Oximun 100 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
OXIMUN 100 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 others, 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.
Contents of the leaflet
- 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 flow into the penis when 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 intended 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 medications 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 medications, which are often administered to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.
If you are using any nitric oxide donor medications 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 suffered 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 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 (bone marrow cancer).
- 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 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 OXIMUN and contact your doctor immediately.
The use of OXIMUN is not recommended simultaneously with any other oral or local treatment 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 or hepatic impairment
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
- Medications containing sacubitril/valsartan, used to treat heart failure.
Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.
OXIMUN tablets may interact with certain medications, 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 medications 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 medications, which are often used to relieve angina (or "chest pain").
Do not take OXIMUN if you are taking medications 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 medications 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 medication used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting up or standing 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 be on a stable daily dose of the alpha-blocker before starting OXIMUN. Your doctor may advise you to begin 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 achieve the maximum benefit from the medication, it is advisable not to consume large amounts of alcohol before taking OXIMUN.
Pregnancy and breastfeeding
The use of OXIMUN is not indicated in women.
Driving and using machines
OXIMUN may cause dizziness and affect vision. You should be aware of 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.
If you have any doubts, consult your doctor or pharmacist. 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 find 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 efficacy.
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 Toxicology Information Service at 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 side effects
Like all medicines, OXIMUN may have side effects, although not everyone gets them. The side effects reported with 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 more 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 common side effect (occurring in 1 out of every 10 patients) is headache.
Frequent side effects (occurring 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 side effects (occurring 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, presence of blood in semen and/or urine.
Rare side effects (occurring in 1 to 10 out of every 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed, and sudden decrease or loss of hearing.
Side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, and transient reduction in blood flow to parts of the brain. Most, but not all, of these patients had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to OXIMUN. Additionally, cases of seizures or fits and serious skin reactions characterized by rash, blistering, skin peeling, and pain have also been reported, which require immediate medical attention.
Reporting of side effects
If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can 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 are required. Store in the original packaging.
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 must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of OXIMUN
- The active substance in OXIMUN is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
- The other components are…
−Tablet core: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), sodium croscarmellose, magnesium stearate.
−Film coating: Polyvinyl alcohol, Polyethylene glycol 3350, titanium dioxide (E171), talc, aluminium lake containing indigo carmine (E 132).
Appearance of the product and contents of the pack
OXIMUN tablets are film-coated, blue in colour, elliptical in shape, marked with a "+" on one side. OXIMUN is available in blisters containing 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