25 mg, 50 mg, and 100 mg film-coated tablets
Sildenafil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Idilico is and what it is used for
2. What you need to know before taking Idilico
3. How to use Idilico
4. Possible side effects
5. How to store Idilico
6. Contents of the packaging and other information

1. What Idilico is and what it is used for

Idilico contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). It works by making it easier for the blood vessels in your penis to dilate so that the blood can flow in when you are sexually stimulated. Idilico only makes it easier to get an erection if you are sexually stimulated.

Idilico is a treatment for adult men with erectile dysfunction, better known as impotence. This means that a man cannot get, or maintain, a hard erect penis sufficient for sexual intercourse.

Sildenafil contained in Idilico may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Idilico

Do not take Idilico

– 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 they in combination with Idilico can lead to a sharp drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often given to relieve angina ( angina pectoris ) or “chest pain”. If you are not sure, ask your doctor or pharmacist.

– if you are taking medicines known as nitric oxide donors such as amyl nitrite, a combination of such medicines with Idilico may also lead to a dangerous drop in blood pressure

– if you have severe heart or liver problems

– if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Idilico, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.

– if you have recently had a stroke or 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 lost your sight due to non-arteritic anterior ischemic optic infarction/neuropathy (NAION).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Idilico:

-if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer ), multiple myeloma ( bone marrow cancer )

– if you have a deformed penis or any disease of the penis such as Peyronie’s disease

– if you have heart problems. In this case, your doctor should carefully check if your heart can tolerate the increased effort that sexual activity entails.

– if you currently have a stomach ulcer or a bleeding disorder (such as haemophilia )

– if you experience a sudden deterioration or loss of vision, stop taking Idilico and contact a doctor immediately.

You should not use Idilico at the same time as any other ( oral or topical) treatment for erectile dysfunction.

You should not use Idilico at the same time as any treatment for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take Idilico if you do not have erectile dysfunction

You should not take Idilico if you are a woman.

Especially to take into account when it comes to patients with liver or kidney problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide that your dose should be lower.

Sodium

This medicine contains less

Children and young people

Idilico should not be given to people under 18 years of age.

Other medicines and Idilico

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Idilico tablets can affect the effectiveness of certain medicines, especially those used to treat chest pain. If you become acutely ill, you should inform your doctor, pharmacist, or nurse that you took Idilico and when you did. Do not take Idilico with other medicines unless your doctor tells you to.

You should not take Idilico if you are taking medicines called nitrates, as they in combination with Idilico can cause a sharp drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often given to relieve angina pectoris or “chest pain”.

You should not take Idilico if you are taking medicines known as nitric oxide donors such as amyl nitrite, as a combination of such medicines with Idilico may also lead to a sharp drop in blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking a so-called protease inhibitor for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of Idilico (25 mg).

Some patients taking alpha-receptor blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when you quickly sit up or stand up. Some patients have experienced these symptoms while taking Idilico with alpha-receptor blockers. This most likely happens within 4 hours of taking Idilico. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Idilico. Your doctor may prescribe a lower dose (25 mg) of Idilico.

Idilico with food, drink and alcohol

Idilico can be taken with or without food, but if you take it with a hearty meal, it may take a little longer before it works.

Alcohol intake may temporarily reduce the ability to get an erection. To get the maximum effect from medicines, you should not drink large amounts of alcohol before taking Idilico.

Pregnancy, breastfeeding and fertility

Idilico should not be used by women.

Driving and using machines

Idilico may cause dizziness and may affect vision. You should be aware of how you react to Idilico before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Idilico

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The recommended starting dose is 50 mg.

You should not take Idilico more than once a day.

Do not take film-coated tablets containing sildenafil in combination with orodispersible tablets containing sildenafil.

You should take Idilico about an hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you have the impression that the effect of Idilico is too strong or too weak, talk to your doctor or pharmacist.

Idilico only gives you an erection if you are sexually stimulated. The time it takes for Idilico to work varies from person to person, but normally it takes between half and an hour. You may notice that it takes longer for Idilico to work if you take it with a heavy meal.

