Sildenafil Ibsa 100 Mg Orodispersible Film
Package leaflet: Information for the patient
SILDENAFIL IBSA 25 mg orodispersible film SILDENAFIL IBSA 50 mg orodispersible film SILDENAFIL IBSA 75 mg orodispersible film SILDENAFIL IBSA 100 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. Y ou 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 IBSA is and what it is used for
2. What you need to know before you take SILDENAFIL IBSA
3. How to take SILDENAFIL IBSA
4. Possible side effects
5. How to store SILDENAFIL IBSA
6. Contents of the pack and other information
1. What SILDENAFIL IBSA is and what it is used for
SILDENAFIL IBSA 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 IBSA will only help you to get an erection if you are sexually stimulated.
SILDENAFIL IBSA 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 IBSA Do not take SILDENAFIL IBSA
• 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).
• If you 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 SILDENAFIL IBSA have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking SILDENAFIL IBSA
• 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 IBSA and contact your doctor immediately.
You should not use SILDENAFIL IBSA with any other oral or local treatments for erectile dysfunction.
You should not use SILDENAFIL IBSA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
You should not take SILDENAFIL IBSA if you do not have erectile dysfunction.
You should not take SILDENAFIL IBSA 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 IBSA should not be given to individuals under the age of 18.
Other medicines and SILDENAFIL IBSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SILDENAFIL IBSA orodispersible films 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 IBSA and when you did. Do not take SILDENAFIL IBSA with other medicines unless your doctor tells you that you can.
You should not take SILDENAFIL IBSA 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, pharmacist or 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 IBSA 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 IBSA.
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 IBSA with alpha-blockers. This is most likely to happen within 4 hours after taking SILDENAFIL IBSA.
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 IBSA. Your doctor may start you on a lower dose (25 mg) of SILDENAFIL IBSA.
Tell your doctor or pharmacist if you are already taking riociguat.
SILDENAFIL IBSA with food and drink and alcohol
SILDENAFIL IBSA can be taken with or without food. However, you may find that SILDENAFIL IBSA 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 IBSA.
Pregnancy, breast-feeding and fertility
SILDENAFIL IBSA is not indicated for use by women.
Driving and using machines
SILDENAFIL IBSA can cause dizziness and can affect vision. You should be aware of how you react to SILDENAFIL IBSA before you drive or use machinery.
3. How to take SILDENAFIL IBSA
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 IBSA more than once a day.
You should take SILDENAFIL IBSA about one hour before you plan to have sex. Sildenafil orodispersible films are for oral use and are taken without water. If desired you may also take Sildenafil with water.
Instructions for use
Important: Do not handle the orodispersible film with wet hands!
a) Take the sachet, locate the arrow mark on the top of the sachet and hold it with this side facing up. The sachet is not sealed here
b) Gently peel both parts of the sachet.
Now you can hold each between your thumb and your index finger using one hand for each part.
c) Carefully tear both parts of the sachet into opposite directions until they are separated.
The orodispersible film is now visible and placed on one of the separated sachet parts.
d) Take the orodispersible film with dry fingers out of the sachet and put it in your mouth directly on your tongue. It will dissolve rapidly, so that it can be easily swallowed.
If you feel that the effect of SILDENAFIL IBSA is too strong or too weak, talk to your doctor or pharmacist. SILDENAFIL IBSA will only help you to get an erection if you are sexually stimulated. The amount of time SILDENAFIL IBSA takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that SILDENAFIL IBSA takes longer to work if you take it with a heavy meal.
If SILDENAFIL IBSA 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 IBSA 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.
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, pharmacist or nurse.
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 IBSA are usually mild to moderate and of a short duration.
If you experience any of the following serious side effects stop taking SILDENAFIL IBSA 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, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) 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.
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.
Additional side effects reported from post-marketing experience:
Unstable angina (a heart condition), sudden death. 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 SILDENAFIL IBSA.
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 MHRA 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 SILDENAFIL IBSA
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 carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package, in order to protect from moisture. This medicinal product 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 SILDENAFIL IBSA 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).
Each orodispersible film contains 100 mg Sildenafil (as citrate).
• The other ingredients are Maltodextrin, Glycerol, Polysorbate 20, Propylene glycol monocaprylate, Polyvinyl acetate dispersion 30%, Lemon and Grapefruit flavours (Lemon essential oil, Citral, Linalool, Grapefruit essential oil, Orange essential oil, Nootkaton, Butylated hydroxyanisol E320, Ascorbic acid E300, Maltodextrin, Arabic gum E414), Sucralose, Titanium dioxide, Indigotine .
What SILDENAFIL IBSA looks like and contents of the pack
SILDENAFIL IBSA is an orodispersible film.
Sildenafil 25 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (30 mm x 15 mm).
Sildenafil 50 mg orodispersible film
The orodispersible film is a square, flexible, light blue film strip (30 mm x 30 mm).
Sildenafil 75 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (30 mm x 45 mm).
Sildenafil 100 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (40 mm x 45 mm).
The orodispersible films are provided in packs containing 2, 4, 8 or 12 orodispersible films. Each sachet contains one orodispersible film.
Some pack sizes may not be marketed in your country.
Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia, 2,
26900 Lodi, Italy
Manufacturer
SPA Italiana Laboratori BOUTY,
S.S. n. 11 Padana Superiore Km 160 - 20060 Cassina de’ Pecchi (Mi) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.