Sildenafil Zentiva

Package leaflet: Information for the user

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

Equivalent medicine
Please read all of 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 or pharmacist.
• 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sildenafil Zentiva 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 the penis, allowing blood to flow into the penis when you are sexually
stimulated. Sildenafil Zentiva will help you achieve an erection only if you are sexually
stimulated.
Sildenafil Zentiva is a treatment for adult men with erectile dysfunction, sometimes
called impotence. This occurs when a man is unable to achieve or maintain a sufficiently firm and erect penis for sexual intercourse.

2. What you need to know before taking Sildenafil Zentiva

Do not take Sildenafil Zentiva if

• You are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• You are taking other medicines called nitrates, as this combination may lead to a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often prescribed to relieve symptoms of angina pectoris (chest pain). If in doubt, ask your doctor or pharmacist.
• You are using any medicine known as a nitric oxide donor ("poppers"), such as amyl nitrite, as this combination may also cause a dangerous decrease in blood pressure.
• 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 Zentiva, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, contact your doctor.
• You have severe heart or liver problems.
• You have recently had a stroke or heart attack, or if you have low blood pressure.
• You have certain inherited eye diseases (such as retinitis pigmentosa).
• You have experienced sudden loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil Zentiva if

• You have sickle cell anaemia (an abnormality of red blood cells), leukaemia (blood cancer), or multiple myeloma (bone marrow cancer).
• You have anatomical deformations of the penis or Peyronie's disease.
• You have heart problems. Your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• You currently have a stomach ulcer or bleeding disorders (such as haemophilia).
• You experience sudden decrease or loss of vision, stop taking Sildenafil Zentiva and contact your doctor immediately.

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

3. How to take Sildenafil Zentiva

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 of sildenafil.
Do not take Sildenafil Zentiva more than once a day.
Do not take Sildenafil Zentiva film-coated tablets together with orodispersible tablets containing sildenafil.
Take Sildenafil Zentiva approximately one hour before sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Zentiva is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Zentiva will help you achieve an erection only if you are sexually stimulated. The time needed for Sildenafil Zentiva to take effect varies from person to person, but normally ranges from half an hour to one hour. You may find that Sildenafil Zentiva takes longer to work if taken with a heavy meal.
If Sildenafil Zentiva 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 Zentiva 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 your doctor has prescribed.
Contact your doctor if you have taken more tablets than prescribed.
If you have any questions about the use of 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 (the active substance in Sildenafil Zentiva) are usually mild to moderate and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil Zentiva and seek immediate medical help:

• An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyes, 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 sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people). If you have an erection lasting more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision – this occurs rarely.
• Severe skin reactions – this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area and around the eyes, fever.
• Seizures or fits – this occurs rarely.

Other side effects:
Very common (may affect more than 1 in 10 people):
Headache.
Common (may affect up to 1 in 10 people):
Dizziness, blurred colour vision, changes in vision, blurred vision, facial flushing, hot flushes (including symptoms of sudden feeling of warmth in the upper body), nasal congestion, nausea, indigestion.
Uncommon (may affect up to 1 in 100 people):
Nasal inflammation (symptoms include runny nose, sneezing and nasal congestion), drowsiness, reduced sense of touch, watery eyes, eye pain, light sensitivity, flashes of light, blood in the eye/ red eyes, changes in visual brightness, eye irritation, vertigo, ringing in the ears, pounding heartbeat, rapid heartbeat, high or low blood pressure, nosebleeds, blocked nasal sinuses or runny nose, gastroesophageal reflux disease (symptoms include heartburn), vomiting, upper abdominal pain, dry mouth, skin rashes, muscle pain, pain in arms or legs, blood in urine, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people):
Stroke, temporary reduction in blood flow to parts of the brain, fainting, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal sensation in the eye, swelling of the eyes or eyelids, vision with small spots or floaters, seeing halos around lights, dilated pupils, discolouration of the white part of the eye, sudden decrease or loss of hearing, heart attack, irregular heartbeat, sensation of tightness in the throat, dry nose, swelling inside the nose, numbness of the mouth, bleeding from the penis, blood in semen, irritability.

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 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 or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Zentiva

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 carton 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 Zentiva contains
The active substance is sildenafil.
Each film-coated tablet contains 25 mg of sildenafil (as 35.12 mg of sildenafil citrate).
Each film-coated tablet contains 50 mg of sildenafil (as 70.24 mg of sildenafil citrate).
Each film-coated tablet contains 100 mg of sildenafil (as 140.48 mg of sildenafil citrate).
The other components are:

• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate
• Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132)

Description of the appearance of Sildenafil Zentiva and package contents
Sildenafil Zentiva 25 mg film-coated tablets
Blue, round, biconvex film-coated tablets, engraved with "124" on one side and "J" on the other.
Sildenafil Zentiva 50 mg film-coated tablets
Blue, round, biconvex, film-coated tablets, engraved with "125" on one side and "J" on the other, with a score line. The tablets can be divided into two equal doses.
Sildenafil Zentiva 100 mg film-coated tablets
Blue, round, biconvex, film-coated tablets, engraved with "126" on one side and "J" on the side with the score line. The tablets can be divided into two equal doses.

Sildenafil Zentiva is available in the following pack sizes:
Sildenafil Zentiva 25 mg film-coated tablets
PVC/aluminium foil blisters in cardboard boxes containing 1, 2, 4, 8, 12, or 24 tablets.
Sildenafil Zentiva 50 mg film-coated tablets
PVC/aluminium foil blisters in cardboard boxes containing 1, 2, 4, 8, 12, or 24 tablets.
Sildenafil Zentiva 100 mg film-coated tablets
PVC/aluminium foil blisters in cardboard boxes containing 1, 2, 4, 8, 12, or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/b – 20158 Milano
Italy

Responsible manufacturers for batch release
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park - Paola
Malta
S.C. Zentiva S.A.
B-dul. Theodor Pallady nr.50, sector 3,
Bucharest - cod 032266
Romania

This medicinal product is authorized in the European Economic Area countries under the following names: