Oximun 50 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
OXIMUN 50 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 it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What OXIMUN is and what it is used for
- Before you take OXIMUN
- How to take OXIMUN
- Possible side effects
- How to store OXIMUN
- Further information
1. What OXIMUN is and what it is used for
OXIMUN belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow in when you are sexually stimulated. OXIMUN will only help you achieve an erection if you are sexually stimulated. You should not take OXIMUN if you do not have erectile dysfunction. OXIMUN is not indicated for use in women.
OXIMUN 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 OXIMUN
Do not take OXIMUN
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 prescribed to relieve chest pain due to angina (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 nitrate ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure. If you are allergic (hypersensitive) to sildenafil or to any of the other components of OXIMUN.
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 suffer from a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Take special care with OXIMUN
Inform your doctor:
- 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 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 physical 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 OXIMUN and contact your doctor immediately.
The use of OXIMUN is not recommended with any other oral or local treatments for erectile dysfunction.
Special considerations in children and adolescents
The use of OXIMUN 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 OXIMUN with other medicines
- Medicines containing sacubitril/valsartan, used to treat heart failure.
Inform your doctor or pharmacist if you are currently taking or have recently taken any other medicines, including those obtained without a prescription.
OXIMUN 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 OXIMUN and when you took it. Do not take OXIMUN with other medicines unless advised by your doctor.
Do not take OXIMUN 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 pain (or "chest pain").
Do not take OXIMUN 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 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 OXIMUN.
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 down or standing up quickly. Some patients have experienced these symptoms when taking OXIMUN with alpha-blockers. This is more likely to occur within 4 hours after taking OXIMUN. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting OXIMUN. Your doctor may advise you to start treatment with the lowest dose (25 mg) of OXIMUN.
Use of OXIMUN with food and drinks
OXIMUN may be taken with or without food. However, you may notice that OXIMUN takes slightly longer to work if taken with a heavy meal.
Alcohol consumption may temporarily impair the ability to achieve an erection. Therefore, to obtain the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking OXIMUN.
Pregnancy and lactation
The use of OXIMUN is not indicated in women.
Driving and use of machines
OXIMUN may cause dizziness and affect vision. You should know how you react to OXIMUN before driving or operating machinery.
3. How to take OXIMUN
Follow exactly the administration instructions for OXIMUN provided by your doctor.
Consult your doctor or pharmacist if you have any doubts. The usual starting dose is 50 mg.
OXIMUN must not be taken more than once a day.
You should take OXIMUN approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you feel that the effect of OXIMUN is too strong or too weak, inform your doctor or pharmacist.
OXIMUN will only help you achieve an erection if you are sexually stimulated. The time OXIMUN takes to work varies from person to person, but generally ranges between half an hour and one hour. The effect of OXIMUN may be delayed if taken with a heavy meal.
If OXIMUN 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 OXIMUN 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 Poison Information Service at telephone number 915 620 420 (indicating the medication and the amount ingested).
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, OXIMUN may have adverse effects, although not everyone experiences them. The adverse effects reported with the use of OXIMUN 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 OXIMUN, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking OXIMUN: 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 OXIMUN. If you have an erection lasting longer than 4 hours, you must contact your doctor immediately.
If you experience sudden decrease or loss of vision, stop taking OXIMUN and contact your doctor immediately.
The most frequently reported 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 1,000 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, irregular or rapid heartbeat, muscle pain, reduced sense of touch, vertigo, tinnitus, nausea, dry mouth, chest pain, feeling of fatigue, watery eyes, 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 loss of hearing and heart attack.
Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or transient reduction in blood flow to parts 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 OXIMUN. In addition, cases of seizures or convulsions and serious skin reactions characterized by rash, blistering, skin peeling and pain have been reported, which require immediate medical attention.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es
5. Storage of OXIMUN
Keep out of the reach and sight of children.
No special storage conditions required. Store in the original container.
Do not use OXIMUN 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 unused medicines and packaging. This will help protect the environment.
6. Additional information
Composition of OXIMUN
- The active substance in OXIMUN is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
- The other components are…
−Tablet core: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium croscarmellose, magnesium stearate.
−Film coating: Polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, aluminium lake containing indigo carmine (E132).
Appearance of the product and contents of the package
OXIMUN tablets are film-coated, blue, elliptical in shape.
OXIMUN is available in blisters containing 2, 4 or 8 film-coated tablets.
Marketing Authorization Holder
Laboratorios Q Pharma S.L.
C/ Moratín 15, Entlo., Oficinas 6-7, Alicante
Telephone: 965 984 446
Fax: 965 984 319
Manufacturer
ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.
Rua da Tapada Grande, No 2, Abrunheira, Sintra 2710-089 (Portugal)
This patient information leaflet was last approved in June 2013