Licosil 25 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Licosil 25 mg film-coated tablets
Sildenafil
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Licosil is and what it is used for
2. Before you take Licosil
3. How to take Licosil
4. Possible side effects
5. How to store Licosil
6. Further information
1. WHAT LicosilIS AND WHAT IT IS USED FOR
Licosil 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. Licosil will only help you to get an erection if you are sexually stimulated. You should not take Licosil if you do not have erectile dysfunction. You should not take Licosilif you are a woman.
Licosilis 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. BEFORE YOU TAKE Licosil Do not take Licosil
- 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.
- If you 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.
- If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Licosil.
- 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).
Take special care with Licosil
Tell your doctor
- 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 in that case 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 Licosil and contact your doctor immediately.
You should not use Licosil with any other oral or local treatments for erectile dysfunction.
Special considerations for children and adolescents Licosil should not be given to individuals under the age of 18.
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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.
Licosil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken Licosil and when you did. Do not take Licosil with other medicines unless your doctor tells you that you can.
You should not take Licosil 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 Licosil if you 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.
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 Licosil.
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 Licosil with alpha-blockers. This is most likely to occur within 4 hours after taking Licosil. 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 Licosil. Your doctor may start you on a lower dose (25 mg) of Licosil.
Taking Licosil with food and drink
Licosil can be taken with or without food. However, you may find that Licosil 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 Licosil.
Pregnancy and Breast feeding
Licosil is not indicated for use by women.
Driving and using machines
Licosil can cause dizziness and can affect vision. You should be aware of how you react to Licosil before you drive or use machinery.
3. HOW TO TAKE Licosil
Always take Licosil 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 Licosil more than once a day.
You should take Licosil 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 Licosil is too strong or too weak, talk to your doctor or pharmacist.
Licosil will only help you to get an erection if you are sexually stimulated. The amount of time Licosil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Licosil takes longer to work if you take it with a heavy meal.
If Licosildoes 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 Licosil 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, Licosil can cause side effects although not everybody gets them. The side effects reported in association with the use of Licosil 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 Licosil can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Licosil: 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 Licosil. 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 Licosil and contact your doctor immediately.
The following frequencies are used to evaluate side effects:
|
very common: |
affects more than 1 user in 10 |
|
common: |
affects 1 to 10 users in 100 |
|
uncommon: |
affects 1 to 10 users in 1,000 |
|
rare: |
affects 1 to 10 users in 10,000 |
|
very rare: |
affects less than 1 user in 10,000 |
|
not known: |
frequency cannot be estimated from the available data |
A very common side effect is headache.
Common side effects 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 include: vomiting, skin rash, bleeding at the back of the eye, eye irritation, 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 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 Licosil. 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.
5. HOW TO STORE Licosil
Keep out of the reach and sight of children
This medicinal product does not require any special storage conditions.
Do not use Licosil after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines 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.
6. FURTHER INFORMATION
What Licosil contains
The active substance is sildenafil. Each tablet Licosil 25 mg film-coated tablets contains sildenafil citrate equivalent to 25 mg sildenafil.
The other ingredients are: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, magnesium stearate, silica, colloidal anhydrous, croscarmellose sodium, hypromellose, titanium dioxide (E-171), macrogol 6000, talc and indigo carmine aluminium lake (E-132).
What Licosil looks like and contents of the pack
Licosil 25 mg film-coated tablets are blue, enlongated. and marked with “25”.
Licosil 25 mg film-coated tablets are supplied in blister packs of 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratorios LICONSA, S.A.
Gran Via Carlos III, 98, 7th floor 08028 Barcelona, SPAIN
Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos - Madrid, SPAIN
LABORATORIOS LICONSA, S.A.
Avenida Miralcampo, 7. Poligono Industrial Miralcampo 19200 Azuqueca de Henares Guadalajara - SPAIN
This medicinal product is authorised in the Member States of the EEA under the following names:
AT/H/303/01-03/DC
AT: Licosil 25/50/100 mg Filmtablette
DE: Licosil 25/50/100 mg Filmtablette
EL: Licosil 25/50/100 mg EmKaA.ugg.evo gs Asrao ugevio Sramo PL: Licosil
UK: Licosil 25/50/100 mg Film-coated tablet