SILDENAFIL 20 mg Film-Coated Tablets

Зміст інструкції

1. Sildenafil Teva Italia 20 mg tablets
2. Sildenafil
   1. What is Sildenafil Teva Italia and what is it used for
   2. What you need to know before taking Sildenafil Teva Italia
   3. How to take Sildenafil Teva Italia
   4. Possible side effects
   5. How to store Sildenafil Teva Italia
   6. Contents of the pack and other information

Sildenafil Teva Italia 20 mg tablets

film-coated
Generic medicine

Sildenafil

Read 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. Do not give it to other people 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 Teva Italia is and what it is used for
• 2. What you need to know before you take Sildenafil Teva Italia
• 3. How to take Sildenafil Teva Italia
• 4. Possible side effects
• 5. How to store Sildenafil Teva Italia
• 6. Contents of the pack and other information

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

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

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

Do not take Sildenafil Teva Italia
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 that contain nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrite (“poppers”). These medicines are often used to treat chest pain
(or “angina pectoris”). Sildenafil Teva 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 are unsure, 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 Teva Italia, increase the hypotensive effect of this medicine. If you are taking riociguat or
have any doubts, tell your doctor.
if you have recently had a stroke, a heart attack or if you have a severe 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 anterior ischaemic optic neuropathy (AION).

Warnings and precautions
Talk to your doctor before taking Sildenafil Teva 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 sweating a lot
or when you do not drink enough fluids. This can happen if you are ill with fever, vomiting or
diarrhoea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of the red blood cells (sickle cell anaemia), a cancer of the blood cells
(leukaemia), 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 haemophilia) or bleeding from the
nose.
you are taking medicines for erectile dysfunction.
When used for the treatment of erectile dysfunction (ED), with PDE5 inhibitors, including sildenafil,
the following adverse reactions to the eyes have been reported, with frequency unknown: partial,
sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience sudden worsening or loss of vision, stop taking Sildenafil Teva Italia and
contact your doctor immediately(see also section 4).
After taking sildenafil, prolonged and sometimes painful erections have been reported in men.
If you have an erection that lasts continuously for more than 4 hours, stop taking Sildenafil
Teva 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 must tell your doctor because a dose adjustment may be
necessary.

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

Other medicines and Sildenafil Teva 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 nitrite
(“poppers”). These medicines are often used to treat angina pectoris or “chest pain” (see section 2
“What you need to know before taking Sildenafil Teva Italia”).
Tell your doctor or pharmacist if you are already taking riociguat.
Therapies for pulmonary arterial hypertension (for example bosentan, iloprost).
Medicines containing St John's Wort (herbal medicinal product), rifampicin (used to treat bacterial
infections), carbamazepine, phenytoin and phenobarbital (used to treat epilepsy).
Medicines that inhibit blood clotting (for example 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.
Alpha-blocker therapy (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 Teva Italia with food and drink
Do not drink grapefruit juice while being treated with Sildenafil Teva Italia.

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

Driving and using machines
Sildenafil Teva Italia can cause dizziness and can alter vision. Before driving and using machines you
should be aware of how you react to this medicine.

3. How to take Sildenafil Teva Italia

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult 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 Teva Italia than you should
Do not take a quantity of medicine greater than that prescribed by your doctor.
If you take a quantity of medicine greater than prescribed, contact your doctor
immediately. Taking more Sildenafil Teva Italia than you should may increase the risk of known
side effects.

If you forget to take Sildenafil Teva Italia
If you forget to take Sildenafil Teva 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 Teva Italia
Sudden interruption of treatment with Sildenafil Teva Italia may lead to a worsening
of symptoms. Do not stop treatment with Sildenafil Teva Italia unless your doctor decides 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, Sildenafil Teva Italia can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking
Sildenafil Teva Italia and contact your doctor immediately (see also section 2):

• if you experience a sudden decrease or loss of vision (frequency not known)
• if you experience an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported with sildenafil, with a frequency not known.

Adults
Very common side effects (may affect more than 1 in 10 people) have been
headache, flushing, indigestion, diarrhoea and pain in the arms or legs.
Common side effects (may affect up to 1 in 10 people) include:
skin infections, flu-like symptoms, sinusitis, decreased number of red blood cells (anaemia),
fluid retention, sleep disorders, 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, eye inflammation/redness, dizziness, bronchitis, nosebleed,
increased nasal secretions, cough, nasal congestion, stomach inflammation, gastroenteritis,
heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss,
skin redness, night sweats, muscle pain, back pain and increased body temperature.
Uncommon side effects (may affect up to 1 in 100 people) reported include: reduced visual
acuity, double vision, abnormal sensation in the eye, bleeding of the penis, blood in semen and/or
urine, and excessive development of male breast tissue.
Skin rash, a sudden decrease or loss of hearing and
decreased blood pressure have also been reported, with a frequency not known (frequency cannot be
estimated from the 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 skin rash, swelling of the face,
lips and tongue, wheezing, difficulty breathing or swallowing),
convulsions, irregular heartbeat, hearing loss, shortness of breath, inflammation of the
digestive tract, wheezing due to breathing problems.
Very common side effects (may affect more than 1 in 10 people) have been:
headache, vomiting, sore throat, fever, diarrhoea, influenza and nosebleeds.
Common 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
http://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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Teva Italia contains
The active ingredient is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),
sodium croscarmellose, magnesium stearate.
Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

Description of the appearance of Sildenafil Teva Italia and contents of the pack
Sildenafil Teva Italia film-coated tablets are from white to off-white, approximately 6.5 mm,
biconvex, circular, with “20” imprinted on one side and smooth on the other.
Sildenafil Teva Italia film-coated tablets are packaged in PVC/PVdC-Aluminum blisters
or in unit-dose perforated blisters of 30, 90, 90x1 or 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer:
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex,
BN22 9AG
United Kingdom
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA
Netherlands
Teva Operations Poland Sp. z.o.o ul.
Mogilska 80,Krakow
31-546
Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren, Baden-Wuerttemberg
89143
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
10000,
Croatia