SILDENAFIL 25 mg Фильм-Coated Таблетки

Содержание инструкции

1. Sildenafil Zentiva 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Sildenafil Zentiva and what is it used for
   2. What you need to know before taking Sildenafil Zentiva
2. Sildenafil (active ingredient of the medicine Sildenafil Zentiva) may interfere with some
   1. How to take Sildenafil Zentiva
   2. Possible side effects
   3. How to store Sildenafil Zentiva
   4. Contents of the pack and other information

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

Generic medicine

Read this leaflet carefully before you start 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 or pharmacist.
• 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 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 you take 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 is Sildenafil Zentiva and what is it used for

Sildenafil Zentiva contains the active ingredient sildenafil which belongs to a group of
medicines called phosphodiesterase type 5 (PDE 5) inhibitors. It works by helping to relax the
blood vessels in the penis, allowing blood to flow into the penis when you are sexually
excited. Sildenafil Zentiva will only help you to achieve an erection if you are sexually stimulated.
Sildenafil Zentiva is a treatment for adult men with erectile dysfunction, sometimes
called impotence. This occurs when a man cannot get, or keep, the
penis hard and erect enough for satisfactory sexual intercourse.

2. What you need to know before taking Sildenafil Zentiva

Do not take Sildenafil Zentiva if

• You are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• You are taking other medicines called nitrates, as the combination can lead to a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines that are often given to relieve the symptoms of angina pectoris (or chest pain). If you are unsure, ask your doctor or pharmacist for advice.
• You are using any medicine known as a nitric oxide donor (“poppers”), such as amyl nitrite, as this combination can also lead to 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 (that is, high blood pressure in the lungs secondary 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 lost 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 anemia (an abnormality of red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• You have anatomical deformities of the penis or Peyronie's disease.
• You have heart problems. Your doctor should carefully verify if your heart can withstand the additional strain from sexual activity.
• You currently have a stomach ulcer or bleeding problems (such as hemophilia).
• You experience sudden reduction or loss of vision, stop taking Sildenafil Zentiva and contact your doctor immediately.

You should not use Sildenafil Zentiva with other oral or topical treatments for erectile dysfunction.
You should not use Sildenafil Zentiva with treatments for pulmonary arterial hypertension (PAH)
that contain sildenafil or any other PDE5 inhibitor.
You should not take Sildenafil Zentiva if you do not have erectile dysfunction.
You should not take Sildenafil Zentiva if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have liver or kidney problems. Your doctor may decide to give you
a lower dose.

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

Other medicines and Sildenafil Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Sildenafil (active ingredient of the medicine Sildenafil Zentiva) may interfere with some

medicines, especially those used to treat chest pain. In the event of an emergency medical treatment, you must inform your 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 tells you that you can.
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 of the medicines often used to relieve the symptoms of angina pectoris (or chest pain).
Do not take Sildenafil Zentiva if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the association 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, such as for the treatment of HIV, your doctor may start treatment with a lower dose (25 mg) of Sildenafil Zentiva.
Some patients who are undergoing therapy with alpha-blockers for the treatment of high blood pressure or for enlarged prostate may experience dizziness or lightheadedness that may be caused by a decrease in blood pressure when sitting or standing quickly. Some patients have experienced these symptoms when they have taken Sildenafil with alpha-blockers. This is very likely to occur within 4 hours of taking Sildenafil. To reduce the likelihood of these symptoms occurring, you should be on a stable dose of 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, Sildenafil may take longer to start working if it is taken with a heavy meal.
Drinking alcohol may temporarily impair the ability to achieve an erection.
To get the maximum benefit from this medicine, it is advisable not to drink excessive amounts of alcohol before taking Sildenafil Zentiva.

Pregnancy and breastfeeding and fertility
Sildenafil Zentiva is not indicated for use in women.

Driving and operating machinery
Sildenafil Zentiva can cause dizziness and may affect vision. You should therefore be aware of your reaction to Sildenafil Zentiva before driving or operating machinery.

Sildenafil Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, such as lactose, contact them before taking Sildenafil Zentiva.

3. How to take Sildenafil Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. The recommended starting dose is 50 mg of sildenafil.

