Sildenafil Almus 100 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Sildenafil ALMUS 100 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- 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 side 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 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 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 Almus and contact your doctor immediately.
It is not recommended to use Sildenafil together 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 intended for 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 recommended for individuals under 18 years of age.
Taking Sildenafil Almus with other medicines
Tell 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. You should not take Sildenafil Almus with other medicines unless your doctor advises you to do so.
Do not take Sildenafil if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in 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).
Do not take Sildenafil 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 blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
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 Sildenafil.
Some patients taking an alpha-blocker (a medicine used to treat high blood pressure or benign prostatic hyperplasia) may experience dizziness or lightheadedness, which 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 Almus. 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.
Drinking alcohol may temporarily impair your ability to get 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 Almus is not indicated in women.
Driving and using machines
Sildenafil may cause dizziness and affect vision. You should know how you react to this 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 using this medicine given by your doctor or pharmacist. If you are unsure, 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 may cause adverse effects, although not everyone experiences them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.
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, flushing (symptoms include sudden sensation of heat in the upper 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, 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, 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 (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, sensation of throat tightness, numbness of the mouth, 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, dilated pupils, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects 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 the 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 requires no special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. 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 Almus
- The active substance is sildenafil.
Each film-coated tablet contains sildenafil citrate equivalent to 100 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 also section 2).
Appearance of the product and contents of the pack
Sildenafil Almus 100 mg tablets are blue, elliptical, film-coated tablets, marked with a “+” on one side, 15.9 mm long and 7.9 mm wide. Available in blisters containing 4, 8, 12 or 24 film-coated tablets.
Only certain pack sizes may 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 Member States of the European Economic Area under the following names:
France: Sildenafil Almus 100 mg, comprimé pelliculé
Italy: Sildenafil Almus
Spain: Sildenafil Almus 100 mg film-coated tablets EFG
Date of the most recent review 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/)