Sildenafil Almus 50 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Sildenafil ALMUS 50 mg film-coated 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, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Sildenafil Almus is and what it is used for
- What you need to know before taking Sildenafil Almus
- How to take Sildenafil Almus
- Possible adverse effects
- How to store Sildenafil Almus
- Contents of the pack and other information
1. What Sildenafil Almus is and what it is used for
Sildenafil Almus contains the active substance sildenafil, which 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 will only help you achieve an erection if you are sexually stimulated.
Sildenafil 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 sexual activity.
2. What you need to know before taking Sildenafil Almus
Do not take Sildenafil Almus
- 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 lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve chest pain (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 lead to 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 (NAION).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Almus:
- 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 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 Almus and contact your doctor immediately.
It is not recommended to use Sildenafil simultaneously with any other oral or local treatments for erectile dysfunction.
You must not take Sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You must not take Sildenafil if you do not have erectile dysfunction.
The use of Sildenafil 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 Sildenafil Almus is not indicated in individuals under 18 years of age.
Taking Sildenafil Almus with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sildenafil 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 Sildenafil and when you took it. Do 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 medicines may lead to 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 (chest pain).
You must not take Sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to 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 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 with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil. To reduce the risk of these symptoms, you should already be on a stable 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.
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
Taking Sildenafil Almus with food, drinks, and alcohol
Sildenafil Almus can be taken with or without food. However, you may notice that this medicine takes slightly longer to work if taken with a heavy meal.
Alcohol intake may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking Sildenafil.
Pregnancy, breastfeeding, and fertility
The use of Sildenafil Almus is not indicated in women.
Driving and using machines
Sildenafil may cause dizziness and affect vision. You should know how you react to the medicine before driving or operating machinery.
Sildenafil Almus contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".
3. How to take Sildenafil Almus
Follow exactly the instructions for use 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 Almus must not be taken more than once a day.
Do not take sildenafil film-coated tablets together with sildenafil orodispersible tablets.
You should take Sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you notice that the effect of this medicine 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 this medicine takes to work 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 this medicine 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 Almus than you should:
You may experience an increase in adverse effects and their severity. Doses higher than 100 mg do not increase efficacy.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
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 will experience them. The adverse effects reported with the use of Sildenafil are generally mild to moderate in intensity and short-lived.
If you experience any of the following serious adverse effects, stop taking Sildenafil Almus 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 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 – this occurs rarely (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 – 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, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, abnormal vision (including color vision disturbances), 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 flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, 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 (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling 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, sensation of tightness in the throat, 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 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, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sildenafil Almus
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister, after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Sildenafil Almus
- The active substance is sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
- The other components are:
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Film coating (Opadry II, 85F20464 Blue): polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, indigo carmine (E132).
(Sildenafil Almus contains sodium; see section 2 for further information.)
Appearance of the product and contents of the pack
Sildenafil Almus 50 mg tablets are blue, elliptically shaped, film-coated tablets, 12.6 mm in length and 6.3 mm in width. Available in blisters containing 4, 8, 12 or 24 film-coated tablets.
Some pack sizes may not be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua De Tapada Grande 2
Abrunheira, Sintra, 2710 – 228
Portugal
This medicinal product is authorized in the European Economic Area member states under the following names:
France: Sildenafil Almus 50 mg, comprimé pelliculé
Italy: Sildenafil Almus
Spain: Sildenafil Almus 50 mg film-coated tablets EFG
Date of the most recent revision of this leaflet: March 2023
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)