Document: leaflet MAH GENERIC_PL 00289-2051 change

• leaflet MAH GENERIC_PL 00289-2051
• leaflet MAH GENERIC_PL 00289-2053

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SILDENAFIL 20 mg FILM-COATED TABLETS

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Sildenafil is and what it is used for

2.    What you need to know before you take Sildenafil

3.    How to take Sildenafil

4.    Possible side effects

5.    How to store Sildenafil

6.    Contents of the pack and other information

What Sildenafil is and what it is used for

Sildenafil contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Sildenafil brings down blood pressure in the lungs by widening the blood vessels in the lungs. Sildenafil is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

*2 What you need to know before you take Sildenafil

Do not take Sildenafil if you:

•    are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6)

•    are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate ("poppers"). These medicines are often given for relief of chest pain (or "angina pectoris"). Sildenafil can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist

•    are taking riociguat. This drug 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). PDE5 inhibitors, such as Sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor

•    have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg)

•    are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV)

•    have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor before taking Sildenafil if you:

•    have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery

•    have a severe heart problem

•    have a problem with the pumping chambers of your heart

•    have high blood pressure in the blood vessels in the lungs

•    have low blood pressure at rest

•    lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea

•    have a rare inherited eye disease (retinitis pigmentosa)

•    have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis

•    currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds

•    take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease or loss of vision, stop taking Sildenafil 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, which lasts continuously for more than 4 hours, stop taking Sildenafil and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Children

Sildenafil should not be given to children below 1 year of age.

Other medicines and Sildenafil

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

•    medicines containing nitrates, or nitric oxide donors such as amyl nitrate ("poppers"). These medicines are often given for relief of angina pectoris or "chest pain" (see section 2. Before you take Sildenafil)

•    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 medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)

•    blood thinning medicines (for example warfarin) although these did not result in any side effect

•    medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted

•    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 resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).

Sildenafil with food and drink

You should not drink grapefruit juice while you are being treated with Sildenafil.

Pregnancy and breast-feeding

If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil should not be used during pregnancy unless strictly necessary.

Sildenafil should not be given to women of child bearing potential unless using appropriate contraceptive methods.

Stop breast-feeding when you start Sildenafil treatment. Sildenafil should not be given to women who are breast-feeding since it is not known if the medicine passes into the breast milk.

Driving and using machines

Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

3 How to take Sildenafil

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.

Use in children and adolescents

For children and adolescents aged 1 year to 17 years old, the recommended dose is either 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, taken with or without food. Higher doses should not be used in children. This medicine should be used only in case of administration of 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients < 20 kg and other younger patients who are not able to swallow tablets.

If you take more Sildenafil than you should

You should not take more medicine than your doctor tells you to.

If you take more medicine than you have been told to take contact your doctor immediately. Taking more Sildenafil than you should may increase the risk of known side effects.

If you forget to take Sildenafil

If you forget to take Sildenafil, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Sildenafil

Suddenly stopping your treatment with Sildenafil may lead to your symptoms getting worse. Do not stop taking Sildenafil unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Sildenafil can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should stop taking Sildenafil and contact a doctor immediately (see also section 2):

•    if you experience sudden decrease or loss of vision (frequency not known)

•    if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults

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.

Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles"-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes/red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (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 heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.

Side effects reported commonly (may affect up to 1 in 10 people) were 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 possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

How to store Sildenafil

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 carton after EXP The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

,6 Contents of the pack and other information

What Sildenafil contains

•    The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as the citrate).

•    The other ingredients are:

Tablet core: cellulose microcrystalline, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.

Film-coat: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

What Sildenafil looks like and contents of the pack

Sildenafil Film-coated Tablets are white to off white, approx. 6.5 mm, biconvex circular, embossed with “20" on one side and plain on the other side.

Sildenafil Film-coated Tablets are packed in PVC/PVdC-Aluminium blisters or perforated unit dose blisters of 30, 90, 90x1 or 300 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne,

BN22 9AG, UK

Manufacturer

Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, Krakow, 31-546, Poland

This leaflet was last revised in 10/2016

PL 00289/2051

TEVA UK LIMITED    12345-A