Package leaflet: Information for the user

Sildenafil Aurobindo 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Sildenafil
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sildenafil Aurobindo contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into the penis when you are sexually aroused. Sildenafil Aurobindo will help you achieve an erection only if you are sexually stimulated.

Sildenafil Aurobindo is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This occurs when a man is unable to achieve or maintain a penile erection sufficient for sexual activity.

2. What you need to know before taking Sildenafil Aurobindo

Do not take Sildenafil Aurobindo

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 the combination may lead to a dangerous drop in your blood pressure. Inform your doctor if you are taking any such medicine, often prescribed to relieve angina pectoris (or “chest pain”). If you are unsure, ask your doctor or pharmacist.
If you are using medicines known as nitric oxide donors such as amyl nitrite (“poppers”), since this combination may also lead to a dangerous drop in your 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 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 certain rare inherited eye diseases (such as retinitis pigmentosa).
If you have experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Inform your doctor or pharmacist before taking Sildenafil Aurobindo.
Inform your doctor:

If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the white blood cells), or multiple myeloma (cancer of the bone marrow).
If you have a penile deformity or Peyronie’s disease.
If you have heart problems. In this case, your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
If you currently have a stomach ulcer or a bleeding disorder (such as haemophilia).
If you experience sudden decrease or loss of vision, stop taking Sildenafil Aurobindo and contact your doctor immediately.

You must not use Sildenafil Aurobindo together with other oral or topical treatments for erectile dysfunction.
You must not use Sildenafil Aurobindo with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.
Do not take Sildenafil Aurobindo if you do not have erectile dysfunction.
Do not take Sildenafil Aurobindo if you are a woman.
Children and adolescents
Sildenafil Aurobindo must not be given to individuals under 18 years of age.
Special recommendations for patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose.
Other medicines and Sildenafil Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Aurobindo tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, inform the doctor or pharmacist that you are taking Sildenafil Aurobindo and when you last took it. Do not take Sildenafil Aurobindo with other medicines unless your doctor has told you it is safe to do so.
Do not take Sildenafil Aurobindo if you are taking medicines called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any such medicine, often prescribed to relieve angina pectoris (or “chest pain”).
Do not take Sildenafil Aurobindo if you are using medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may lead to a dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, for example for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil Aurobindo.
Some patients taking alpha-blockers for high blood pressure or for enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have developed these symptoms when taking Sildenafil Aurobindo together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Aurobindo. To reduce the likelihood of these symptoms, you should be regularly taking your alpha-blocker before starting Sildenafil Aurobindo. Your doctor may start you on a lower dose (25 mg) of Sildenafil Aurobindo.
Sildenafil Aurobindo with food, drinks and alcohol
Sildenafil Aurobindo can be taken with or without food. However, you may notice that Sildenafil Aurobindo takes longer to work if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from the medicine, it is recommended not to drink excessive amounts of alcohol before taking Sildenafil Aurobindo.
Pregnancy, breastfeeding and fertility
Sildenafil Aurobindo is not indicated for use in women.
Driving and using machines
Sildenafil Aurobindo may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil Aurobindo before driving or operating machinery.
Sildenafil Aurobindo contains lactose
Sildenafil Aurobindo contains monohydrate lactose. If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take Sildenafil Aurobindo

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.
Do not take Sildenafil Aurobindo more than once a day.
Do not take Sildenafil Aurobindo film-coated tablets together with Sildenafil Aurobindo
orally disintegrating tablets.
Take Sildenafil Aurobindo approximately one hour before sexual activity. Swallow the
tablet whole with a glass of water.
If you feel that the effect of Sildenafil Aurobindo is too strong or too weak, talk to your doctor or
pharmacist.
Sildenafil Aurobindo will help you achieve an erection only if you are sexually stimulated. The
time required for Sildenafil Aurobindo to take effect varies from person to person, but normally it takes
between half an hour and one hour. You may notice that Sildenafil Aurobindo takes longer to work if taken
together with a heavy meal.
If Sildenafil Aurobindo 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 Aurobindo than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not
increase the effectiveness of sildenafil.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you take more tablets than prescribed.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects reported with sildenafil are usually mild to moderate and short-lived.
If you experience any of the following side effects, stop taking Sildenafil Aurobindo and seek immediate medical help:

An allergic reaction, which occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden breathlessness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain (this occurs uncommonly). If this occurs during or after sexual intercourse:
- Sit in a semi-upright position and try to relax.
- Do not use nitrates to treat your chest pain.
Prolonged and often painful erections, which occur rarely (may affect up to 1 in 1,000 people). If you have an erection lasting more than 4 hours, you must contact your doctor immediately.
Sudden decrease or loss of vision, which occurs rarely.
Severe skin reactions, which occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters on the mouth, genitals or around the eyes, fever.
Seizures or epileptic fits, which occur rarely.

Other side effects:
Very common (may affect up to 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, blurred colour vision, blurred vision, visual disturbances, nasal congestion, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, bloodshot/red eyes, eye pain, seeing flashes of light, increased light perception, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of 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, gastro-oesophageal reflux disease (symptoms include 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, numbness of 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 floaters in the visual field, seeing halos around lights, pupil dilation, change in the white 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 men who experienced these side effects, but not all, already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these effects are directly related to the use of Sildenafil Aurobindo.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
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 Aurobindo contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt). Each tablet contains 50 mg of sildenafil (as citrate salt). Each tablet contains 100 mg of sildenafil (as citrate salt).
The excipients are: Tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Coating: lactose monohydrate, hypromellose 15 cP, titanium dioxide (E171), triacetin.
Description of the appearance of Sildenafil Aurobindo and package contents
Film-coated tablet.
Sildenafil Aurobindo 25 mg film-coated tablets
White to off-white, round (7.1 mm in diameter), biconvex, film-coated tablets, printed with “SL” on one side and “25” on the other.
Sildenafil Aurobindo 50 mg film-coated tablets
White to off-white, round (9.6 mm in diameter), biconvex, film-coated tablets, printed with “SL” on one side and “50” on the other.
Sildenafil Aurobindo 100 mg film-coated tablets
White to off-white, round (11.2 mm in diameter), biconvex, film-coated tablets, printed with “SL” on one side and “100” on the other.
Sildenafil Aurobindo film-coated tablets are available in blisters and in HDPE bottles.
Blister pack:
25 mg: 2, 4, 8 and 12 film-coated tablets
50 mg and 100 mg: 1, 2, 4, 8 and 12 film-coated tablets.
HDPE bottle:
50 mg: 30, 1000 film-coated tablets.
100 mg: 30, 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 – 21047 Saronno (VA) – Italy
Manufacturer
APL Swift Services (Malta)
Limited, HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia,
BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom
This medicinal product is authorized in the European Economic Area countries under the
following names:
Estonia: Sildenafil Aurobindo 100 mg, õhukese polümeerikattega tabletid
France: SILDENAFIL ARROW LAB 25mg/50 mg/100 mg, comprimé pelliculé
Germany: Sildenafil PUREN 25 mg Filmtabletten
Sildenafil Aurobindo 50 mg/100 mg Filmtabletten
Italy: Sildenafil Aurobindo
Latvia: Sildenafil Aurobindo 100 mg apvalkotās tabletes
Malta: Sildenafil 50 mg/100 mg film-coated tablets
Netherlands: Sildenafil Aurobindo 25 mg/50 mg/100 mg, filmomhulde tabletten
Portugal: Sildenafil Aurobindo
Spain: Sildenafilo Aurobindo 25 mg/50 mg/100 mg comprimidos recubiertos con
película EFG
United Kingdom: Sildenafil 25mg/50 mg/100 mg film-coated tablets