Read this information leaflet with care, before you start using this medicine.
- If you have any questions, consult your doctor or pharmacist.
- When you have a harmful side effect, or you suffer from a side effect that isn't mentioned in this leaflet, consult your doctor or pharmacist.
In this information leaflet:
- What is APCALIS and for what is it used?
- What do you need to know before you take APCALIS.
- How do you take APCALIS.
- Possible side effects.
- How do you preserve APCALIS.
- More information.
What is APCALIS and for what is it used?
APCALIS belongs to the group of fosfodiesterase-inhibitors type 5. After sexual stimulation, APCALIS helps relax the blood vessels in the penis allowing blood to flow in your penis. This results in an improvement of your erection. APCALIS does not work if you don't have an erectile dysfunction.
It is important to note that APCALIS does not work in the absence of a sexual stimulus. You and your partner should know that foreplay is needed, just as you would do if you weren't using a medicine for your erectile dysfunction.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APCALIS
Don't take APCALIS
- If you use medicines that contain organic nitrates or release nitric oxide, such as Amyl nitrites. These medicines are used to treat angina pectoris (chest pain). APCALIS showed that the effects of these drugs were strengthened. Tell your doctor if you use a drug that contains nitrates, or if you are unsure of this.
- If you are hypersensitive (allergic) to sildenafil or for any of the other substances of APCALIS.
- You have severe heart or liver problems.
- If you recently have had a stroke or heart-attack or when you have a low blood-pressure.
- If you have certain rare inherited eye (such as Retinitis pigmentosa).
- If you ever had a loss of sight because of non-arteritic anterior ischaemic optic neuropathy (NAION).
Be extra cautious with APCALIS
Tell your doctor:- If you have sickle cell anemia (a deviation of the red blood cells), leukemia (blood cell cancer), multiple myeloma (bone marrow cancer) or a disease or deformity of your penis. With this diseases, you should be extra careful when you take medicines for an erectile dysfunction.
- If you have heart problems. Your doctor should carefully check whether your heart can handle the extra effort that sexual activities require.
- If you have an ulcer or a bleeding disorder (like haemophilia).
- If you suddenly experience a reduction or loss of vision, stop the taking of APCALIS and please contact your doctor. APCALIS should not be used in combination with other treatments for erectile dysfunction.
Special precautions for children
APCALIS must not be used by children younger than 18 years.
Special precautions for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide to prescribe you a lower dose.
Special precautions in combination with other medicines
Tell your doctor or pharmacist if you use other medicines or have recently used some. This also applies to non-prescription medicines that you can get.APCALIS tablets can influence the effect of certain drugs, in particular drugs that are used against “chest pain”. In a medical emergency, you should tell the person who treats you that you've used APCALIS. Don't use APCALIS in combination with other medicines unless your doctor has indicated that it allowed. APCALIS can cause a significant increase of the effect of drugs such as nitrates and nitric oxide substances like Amyl nitrites. These are often used to relieve angina pectoris or (“chest pain”).
You can't use APCALIS if you use one of these medicines. When you use protease-inhibitors, such as for the treatment of HIV, your doctor may start you with the lowest dose of APCALIS.
Some patients who receive alpha blocker-therapy for treatment of high blood pressure or prostate problems may feel dizzy or light in the head when they stand up. These are symptoms of ortho-static hypotension which means you get low blood pressure when quickly sitting or standing up. Some patients have encountered these symptoms when using APCALIS with alpha blockers. The probability of these effects is the greatest within 4 hours after taking APCALIS. To reduce the likelihood that these symptoms occur, your daily dose of alpha-blockers should be consistent before your use APCALIS. Your doctor may start prescribing you with a dose of 20 mg APCALIS.
Using APCALIS with food and drinks.
When APCALIS is taking with food, it may take a little longer before APCALIS works.
Pregnancy and lactation
APCALIS is not indicated for use by women.
Driving and using machines
APCALIS can cause dizziness and can affect your vision. You should be aware of how your reaction is to APCALIS before you drive or use machinery.
Important information about some components of APCALIS
If your doctor has told you that you cant tolerate certain sugars such as lactose, please contact your doctor before taking APCALIS.
How do you take APCALIS?
Take APCALIS about an hour before sexual activity. Swallow the tablet in whole with water. If you have the impression that the effect of APCALIS is too strong or too weak, inform your doctor or pharmacist. APCALIS helps you to get an erection when you are sexually aroused. The time till APCALIS work varies per person, but usually it takes about an half hour to an hour. It may take longer before APCALIS starts to work when you have eaten a heavy meal. Drinking alcohol can temporarily diminish the opportunity to get an erection. For maximum effect of this drug, you are advised not to drink large quantities of alcohol before taking APCALIS.
If APCALIS doesn't help you to get an erection or if the erection doesn't persist long enough to complete sexual intercourse, you should report this to your doctor.
Don't take APCALIS more than once a day.
What to do if you have taken more APCALIS than you should:
Doses above 100 mg do not increase the effect. The number of side effects does, and they can be serious.
You should not to take more tablets than your doctor has told you.
Contact your doctor if you have taken more tablets than prescribed.If you have questions about using this product, contact your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines APCALIS can cause side effects, although not everybody gets them. These are usually mildly to moderately severe. In controlled medical studies the most common side effects were an headache, or blushing, and less frequently a disordered digestion, dizziness, clogged nose, a heavy heartbeat or effects on vision (including defects in colour vision, increased sensitivity to light or blurred vision). If you have an erection that lasts longer than 6 hours, consult your doctor immediately. If you have chest pain during or after sexual activity you should not use nitrates but you should immediately contact your doctor. Muscle pain may occur if APCALIS is used more than once per day. If any side effects gets serious, or a side effects occurs which us not listed in this leaflet, consult your doctor.
HOW DO YOU STORE APCALIS?
Keep out of the reach and sight of children. Store below 30 degrees. Store in the original packaging to protect against moisture. Don't use APCALIS after the expiry date which is stated on the blister. The expiry date refers to the last day of that month. Medicines should not be disposed via the waste water or with the household waste. Ask your pharmacist what you should do with the medicines when they are no longer needed. These measures will help with protecting the environment.