You must not take Sildenafil Zentiva more than once a day.
Do not take Sildenafil Zentiva film-coated tablets in association with orodispersible tablets containing sildenafil.
You should 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 only help you to achieve an erection if you are sexually stimulated. The time needed for Sildenafil Zentiva to take effect varies from person to person, but is normally between half an hour and 1 hour. You may find that Sildenafil Zentiva takes a longer interval of time to take effect if it is taken with a heavy meal.
If Sildenafil Zentiva does not help you to achieve an erection, or if the erection does not last long enough to complete sexual intercourse, you should inform your doctor.

If you take more Sildenafil Zentiva than you should:
You may experience an increase in side effects and their severity. Doses greater than 100 mg do not increase efficacy.

You must not take more tablets than your doctor has told you.
Contact your doctor if you have taken more tablets than you should.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported in association with the use of sildenafil (the active ingredient of Sildenafil Zentiva) are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop taking
Sildenafil Zentiva and seek medical help immediately:

• An allergic reaction - this happens not commonly(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 happens not commonly. If this happens during or after sexual intercourse
• Sit in a semi-sitting position and try to relax
• Do not use nitratesto treat your chest pain
• Prolonged and sometimes painful erections - this happens rarely(may affect up to 1 in 1000 ). If you have an erection that lasts longer than 4 hours, contact your doctor immediately.
• A sudden decrease or loss of vision -this happens rarely.
• Severe skin reactions - this happens rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genitals and around the eyes, fever.
• Convulsions or seizures - this happens rarely.

Other side effects:
Very common(may affect more than 1 in 10):
Headache.

Common(may affect up to 1 in 10):
Dizziness, blurred vision of colors, visual disturbances, blurred vision, flushing of the
face, hot flushes (including symptoms of a sudden feeling of warmth in the upper part of the
body) nasal congestion, nausea, indigestion.

Not common(may affect up to 1 in 100):
Nasal inflammation (symptoms include runny nose, sneezing and nasal congestion) feeling of
sleepiness, reduced sense of touch, tearing, eye pain, sensitivity to light,
flashes of light, blood in the eyes/red eyes, changes in visual brightness, eye irritation,
vertigo, ringing in the ears, pounding heartbeat, fast heartbeat, high or low blood
pressure, nosebleeds, blocked sinuses or runny nose, gastroesophageal reflux disease (symptoms include heartburn), vomiting, upper abdominal pain, dry mouth, skin rash, muscle pain, pain in the arms or legs,
blood in the urine, feeling of heat and feeling of fatigue.

Rare(may affect up to 1 in 1000):
Stroke, temporary decrease in blood flow to the parts of the brain, fainting,
bleeding in the back of the eye, double vision, reduced visual acuity, abnormal sensation in the eye, swelling of the eyes or eyelid, vision with small particles or
spots, seeing halos around lights, dilation of the pupil of the eye, discoloration of the
white of the eye, sudden decrease or loss of hearing, heart attack, irregular heartbeat, sensation of a lump in the throat, dry nose, swelling of the inside of the
nose, numb mouth, bleeding of the penis, blood in the seminal fluid,
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, men
who have experienced these side effects had 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 effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package, on the blister after
EXP. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Sildenafil Zentiva contains
The active ingredient 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 ingredients are:

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

Description of the appearance of Sildenafil Zentiva and contents of the pack
Sildenafil Zentiva 25 mg film-coated tablets
Film-coated tablets of blue colour, round, biconvex with imprinted 124 on one side and J
on the other side.
Sildenafil Zentiva 50 mg film-coated tablets
Film-coated tablets of blue colour, round, biconvex and notched, with imprinted 125 on one
side and J on the other side with a score line. The tablets can be divided into two equal doses
.
Sildenafil Zentiva 100 mg film-coated tablets
Film-coated tablets of blue colour, round, biconvex, notched with imprinted 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
Blisters in PVC/aluminium foil in a cardboard box containing 1, 2, 4, 8, 12, 24 tablets.

Sildenafil Zentiva 50 mg film-coated tablets
Blisters in PVC/aluminium foil in a cardboard box containing 1, 2, 4, 8, 12, 24 tablets .
Sildenafil Zentiva 100 mg film-coated tablets
Blisters in PVC/aluminium foil in a cardboard box containing 1, 2, 4, 8, 12, 24 tablets.
Not all pack sizes may be marketed.

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

Manufacturers responsible 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,
Bucarest - cod 032266
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: