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What Spedra is and what it is used for
Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is used to treat men suffering from erectile dysfunction (also known as impotence). This is a condition in which you cannot obtain or maintain a penile erection suitable for sexual activity.
Spedra works by helping the blood vessels in the penis to relax. This increases the blood flow to the penis, which helps it stay firm and erect during sexual arousal.
Spedra does not cure your condition.
It is important to note that Spedra only works if you are sexually stimulated. You and your partner will need to use a love game as a preparation for sex - just as much as if you are not taking a medicine to help you.
Spedra will not help if you do not have erectile dysfunction. Spedra is 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 "nitrates" for chest pain (angina pectoris), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effect of these medicines and can seriously lower your blood pressure;
If you are taking HIV or AIDS medicines, such as ritonavir, indinavir, saquinavir, nelfinavir, or atazanavir;
If you are taking medicines to treat fungal infections, such as ketoconazole, itraconazole or voriconazole, or some antibiotics for bacterial infections such as clarithromycin or 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 an irregular heart rhythm ("arrhythmia") or heart problems that are inherent in your family and are found with cardiac monitoring (ECG);
If you have low blood pressure or high blood pressure that is not controlled by medication;
If you have chest pain (angina pectoris) or have chest pain during intercourse;
If you have a serious liver or kidney problem;
If you have loss of vision in one eye due to insufficient blood supply to the eye (non-arterial ischemic optic neuropathy [NAION]);
If you have data on certain serious eye diseases (such as retinitis pigment) in the family.
If you are taking rhyociguate. This medicine is used to treat pulmonary arterial hypertension (ie, high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie, high blood pressure in the lungs due to blood clots). PDE5 inhibitors have been shown to increase the hypotonic effect of this medicine. Talk to your doctor if you are taking rhiziguat or you are not sure.
Do not take Spedra if any of the above applies to you. If you are not sure, 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 may be risky for you to have sexual intercourse;
If you suffer from priapism, which is a permanent erection lasting 4 hours or more. This can happen in men with diseases such as sickle cell disease, multiple myeloma or leukemia;
If you have an anatomical deformity 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 ulcer.
If any of the above apply to you, talk to your doctor or pharmacist before taking Spedra. If you are not sure, ask your doctor or pharmacist.
Problems with your vision or hearing
Some men who take medications like Spedra have had problems with their eyesight or hearing - see "Serious Side Effects" in Section 4 for more details. It is not known whether these problems are directly related to taking Spedra, other diseases you may have, or a combination of factors.
Children and adolescents
Spedra should not be taken by children and adolescents under 18 years.
Other medicines and Spedra
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is required because Spedra may affect the way some other medicines work. Also, some of the other medicines may affect the way Spedra works.
In particular, tell your doctor and do not take Spedra if you are taking "nitrates" for chest pain (angina pectoris), such as amyl nitrite or glycerin trinitrate. Spedra has been shown to increase the effect of these medicines and can severely lower your blood pressure.
Do not take Spedra also if you are taking medicines to treat HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir, or if you are taking medicines to treat fungal infections like ketoconase
3. How to take Spedra
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 100 mg tablet, if needed. You should not take Spedra more than once a day. Tell your doctor if you consider Spedra's action too strong or weak. He / she may suggest that you switch to a different dose of medication. Dose adjustments may also be required if Spedra is given with some other medicines. If you are taking a medication such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil ("moderate CYP3A4 inhibitors"), the recommended dose of Spedra is 100 mg tablet with at least 2 days dose interval.
You must take Spedra about 15 to 30 minutes before sexual intercourse. Remember that Spedra will only help you get an erection if you are sexually stimulated.
Spedra can be taken with or without food. When taken while eating, the onset of action may be delayed.
If you take more Spedra than you should
If you take too much Spedra, you should tell your doctor immediately. More side effects may occur and 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 contact your doctor immediately if you notice any of the following serious side effects - you may need medical attention:
an 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 not being able to get erections);
sudden decrease or loss of vision in one or both eyes;
sudden decrease or loss of hearing (in some cases you may feel dizzy or have tinnitus).
Stop taking Spedra and seek medical attention immediately if you notice any of the serious side effects listed above.
Other side effects include:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
feeling drowsy or tired;
shortage of air in exertion;
changes in heart rhythm, noticeable in cardiac monitoring (ECG);
accelerated heart rate;
feeling the heartbeat in your chest (palpitations);
indigestion, feeling of stomach upset;
increased values of liver enzymes.
Rare (may affect up to 1 in 1,000 people):
stuffy nose or runny nose;
obstruction of the nose, sinuses, or upper respiratory tract, which supplies air to the lungs;
sleep problems (insomnia);
a sense of inability to remain stationary;
severe chest pain;
increased heart rate;
high blood pressure;
stomach pain or heartburn;
pain or discomfort in the lower abdomen;
lower back pain or side lower chest pain;
muscle pain or other pain;
anomalies of the penis;
spontaneous erection without sexual stimulation;
itching in the genital area;
a feeling of constant weakness or fatigue;
swelling of the legs or ankles;
high blood pressure;
pink or red colored urine, blood in the urine;
unusual extra heart sounds;
deviation from the result of a blood test for a prostate test called "PSA";
deviation from the result of the blood test for bilirubin, a chemical produced by normal erythrocyte destruction;
deviation from the result of the blood test for creatinine, a chemical and a measure of renal function;
How to store Spedra
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Spedra contains
The active substance is avanafil. Each tablet contains 200 mg of avanafil.
Other ingredients are mannitol, fumaric acid, hydroxylpropylene cellulose, low substitution hydroxylpropylene cellulose, calcium carbonate, magnesium stearate and yellow iron oxide (E172).
What Spedra looks like and contents of the pack
Spedra is a pale yellow oval tablet with a concave embossed "100" on one side. The tablets are available in blister packs containing 4, 8 or 12 tablets.
Not all pack sizes may be marketed in your country.
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