Patient leaflet - Silandyl 100 mg orodispersible film
1. What SILANDYL is and what it is used for
- If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
SILANDYL 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. SILANDYL will only help you to get an erection if you are sexually stimulated.
- 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.
SILANDYL 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.
- 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 SILANDYL and contact your doctor immediately.
2. What you need to know before you take SILANDYL
You should not use SILANDYL with any other oral or local treatments for erectile dysfunction.
Do not take SILANDYL
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
You should not use SILANDYL with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
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.
You should not take SILANDYL if you do not have erectile dysfunction.
You should not take SILANDYL if you are a woman.
Special considerations for patients with kidney or liver problems
- If you are using any of the medicines known as nitric oxide donors such as amyl
decide on a lower dose for you.
Children and adolescents
SILANDYL should not be given to individuals under the age of 18.
Other medicines and SILANDYL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SILANDYL 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 SILANDYL and when you did. Do not take SILANDYL with other medicines unless your doctor tells you that you can.
You should not take SILANDYL 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 SILANDYL 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 SILANDYL. 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 SILANDYL with alpha-blockers. This is most likely to happen within 4 hours after taking SILANDYL.
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start SILANDYL. Your doctor may start you on a lower dose (25 mg) of SILANDYL. Tell your doctor or pharmacist if you are already taking riociguat.
SILANDYL with food and drink and alcohol
SILANDYL can be taken with or without food. However, you may find that SILANDYL 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 SILANDYL.
Pregnancy, breast-feeding and fertility
SILANDYL is not indicated for use by women.
Driving and using machines
SILANDYL can cause dizziness and can affect vision. You should be aware of how you react to SILANDYL before you drive or use machinery.
3. How to take SILANDYL
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 SILANDYL more than once a day.
You should take SILANDYL 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 SILANDYL is too strong or too weak, talk to your doctor or pharmacist. SILANDYL will only help you to get an erection if you are sexually stimulated. The amount of time SILANDYL takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that SILANDYL takes longer to work if you take it with a heavy meal. If SILANDYL 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 SILANDYL 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.
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 SILANDYL are usually mild to moderate and of a short duration
If you experience any of the following serious side effects stop taking SILANDYL 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 or 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. 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) and sudden death have been reported rarely. 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 SILANDYL.
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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at
http://www.mhra.gov.uk/yellowcard www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store SILANDYL
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. If the expiry date is reported as month/year, 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 SILANDYL contains
- The active substance is sildenafil (as citrate).