Sildenafil Alter 100 mg chewable tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Sildenafil Alter 100 mg chewable tablets EFG
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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Sildenafil Alter is and what it is used for
- What you need to know before taking Sildenafil Alter
- How to take Sildenafil Alter
- Possible side effects
- How to store Sildenafil Alter
- Contents of the pack and other information
1. What Sildenafil Alter is and what it is used for
Sildenafil 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 into the penis when sexually stimulated. Sildenafil Alter will only help achieve an erection if you are sexually stimulated.
Sildenafil Alter 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 Sildenafil Alter
Do not take Sildenafil Alter
- 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 (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
- If you are using any nitric oxide donors such as amyl nitrate ("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 severe 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 hereditary eye disease (such as retinitis pigmentosa).
- If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NA-AION).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil Alter.
- 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. Your doctor should carefully assess whether your heart can tolerate the added stress 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 Alter and contact your doctor immediately.
It is not recommended to use Sildenafil Alter simultaneously with any other oral or local treatment for erectile dysfunction.
You must not take Sildenafil Alter with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.
You must not take Sildenafil Alter if you do not have erectile dysfunction.
The use of Sildenafil Alter is not indicated in women.
Special considerations in patients with renal impairment or hepatic 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 sildenafil is not indicated in individuals under 18 years of age.
Taking Sildenafil Alter with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:
- Medicines containing sacubitril/valsartan, used to treat heart failure.
Sildenafil 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. You should not take sildenafil with other medicines unless your doctor advises you to do so.
You must not take sildenafil if you are taking medicines called nitrates, as the combination of these products can 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 (or "chest pain").
You must not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
If you are taking 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 taking an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness due to 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.
Taking Sildenafil Alter with food, drinks, and alcohol
Sildenafil can be taken with or without food. However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.
Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking sildenafil.
Pregnancy, breastfeeding, and fertility
The use of sildenafil is not indicated in women.
Driving and using machines
Sildenafil may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.
Sildenafil Alter contains aspartame
This medicine contains 4.3 mg of aspartame per tablet, equivalent to 0.016 mg/mg.
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.
Sildenafil Alter contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Sildenafil Alter
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
Do not take Sildenafil Alter more than once a day.
You should take Sildenafil Alter approximately one hour before planning to have sexual intercourse.
The tablet should be chewed and swallowed.
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, usually between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.
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 Alter 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, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420 (indicating the medicine 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, 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 this medicine and seek immediate medical attention:
- Allergic reaction – this occurs uncommonly (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 – this occurs uncommonly.
If it 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 – this occurs rarely (may affect up to 1 in 1,000 people).
If you have an erection lasting more than 4 hours, you must contact your doctor immediately.
- Sudden decrease or loss of vision – this occurs rarely.
- Severe skin reactions – this occurs rarely.
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 – this occurs rarely.
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, feeling of warmth (symptoms include sudden sensation of heat in the upper body), indigestion, abnormal color vision, 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, perception of flickering lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, 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 (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of 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, numbness of the mouth, bleeding behind the eye, double vision, decreased 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 color of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritability, 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 problems 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, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sildenafil Alter
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
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 you are 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 Alter
- The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
- The other components are: potassium polacrilin, potassium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH), magnesium stearate, anhydrous colloidal silica, aspartame (E951), sodium croscarmellose, lactose monohydrate, povidone K-30 and mint flavour (containing flavourings: maltodextrin, modified corn starch, peppermint essential oil and pulegone).
Appearance of the product and contents of the pack
Triangular, biconvex, white tablets, engraved with “100” on one side.
The tablets are presented in blister packs containing 1, 4, 8 or 12 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Manufacturer
Genepharm S.A.
18 km Marathon Avenue, 15351 Pallini Attikis
Greece
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Date of the most recent revision of this leaflet: April 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/