Sildenafil Accord

Patient Information Leaflet: Information for the User

Sildenafil Accord 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Sildenafil Accord is and what it is used for
2. What you need to know before taking Sildenafil Accord
3. How to take Sildenafil Accord
4. Possible side effects
5. How to store Sildenafil Accord
6. Contents of the pack and other information

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

Sildenafil Accord contains the active substance sildenafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood flow
into the penis when sexually stimulated. Sildenafil Accord will help you get an erection only if you are
sexually stimulated.
Sildenafil Accord is a treatment for adult men who have erectile dysfunction, sometimes called impotence.
This condition occurs when a man is unable to achieve or maintain an erection suitable for sexual intercourse.

2. What you need to know before taking Sildenafil Accord

Do not take Sildenafil Accord

• If you are allergic (hypersensitive) to sildenafil or to any of the excipients of Sildenafil Accord (see section 6).
• If you are taking medicines called nitrates, as this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"). If in doubt, consult your doctor or pharmacist.
• If you are taking medicines known as nitric oxide donors such as amyl nitrite ("poppers"), because this combination may cause a dangerous drop in blood pressure.
• 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 secondary to blood clots). It has been shown

that PDE5 inhibitors, such as Sildenafil Accord, increase the hypotensive effect of this medicine. If you are
taking riociguat or have any doubts, inform your doctor.

• If you have a serious heart or liver condition.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have a rare inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Inform your doctor, pharmacist, or nurse before taking Sildenafil Accord

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (blood cell cancer), or multiple myeloma (a cancer of the bone marrow).
• If you have a penile deformity or Peyronie’s disease.
• If you have heart problems. Your doctor should carefully assess whether your heart condition allows you to tolerate the physical strain of sexual intercourse.
• If you currently have a stomach ulcer or bleeding disorders (such as haemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Accord and contact your doctor immediately.
• You must not use Sildenafil Accord together with other oral or topical treatments for erectile dysfunction.
• You must not take Sildenafil Accord with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
• You must not take Sildenafil Accord if you do not have erectile dysfunction.
• You must not take Sildenafil Accord if you are a woman.

Special precautions for patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose.
Children and adolescents
Sildenafil Accord must not be administered to individuals under 18 years of age.
Other medicines and Sildenafil Accord:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Sildenafil Accord may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Sildenafil Accord and when it was taken. Do not take Sildenafil Accord
together with other medicines unless authorized by your doctor.
Do not take Sildenafil Accord if you are taking medicines called nitrates, because the combination
of these medicines may lead to a dangerous drop in blood pressure. Always inform your doctor,
pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve
angina attacks (or "chest pain").
Do not take Sildenafil Accord if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also lead to a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example for the treatment of HIV, your doctor may initially prescribe the lowest dose of Sildenafil Accord (25 mg).
Some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or a sensation of emptiness in the head, which may be due to low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Accord together with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil Accord. To reduce the likelihood of these symptoms occurring, you should be on a stable daily dose of the alpha-blocker before starting treatment with Sildenafil Accord. Your doctor may start you on a lower dose of Sildenafil Accord (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used for the treatment of heart failure.
Taking Sildenafil Accord with food, drinks, and alcohol
Sildenafil Accord can be taken with or without food. However, you may notice that the onset of effect of
Sildenafil Accord may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid excessive alcohol consumption before taking Sildenafil Accord.
Pregnancy, breastfeeding and fertility
Sildenafil Accord is not indicated for use in women.
Driving and using machines
Sildenafil Accord may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to Sildenafil Accord.
Important information about some excipients of Sildenafil Accord
Sildenafil Accord contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain
sugars, contact them before taking Sildenafil Accord.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Sildenafil Accord

Always take Sildenafil Accord exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Accord more than once a day.
Take Sildenafil Accord approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Accord is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Accord will help you achieve an erection only if you are sexually stimulated. The time required for Sildenafil Accord to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of Sildenafil Accord may take longer if you have recently eaten a heavy meal.
If Sildenafil Accord does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more Sildenafil Accord than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than instructed by your doctor.
Contact your doctor if you have taken more tablets than prescribed.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported in association with the use of Sildenafil Accord are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious side effects, stop taking Sildenafil Accord and
contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If it occurs during or after sexual intercourse:
  • Sit in a semi-upright position and try to relax. Do not use nitrates for chest pain.

Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people).
After taking Sildenafil Accord, prolonged and sometimes painful erections have occasionally been reported. If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – these occur rarely. Symptoms may include severe skin peeling and swelling, blisters in the mouth, genitals and around the eyes, fever.
• Seizures or epileptic fits – occur rarely

Other side effects:
Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• facial flushing
• hot flushes (symptoms include a sudden feeling of warmth in the upper body)
• nausea
• indigestion
• visual disturbances (increased colour intensity, blurred vision)
• stuffy nose
• dizziness

Uncommon (may affect up to 1 in 100 people)

• vomiting
• rash
• eye irritation
• bloodshot eyes/red eyes
• eye pain
• seeing flashes of light
• visual brightness
• light sensitivity
• pounding heartbeat
• rapid heartbeat
• high blood pressure
• low blood pressure
• muscle pain, drowsiness
• reduced sensitivity to touch
• vertigo
• ringing in the ears
• dry mouth
• stuffy nose or sinusitis
• inflammation of the nasal mucosa (symptoms include runny nose, sneezing and stuffy nose)
• upper abdominal pain
• gastro-oesophageal reflux disease (symptoms include heartburn)
• feeling of fatigue
• feeling of warmth
• pain in arms or legs
• nosebleeds
• blood in the urine
• tearing

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

• heart attack
• irregular heartbeat
• fainting
• stroke
• temporary reduction in blood flow to certain areas of the brain
• sensation of throat tightness
• numbness of the mouth
• bleeding in the back of the eye
• double vision
• reduced visual acuity
• abnormal sensation in the eye
• swelling of the eyes or eyelids
• seeing small particles or spots
• dilation of the pupil
• discolouration of the white part of the eye
• penile bleeding
• blood in the semen
• dry nose
• swelling inside the nose
• feeling of irritability
• sudden decrease or loss of hearing

Rare cases of unstable angina (a heart condition) and sudden death have been reported during post-marketing experience.
It should be noted that most, but not all, of the men who experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to the use of Sildenafil Accord.
Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Accord

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Sildenafil Accord after the expiry date stated on the carton and on the aluminium of the blister after 'Exp.'. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Accord contains
The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil as
sildenafil citrate.
The other components are:

• Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose 5cp (E464), magnesium stearate.
• Film coating: hypromellose 15cp (E464), titanium dioxide (E171), monohydrate lactose, triacetin, aluminium lake containing indigo carmine (E132) ( see section 2: Important information about some components of Sildenafil Accord )

Description of the appearance of Sildenafil Accord and contents of the pack
Sildenafil Accord 25 mg tablets are film-coated, blue, almond-shaped, biconvex tablets, marked with '25' on one side and smooth on the other.
Sildenafil Accord 50 mg tablets are film-coated, blue, almond-shaped, biconvex tablets, marked with '50' on one side and smooth on the other.
Sildenafil Accord 100 mg tablets are film-coated, blue, almond-shaped, biconvex tablets, marked with '100' on one side and smooth on the other.
Sildenafil Accord is available in blister packs containing:
25 mg: 2, 4, 8 or 12 tablets.
50 mg: 2, 4, 8, 12 or 24 tablets.
100 mg: 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the European Economic Area countries under the following names:

Member State Name of the medicinal product
Czech Republic Sildenafil Accord 100mg
Denmark Sildenafil Accord 25mg /50mg/100mg
Estonia Sildenafil Accord 50mg/100mg
Finland Sildenafil Accord 50mg/100mg
France Sildenafil Accord 25mg /50mg/100mg
Ireland Sildenafil Accord 25mg /50mg/100mg
Italy Sildenafil Accord 25mg /50mg/100mg film-coated tablets
Latvia Sildenafil Accord 50mg/100mg
Lithuania Sildenafil Accord 50mg/100mg
Sweden Sildenafil Accord 25mg /50mg/100mg
The Netherlands Sildenafil Accord 25mg /50mg/100mg
United Kingdom Sildenafil Accord 25mg /50mg/100mg