Sildenafil-Hameln 100 Mg Film-Coated Tablets
hameln
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sildenafil 25 mg film-coated tablets Sildenafil 50 mg film-coated tablets Sildenafil 100 mg film-coated tablets
Sildenafil citrate
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 your 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.
What is in this leaflet
1. What Sildenafil is and what it is used for
2. What you need to know before you take Sildenafil
3. How to take Sildenafil
4. Possible side effects
5. How to store Sildenafil
6. Contents of the pack and other information
1. What Sildenafil is and what it is used for
Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) 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 will only help you to get an erection if you are sexually stimulated. You should not take Sildenafil if you do not have erectile dysfunction. You should not take Sildenafil if you are a woman.
Sildenafil is a treatment for 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 Do not take Sildenafil if you:
• are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease 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 drugs known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease in your blood pressure.
• are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• have a severe heart or liver problem.
• 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 because of non-arteritic anterior ischaemic optic neuropathy (NAION).
Warnings and precautions
Tell your doctor before taking Sildenafil 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 in that case carefully check whether your heart can take the additional strain of having sex.
• currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
• experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately. You should not use Sildenafil with any other oral or local treatments for erectile dysfunction.
Children and adolescents
Sildenafil should not be given to individuals under the age of 18.
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.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken other medicines or might take any other medicines, including medicines obtained without prescription.
Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any healthcare professional treating your condition that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can. You should not take Sildenafil if you are taking medicines called nitrates as the combination of these products may cause a potentially dangerous decrease 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 Sildenafil 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 potentially dangerous decrease 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.
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 with alpha-blockers.
This is most likely to occur within 4 hours after taking Sildenafil. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.
Sildenafil with food and drink
Sildenafil can be taken with or without food. However, you may find that Sildenafil 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.
Pregnancy and Breast-feeding
Sildenafil is not indicated for use by women.
Driving and using machines
Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil before you drive or use machinery.
3. How to take Sildenafil
Always take Sildenafil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 50 mg.
You should not take Sildenafil more than once a day.
You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you have the impression that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist. Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil takes longer to work if you take it with a heavy meal. If Sildenafil 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 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 tablets than your doctor tells you to.
Contact your doctor if you take more tablets 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 Sildenafil are usually mild to moderate and of a short duration.
If you have chest pains during or after intercourse:
• Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.
• Contact your doctor immediately.
All medicines including Sildenafil can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat. Prolonged and sometimes painful erections have been reported after taking Sildenafil. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
If you experience a sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.
A very common side effect (likely to occur in more than 1 in 10 patients) is headache.
Common side effects (likely to occur in 1 to 10 patients in 100) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.
Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include: vomiting, skin rash, bleeding at the back of the eye, bloodshot eyes/red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.
Rare side effects (likely to occur in 1 to 10 patients in 10000) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.
Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, heart attack or temporary decreased blood flow to parts of the brain.
Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil. Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.
If you get any side effects, talk to your doctor pharmacist.
This includes any possible side effects not listed in this leaflet.
5. How to store Sildenafil
Keep this medicine out of the sight and reach of children. Store in the outer carton in order to protect from light.
Do not use Sildenafil after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
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 contains
• Sildenafil 25 mg: Each tablet contains 35.12 mg of sildenafil citrate quantitatively equivalent to 25 mg sildenafil.
• Sildenafil 50 mg: Each tablet contains 70.24 mg of sildenafil citrate quantitatively equivalent to 50 mg of sildenafil.
• Sildenafil 100 mg: Each tablet contains 140.48 mg of sildenafil citrate quantitatively equivalent to 100 mg of sildenafil.
The other ingredients are:
• Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), povidone 25, croscarmellose sodium, magnesium stearate, macrogol 6000.
• Film-coat:
Hypromellose, microcrystalline cellulose titanium dioxide (E171), brilliant blue FCF aluminium lake (E133), macrogol stearate.
What Sildenafil looks like and contents of the pack
• Sildenafil 25 mg film-coated tablets are blue, oval and biconvex.
• Sildenafil 50 mg film-coated tablets are blue, oval and biconvex with break-marks on both sides to facilitate ease of dosing.
• Sildenafil 100 mg film-coated tablets are blue, oval and biconvex with break-marks on both sides to facilitate ease of dosing.
The tablets are provided in blister packs containing 4, 10, 12 or 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder hameln pharmaceuticals ltd Nexus, Gloucester Business Park Gloucester, GL3 4AG, United Kingdom Manufacturer hameln rds a.s.
Horna 36, 900 01 Modra, Slovak Republic This leaflet was last revised in July 2013.