is used for

Sildenafil EG STADA 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. Sildenafil EG STADA will help you achieve an erection only if you are sexually stimulated.
Sildenafil EG STADA 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 satisfactory sexual intercourse.

2. What you need to know before taking Sildenafil EG STADA

DO NOT take Sildenafil EG STADA

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, as 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 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 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 Sildenafil EG STADA, have been shown to increase the blood pressure-lowering effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor.
If you have a severe 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 Sildenafil EG STADA

if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (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 haemophilia).
if you experience a sudden decrease or loss of vision, stop taking Sildenafil EG STADA and contact your doctor immediately.

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

Other medicines and Sildenafil EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil EG STADA chewable tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, inform the doctor, pharmacist, or nurse that you have taken Sildenafil EG STADA and when you took it. Do not take Sildenafil EG STADA with other medicines unless your doctor has approved it.
Do not take Sildenafil EG STADA 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").
Do not take Sildenafil EG STADA 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, such as medicines used to treat HIV, your doctor may initially prescribe the lowest dose of Sildenafil EG STADA (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mild confusion, which may be due to low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking sildenafil together with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil EG STADA. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Sildenafil EG STADA. Your doctor may start you on a lower dose of Sildenafil EG STADA (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Sildenafil EG STADA with food, drinks, and alcohol
Sildenafil EG STADA can be taken with or without food. However, you may notice that the onset of action of Sildenafil EG STADA is 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 taking Sildenafil EG STADA.

Pregnancy, breastfeeding, and fertility
Sildenafil EG STADA is not indicated for use in women.

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

Sildenafil EG STADA contains aspartame
This medicine contains 2.2 mg of aspartame in each 25 mg chewable tablet.
This medicine contains 4.3 mg of aspartame in each 50 mg chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

Sildenafil EG STADA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Sildenafil EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Sildenafil EG STADA

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.
Sildenafil EG STADA must not be taken more than once a day.
Do not take Sildenafil EG STADA chewable tablets in combination with sildenafil in the form of
film-coated tablets.
Take Sildenafil EG STADA approximately one hour before anticipated sexual activity. The tablet must
be chewed completely.
If you feel that the effect of Sildenafil EG STADA is too strong or too weak, consult your
doctor or pharmacist.
Sildenafil EG STADA will help you achieve an erection only if you are sexually stimulated. The time required
for Sildenafil EG STADA to take effect may vary from person to person, but generally ranges
from half an hour to one hour. The effect of Sildenafil EG STADA may take longer if you have
recently eaten a heavy meal.
If Sildenafil EG STADA 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 Sildenafil EG STADA 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 gets them.

The side effects reported in association with sildenafil use are usually mild to moderate in intensity and of short duration.

If you experience any of the following serious side effects, stop taking Sildenafil EG STADA 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 it occurs during or after sexual intercourse:
o Sit in a semi-upright position and try to relax.
o 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, rash with blisters in the mouth, genital area or around the eyes, fever.
Seizures or fits – 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 part of the body), indigestion, colour tinge in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, red eyes, eye pain, seeing flashes of light, visual brightness, light-sensitive eyes, 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, 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, nosebleeds, feeling 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 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 your visual field, seeing halos around lights, dilated pupils, change 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 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 sildenafil.

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 https://www.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 Sildenafil EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to
protect the medicine from light.
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. Package contents and other information

What Sildenafil EG STADA contains

The active substance is sildenafil.

Each chewable tablet contains 25 mg of sildenafil (as citrate).
Each chewable tablet contains 50 mg of sildenafil (as citrate).

The other components are: cross-linked polyvinylpyrrolidone potassium, anhydrous colloidal silica, monohydrate lactose (see section 2 “Sildenafil EG STADA contains lactose”), povidone K-30, aspartame (E951) (see section 2 “Sildenafil EG STADA contains aspartame”), sodium croscarmellose, peppermint flavour (maltodextrin (from maize), modified starch E1450, peppermint oil), magnesium stearate, potassium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment).

Description of the appearance of Sildenafil EG STADA and contents of the pack
Sildenafil EG STADA 25 mg are white, triangular, biconvex chewable tablets with a nominal diameter of 7.3×7.0 mm, marked with the number “25” in relief on one side.
Sildenafil EG STADA 50 mg are white, triangular, biconvex chewable tablets with a nominal diameter of 8.8×8.6 mm, marked with the number “50” in relief on one side.
Blister packs in cardboard boxes:
25 mg: packs containing 2, 4 or 8 chewable tablets.
50 mg: packs containing 2, 4 or 8 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Genepharm S.A., 18th km Marathonos Avenue, 15351 Pallini, Greece
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Clonmel Healthcare Limited, Waterford Road 3, Clonmel, Co. Tipperary, Ireland
Centrafarm Services B.V., Van de Reijtstraat 31 E, 4814 NE, Breda, The Netherlands

The medicine is authorised in the European Economic Area member states under the following names:
BG Sildenafil STADA AG 25 mg/50 mg chewable tablets
CZ Sildenafil STADA
EE Sildenafil STADA
HU Sildenafil STADA 25 mg/50 mg rágótabletta
IE Sildenafil Clonmel 25 mg/50 mg chewable tablets
IT Sildenafil EG STADA
LT Sildenafil STADA AG 25 mg/50 mg kramtomosios tabletės
LV Sildenafil STADA 25 mg/50 mg košļājamās tabletes
MT Sildenafil Clonmel 25 mg/50 mg chewable tablets
NL Sildenafil HTP 25 mg/50 mg, kauwtabletten
NO Sildenafil STADA
RO Sildenafil Stada 25 mg/50 mg comprimate masticabile
SK Sildenafil STADA 25 mg/50 mg