OXIMUN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

OXIMUN 50 mg film-coated tablets EFG

Sildenafil Citrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What OXIMUN is and what it is used for
2. Before you take OXIMUN
3. How to take OXIMUN
4. Possible side effects
5. Storing OXIMUN
6. Further information

1. What OXIMUN is and what it is used for

OXIMUN belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels in the penis, allowing blood flow when you are sexually stimulated. OXIMUN will only help you to get an erection if you are sexually stimulated. You should not take OXIMUN if you do not have erectile dysfunction. The use of OXIMUN is not indicated in women.

OXIMUN is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot get or maintain a firm erection, adequate for satisfactory sexual activity.

2. Before you take OXIMUN

Do not take OXIMUN

If you are taking medicines called nitrates, as the combination can cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain"). If you are not sure, consult your doctor or pharmacist.

If you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a potentially dangerous drop in your blood pressure. If you are allergic (hypersensitive) to sildenafil or any of the other ingredients 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 have a rare inherited eye disease (such as retinitis pigmentosa).

If you have previously experienced a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Be cautious when taking OXIMUN

Tell your doctor:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden loss of vision, stop taking OXIMUN and contact your doctor immediately.

It is not recommended to use OXIMUN at the same time as any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of OXIMUN is not indicated in persons under 18 years of age.

Special considerations in patients with kidney or liver problems.

You should 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.

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

OXIMUN tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform any healthcare professional that you are taking OXIMUN and when you took it. Do not take OXIMUN with other medicines unless your doctor advises you to.

Do not take OXIMUN if you are taking medicines called nitrates, as the combination of these products can 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 pectoris (or "chest pain").

Do not take OXIMUN if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products can also cause a potentially dangerous drop in your blood pressure.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of OXIMUN.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a drop in blood pressure when sitting 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 of taking OXIMUN. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting OXIMUN. Your doctor may indicate that you start treatment with the lower dose (25 mg) of OXIMUN.

Using OXIMUN with food and drinks

OXIMUN can be taken with or without food. However, you may notice that OXIMUN takes a little longer to work if you take it with a large meal.

Drinking alcohol can temporarily make it more difficult to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking OXIMUN.

Pregnancy and breastfeeding

The use of OXIMUN is not indicated in women.

Driving and using machines

OXIMUN can cause dizziness and affect vision. You should know how you react to OXIMUN before driving vehicles or using machinery.

3. How to take OXIMUN

Follow exactly the administration instructions of OXIMUN indicated by your doctor.

Consult your doctor or pharmacist if you have doubts. The normal starting dose is 50 mg.

Do not take OXIMUN more than once a day.

You should take OXIMUN approximately one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you think the effect of OXIMUN is too strong or too weak, tell your doctor or pharmacist.

OXIMUN will only help you to get an erection if you are sexually stimulated. The time it takes for OXIMUN to work varies from person to person, usually between half an hour and one hour. The effect of OXIMUN may be delayed if you take it with a large meal.

In case OXIMUN does not help you to get an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more OXIMUN than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Do not take more tablets than your doctor recommends

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420 (indicating the medicine and the amount ingested.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, OXIMUN can cause side effects, although not everybody gets them. The side effects reported in association with the use of OXIMUN are generally mild to moderate and short-lived.

If you experience chest pain during or after having sex:

• 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.

There have been reports of prolonged and sometimes painful erections after taking OXIMUN. If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

If you experience a sudden loss of vision, stop taking OXIMUN and contact your doctor immediately.

The most common side effect (in 1 in 10 patients) is headache.

Common side effects (between 1 and 10 in 100 patients) include: facial flushing, indigestion, effects on vision (including abnormal color perception, sensitivity to light or blurred vision or decreased visual acuity), nasal congestion and dizziness.

Uncommon side effects (between 1 and 10 in 1,000 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling of tiredness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling of fatigue, watery eyes, bleeding from the penis, presence of blood in the semen and/or urine.

Rare side effects (between 1 and 10 in 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed, sudden loss of hearing and heart attack.

Side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or transient reduction of blood flow to some 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. There have also been reports of seizures or convulsions and severe skin reactions that cause rash, blisters, peeling of the skin and pain, which require immediate medical attention.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaram.es

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5. Storing OXIMUN

Keep out of the reach and sight of children.

No special storage conditions are required. Store in the original package.

Do not use OXIMUN after the expiration date stated on the package.

The expiration date is 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 medicines no longer required. This will help protect the environment.

6. Further information

Composition of OXIMUN

• The active ingredient of OXIMUN is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are…

−Core of the tablet: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), croscarmellose sodium, magnesium stearate.

−Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, aluminum lake containing carmine (E 132).

Appearance of the product and package contents

OXIMUN tablets have a film coating, are blue, and elliptical in shape.

OXIMUN is presented 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

Phone: 965 984 446

Fax: 965 984 319

info@q-pharma.net

Manufacturer

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2, Abrunheira, Sintra 2710-089 (Portugal)

This leaflet was approved in June 2013