If Idilico does not help you get an erection or if an erection does not last long enough to complete sexual intercourse, tell your doctor.

Do not take more tablets than your doctor tells you to do.

Contact your doctor if you take more tablets than you should.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

If you use more Idilico than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

You may find that the side effects and their severity increase. Doses above 100 mg do not increase the effect.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported with the use of Idilico are usually mild to moderate and last only a short time.

Stop using Idilico and contact your doctor immediately if you experience any of the following severe symptoms :

  • An allergic reaction – less common (may affect up to 1 in 100 people)Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
  • Chest pain – less commonIf this happens during or after intercourse:
    • Get up in a semi-sitting position and try to relax.
    • Do not take nitrates to treat chest pain.
  • Prolonged and sometimes painful erections – rare (may affect up to 1 in 1,000 users)If you get such an erection that lasts longer than 4 hours, you should contact a doctor immediately.
  • Sudden decrease or loss of vision – rare
  • Severe skin reaction – rareSymptoms include severe dandruff and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
  • Seizures – rare

Other side effects are :

Very common (may affect more than 1 user in 10): headache.

Common (may affect up to 1 in 10 people): nausea, flushing, hot flashes (symptoms may include a sudden feeling of warmth in the upper body), digestive problems, altered color vision, blurred vision, visual disturbances, nasal congestion and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes / red eye, eye pain, seeing flashes of light or perceiving light as very strong, photosensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure , low blood pressure , muscle pain, drowsiness, decreased sensation, dizziness, ringing in the mouth , dry mouth , blocked or blocked sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux (symptoms include heartburn), presence of blood in the urine, pain in the arms or legs, nosebleeds, feeling hot and tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke , heart attack, irregular heartbeat, temporary decrease in blood flow to parts of the brain, a feeling of tightness in the throat, numb mouth, bleeding in the back of the eye , double vision , decreased visual acuity , abnormal sensation in the eye, swelling in the eye or eyelid, small dots or spots in the visual field , that you see a halo around light sources, dilated pupils , discoloration of the whites of the eyes, bleeding in the penis, blood in the semen, dry nose, swelling inside the nose, irritability and sudden loss or loss of hearing.

After the drug has been marketed and used by patients, rare cases of unstable angina (a type of heart problem) and sudden death have been reported. It is worth noting that most – but not all – of the men who experienced these symptoms had heart problems before taking this medication. It is impossible to say whether these events were due to Idilico.

5. How to store Idilico

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. and on the blister after EXP. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

The active substance is sildenafil. Each tablet contains 25 mg / 50 mg / 100 mg sildenafil (as sildenafil citrate).

Other ingredients are:

  • Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, silica colloidal anhydrous, croscarmellose sodium,
  • Coating: hypromellose, titanium dioxide (E171), macrogol 6000, talc, indigo carmine aluminum lacquer (E132)

What the medicine looks like and contents of the pack

Idilico 25 mg film-coated tablets are blue, diamond-shaped and marked “25”.

Idilico 50 mg film-coated tablets are blue, diamond-shaped and marked “50”.

Idilico 100 mg film-coated tablets are blue, diamond-shaped and marked “100”.

Idilico 25 mg film-coated tablets are supplied in blister packs of 4 or 12 tablets.

Idilico 50 mg film-coated tablets are supplied in blister packs of 1, 4, 8 or 12 tablets.

Idilico 100 mg film-coated tablets are supplied in blister packs of 4, 8 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Evolan Pharma AB

SE-Box 120

182 12 Danderyd

Manufacturer:

LABORATORIOS NORMON, SA

Ronda de Valdecarrizo, 6

E-28760 Tres Cantos – Madrid, Spain

LICONSA LABORATORIES, SA

Avenida Miralcampo, 7. Polígono Industrial Miralcampo

19200 Azuqueca de Henares

Guadalajara, Spain

Muhammad Nadeem

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