PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sildenafil Sandoz 25 mg tablets, 50 mg tablets, 100 mg tablets

Generic Medicine
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Sildenafil Sandoz is and what it is used for
What you need to know before taking Sildenafil Sandoz
How to take Sildenafil Sandoz
Possible side effects
How to store Sildenafil Sandoz
Further information

1. What Sildenafil Sandoz is and what it is used for

Sildenafil Sandoz contains the active substance sildenafil, which belongs to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by
helping to relax the blood vessels in the penis, allowing blood to flow into the penis when
sexually stimulated. Sildenafil Sandoz will help you achieve an erection only if you are
sexually stimulated.
Sildenafil Sandoz is a treatment for adult men who suffer from 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 Sildenafil Sandoz

Do not take Sildenafil Sandoz

If you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
if you are already taking medicines called nitrates, because this combination can cause a dangerous drop in blood pressure. If you are taking any of these medicines, which are often used to relieve angina pectoris (or “chest pain”), inform your doctor. 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 Sildenafil Sandoz, 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 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 caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Sandoz

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 additional physical strain of sexual activity;
if you currently have a stomach ulcer or coagulation disorders (such as hemophilia);
if you suddenly experience a decrease or loss of vision, stop taking Sildenafil Sandoz and contact your doctor immediately.

Do not take Sildenafil Sandoz together with any other oral or
topical treatment for erectile dysfunction.
Do not use Sildenafil Sandoz together with treatments for pulmonary arterial
hypertension (PAH) containing sildenafil or with any other phosphodiesterase
type 5 (PDE5) inhibitors.
Do not use Sildenafil Sandoz if you do not have erectile dysfunction.
Do not take Sildenafil Sandoz if you are a woman.
Special considerations for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor. Your doctor may
decide to prescribe a lower dose.
Children and adolescents
Sildenafil Sandoz must not be administered to individuals under 18 years of age.
Other medicines and Sildenafil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Sandoz may interact with certain medicines, particularly those used for chest pain. In case of a medical emergency, inform your doctor, pharmacist, or nurse that you have taken Sildenafil Sandoz and when you took it. Do not take Sildenafil Sandoz with other medicines unless specifically instructed by your doctor.
Do not take Sildenafil Sandoz if you are taking medicines called nitrates, because combining these medicines can cause a dangerous drop in blood pressure. Always 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 Sildenafil Sandoz if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a potentially 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 Sildenafil Sandoz (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 up from lying down or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Sandoz together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Sandoz. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Sildenafil Sandoz. Your doctor may start you on a lower dose of Sildenafil Sandoz (25 mg).
Sildenafil Sandoz with food, drinks, and alcohol
Sildenafil Sandoz can be taken with or without food. However, you may notice that the onset of effect of Sildenafil Sandoz is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To get the maximum benefit from this medicine, it is advisable to avoid excessive alcohol consumption before using Sildenafil Sandoz.
Pregnancy, breastfeeding, and fertility
Sildenafil Sandoz is not indicated for use in women.
Driving and using machines
Sildenafil Sandoz may cause dizziness and visual disturbances. Before driving and operating machinery, you should be aware of how you react to Sildenafil Sandoz.
Sildenafil Sandoz 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 Sandoz

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Sandoz more than once a day.
Do not take Sildenafil Sandoz tablets in combination with orodispersible sildenafil-containing medicines.
Take Sildenafil Sandoz approximately one hour before planned sexual activity. Swallow the tablet whole, without chewing, with a glass of water.

Sildenafil Sandoz 25 mg
The score line is only intended to facilitate swallowing the tablet.
How to divide the tablet
Place the tablet on a hard, flat surface with the score line facing upwards. Press your thumb down on the centre of the tablet, which will split into two equal doses. You must take both halves to achieve the minimum effective dose.

Sildenafil Sandoz 50 mg
The tablet may be divided into four equal parts. To take the minimum effective dose, you should take at least two quarters (equivalent to 25 mg).
How to divide the tablet
Place the tablet on a hard, flat surface with the score line facing upwards. Press your thumb down on the centre of the tablet, which will split into four equal doses.

Sildenafil Sandoz 100 mg
The tablet may be divided into four equal parts.
How to divide the tablet
Place the tablet on a hard, flat surface with the deeper score line facing upwards. Press your thumb down on the centre of the tablet, which will split into four equal doses.

If you think that the effect of Sildenafil Sandoz is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Sandoz will help you achieve an erection only if you are sexually stimulated. The time required for Sildenafil Sandoz to take effect varies from person to person, but usually ranges from half an hour to one hour. If you take the medicine with a heavy meal, the effect of Sildenafil Sandoz may take longer to occur.
If Sildenafil Sandoz 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 Sandoz 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, ask 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 the use of Sildenafil Sandoz are usually mild to moderate in intensity and of short duration.

If you experience any of the following serious side effects, stop taking
Sildenafil Sandoz and go to hospital immediately:

An 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 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 you have an erection lasting more than 4 hours, you must contact a 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, blistering of the mouth, genitals and around the eyes, fever.
Seizures or epileptic fits – occur rarely

Other side effects
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,
stuffy nose,
dizziness.

Uncommon (may affect up to 1 in 100 people):

vomiting,
rash,
eye irritation, bloodshot/red eyes, eye pain, flashes of light, visual brightness, light sensitivity, tearing,
palpitations, rapid 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 (including heartburn),
blood in the urine,
pain in arms or legs,
nosebleeds,
sensation of warmth,
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 tightness in the throat,
numbness of the 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 floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the eye,
penile bleeding,
blood in the semen,
dry nose,
swelling of the nasal mucosa,
irritability,
sudden decrease or loss of hearing.

Since marketing, 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 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 Sandoz.

Reporting of side effects
If you get any side effects, including ones 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 Sandoz

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 Sildenafil Sandoz contains
The active substance is sildenafil.
Each tablet contains 25 mg/50 mg/100 mg of sildenafil (as citrate).
The other components are: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose,
copovidone, sodium croscarmellose, magnesium stearate, sodium saccharin, aluminium lake containing indigo carmine (E 132).

Description of the appearance of Sildenafil Sandoz and contents of the pack
The Sildenafil Sandoz 25 mg tablet is round, blue in colour, slightly speckled, with a single break line on one side and engraved with "25" on the other.
The Sildenafil Sandoz 50 mg tablet is round, blue in colour, slightly speckled, with two break lines forming a cross on one side and engraved with "50" on the other.
The Sildenafil Sandoz 100 mg tablet is round, blue in colour, slightly speckled, with two break lines forming a cross on both sides and engraved with "100" on one side.
Sildenafil Sandoz is available in blister packs containing 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer:
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1,
39179 Barleben
Germany
LEK Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana
Slovenia
S.C. Sandoz S.R.L.
7A Livezeni Street,
540472 Targu Mures, Jud. Mures
Romania
LEK S.A.
Ul. Podlipie 16 C, 95 010 Strykow
Poland
LEK S.A.
Ul. Domaniewska 50 C, 02-672 Warszawa
Poland
LEK Pharmaceuticals d.d.
Trimlini 2d, 9220 Lendava
Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria Sildenafil Sandoz 50 mg - Tabletten
Sildenafil Sandoz 100 mg - Tabletten
Belgium Sildenafil Sandoz 25 mg tabletten
Sildenafil Sandoz 50 mg tabletten
Sildenafil Sandoz 75 mg tabletten
Sildenafil Sandoz 100 mg tabletten
Czech Republic Sildenafil Sandoz 50 mg
Sildenafil Sandoz 100 mg
Denmark Sildenafil “1A Farma”
Sildenafil Sandoz 50 mg
Estonia
Sildenafil Sandoz 100 mg
Spain Sildenafilo Sandoz 25 mg comprimidos EFG
Sildenafilo Sandoz 50 mg comprimidos EFG
Sildenafilo Sandoz 100 mg comprimidos EFG
Finland Sildenafil Sandoz 50 mg tabletti
Sildenafil Sandoz 100 mg tabletti
France Sildenafil Sandoz 25 mg, comprimé
Sildenafil Sandoz 50 mg, comprimé
Sildenafil Sandoz 100 mg, comprimé
United Kingdom Sildenafil Sandoz 25 mg tablets
Sildenafil Sandoz 50 mg tablets
Sildenafil Sandoz 100 mg tablets
Greece Sildenafil / Sandoz
Hungary Sildenafil Sandoz 50 mg tabletta
Sildenafil Sandoz 100 mg tabletta
Italy SILDENAFIL SANDOZ
Lithuania Sildenafil Sandoz 50 mg tabletės
Sildenafil Sandoz 100 mg tabletės
Latvia Sildenafil Sandoz 100 mg tabletes
Malta Sildenafil Sandoz 25 mg tablets
Sildenafil Sandoz 50 mg tablets
Sildenafil Sandoz 100 mg tablets
Netherlands Sildenafil Sandoz 25 mg, tabletten
Sildenafil Sandoz 50 mg, tabletten
Sildenafil Sandoz 75 mg, tabletten
Sildenafil Sandoz 100 mg, tabletten
Poland Sildenafil Sandoz
Portugal Sildenafil Sandoz
Sweden Sildenafil 1A Farma 25 mg tablett
Sildenafil 1A Farma 50 mg tablett
Sildenafil 1A Farma 100 mg tablett
Slovakia Sildenafil Sandoz 100 mg tablety