Sildenafil Teva Italia

Package leaflet: Information for the patient

Sildenafil Teva Italia 20 mg film-coated tablets

Generic medicine
Sildenafil
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 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

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

Sildenafil Teva Italia contains the active substance sildenafil, which belongs to a 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 to treat adults, children, and adolescents aged 1 to 17 years with high blood pressure in the lung blood vessels (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 containing nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrite ("poppers"). These medicines are often used
to relieve episodes of chest pain (or "angina pectoris"). Sildenafil Teva Italia may
cause a significant increase in the effects of these medicines. Inform 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 due to blood clots). PDE5 inhibitors, such as Sildenafil Teva Italia, 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 recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).
if you are taking a medicine for fungal infections, such as ketoconazole or itraconazole, or medicines containing ritonavir (for HIV).
if in the past you have experienced vision loss caused by reduced blood flow to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Sildenafil Teva Italia if:
your condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
you have a serious heart condition.
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 may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of red blood cells (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (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 used to treat erectile dysfunction (ED), visual side effects such as partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes have been reported with PDE5 inhibitors, including sildenafil, with unknown frequency.
If you experience sudden decrease 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 inform your doctor, as a dose adjustment may be necessary.

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

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

Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrite ("poppers"). These medicines are often used to relieve angina pectoris or "chest pain" (see section 2 "What you need to know before taking Sildenafil Teva Italia").
Inform your doctor or pharmacist if you are already taking riociguat.
Treatments for pulmonary arterial hypertension (e.g. bosentan, iloprost).
Medicines containing St. John's Wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy).
Medicines that inhibit blood clotting (e.g. warfarin), although no adverse effect has been observed.
Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as dose adjustment may be required.
Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of these medicines may cause symptoms leading to low blood pressure (e.g. dizziness, lightheadedness).

Sildenafil Teva Italia with food and drink
You should not drink grapefruit juice while being treated with Sildenafil Teva Italia.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil Teva Italia must not be taken during pregnancy unless absolutely necessary.
Sildenafil Teva Italia must not be given to women of childbearing age unless they are using adequate contraceptive methods.
Discontinue breastfeeding when starting treatment with Sildenafil Teva Italia. Sildenafil Teva Italia must 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 may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to this medicine.

3. How to take Sildenafil Teva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, 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 aged 1 to 17 years, the recommended dose is 10 mg three times daily for those weighing ≤ 20 kg, or 20 mg three times daily for those weighing > 20 kg, taken with or without food. Higher doses must not be used in children.
This medicine should only be used when administering a dose of 20 mg three times daily. Other pharmaceutical forms may be more suitable for administration to patients weighing ≤ 20 kg and to younger patients who are unable to swallow tablets.

If you take more Sildenafil Teva Italia than you should
Do not take more medicine than your doctor has prescribed.
If you take more than the prescribed amount, contact your doctor immediately. Taking more Sildenafil Teva Italia than recommended 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 missed dose as soon as you remember, then continue taking the medicine at your usual times. Do not take a double dose to make up for the forgotten dose.

If you stop taking Sildenafil Teva Italia
Stopping treatment with Sildenafil Teva Italia suddenly may cause symptoms to worsen. Do not stop treatment unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before stopping completely.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Teva Italia can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, you must 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 have an erection that persists continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafil, with frequency not known.

Adults
The side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea, and pain in the arms or legs.
The side effects reported commonly (may affect up to 1 in 10 people) include: subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, sleep disorders, anxiety, migraine, tremor, prickling sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, visual disturbances, blurred vision and light sensitivity, disturbances in colour perception, eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds, 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.
The side effects reported uncommonly (may affect up to 1 in 100 people) include: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, blood in semen and/or urine, and excessive development of breast tissue in males.
Skin rash, sudden decrease or loss of hearing, and low blood pressure have also been reported, with 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 people): pneumonia, heart failure, right-sided heart failure, cardiac shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection of the stomach and intestine, urinary tract infection, and dental caries.
The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to respiratory problems.
The side effects reported very commonly (may affect more than 1 in 10 people) were: headache, vomiting, throat infection, fever, diarrhoea, influenza, and nosebleeds.
The side effects reported commonly (may affect up to 1 in 10 people) were: nausea, increased number of erections, pneumonia, and runny nose.

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 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 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 Teva Italia contains
The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The other components 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 white to off-white, approximately 6.5 mm,
biconvex, circular tablets, with "20" engraved on one side and smooth on the other.
Sildenafil Teva Italia film-coated tablets are packed in PVC/PVdC-aluminium blisters
or in perforated unit dose blisters containing 30, 90, 90x1 or 300 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturers:
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex,
BN22 9AG
United Kingdom
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, Krakow
31-546
Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren, Baden-Wuerttemberg
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
10000
Croatia