25 mg, 50 mg, and 100 mg film-coated tablets
sildenafil
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). They work by making it easier for the blood vessels in your penis to dilate so that the blood can flow in when you are sexually stimulated. Sildenafil Accord only makes it easier to get an erection if you are sexually stimulated. You should not take Sildenafil Accord if you do not have erectile dysfunction. If you are a woman, do not use Sildenafil Accord.
Sildenafil Accord is a treatment for adult men with erectile dysfunction, better known as impotence. This means that a man cannot get, or maintain, a hard erect penis for sexual intercourse.
Sildenafil contained in Sildenafil Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Sildenafil Accord
Do not take Sildenafil Accord
- if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of this medicine (listed in section 6)
- if you are taking medicines that contain nitrates, as the combination can lead to a sharp drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often given to relieve angina ( angina pectoris ) or “chest pain”. If you are not sure, ask your doctor or pharmacist
- if you are taking medicines called nitric oxide donors such as amyl nitrite (poppers), as a combination with such medicines may also lead to a sharp drop in blood pressure
- if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as sildenafil have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
- if you have severe heart or liver problems
- if you have recently had a stroke or heart attack or if you have low blood pressure
- if you have specific, rare, inherited eye diseases (such as retinitis pigmentosa)
- if you have ever lost your sight due to non-arteritic anterior ischemic optic infarction/neuropathy (NAION)
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Accord
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer), or multiple myeloma ( bone marrow cancer )
- if you have a deformed penis or any disease of the penis such as Peyronie’s disease
- if you have heart problems. Your doctor should carefully check if your heart can tolerate the increased effort that sexual activity entails
- if you currently have a stomach ulcer or a bleeding disorder (such as hemophilia)
- if you experience sudden impairment or loss of vision, stop taking Sildenafil Accord and contact a doctor immediately
- You should not use Sildenafil Accord at the same time as other ( oral or local) treatments for erectile dysfunction.
- You should not use Sildenafil Accord with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
- You should not take Sildenafil Accord if you do not have erectile dysfunction.
- You should not take sildenafil Accord if you are a woman.
Especially to take into account when it comes to patients with liver or kidney problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide that your dose should be lower.
Children and young people
Sildenafil Accord should not be given to people under 18 years of age.
Other medicines and Sildenafil Accord
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Sildenafil Accord may affect the way some medicines are used, especially those used to treat chest pain. If you become acutely ill, you should inform your doctor, pharmacist, or nurse that you have taken Sildenafil Accord and when. Do not take Sildenafil Accord with other medicines unless your doctor tells you to.
You should not take Sildenafil Accord if you are taking medicines called nitrates, as the combination of these medicines can lead to a sharp drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often given to relieve angina pectoris or “chest pain”.
You should not take Sildenafil Accord if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), as a combination of such medicines with Sildenafil Accord may lead to a sharp drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking so-called protease inhibitors for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of Sildenafil Accord (25 mg).
Some patients taking alpha-receptor blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when you quickly sit up or stand up. Some patients have experienced these symptoms while taking Sildenafil Accord with alpha-receptor blockers. This is most likely to occur within 4 hours of taking the Sildenafil Accord. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil Accord. Your doctor may prescribe a lower dose (25 mg) of Sildenafil Accord.
Using Sildenafil Accord with food, drink, and alcohol
Sildenafil Accord can be taken with or without food, but if you take them with a heavy meal, it may take a little longer before they work.
Alcohol intake may temporarily reduce the ability to get an erection. To get the maximum effect from your medicine, you should not drink large amounts of alcohol before taking Sildenafil Accord.
Pregnancy, breastfeeding, and fertility
Sildenafil Accord should not be used by women.
Driving and using machines
Sildenafil Accord may cause dizziness and impair vision. You should be aware of how you react to Sildenafil Accord before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of the Sildenafil Accord
Sildenafil Accord contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Sildenafil Accord.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Sildenafil Accord
Always take Sildenafil Accord exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Accord more than once a day.
You should take Sildenafil Accord approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you have the impression that the effect of Sildenafil Accord is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Accord only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil Accord to work varies from person to person, but normally it takes between half and an hour. You may notice that it takes longer for Sildenafil Accord to work if you take it with a heavy meal.
If Sildenafil Accord does not help you get an erection or if an erection does not last long enough to complete sexual intercourse, tell your doctor.
