PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000TL000

Sildenafil 25 mg Tablets Sildenafil 50 mg Tablets Sildenafil 100 mg Tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Sildenafil is and what it is used for

2.    Before you take Sildenafil

3.    How to take Sildenafil

4.    Possible side effects

5.    How to store Sildenafil

6.    Further information

A

What Sildenafil is and what it is used for

Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil will only help you to get an erection if you are sexually stimulated. You should not take Sildenafil if you do not have erectile dysfunction. You should not take Sildenafil if you are a woman.

Sildenafil is a treatment for men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2 Before you take Sildenafil

Do not take Sildenafil

•    if you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

•    if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a potentially dangerous decrease in your blood pressure.

•    if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil

•    if you have a severe heart or liver problem

•    if you have recently had a stroke or a heart attack, or if you have low blood pressure

•    if you have certain rare inherited eye diseases (such as retinitis pigmentosa)

•    if you have ever had loss of vision because of non-arteritic anterior ischaemic optic neuropathy (NAION).

Take special care with Sildenafil

Tell your doctor

•    if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

•    if you have a deformity of your penis or Peyronie’s Disease.

•    if you have problems with your heart. Your doctor should in that case carefully check whether your heart can take the additional strain of having sex

•    if you currently have a stomach ulcer, or a bleeding disorder (such as haemophilia)

•    if you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

You should not use Sildenafil with any other treatment for erectile dysfunction.

Special considerations for children and adolescents

Sildenafil should not be given to individuals under the age of 18.

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

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.

You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take Sildenafil if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease in your blood pressure.

If you are taking protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate problems may experience dizziness or lightheadedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.

Taking Sildenafil with food and drink

Sildenafil can be taken with or without food. However, you may find that Sildenafil takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.

Pregnancy and breast-feeding

Sildenafil is not indicated for use by women.

Driving and using machines

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

3 How to take Sildenafil

Always take Sildenafil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 50 mg.

You should not take Sildenafil more than once a day.

You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet unchewed with a glass of water.

Sildenafil 25 mg:

The scoreline is only to facilitate breaking for ease of swallowing.

Dividing the tablets

Place the tablet on a hard, flat surface with the scoreline facing upwards. Press with your thumb on the middle of the tablet and the tablet breaks into equal halves.

Sildenafil 50 mg:

The tablet can be divided into equal quarters. You have to take at least two quarters (corresponding to 25 mg) to reach the minimum effective dose.

Dividing the tablets

Place the tablet on a hard, flat surface with the scoreline facing upwards. Press with your thumb on the middle of the tablet and the tablet breaks into equal quarters.

Continued on the next page >>

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU 16 7SR, United Kingdom.

T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com

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Sildenafil 100 mg:

The tablet can be divided into equal quarters.

Dividing the tablets

Place the tablet on a hard, flat surface with the deeper scoreline facing upwards. Press with your thumb on the middle of the tablet and the tablet breaks into equal quarters.

If you have the impression that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil takes longer to work if you take it with a heavy meal.

If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more Sildenafil than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

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

Contact your doctor if you take more tablets than you should.

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

5 How to store Sildenafil

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Sildenafil after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

4 Possible side effects

Like all medicines, Sildenafil can cause side effects although not everybody gets them. The side effects reported in association with the use of Sildenafil are usually mild to moderate and of a short duration.

If you have chest pains during or after intercourse:

•    Get in a semi-sitting position and try to relax.

•    Do not use nitrates to treat your chest pain.

•    Contact your doctor immediately.

All medicines including Sildenafil can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

Prolonged and sometimes painful erections have been reported after taking Sildenafil. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

A very common side effect (likely to occur in more than 1 in 10 patients) is headache.

Common side effects (likely to occur in 1 to 10 patients in 100) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.

Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include: vomiting, skin rash, bleeding at the back of the eye, eye irritation, bloodshot eyes /red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.

Rare side effects (likely to occur in 1 to 10 patients in 10000) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.

Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, heart attack or temporary decreased blood flow to parts of the brain. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil. Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

What Sildenafil contains

The active substance is Sildenafil.

Each tablet contains 25 mg/50 mg/

100 mg of Sildenafil (as the citrate salt).

The other ingredients are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, copovidone, croscarmellose sodium, magnesium stearate, saccharin sodium, indigo carmine aluminium lake (E 132).

What Sildenafil looks like and contents of the pack

Sildenafil 25 mg tablets Sildenafil 25 mg tablets are light blue round slightly dotted tablets, with breaking notch on one side and embossment “25” on the other side.

Sildenafil 50 mg tablets Sildenafil 50 mg tablets are light blue round slightly dotted tablets, with cross breaking notch on one side and embossment “50”on the other side.

Sildenafil 100 mg tablets Sildenafil 100 mg tablets are light blue round slightly dotted tablets, with cross breaking notch on both sides and embossment “100” on one side.

Sildenafil is available in blister packs with 1,2, 4, 6, 8, 10, 12, 16, 20, 24 or 28 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder UK

Sandoz Limited,

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR,

United Kingdom

Malta

Sandoz d.d.,

Verovskova 57,

1000 Ljubljana,

Slovenia

Manufacturer’s

Lek Pharmaceuticals d.d.,

Verovskova 57,

1526 Ljubljana,

Slovenia

LEK S.A.,

ul. Domaniewska 50 C,

02-672 Warszawa,

Poland

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

Salutas Pharma GmbH,

Dieselstrasse 5,

70839 Gerlingen,

Germany

S.C. Sandoz S.R.L.,

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures,

Romania

This leaflet was last approved in 08/2011 (to be amended upon approval)

SZ00000LT000

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU 16 7SR, United Kingdom.

T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com

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