Leaflet: information for the user

OXIMUN 50 mg film-coated tablets EFG

Sildenafilo Citrate

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

1. What isOXIMUNand for what it is used

2. Before takingOXIMUN

3. How to takeOXIMUN

4. Possible side effects

5. Storage ofOXIMUN

6. Additional information

OXIMUN belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. OXIMUN will only help you achieve an erection if you are sexually stimulated. Do 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 referred to as impotence. This occurs when a male is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take OXIMUN

If you are taking certain 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 used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

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

If you have previously experienced vision loss due to ischemic optic neuropathy (NOIA-NA).

Be especially careful with OXIMUN

Inform your doctor:

- If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cancer), multiple myeloma (bone marrow cancer).

- If you have a penile deformity or Peyronie's disease.

- If you have heart problems. In this case, your doctor must carefully check if your heart can withstand the additional effort of having sex.

- If you have a stomach ulcer or bleeding problems (such as hemophilia).

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

It is not recommended to use OXIMUN 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 people under 18 years old

Special considerations in patients with kidney or liver 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 medications

• Medications containing sacubitril/valsartan, used to treat heart failure.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

OXIMUN tablets may interfere with some medications, especially those used to treat chest pain. In case of 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 medications unless your doctor advises you to.

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 chest pain (or "chest pain").

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

If you are taking medications known as protease inhibitors, such as those used in the treatment of 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 medication used to treat high blood pressure or prostate hypertrophy, may experience dizziness or lightheadedness that may 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 in the 4 hours following OXIMUN intake. To reduce the likelihood of these symptoms, you should be receiving 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.

Use of OXIMUN with food and drinks

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

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking OXIMUN

Pregnancy and breastfeeding

The use of OXIMUN is not indicated in women

Driving and operating machinery

OXIMUN may cause dizziness and affect vision. You must know how you react to OXIMUN before driving vehicles or operating machinery.

Follow exactly the administration instructions for OXIMUN as indicated by your doctor.

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

Do not take OXIMUN more than once a day.

Take OXIMUN approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you estimate 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 it takes for OXIMUN to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of OXIMUN may be delayed if taken with a large meal.

If OXIMUN does not help you achieve an erection or if the erection does not last long enough to complete the sexual act, 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 recommended by your doctor

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

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

Like all medicines, OXIMUN may cause side effects, although not everyone will experience them. The side effects reported associated with the use of OXIMUN are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual intercourse:

- Sit in a semi-recumbent 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 hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

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

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

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

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

Rare side effects (between 1 and 10 in 1000 patients) include: vomiting, skin rashes, 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 drowsiness, reduced tactile sensation, vertigo, ringing in the ears, nausea, dry mouth, chest pain, and feeling of fatigue, watery eyes, penile bleeding, presence of blood in semen and/or urine.

Very rare side effects (between 1 and 10 in 10000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nasal bleeding,sudden loss of hearing, and heart attack

Notified side effects from post-marketing experience include: palpitations, chest pain, sudden death, or transient decrease in blood flow to some parts of the brain. Most, but not all, had heart problems before taking this medication. It is not possible to determine if these events were directly related to OXIMUN. Also, cases of seizures or crises and severe skin reactions that require immediate medical attention have been reported.

Reporting of side effects

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

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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 expiration date shown on the packaging.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of OXIMUN

- The active ingredient of OXIMUN is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

- The other components are…

−Tablet core: microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmelosa sodium, magnesium stearate.

−Film coating: Alcoholpolivinílico, Polietilenglicol 3350, titanium dioxide (E171), talc, aluminum lacquer containing carmín de índigo (E 132).

Appearance of the product and contents of the package

The OXIMUN tablets have a film coating, are blue in color, and are in an eliptical shape.

OXIMUN is presented in blisters containing 2, 4, or 8 coated tablets.

Holder of the marketing authorization

Laboratorios Q Pharma S.L.

C/ Moratín 15, Ground floor, Offices 6-7, Alicante

Phone: 965 984 446

Fax: 965 984 319

[email protected]

Responsible for manufacturing

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

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

This leaflet was approved in June 2013