Sildenafil Farmalider 100 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sildenafilo Farmalider 100 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet
- What Sildenafilo Farmalider is and what it is used for
- What you need to know before taking Sildenafilo Farmalider
- How to take Sildenafilo Farmalider
- Possible side effects
- How to store Sildenafilo Farmalider
- Contents of the pack and other information
1. What Sildenafil Farmalider is and what it is used for
Sildenafil Farmalider 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. Sildenafil Farmalider will only help achieve an erection if you are sexually stimulated. You should not take Sildenafil Farmalider if you do not have erectile dysfunction. The use of Sildenafil Farmalider is not indicated in women.
Sildenafil Farmalider 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 suitable for satisfactory sexual activity.
2. Before taking Sildenafil Farmalider
Do not take Sildenafil Farmalider
- 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 chest pain (or “angina”). 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 any of the other components of Sildenafil Farmalider.
- If you have severe heart or liver problems.
- If you have suffered from 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 Farmalider
Inform your doctor:
- If you have sickle cell anemia (an abnormality of red blood cells), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).
- If you have 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 Farmalider and contact your doctor immediately.
It is not recommended to use Sildenafil Farmalider simultaneously with any other oral or local treatments for erectile dysfunction.
Special considerations in children and adolescents
The use of Sildenafil Farmalider 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 using or have recently used any other medicines, including those obtained without a prescription.
Sildenafil Farmalider 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 Farmalider and when you took it. Do not take Sildenafil Farmalider with other medicines unless advised by your doctor.
Do not take Sildenafil Farmalider 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 (or “chest pain”).
Do not take Sildenafil Farmalider 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 Farmalider.
Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil Farmalider with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Farmalider. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil Farmalider. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil Farmalider.
Medicines containing sacubitril/valsartan, used to treat heart failure.
Use of Sildenafil Farmalider with food and drinks
Sildenafil Farmalider can be taken with or without food. However, you may notice that Sildenafil Farmalider takes slightly longer to work if taken with a large meal.
Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking Sildenafil Farmalider.
Pregnancy and breastfeeding
The use of Sildenafil Farmalider is not indicated in women.
Driving and using machines
Sildenafil Farmalider may cause dizziness and affect vision. You should know how you react to Sildenafil Farmalider before driving or operating machinery.
3. How to take Sildenafil Farmalider
Follow exactly the administration instructions for Sildenafil Farmalider provided by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual starting dose is 50 mg.
Do not take Sildenafil Farmalider more than once a day.
Take Sildenafil Farmalider approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with some water.
If you feel that the effect of Sildenafil Farmalider is too strong or too weak, inform your doctor or pharmacist.
Sildenafil Farmalider will only help you achieve an erection if you are sexually stimulated. The time needed for Sildenafil Farmalider to take effect varies from person to person, usually ranging between half an hour and one hour. The effect of Sildenafil Farmalider may be delayed if taken with a heavy meal.
If Sildenafil Farmalider 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 Sildenafil Farmalider than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than recommended by your doctor.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420 (indicating the medication and the amount ingested).
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Sildenafilo Farmalider may cause adverse effects, although not everyone experiences them. The adverse effects reported with the use of Sildenafilo Farmalider 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 Sildenafilo Farmalider, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafilo Farmalider: 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 Sildenafilo Farmalider. 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 Sildenafilo Farmalider and contact your doctor immediately.
The most common adverse effect (in 1 out of every 10 patients) is headache.
Frequent adverse effects (in 1 to 10 out of every 100 patients) include: facial flushing, indigestion, visual disturbances (including abnormal colour vision, light sensitivity, blurred vision or decreased visual acuity), nasal congestion and dizziness.
Uncommon adverse effects (in 1 to 10 out of every 1000 patients) include: vomiting, skin rash, bleeding at the back of the eye, eye irritation, eye haemorrhage/red eyes, eye pain, double vision, abnormal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, nausea, dry mouth, chest pain, feeling of fatigue, penile bleeding, blood in semen and/or urine.
Rare adverse effects (in 1 to 10 out of every 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleeds, sudden decrease or loss of hearing, heart attack.
Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or reduced blood flow to certain areas 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 Sildenafilo Farmalider. Seizures or convulsions and serious skin reactions characterized by rash, blistering, skin peeling and pain requiring immediate medical attention have also been reported.
If you consider any of these 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 Sildenafil Farmalider
Keep out of the reach and sight of children.
Store in the original packaging to protect it from moisture.
Do not use Sildenafil Farmalider after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
6. Information for the user
Composition of Sildenafil Farmalider 25 mg
The active substance of Sildenafil Farmalider is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
The other components are:
Tablet core: microcrystalline cellulose, calcium dibasic phosphate, sodium croscarmellose, and magnesium stearate.
Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and indigo carmine aluminum lake.
Appearance of the medicinal product and content of the container
Sildenafil Farmalider 25 mg film-coated tablets are elliptical in shape and blue in colour. They are marked with a “-” on one side.
Sildenafil Farmalider is available in blister packs containing 1, 4, 8, 12 tablets per package.
Only certain pack sizes may be marketed.
Other presentations:
Sildenafil Farmalider 50 mg, packs containing 1, 2, 4, 8, and 12 tablets.
Sildenafil Farmalider 100 mg, packs containing 1, 4, 8, and 12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Farmalider S.A.
C/Aragoneses 15
28108 Alcobendas
Madrid
Manufacturer:
West Pharma - Producções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº 11, Venda Nova, 2700 Amadora (Portugal)
This patient information leaflet has been reviewed in August 2022.