SILDENAFIL 20 mg Фильм-Coated Таблетки

Содержание инструкции

1. Sildenafil Aurobindo Italia 20 mg film-coated tablets
   1. What is Sildenafil Aurobindo Italia and what is it used for
   2. What you need to know before taking Sildenafil Aurobindo Italia
   3. How to take Sildenafil Aurobindo Italia
   4. Possible side effects
   5. How to store Sildenafil Aurobindo Italia
   6. Package contents and other information

Sildenafil Aurobindo Italia 20 mg film-coated tablets

Sildenafil

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 their
• symptoms are the same as yours, as it could 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 Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Sildenafil Aurobindo Italia
• 3. How to take Sildenafil Aurobindo Italia
• 4. Possible side effects
• 5. How to store Sildenafil Aurobindo Italia
• 6. Contents of the pack and other information

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

Sildenafil Aurobindo Italia contains the active ingredient sildenafil which belongs to the class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Aurobindo Italia reduces blood pressure in the lungs by dilating the pulmonary
blood vessels.
Sildenafil Aurobindo Italia is used for the treatment of adults and children and adolescents from 1 to 17 years with
high pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

2. What you need to know before taking Sildenafil Aurobindo Italia

Do not take Sildenafil Aurobindo Italia

• if you are allergic to sildenafil or any of the other ingredients of this medicine
• (listed in section 6).
• if you are taking medicines that contain nitrates, or nitric oxide donors, such as amyl nitrate (“poppers”). These medicines are often used to relieve chest pain attacks (or “angina pectoris”). Sildenafil Aurobindo Italia may cause a considerable increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you have any doubts, consult your doctor or pharmacist.
• 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 Aurobindo Italia, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
• if you have recently had a stroke, a heart attack or if you have a serious liver disease or very low blood pressure (< 90/50 mmHg).
• if you are taking a medicine to treat fungal infections, such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
• if you have previously had a loss of vision caused by a problem with blood flow to the eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil Aurobindo Italia if:

• the disease is due to obstruction or narrowing of a pulmonary vein rather than an artery.
• you have a serious heart problem.
• you have problems with the heart ventricles.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure while at rest.
• you are losing large amounts of body fluids (dehydration), which can occur when you sweat a lot or when you do not drink enough fluids. This can happen if you are sick with fever, vomiting or diarrhea.
• you have a rare hereditary eye disease (retinitis pigmentosa).
• you have an abnormality of the red blood cells (sickle cell anemia), a cancer of the blood cells (leukemia), a cancer of the bone marrow (multiple myeloma) or any disease or deformity of the penis.
• you currently have a stomach ulcer, a bleeding disorder (such as hemophilia) or nosebleeds.
• you are taking medicines for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, have been used for the treatment of erectile
dysfunction (ED), the following visual side effects have been reported, with unknown frequency:
partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience a sudden decrease or loss of vision, stop taking Sildenafil
Aurobindo Italia and contact your doctor immediately(see also section 4).
Prolonged and sometimes painful erections have been reported in men after taking sildenafil.
If you have an erection that lasts continuously for more than 4 hours, stoptaking Sildenafil
Aurobindo Italia and contact your doctor immediately(see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you should tell your doctor because a dose adjustment
may be necessary.

Children
Sildenafil Aurobindo Italia should not be given to children under 1 year of age.

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

• Medicines that contain nitrates or substances that release nitric oxide, such as amyl nitrate (“poppers”). These medicines are often used to relieve angina pectoris or “chest pain” (see section 2. What you need to know before taking Sildenafil Aurobindo Italia).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines containing St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (also used for epilepsy).
• Medicines that inhibit blood clotting (e.g. warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (are antibiotics used to treat some bacterial infections), saquinavir (for HIV) or nefazodone (for depression), because a dose adjustment may be necessary.
• Therapy with alpha-blockers (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms leading to low blood pressure (e.g. dizziness, lightheadedness).

Sildenafil Aurobindo Italia with food, beverages and alcohol
Do not drink grapefruit juice while being treated with Sildenafil Aurobindo Italia.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Sildenafil Aurobindo Italia should not be taken during pregnancy unless absolutely
necessary.
Sildenafil Aurobindo Italia should not be given to women of childbearing potential unless they use adequate
contraceptive methods.
Stop breastfeeding when you start treatment with Sildenafil Aurobindo Italia. Sildenafil Aurobindo
Italia should not be given to women during breastfeeding because it is not known whether the
medicine passes into breast milk.

Driving and operating machinery
Sildenafil Aurobindo Italia can cause dizziness and can alter vision. Before driving and operating
machinery, you should be aware of how you react to this medicine.

Sildenafil Aurobindo Italia contains lactose
Sildenafil Aurobindo Italia film-coated tablets contains lactose monohydrate. If your doctor has
diagnosed you as having intolerance to some sugars, such as lactose, contact him before taking this
medicine.

3. How to take Sildenafil Aurobindo Italia

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (to be taken 6-8 hours apart) with or
without food.

Use in children and adolescents
For children and adolescents from 1 to 17 years of age, the recommended dose is 10 mg three times a day for
children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, to be
taken with or without food. Higher doses should not be used in children. This medicine should only be
used in case of administration of 20 mg three times a day. Other pharmaceutical forms may
be more appropriate for administration to patients weighing ≤ 20 kg and to other younger patients who
are unable to swallow the tablets.

If you take more Sildenafil Aurobindo Italia than you should
Do not take a quantity of medicine greater than what has been prescribed by your doctor.
If you take a quantity of medicine greater than prescribed, contact your doctor immediately.
Taking more Sildenafil Aurobindo Italia than you should may increase the risk of known side effects.

If you forget to take Sildenafil Aurobindo Italia
If you forget to take Sildenafil Aurobindo Italia, take the dose as soon as you remember and then continue
to take the medicine at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Sildenafil Aurobindo Italia
Sudden discontinuation of treatment with Sildenafil Aurobindo Italia may lead to a worsening
of symptoms. Do not stop treatment with Sildenafil Aurobindo Italia unless your doctor decides to do so.
Your doctor may tell you to reduce the dose over a few days before stopping
treatment completely.
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 everybody gets them.
If you experience any of the following side effects, you must stop taking Sildenafil
Aurobindo Italia and contact your doctor immediately (see also section 2):

• if you experience sudden vision impairment or loss of vision (frequency not known)
• if you experience an erection that lasts continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported (frequency not known). Adults Commonly reported side effects (may affect more than 1 in 10 people) have been headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.

Commonly reported side effects (may affect up to 1 in 10 people) include:
skin infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia),
fluid retention, difficulty sleeping, anxiety, migraine, tremor, pins and needles sensation,
burning sensation, reduced sense of touch, bleeding in the back of the eye, effects on
vision, blurred vision and sensitivity to light, effects on colour perception,
eye irritation, red/bloodshot eyes, dizziness, bronchitis, nosebleed, runny nose, cough, nasal congestion, inflammation of the stomach, gastroenteritis, heartburn, haemorrhoids,
abdominal distension, dry mouth, hair loss, skin redness, night sweats,
muscle pain, back pain and increased body temperature.

Uncommonly reported side effects (may affect up to 1 in 100 people) include:reduced visual acuity, double vision, abnormal sensation in the eye, bleeding of the
penis, blood in semen and/or urine, and increased breast size in men.
Skin rash and a sudden decrease or loss of hearing and decreased
blood pressure have also been reported, with frequency not known (frequency cannot be established on the basis of available data).

Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in
10): pneumonia, heart failure, right-sided heart failure, heart-related shock, high
blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection of the
stomach and intestines, urinary tract infection and tooth decay.
The following serious adverse events have been considered treatment-related and have been reported uncommonly (may affect up to 1 in 100): allergic reactions (such as rash, swelling
of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing loss, shortness of breath, inflammation of the digestive tract, wheezing due to breathing problems.

Very commonly reported side effects (may affect more than 1 in 10 people) have been:headache, vomiting, sore throat, fever, diarrhoea, influenza and nosebleed.

Commonly reported side effects (may affect up to 1 in 10 people) have been:
nausea, increased erections, pneumonia and runny nose.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and blister, after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Italia contains

• The active ingredient is sildenafil. Each tablet contains 20 mg of Sildenafil (as sildenafil citrate).
• The other ingredients are: Tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose (2910) 15cP, titanium dioxide (E171),
triacetin.

Description of the appearance of Sildenafil Aurobindo Italia and package contents
Film-coated tablet.
White, round (6.6 mm diameter), biconvex, film-coated tablets imprinted with “20” on one
side and smooth on the other side.
Sildenafil Aurobindo Italia tablets are available in blisters containing 28, 30 and 90 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)

Manufacturers
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, Ruislip
HA4 6QD
United Kingdom
Arrow Génériques
26 avenue Tony Garnier
69007 Lyon – France
France

This medicinal product is authorised in the EEA Member States with the following names
Belgium: Sildenafil AB 20 mg film-coated tablets
Czech Republic: Sildenafil Aurobindo Italia
France: SILDENAFIL ARROW 20 mg, film-coated tablet
Germany: Sildenafil PUREN PAH 20 mg film-coated tablets
Italy: Sildenafil Aurobindo Italia
Netherlands: Sildenafil Aurobindo 20 mg, film-coated tablets
Poland: Sildenafil Aurobindo Italia
Portugal: Sildenafil Aurobindo Italia
Spain: Sildenafilo Aurovit 20 mg film-coated tablets EFG