SILDENAFIL 25 mg Chewable Tablets

Зміст інструкції

1. Sildenafil EG STADA 25 mg chewable tablets, 50 mg chewable tablets
   1. What is Sildenafil EG STADA and what is it used for
   2. What you need to know before taking Sildenafil EG STADA
   3. How to take Sildenafil EG STADA
   4. Possible side effects
   5. How to store Sildenafil EG STADA
   6. Package Contents and Other Information

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

Generic medicine

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 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 Sildenafil EG STADA is and what it is used for
• 2. What you need to know before you take Sildenafil EG STADA
• 3. How to take Sildenafil EG STADA
• 4. Possible side effects
• 5. How to store Sildenafil EG STADA
• 6. Contents of the pack and other information

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

Sildenafil EG STADA 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. Sildenafil EG STADA will only help you
to achieve an erection if you are sexually stimulated.
Sildenafil EG STADA 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 sufficient for 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, because this combination can induce a dangerous drop in blood pressure. Tell 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, 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 induce 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 Sildenafil EG STADA, 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 a 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 had a loss of vision caused by 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 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 should carefully check that your heart condition allows you to cope with the exertion of sexual intercourse.
• if you currently have a stomach ulcer, or bleeding problems (such as hemophilia).
• 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 with 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, you should tell your doctor. Your doctor may decide to give you
a lower dose.

Children and adolescents
Sildenafil EG STADA should not be given to people under the age of 18.

Other medicines and Sildenafil EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The chewable tablets of Sildenafil EG STADA can interfere with some medicines, particularly
those used to treat chest pain. If a medical emergency occurs, you should
tell your doctor, pharmacist or nurse that you have taken Sildenafil EG STADA and when you
used it. Do not take Sildenafil EG STADA together with other medicines, unless authorized by
your doctor.
You must not take Sildenafil EG STADA if you are taking medicines called nitrates because
the combination of these medicines can induce a dangerous drop in blood pressure. Tell your
doctor, pharmacist or nurse if you are taking any of these medicines which are often used
to relieve angina attacks (or “chest pain”).
You must not take Sildenafil EG STADA if you are using one of the medicines known as nitric oxide donors,
such as amyl nitrite (“poppers”) because this combination can also induce 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 Sildenafil EG STADA at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness that may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms
when they have taken sildenafil together with alpha-blockers. This is more likely to occur within 4 hours
of taking Sildenafil EG STADA. To reduce the possibility of these symptoms appearing,
you should be on a regular dose of the alpha-blocker before starting treatment with
Sildenafil EG STADA. Your doctor may start you on a lower dose of Sildenafil EG STADA (25 mg).
Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used for
the treatment of 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 the effect of Sildenafil EG STADA may be slower if you take it after having a substantial meal.
Drinking alcohol can temporarily impair the ability to get an erection. To
get the most 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 operating machinery
Sildenafil EG STADA can cause dizziness and can alter vision. Before driving and operating
machinery you should be aware of 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 that causes a build-up of phenylalanine because the body cannot process it properly.

Sildenafil EG STADA contains lactose
If your doctor has told you that you have an intolerance to some 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 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.

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.
You should take Sildenafil EG STADA approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes
for Sildenafil EG STADA to take effect varies from person to person, but generally ranges
from half an hour to one hour. The effect of Sildenafil EG STADA may be obtained after a
longer interval of time if you have just consumed a substantial meal.
If Sildenafil EG STADA does not help you to achieve an erection, or if the erection does not last for a time
sufficient to complete sexual intercourse, inform your doctor.

If you take more Sildenafil EG STADA 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 prescribed, contact your doctor.
If you have any doubts 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 everybody gets them.
The side effects reported in association with the use of sildenafil are usually mild to
moderate 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 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: o Assume a semi-sitting position and try to relax. o 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, rash with 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 (the
symptoms include a sudden feeling of warmth in the upper part of the body), indigestion,
color disturbances in vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation,
red eyes, eye pain, seeing flashes of light, visual brightness, light-sensitive eye, tearing,
heart palpitations, fast heartbeat, high blood pressure, low blood pressure,
muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, 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 (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds,
feeling of heat 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, feeling of
constriction in the throat, numbness in the 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 your visual field, seeing halos around lights, dilation of the pupils, change in 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 condition) 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 sildenafil.

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://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 on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from light.
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. Package Contents and Other Information

What Sildenafil EG STADA contains

• The active ingredient is sildenafil.

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

• The other ingredients are: potassium polyacrilin, anhydrous colloidal silica, lactose monohydrate (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 corn), modified starch E1450, peppermint oil), magnesium stearate, potassium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment).

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

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

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, Netherlands

The medicinal product is authorised in the Member States of the European Economic Area with 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 chewable tablet
IE Sildenafil Clonmel 25 mg/50 mg chewable tablets
IT Sildenafil EG STADA
LT Sildenafil STADA AG 25 mg/50 mg chewable tablets
LV Sildenafil STADA 25 mg/50 mg chewable tablets
MT Sildenafil Clonmel 25 mg/50 mg chewable tablets
NL Sildenafil HTP 25 mg/50 mg, chewable tablets
NO Sildenafil STADA
RO Sildenafil Stada 25 mg/50 mg chewable tablets
SK Sildenafil STADA 25 mg/50 mg