If you take more Sildenafil Accord than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
You may find that the side effects and their severity increase. Doses above 100 mg do not increase the impact.
Do not take more tablets than your doctor tells you to do.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with Sildenafil Accord are usually mild to moderate and last only a short time.
Stop using Sildenafil Accord and contact your doctor immediately if you experience any of the following
- Severe symptoms: An allergic reaction – less common (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, and swelling of the eyelids, face, lips, or throat.
- Chest pain – uncommon
If this occurs during or after intercourse:- Get up in a semi-sitting position and try to relax.
- Do not take nitrates to treat chest pain.
Prolonged and sometimes painful erections are – rare (may affect up to 1 in 1,000 people)
If you get such an erection that lasts longer than 4 hours, you should contact your doctor immediately.
- A sudden decrease or loss of vision – rare
- Severe skin reactions – rare
Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genitals, and around the eyes, and fever. - Seizures or seizures – rare
Other side effects:
Very common (may affect more than 1 user in 10)
- Headache.
Common (may affect up to 1 in 10 people)
- Blush
- Hot flashes (symptoms may include a sudden feeling of warmth in the upper body)
- Nausea
- Digestive problems
- Effects on vision (altered color vision, blurred vision)
- Nasal congestion
- Dizziness.
Uncommon (may affect up to 1 in 100 people)
- Vomiting
- Rash
- Eye irritation
- Bloodshot eyes / red eyes
- Eye pain
- Experience of seeing flashes of light
- Experience of light as very strong
- Light sensitivity
- Palpitation
- Fast heartbeat
- High blood pressure
- Low blood pressure
- Muscle pain, drowsiness
- Decreased feeling
- Dizziness
- Earrings
- Dry mouth
- Blocked or blocked sinuses
- Inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion)
- Pain in the upper abdomen
- Gastroesophageal reflux disease (symptoms include heartburn)
- Feeling tired
- Feeling of warmth
- Pain in arms or legs
- Nosebleed
- Blood in the urine
- Watery eyes
Rare (may affect up to 1 in 1,000 people)
- Heart attack
- Irregular heartbeats
- Fainting
- Stroke
- Temporarily reduced blood flow to parts of the brain
- A feeling of it getting crowded in the throat
- Dull mouth
- Bleeding in the back of the eye
- Double vision
- Decreased visual acuity
- Abnormal feeling in the eye
- Swelling of the eye or eyelid
- Small dots or spots in the field of view
- Sees a halo around light sources
- Dilated pupils are
- Discoloration of the whites of the eyes
- Bleeding in the penis
- Blood in the semen
- Dry nose
- Swelling inside the nose
- Irritability
- Sudden loss or loss of hearing
After the drug has been marketed and used by patients, rare cases of unstable angina (a type of heart problem) and sudden death have been reported. It is worth noting that most – but not all – of the men who experienced these symptoms had heart problems before taking this medication. It is impossible to say whether these events were due to the Sildenafil Accord.
How to store Sildenafil Accord
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use Sildenafil Accord after the expiry date which is stated after “EXP”. on the box and “EXP” on the blister card. The expiration date is the last day of the specified month.
The medicine 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.
Contents of the packaging and other information
Content declaration
The active substance is sildenafil. Each tablet contains 25 mg, 50 mg, or 100 mg of sildenafil as sildenafil citrate.
Other ingredients are:
- Tablet core:
Microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, hypromellose 5cp (E464), magnesium stearate - Film coating:
Hypromellose 15cp (E464), titanium dioxide (E171), lactose monohydrate, triacetin, indigo carmine aluminum substrate pigment (E132) ( see section 2 for Important information about some of the ingredients of Sildenafil Accord )
What the medicine looks like and the contents of the pack
Sildenafil Accord 25 mg are blue, almond-shaped, biconvex, film-coated tablets, unlabeled on one side and marked with “25” on the other.
Sildenafil Accord 50 mg are blue, almond-shaped, biconvex, film-coated tablets, unlabeled on one side and marked with “50” on the other.
Sildenafil Accord 100 mg are blue, almond-shaped, biconvex, film-coated tablets, unlabeled on one side and marked with “100” on the other.
Sildenafil Accord is available in blister cards with:
25mg: 2, 4, 8 or 12 tablets.
50mg: 2, 4, 8, 12 or 24 tablets.
100mg: 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Polska Sp.z oo
ul. Lutomierska 50
95-200 Pabianice
Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands