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Package Leaflet: Information for the user

SildeHEXAL SF 25 mg orodispersible film SildeHEXAL SF 50 mg orodispersible film SildeHEXAL SF 75 mg orodispersible film

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 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 SildeHEXAL SF is and what it is used for

2.    What you need to know before you take SildeHEXAL SF

3.    How to take SildeHEXAL SF

4.    Possible side effects

5.    How to store SildeHEXAL SF

6.    Contents of the pack and other information

What SildeHEXAL SF is and what it is used for

SildeHEXAL SF 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. SildeHEXAL SF will only help you to get an erection if you are sexually stimulated.

SildeHEXAL SF 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 SildeHEXAL SF Do not take SildeHEXAL SF if you

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

•    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.

•    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.

•    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 SildeHEXAL SF have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

•    have a severe heart or liver problem

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

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

•    have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION). Warnings and precautions

Talk to your doctor before taking SildeHEXAL SF. if you

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

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

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

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

•    experience sudden decrease or loss of vision, stop taking SildeHEXAL SF and contact your doctor immediately.

You should not use SildeHEXAL SF with any other oral or local treatments for erectile dysfunction.

You should not use SildeHEXAL SF with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take SildeHEXAL SF if you do not have erectile dysfunction.

You should not take SildeHEXAL SF 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

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

Other medicines and SildeHEXAL SF

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

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

You should not take SildeHEXAL SF 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 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 SildeHEXAL SF 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.

Tell your doctor or pharmacist if you are already taking riociguat.

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 SildeHEXAL SF.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate

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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 SildeHEXAL SF with alpha-blockers. This is most likely to happen within 4 hours after taking SildeHEXAL SF. In order to reduce the chance that these symptomsmight happen, you should be on a regular daily dose of your alpha-blocker before you start SildeHEXAL SF. Your doctor may start you on a lower dose (25 mg) of SildeHEXAL SF.

SildeHEXAL SF with food, drink and alcohol

SildeHEXAL SF can be taken with or without food. However, you may find that SildeHEXAL SF 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 SildeHEXAL SF.

Pregnancy, breast-feeding and fertilitySildeHEXAL SF is not indicated for use by women.

Driving and using machines

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

3. How to take SildeHEXAL SF

Always take this medicine exactly as your doctor 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 SildeHEXAL SF more than once a day.

Do not take SildeHEXAL SF orodispersible films in combination with other sildenafil containing medicines

You should take SildeHEXAL SF about one hour before you plan to have sex. SildeHEXAL SF orodispersible films are for oral use and are taken without water. If desired you may also take SildeHEXAL SF with water.

Instructions for use

Important: Do not handle the orodispersible film with wet hands!

a) Take the sachet, locate the arrow mark at one of the shorter sides and hold the sachet with this side facing up. The sachet is not sealed here.

b) Gently peel both parts of the sachet apart at the arrow mark. Now you can hold each between your thumb and

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your index finger using one hand for each part.

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

If SildeHEXAL SF 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 SildeHEXAL SF 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 orodispersible films than your doctor tells you to.

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Contact your doctor if you take more orodispersible films than you should.

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

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 SildeHEXAL SF are usually mild to moderate and of a short duration.

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

•    An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people)

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

•    Chest pains - this occurs uncommonly 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.

•    Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)

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

•    A sudden decrease or loss of vision - this occurs rarely

•    Serious skin reactions - this occurs rarely

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

•    Seizures or fits - this occurs rarely Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

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Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to SildeHEXAL SF.

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 (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store SildeHEXAL SF

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

Store in the original package. This medicine does not require any special temperature 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 protect the environment.

6.    Contents of the pack and other information

What SildeHEXAL SF contains

-    The active substance is sildenafil (as citrate).

Each orodispersible film contains 25 mg sildenafil (as citrate).

Each orodispersible film contains 50mg sildenafil (as citrate).

Each orodispersible film contains 75 mg sildenafil (as citrate).

-    The other ingredient(s) are: Hydroxypropylcellulose, glycerol 85 %, sucralose, peppermint flavour (SYM 353592), levomenthol, sodium chloride, contramarum forte (SYM 225023), indigocarmin E132

What SildeHEXAL SF looks like and contents of the pack

This medicinal product is presented as orodispersible film.

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SildeHEXAL SF 25 mg orodispersible film

The orodispersible film is a rectangular, flexible, light blue film strip (14 mmx25 mm). SildeHEXAL SF 50 mg orodispersible film

The orodispersible film is a rectangular, flexible, light blue film strip (28 mmx25 mm). SildeHEXAL SF 75 mg orodispersible film

The orodispersible film is a rectangular, flexible, light blue film strip (42 mmx25 mm).

Each orodispersible film is packed in a PET/Alu/PE - Sachet.

Pack sizes of 1, 2, 4, 8, 10, 12, 16, 20, 24 or 28 orodispersible film(s).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

Manufacturers

HEXAL AG IndustriestraBe 25,

D-83607 Holzkirchen Germany

Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany

LEK S.A.

ul. Domaniewska 50 C, 02-672 Warszawa Poland

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

Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Jud. Mures Romania