Sildenafil CINFA 100 mg chewable tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
sildenafil cinfa 100 mg chewable tablets EFG
Sildenafil citrate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- 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 others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.
Leaflet contents
- What sildenafil cinfa is and what it is used for
- What you need to know before taking sildenafil cinfa
- How to take sildenafil cinfa
- Possible side effects
- How to store sildenafil cinfa
- Contents of the pack and other information
1. What sildenafilo cinfa is and what it is used for
sildenafilo cinfa contains the active substance sildenafilo, which belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into the penis when sexually stimulated. sildenafilo cinfa will only help you achieve an erection if you are sexually stimulated.
sildenafilo cinfa is indicated for the treatment of erectile dysfunction in adult men, 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. What you need to know before taking sildenafilo cinfa
Do not take sildenafilo cinfa
- 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 cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used 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 dangerous drop in your blood pressure.
- If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as sildenafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
- If you have a serious heart or liver problem.
- If you have recently had 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 (NA-AION).
Warnings and precautions
Consult your doctor or pharmacist before taking sildenafilo cinfa:
- If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow).
- If you have a penile deformity or Peyronie’s disease.
- If you have heart problems. 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 sildenafilo and contact your doctor immediately.
It is not recommended to use sildenafilo simultaneously with any other oral or local treatment for erectile dysfunction.
You must not take sildenafilo with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You must not take sildenafilo if you do not have erectile dysfunction.
The use of sildenafilo is not indicated in women.
Special considerations in patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.
Children and adolescents
The use of sildenafilo is not indicated in individuals under 18 years of age.
Other medicines and sildenafilo cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sildenafilo tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking sildenafilo and when you took it. Do not take sildenafilo with other medicines unless advised by your doctor.
Do not take sildenafilo if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”).
Do not take sildenafilo if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these medicines may also cause a dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
Inform your doctor if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
If you are taking protease inhibitors, medicines used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafilo.
Some patients taking alpha-blockers, medicines 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 sildenafilo with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafilo. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafilo. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafilo.
Taking sildenafilo cinfa with food, drinks and alcohol
Sildenafilo can be taken with or without food. However, you may notice that this medicine takes longer to work if taken with a heavy meal.
Alcohol consumption may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking sildenafilo.
Pregnancy, breastfeeding and fertility
The use of sildenafilo is not indicated in women.
Driving and using machines
Sildenafilo may cause dizziness and affect vision. You should know how you react to sildenafilo before driving or operating machinery.
sildenafilo cinfa contains lactose.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
sildenafilo cinfa contains aspartame.
This medicine contains 8.6 mg of aspartame per tablet.
Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
sildenafilo cinfa contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take sildenafil cinfa
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is 50 mg.
Sildenafil cinfa must not be taken more than once a day.
Do not take sildenafil chewable tablets together with film-coated tablets containing sildenafil, including sildenafil film-coated tablets.
You should take sildenafil approximately one hour before planning to have sexual intercourse.
The tablet should be chewed and swallowed.
Chewable tablets should be taken on an empty stomach, as you will notice it takes longer to start working if taken with a heavy meal.
If you notice that the effect of sildenafil is too strong or too weak, inform your doctor or pharmacist.
Sildenafil will only help you achieve an erection if you are sexually stimulated. The time required for sildenafil to take effect varies from person to person, but generally ranges between half an hour and one hour.
If sildenafil 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 cinfa than you should
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 medicine and the amount ingested.
You may experience an increase in the frequency and severity of adverse 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.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects reported with sildenafil use are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious adverse effects, stop taking sildenafil and seek immediate medical attention:
-
Allergic reaction – uncommon adverse effects (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 – uncommon adverse effects (may affect up to 1 in 100 people).
If chest pain occurs during or after sexual activity:
-
Sit in a semi-upright position and try to relax.
-
Do not use nitrates to treat chest pain.
-
Prolonged and sometimes painful erections – rare adverse effects (may affect up to 1 in 1,000 people).
If you have an erection lasting longer than 4 hours, you must contact your doctor immediately.
-
Sudden decrease or loss of vision – rare adverse effects (may affect up to 1 in 1,000 people).
-
Severe skin reactions – rare adverse effects (may affect up to 1 in 1,000 people). Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.
-
Seizures or fits – rare adverse effects (may affect up to 1 in 1,000 people).
Other adverse effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (including sudden sensation of heat in the upper part of the body), indigestion, colour vision abnormalities, blurred vision, visual disturbance, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensation, dizziness, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, mouth numbness, bleeding behind the eye, double vision, reduced visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.
During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of sildenafil cinfa
Keep this medicine out of the sight and reach of children.
This medicine does not require special storage temperature conditions.
Store in the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater 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 dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of sildenafil cinfa
- The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as 140.48 mg of sildenafil citrate).
- The other components are: potassium polacrilin, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), sodium croscarmellose, mint flavour (composed of maltodextrin (corn), modified corn starch and mint oil (Mentha arvensis)), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).
Appearance of the product and contents of the pack
Triangular, biconvex white tablets engraved with "100" on one side.
Presented in transparent PVC/PCTFE-Aluminum blisters. Each pack contains 1, 4, 8 or 12 chewable tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
or
GENEPHARM S.A.,
18th Marathon Av. 153 51 Pallini Attikis, - Greece
or
PHARMADOX HEALTHCARE Ltd.,
KW20A Kordin Industrial Park, Paola PLA 3000, Malta
Date of the most recent review of this leaflet: May 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.
You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80115/P_80115.html
QR code to: https://cima.aemps.es/cima/dochtml/p/80115/P_80115.html