SPEDRA 50 mg. 4 tablets

What is Spedra and what it is used
Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5). Spedra be used for the treatment of men suffering from erectile dysfunction (also known as impotence). This is a condition where you can not get or maintain an erection of the penis suitable for sexual activity.
Spedra works by helping the blood vessels in the penis to relax. This increases blood flow to the penis which helps him to stay hard and erect during sexual excitement.
Spedra not cure your condition.
It is important to note that Spedra only work if you are sexually stimulated. You and your partner will need to use foreplay in preparation for sex - just as much, if not taking medication to help you.
Spedra will not help you if you do not have erectile dysfunction. Spedra not for women.

2. What you need to know before taking Spedra
Do not take Spedra:
If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6);
If you are taking medications "nitrates" pain in the chest (angina), such as amyl nitrite or glyceryl trinitrate. Spedra may enhance the effects of these drugs and seriously lower your blood pressure;
If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, atazanavir or nelfinavir;
If medicines to treat fungal infections, such as ketoconazole, itraconazole or voriconazole, or some antibiotics in bacterial infections such as clarithromycin and telithromycin;
If you have a severe heart problem;
If you have had a stroke or heart attack in the last 6 months;
If you have irregular heart rhythms ("arrhythmias") or heart problems inherent in your family and settle down to follow up the activity of the heart (ECG);
If you have low blood pressure or high blood pressure that is not controlled with medication;
If you have pain in the chest (angina) or have pain in the chest during intercourse;
If you have serious liver or kidney problems;
If you have loss of vision in one eye due to insufficient blood supply to the eye (non-arteritic ischemic optic neuropathy [NAION]);
If your family has a history of certain serious eye diseases (such as retinitis pigmentosa).
Do not take Spedra, if any of the above applies to you. If you are unsure, talk to your doctor or pharmacist before taking Spedra.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Spedra:
If you have a heart problem. It can be risky for you to have sexual intercourse;
If you suffer from priapism, which is continuous erection lasting four hours or more. This can happen in men with diseases such as sickle cell anemia, multiple myeloma, or leukemia;
If you have anatomical deformation that affects the shape of your penis (such as angulation, Peyronie's disease, or cavernous fibrosis);
If you have any bleeding disorder or active peptic ulceration.
If any of the above applies to you, talk to your doctor or pharmacist before taking Spedra. If you're not sure, ask your doctor or pharmacist.

Problems with your vision or hearing
Some men who take drugs like Spedra, have problems with vision or hearing - see "Serious side effects' in section 4 for details. It is not known whether these problems are directly related to the adoption of Spedra, other diseases that may have, or combination of factors.

Children and adolescents
Spedra should not be taken by children and adolescents under 18 years.

Other medicines and Spedra
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. This is required as Spedra may affect the operation of some other medicines. Also some other medicines can affect the operation of Spedra.
In particular, tell your doctor and do not take Spedra, if you are taking 'nitrates' pain in the chest (angina), such as amyl nitrite or glycerine trinitrate. It has been shown that Spedra enhances the action of these drugs and may seriously reduce the blood pressure.
Do not take Spedra and if you are taking medicines to treat HIV or AIDS such as ritonavir, indinavir, saquinavir, atazanavir or nelfinavir or are taking medicines to treat fungal infections such as ketoconazole, itraconazole or voriconazole or some antibiotics for bacterial infections such as clarithromycin or telithromycin (see. the beginning of paragraph 2, "Do not take Spedra").

Tell your doctor or pharmacist if you are taking any of the following medications:
so-called "alpha-blockers" - in prostate problems or for lowering high blood pressure;
medicines for irregular heart rhythms ("arrhythmias") such as quinidine, procainamide, amiodarone or sotalol;
antibiotics to treat infections such as erythromycin;
phenobarbital or primidone - for epilepsy;
Carbamazepine - for epilepsy, mood stabilization or for certain types of pain;
other drugs that can reduce the decomposition of the body Spedra ("moderate CYP3A4 inhibitors") including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
Spedra not take concomitantly with other drugs to treat erectile dysfunction such as sildenafil, tadalafil or vardenafil.
If any of the above applies to you, talk to your doctor or pharmacist before taking Spedra. If you're not sure, ask your doctor or pharmacist.

Fertility
No influence on the mobility or the structure of the sperm after oral administration of single doses of 200 mg avanafil in healthy volunteers.
There is currently no data on the effect on spermatogenesis in healthy elderly men and elderly men with mild erectile dysfunction.

Spedra drinks and alcohol
Grapefruit juice can increase the concentration of the drug and should be avoided within 24 hours before the Spedra.
Drinking alcohol while taking Spedra, can accelerate your heart rate and lower your blood pressure. You may feel dizzy (particularly when standing up), get a headache or feel the heart pumping in your chest (palpitations). Alcohol may further reduce the ability to obtain an erection.

Driving and using machines
Spedra can cause feelings of dizziness or affect your vision. If this happens, do not drive, ride a bicycle or operate machinery.

3. How to take Spedra
Always take this medicine exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.
The recommended dose is 100 mg tablet as needed. You should not take Spedra more than once a day. Tell your doctor if you feel the effect of Spedra too strong or too weak. He / she may suggest that you switch to a different dose of the drug. It may be necessary and dose adjustments, if Spedra be given with some other medicines. If you are taking medication such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil ("moderate CYP3A4 inhibitors") Spedra recommended dose is 100 mg tablet at least two days between doses.
You should take Spedra about 30 minutes before sexual intercourse. Remember that Spedra will help you get an erection if you are sexually stimulated.
Spedra can be taken with or without food. In intake during meals early action may be delayed.

If you take more dose Spedra
If you take too much Spedra, you should immediately notify your doctor. May show more side effects, as they may be more severe.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop taking Spedra and immediately contact a doctor if you notice any of the following serious side effects - you may need urgent medical attention:
erection that does not go away ("priapism"). If you get an erection that lasts more than 4 hours, this condition should be treated as soon as possible, otherwise you may get permanent damage to the penis (including if you are not able to get erections);
blurred vision;
Sudden decrease or loss of vision in one or both eyes;
sudden decrease or loss of hearing (in some cases you may feel dizzy and have tinnitus).
Stop taking Spedra and seek immediate medical attention if you notice any of the above serious side effects.

Other side effects include:
Common (may affect up to 1 in 10 people):
headache;
redness;
nasal congestion.
Uncommon (may affect up to 1 in 100 people):
feeling dizzy;
feelings of sleepiness or fatigue;
sinus congestion;
back pain;
hot flashes;
shortness of breath on exertion;
changes in heart rhythm, notable for monitoring heart activity (ECG);
rapid pulse;
feeling the heart pumping in your chest (palpitations);
indigestion, feeling of indigestion;
blurred vision;
elevated liver enzymes.
Rare (may affect up to 1 in 1000 people):
flu;
flu-like illness;
stuffy or runny nose;
hay fever;
nasal congestion, sinus or upper airway supplying air to the lungs;
gout;
sleep problems (insomnia);
premature ejaculation;
strange feeling;
a feeling of inability to stay still;
chest pain;
severe pain in the chest;
increased heart rate;
high blood pressure;
dry mouth;
stomach pain or heartburn;
pain or discomfort in the lower abdomen;
diarrhea;
rash;
pain in the lower back or side of the lower part of the thorax;
muscle pain or other pain;
muscular spasms;
frequent urination;
abnormalities of the penis;
spontaneous erection without sexual stimulation;
itching in the genital area;
feeling of constant fatigue or weakness;
swelling of feet or ankles;
high blood pressure;
pink or red colored urine, blood in the urine;
additional unusual noises from the heart;
deviation in the results of a blood test for the study of the prostate called "PSA";
variation in the results of a blood test for bilirubin, a chemical produced by the normal red cell destruction;
variation in the results of a blood test for creatinine, a chemical and a measure of kidney function;
weight gain;
fever.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Spedra
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.