Package leaflet: Information for the patient

Sildenafil Pharmathen 25 mg film-coated tablets

Sildenafil Pharmathen 50 mg film-coated tablets

Sildenafil Pharmathen 100 mg film-coated tablets

Sildenafil

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, pharmacist or nurse.

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sildenafil Pharmathen is and what it is used for

Sildenafil Pharmathen contains the active substance sildenafil which 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 Pharmathen will only help you to get an erection if you are sexually stimulated.

Sildenafil Pharmathen is a treatment for adult 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. What you need to know before you take Sildenafil Pharmathen

Do not take Sildenafil Pharmathen

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

• If you are taking medicines called nitrates, as the combination may lead to a dangerous fall 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 medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

• 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 due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Sildenafil Pharmathen

• 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 carefully check whether your heart can take the additional strain of having sex.

• If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

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

You should not use Sildenafil Pharmathen with any other oral or local treatments for erectile dysfunction.

You should not take Sildenafil Pharmathen if you do not have erectile dysfunction.

You should not take Sildenafil Pharmathen if you are a woman.

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.

Children and adolescents

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

Other medicines and Sildenafil Pharmathen

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

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

You should not take Sildenafil Pharmathen if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacistor nurse 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 Pharmathen if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

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

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

Sildenafil Pharmathen with food, drink and alcohol

Sildenafil Pharmathen can be taken with or without food. However, you may find that Sildenafil Pharmathen 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 Pharmathen.

Pregnancy, breast feeding and fertility

Sildenafil Pharmathen is not indicated for use by women.

Driving and using machines

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

Sildenafil Pharmathen contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking Sildenafil Pharmathen.

3. How to take Sildenafil Pharmathen

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take Sildenafil Pharmathen more than once a day.

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

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

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

If Sildenafil Pharmathen 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 Pharmathen 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, pharmacistor nurse.

4. Possible side effects

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

If you experience any of the following serious side effects stop taking Sildenafil Pharmathen and seek medical help immediately:

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

If this occurs during or after intercourse:

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

• Do not use nitrates to treat your chest pain.

If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

Other side effects:

Very common (may affect more than 1 in 10 people) is:

Common (may affect up to 1 in 10 people):

• facial flushing

• indigestion

• effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision)

• stuffy nose

• dizziness

Uncommon (may affect up to 1 in 100 people:

• 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

• watery eyes

• pounding heartbeat

• rapid heartbeat

• muscle pain

• feeling sleepy

• reduced sense of touch

• vertigo

• ringing in the ears

• nausea

• dry mouth

• penile bleeding

• presence of blood in semen and/or urine

• chest pain

• feeling tired

Rare (may affect up to1 in 1,000 people):

• high blood pressure

• low blood pressure

• fainting

• stroke

• heart attack

• irregular heartbeat

• nosebleed

• sudden decrease or loss of hearing

Not known (frequency cannot be estimated from the available data):

Additional side effects reported from post-marketing experience:

• Unstable angina (a heart condition)

• sudden death

• temporary decreased blood flow to parts of the brain

Most, but not all, of the men who experience these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil Pharmathen.

Reporting of side effects

If you get any side effects, talk to you doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Pharmathen

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

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.

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 Pharmathen contains

• The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as the citrate salt).

• The other ingredients are:

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

- Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin,

What Sildenafil Pharmathen looks like and contents of the pack

Sildenafil Pharmathen 25 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets plain on one side and debossed with ‘B9’ on one the other side.

Sildenafil Pharmathen 50 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets plain on one side and debossed with ‘C1’ on one the other side.

Sildenafil Pharmathen 100 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets plain on one side and debossed with ‘436’ on one the other side.

The tablets are provided in blister packs containing 1 2, 4, 8 or 12 tablets in a carton.

Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing authorization holder

Pharmathen S.A.

6 Dervenakion str.

15351 Pallini Attiki

Greece

Manufacturer

PSI supply nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

Or

Pharmathen S.A

6 Dervenakion str.,

15351 Pallini Attiki

Greece

Or

Pharmathen International S.A

4 Dervenakion str.,

15351 Pallini

Greece

This medicinal product is authorised in the Member States of the EEA under the following names

Cyprus: Sildenafil Pharmathen

Germany: Sildenafil Pharmathen

Greece: Sildenafil Pharmathen

Sweden: Sildenafil Pharmathen

The Netherlands: Sildenafil Pharmathen

This leaflet was last approved in

28 May 2014