Malegra FXT

Precautions

Before taking Malegra FXT (Fluoxetine, Sildenafil), notify your doctor of your personal and family medical history, including:

• Allergies to any medications
• Myocardial infarction
• Stroke
• Life-threatening arrhythmia
• Hypotension or hypertension
• Cardiac failure
• Coronary artery disease
• Penis deformity
• Sickle-cell anemia
• Multiple myeloma
• LeukemiA
• Cardiovascular problems
• A recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure
• High or low blood pressure
• Coronary artery disease
• Liver or kidney disease
• A blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia
• A bleeding disorder such as hemophilia
• A stomach ulcer
• Retinitis pigmentosa (an inherited condition of the eye)
• A physical deformity of the penis (such as Peyronie's disease)
• If you have been told you should not have sexual intercourse for health reasons

Because there are a number of medications that interact with Malegra FXT (Fluoxetine, Sildenafil), it is highly recommended to speak with your local physician about your medical history, including information regarding the prescribed and non-prescribed medications that you have taken in the past. It is also advised that the elderly handle this medication with extreme caution, as they may be more sensitive to the side effects and experience greater symptoms.

To ensure complete safety while taking this medication, make sure to notify your doctor if you have any or all of the following listed conditions:

• Cirrhosis of the liver
• Kidney disease
• Diabetes
• Seizures or epilepsy
• Bipolar disorder (manic depression)
• A history of drug abuse or suicidal thoughts

If you suffer from any of the above medical conditions, you may not be able to take this medication or you may need a dosage adjustment.

Drug Interactions

Before using taking Malegra FXT (Fluoxetine, Sildenafil), notify your doctor about other medications you use, especially:

• Pimozide (Orap)
• Thioridazine (Mellaril)
• A MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)

The above medications can cause fatal reactions if taken with Malegra FXT (Fluoxetine, Sildenafil). Before taking this medication, make sure to wait 14 days after stopping the use of a MAO inhibitor. It is crucial to also wait about 5 weeks after stopping the use of this medication, if you want to take thioridazine (Mellaril) or a MAOI.

Notify your doctor if you are currently taking any of the following medications, as they may cause you to bruise or bleed easily:

• Any medicine that is used to treat pain, arthritis, fever, or swelling
• Aspirin
• Ibuprofen (Advil, Motrin)
• Naproxen (Aleve, Naprosyn, Naprelan, Treximat)
• Celecoxib (Celebrex)
• Diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze)
• Indomethacin (Indocin)
• Meloxicam (Mobic)

Inform your doctor if you are currently taking any of the following medications, as they can add to sleepiness caused by fluoxetine:

• Cold or allergy medicine
• Sedatives
• Narcotic pain medicine
• Sleeping pills
• Muscle relaxers
• Medicines for seizures or anxiety

Tell your doctor about any other medicines you use, specifically:

• Tadalafil (Cialis)
• Vardenafil (Levitra)
• Bosentan (Tracleer)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Imatinib (Gleevec)
• Isoniazid (for treating tuberculosis)
• Rifampin (Rifadin, Rimactane Rifater, Rifamate)
• An antidepressant such as nefazodone
• An antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek)
• Antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend)
• Heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), doxazosin (Cardura), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin,
• Verelan)
• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra)

Inform your doctor if you are planning to take this medication along with a nitrate drug, as it can impact level of blood pressure:

• Nitroglycerin (e.g. Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid)
• Isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate)
• Isosorbide mononitrate (Imdur, ISMO, Monoket)
• Recreational drugs, as they also contain nitrates

Even though this medication is not intended for women, it is important to note that it was approved by the FDA as pregnancy category C and could be extremely harmful to an unborn or nursing baby.

This is not a complete list of medications that interact with Malegra FXT Plus (Fluoxetine, Sildenafil). Inform your doctor about any prescribed and non-prescribed medications that you use, such as herbal products, over-the-counter medicines, vitamins, and allergy or cough-and-cold products, as they may contain supplements which lead to drowsiness. Do not start or stop using any medication without first discussing this with your doctor.

If you have the following of these extremely serious side effects, stop using Malegra FXT (Sildenafil, Fluoxetine)and seek emergency medical attention immediately:

• Severe blistering, peeling, and red skin rash
• Very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes
• Nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination
• Trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops, difficulty breathing
• Sudden vision loss
• Ringing in your ears, or sudden hearing loss
• Chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling
• Irregular heartbeat
• Swelling in your hands, ankles, feet, or face
• Shortness of breath
• Vision changes
• Feeling light-headed, fainting
• Erection that is painful or lasts 4 hours or longer

 The following are common side effects of Malegra FXT (Fluoxetine, Sildenafil) that may occur:

• Headache
• Indigestion
• Back pain
• Muscle aches
• Flushing
• Temporary visual abnormalities (e.g. changes in color perception, sensitivity to light, and blurred vision)
• Urinary tract infections
• Temporary heat rashes
• Stuffy or runny nose
• Memory problems
• Upset stomach
• Back pain

If you experience new or worsening symptoms of conditions listed in the following list, report these changes to your doctor:

• Mood or behavior changes
• Anxiety
• Panic Attacks
• Trouble sleeping
• Feeling of impulsiveness
• Feeling of irritation, agitation, hostility, aggressiveness, restlessness, hyperactivity (mental or physical)
• Thoughts about suicide or hurting yourself

Less serious side effects that may occur during treatment:

• Warmth or redness in your face, neck, or chest
• Stuffy nose
• Headache
• Memory problems
• Upset stomach
• Back pain
• Cold symptoms such as stuffy nose, sneezing, sore throat
• Drowsiness, dizziness, feeling nervous
• Mild nausea, upset stomach, constipation
• Increased appetite, weight changes
• Sleep problems (insomnia)
• Decreased sex drive, impotence, or difficulty having an orgasm
• Dry mouth

This is only a partial list and other side effects may occur. Inform your doctor straightaway if you experience any other side effects than the ones mentioned above, especially if they are bothersome or seem serious.