Patient leaflet - LICOSIL 100 MG FILM-COATED TABLETS
5. How to store Licosil
Keep this medicine out of the sight and reach of children
This medicinal product does not require any special storage conditions.
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.
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.
What Licosil is and what it is used for
What you need to know before you take Licosil
How to take Licosil
Possible side effects
How to store Licosil
Contents of the pack and other information
What Licosil is and what it is used for
Licosil 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. Licosil will only help you to get an erection if you are sexually stimulated.
Licosil 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 Licosil
Do not take Licosil
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 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).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Licosil
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 Licosil and contact your doctor immediately.
You should not take Licosil 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 Licosil 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 Licosil.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, 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 happen within 4 hours after taking Licosil. To reduce the chance that these symptoms might happen, 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.
Licosil with food and drink and alcohol
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, breast-feeding and fertility 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 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 Licosil more than once a day.
Do not take sildenafil film-coated tablets in combination with sildenafil orodispersible tablets.
You should take Licosil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel 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.
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 Licosil are usually mild to moderate and of a short duration.
If you experience any of the following serious side effects stop taking Licosil 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): is 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, 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.
From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, 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 Licosil.
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. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
6. Contents of the pack and other information
What Licosil contains
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– The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as the citrate salt).
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– The other ingredients are:
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– Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, silica colloidal anhydrous, sodium croscarmellose,
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– Film-coat: 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 100 mg film-coated tablets are blue, enlongated and marked with “100”.
Licosil 100 mg film-coated tablets are supplied in blister packs of 4 and 8 tablets.
Some pack sizes may not be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Laboratorios LICONSA, S.A.
C/ Dulcinea S/N
28805 Alcala de Henares, Guadalajara, Spain.
Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid, Spain
LABORATORIOS LICONSA, S.A.
Avenida Miralcampo, 7. PoKgono Industrial Miralcampo
19200 Azuqueca de Henares Guadalajara – Spain
This leaflet was last revised in: October 2020
577098–01
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