Sildenafil Kern Pharma 50 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sildenafil KERN PHARMA 50 mg film-coated tablets EFG
Sildenafil citrate
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Sildenafil KERN PHARMA is and what it is used for
- Before you take Sildenafil KERN PHARMA
- How to take Sildenafil KERN PHARMA
- Possible side effects
- How to store Sildenafil KERN PHARMA
- Further information
1. What SILDENAFILO KERN PHARMA is and what it is used for
Sildenafilo Kern Pharma belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow when sexually stimulated. Sildenafilo Kern Pharma will only help you achieve an erection if you are sexually stimulated. You should not take Sildenafilo Kern Pharma if you do not have erectile dysfunction. The use of Sildenafilo Kern Pharma is not indicated in women.
Sildenafilo Kern Pharma is indicated for the treatment of male erectile dysfunction, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection adequate for satisfactory sexual activity.
2. BEFORE TAKING SILDENAFILO KERN PHARMA
Do not take Sildenafil Kern Pharma
- If you are taking medicines called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often administered to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
- If you are using any medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure.
- If you are allergic (hypersensitive) to sildenafil or to any of the other components of Sildenafil Kern Pharma.
- If you have a serious heart or liver problem.
- If you have recently suffered a stroke or heart attack, or if you have low blood pressure.
- If you have a rare inherited eye disease (such as retinitis pigmentosa).
- If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Take special care with Sildenafil Kern Pharma
Inform your doctor:
- If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
- If you have a penile deformity or Peyronie's disease.
- If you have heart problems. In such cases, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
- If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
- If you experience sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.
It is not recommended to use Sildenafil Kern Pharma simultaneously with any other oral or local treatment for erectile dysfunction.
Special considerations in children and adolescents
The use of Sildenafil Kern Pharma is not indicated in individuals under 18 years of age.
Special considerations in patients with renal impairment or hepatic problems
You must inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.
Taking other medicines
Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.
Sildenafil Kern Pharma tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking sildenafil and when you took it. Do not take Sildenafil Kern Pharma with other medicines unless advised by your doctor.
Do not take sildenafil if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous drop in your blood pressure.
Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pain (or "chest pain").
Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also lead to a potentially dangerous drop in your blood pressure.
If you are taking medicines known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.
Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness that may be caused by a drop in blood pressure when sitting or standing up quickly.
Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.
Caution should be exercised when initiating treatment with sildenafil in patients treated with medicines containing sacubitril/valsartan, used to treat heart failure.
Use of Sildenafil Kern Pharma with food and drinks
Sildenafil Kern Pharma can be taken with or without food. However, you may notice that Sildenafil Kern Pharma takes slightly longer to work if taken with a large meal.
Alcohol consumption may temporarily impair the ability to achieve an erection. Therefore, to obtain the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking sildenafil.
Pregnancy and breastfeeding
The use of sildenafil is not indicated in women.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Sildenafil Kern Pharma may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.
Important information about some of the components of Sildenafil Kern Pharma
This medicine may cause allergic reactions as it contains Tartrazine (E-102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to TAKE SILDENAFILO KERN PHARMA
Follow exactly the administration instructions for SILDENAFILO KERN PHARMA provided by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual starting dose is 50 mg.
SILDENAFILO KERN PHARMA must not be taken more than once a day.
Take SILDENAFILO KERN PHARMA approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you feel that the effect of sildenafilo is too strong or too weak, inform your doctor or pharmacist.
SILDENAFILO KERN PHARMA will only help you achieve an erection if you are sexually stimulated.
The time required for sildenafilo to take effect varies from person to person, but generally ranges between half an hour and one hour. The effect of sildenafilo may be delayed if taken with a heavy meal.
If SILDENAFILO KERN PHARMA does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.
If you take more SILDENAFILO KERN PHARMA than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase efficacy.
Do not take more tablets than recommended by your doctor.
Contact your doctor if you have taken more tablets than advised. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Sildenafil Kern Pharma can have adverse effects, although not everyone will experience them. Adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.
If you experience chest pain during or after sexual activity:
- Sit in a semi-upright position and try to relax
- Do not use nitrates to treat your chest pain
- Contact your doctor immediately
All medicines, including Sildenafil Kern Pharma, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil Kern Pharma: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
Cases of prolonged and sometimes painful erections have been reported after taking sildenafil. If you have an erection lasting more than 4 hours, you must contact your doctor immediately.
If you experience sudden decrease or loss of vision, stop taking Sildenafil Kern Pharma and contact your doctor immediately.
The most common adverse effect (may affect more than 1 in 10 patients) is headache.
Frequent adverse effects (may affect between 1 and 10 in 100 patients) include: facial flushing, indigestion, visual disturbances (including abnormal color vision, light sensitivity, blurred vision or decreased visual acuity), nasal congestion, and dizziness.
Uncommon adverse effects (may affect between 1 and 10 in 1,000 patients) include: vomiting, skin rash, bleeding behind the eye, eye irritation, watery eyes/red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, nausea, dry mouth, chest pain, feeling of fatigue, watery eyes, penile bleeding, and presence of blood in semen and/or urine.
Rare adverse effects (may affect between 1 and 10 in 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleeds, sudden decrease or loss of hearing, and heart attack.
Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, transient reduction in blood flow to certain parts of the brain. Most, but not all, of these patients had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil. In addition, cases of seizures or convulsions and serious skin reactions characterized by rash, blisters, skin peeling, and pain have been reported, which require immediate medical attention.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of SILDENAFILO KERN PHARMA
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use Sildenafilo Kern Pharma after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Sildenafil Kern Pharma
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The active substance is sildenafil. Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
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The other components are:
- Tablet core: microcrystalline cellulose, colloidal anhydrous silica, dibasic calcium phosphate (anhydrous), sodium croscarmellose, magnesium stearate.
- Film coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), indigo carmine (E132), brilliant blue FCF (E133) and tartrazine (E102).
Appearance of the product and pack sizes
Sildenafil Kern Pharma 50 mg film-coated tablets are blue, circular, biconvex tablets. Sildenafil Kern Pharma is available in blisters containing 2, 4, 8 or 12 tablets. Packaging for 25 mg and 100 mg strengths is also available.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Kern Pharma S.L.
Polígono Ind. Colón II. Venus, 72
08228 Terrassa (Barcelona)
Manufacturer
INDUSTRIA QUIMICA Y FARMACEÚTICA VIR S.A
C/ Laguna 66-68-70, Pol. Industrial Urtinsa II,
Alcorcon, 28923 Madrid
Spain
This leaflet was approved in April 2013.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .