Patient leaflet - Simarax 50 mg film-coated tablets
1. What Simarax is and what it is used for
What Simarax is
Simarax contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited and causing an erection. Simarax will only help you to get an erection if you are sexually excited (stimulated).
What Simarax is used for
Simarax is a treatment for men aged 18 years and older with erectile dysfunction. Erectile dysfunction, also known as impotence, is an inability to achieve or maintain an erection that is firm enough to have sex. Erections depend on many different factors, including proper blood flow to the penis. Reduced blood flow to the penis may cause erectile dysfunction. Erectile dysfunction can affect men differently. Some cannot achieve an erection. Others may achieve an erection, but not firm enough for having sex
or they may lose the erection before or during sex.
2. What you need to know before you take Simarax
Do not take Simarax if you:
- do not have an erection problem
take any nitrate medicine for chest pain, or
heart failure (see “Other medicines and Simarax”);
take amyl nitrite, so called “poppers” as
recreational drugs
take riociguat (or other guanylate cyclase
stimulators) for high blood pressure in the lungs (see “Other medicines and Simarax”);
take ritonavir for the treatment of HIV (see
“Other medicines and Simarax”);
have been advised by your doctor to avoid
sexual activity because of a problem with your heart or blood vessels (see “Warnings and precautions”)
have a severe heart problem such as a recent
heart attack or stroke (within the last 6 months), unstable angina (chest pain) or severe cardiac failure (reduced pumping capacity of the heart)
- have a severe liver problem;
have low blood pressure (below 90/50
mmHg) which can cause symptoms such as tiredness, dizziness, light-headedness, feeling sick, clammy skin, depression, loss of consciousness, or blurry vision
have ever had severe vision loss because of
nerve damage in the eyes, such as non-arteritic anterior ischaemic optic neuropathy (NAION); or have a rare inherited eye disease, such as retinitis pigmentosa (see “Warnings and precautions”);
- have a deformed penis
- are a woman
- are under 18 years of age
are allergic to sildenafil or any of the other
ingredients of this medicine (listed in section 6)
Warnings and precautions
Erectile dysfunction may be an early sign of: You should schedule a health check-up with your doctor as soon as possible within the first 6 months of starting to use Simarax to ensure that your erection problems are not caused by any serious health condition.
Ÿ cardiovascular disease
Ÿ diabetes
Ÿ high blood pressure
Ÿ high cholesterol
Tell your doctor about your problems if you have not already done so.
Cardiovascular risk factors
Sexual activity can put a strain on your heart (see “Do not take Simarax if you” above).
Talk to your doctor before taking Simarax if you:
Ÿ get very breathless or feel any pain in the chest with light or moderate activity (e.g. walking briskly for 20 minutes or climbing two flights of stairs). Your doctor may need to check whether your heart can take the additional strain of having sex.
Ÿ have a problem with a valve in your heart
(valvular heart disease).
Ÿ have a disease in which the heart muscle becomes inflamed and does not work as well as it should (cardiomyopathy). Ÿ have an irregular heart beat (arrhythmia). Ÿ you have had surgery to improve blood flow to your heart, or you have high blood pressure which is now adequately treated. Ÿ have high blood pressure that is not
controlled.
Other risk factors:
Talk to your doctor before taking Simarax if you: Ÿ have ever had an erection that lasted more than 4 hours (priapism). Some conditions can increase the probability of having a persistent erection, such as sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow). Use of impotence medicines may increase the risk of priapism.
Ÿ Long lasting erection may cause damage to the tissue in the penis and permanent loss of ability to have an erection.
Ÿ have a stomach ulcer or a bleeding disorder
(such as haemophilia), since Simarax can affect the aggregation of thrombocytes.
Ÿ have previously been diagnosed with mild to moderate liver disease, or severe kidney problems. Simarax may not be suitable for you, you should consult your doctor before taking Simarax.
Ÿ have ever had severe vision loss because of nerve damage in the eyes or a rare inherited eye disease (see “Do not take Simarax if you” above). Cases of visual effects have been reported when using sildenafil. If you experience any sudden visual defect you should stop taking Simarax and contact your doctor immediately.
Children and adolescents
This medicine should not be given to children or adolescents under the age of 18 years.
Other medicines and Simarax
Tell your pharmacist or doctor if you are taking, have recently taken or might take any other taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators). Riociguat is used to treat high blood pressure in the lungs and can lead to a dangerous fall in blood pressure if taken together with Simarax. medicines. Some medicines may be affected by Simarax or they may affect how Simarax works and this may result in side effects.
Do not use Simarax if you
take:
Ÿ Nitrate medicines: Do
not take Simarax if you
are taking nitrate
medicines (such as
glyceryl trinitrate,
isosorbide mononitrate,
isosorbide dinitrate) against chest pain (angina pectoris) or heart failure or “poppers” as recreational drugs (nitric oxide donors (such as amyl nitrite), nicorandil or sodium nitroprusside)). This is because these substances could lead to a dangerous fall in blood pressure if taken together with Simarax.
Ÿ Riociguat: Do not take Simarax if you are
Ÿ Medicines to treat HIV-infections: Ritonavir is a medicine used to treat HIV-infections. Do not take Simarax if you are taking ritonavir since this combination can lead to dangerous fall in blood pressure.
Talk to your pharmacist or doctor before using Simarax if you are taking:
heartburn, cimetidine, increases the concentration of Simarax in the body and may result in side effects. You should contact your doctor before taking Simarax. Ÿ Medicines to treat fungal infections and antibiotics: Medicines to treat fungal infections called itraconazole or
ketoconazole and an antibiotic called erythromycin increase the concentration of Simarax in the body and may result in side effects. You should contact your doctor before taking Simarax if you are using these medicines.
The safety and efficacy of combinations of Simarax with other treatments for erectile dysfunction have not been studied and this combination is therefore not recommended. Ÿ Heartburn treatment: The medicine to treat
Ÿ Other treatments for erectile dysfunction:
Ÿ Alpha-blockers used to treat urinary
problems or high blood pressure: Alpha-blockers used to treat urinary problems due to enlarged prostate (such as alfuzosin, doxazosin or tamsulosin) may lead to dizziness, light-headedness, nausea, fainting, lack of concentration, or blurred vision due to low blood pressure
(symptomatic hypotension).
Simarax with food and drink
Simarax can be taken with or without food. When this medicine is taken after a
high-fat meal, it may take a little longer to start working. Do not take Simarax with grapefruit or grapefruit juice, because this can affect how the medicine works.
Drinking excessive alcohol can temporarily reduce your ability to achieve an erection. To get a benefit from the medicine, you are advised not to drink large amounts of alcohol before sexual activity.
This medicine should not be used by women. Pregnancy, breast-feeding and fertility
Driving and using machines
Simarax can cause dizziness and can affect your vision. Do not drive or use machines if you suffer from these side effects after taking this medicine.
Important information about some of the ingredients of Simarax
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free’
3. How to take Simarax
Always take this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you. Check with your pharmacist or doctor if you are not sure.
Ÿ Do not take more than 1 tablet a day. Ÿ Take 1 tablet, as needed, approximately 1
hour before sexual activity.
Ÿ Swallow the tablet whole with water.
Simarax will only help you achieve an erection if you are sexually aroused. You and your partner should engage in foreplay just as you would if you were not taking a medicine for erectile dysfunction.
The amount of time this medicine takes to work varies from person to person, but it normally takes between 30 to 60 minutes. You may take it up to 4 hours before sexual activity.
Relax and be patient if Simarax does not help you the first time.
You can try again later but remember you can only take 1 tablet a day. For most men, Simarax will work the first or second time they try it. If it has been some time since you were able to get or keep an erection, it may take a couple of attempts before you achieve the desired effect. Talk to your doctor if you have tried Simarax, and are still not able to get and keep an erection. If you feel the effect of Simarax is too strong, talk to your pharmacist or doctor.
If you take more Simarax than you should
If you have any further questions on the use of this medicine, ask your pharmacist or doctor. If you take more tablets than recommended, contact your pharmacist or doctor immediately. Taking more than the recommended dose may result in side effects and/or more severe side effects.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild to moderate and of a short duration.
Seek medical attention immediately if you experience any of the following serious side effects:
Ÿ Chest pains: this occurs uncommonly. If this occurs before, during or after sexual activity: Get in a semi-sitting position and try to relax. Do NOT use nitrates to treat your chest pain.
Ÿ A prolonged and sometimes painful erection lasting longer than 4 hours: this rarely occurs.
Ÿ A sudden decrease or loss of vision: this occurs rarely.
Ÿ An allergic reaction: this occurs uncommonly. Symptoms include sudden wheeziness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Ÿ Serious skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Syndrome (TEN): this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes and fever.
Ÿ Seizures or fits: this occurs rarely.
Other side effects
Very common (may affect more than 1 in 10 people):
Ÿ nausea, indigestion, stuffy nose, dizziness Common (may affect up to 1 in 10 people): Ÿ headache
Ÿ facial flushing, hot flush (a sudden feeling
of heat in your upper body)
Ÿ colour tinge to vision, blurred vision, visual
disturbance
nosebleed, feeling hot, feeling tired (fatigue) Uncommon (may affect up to 1 in 100 people):
Ÿ vomiting, upper abdominal pain, acid reflux
(including heartburn)
Ÿ skin rash, pain in the arms or legs,
Ÿ eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes
Ÿ pounding heartbeat, rapid heartbeat
Ÿ high blood pressure
Ÿ low blood pressure (typical signs are dizziness, fainting, blurred vision, nausea and tiredness)
Ÿ muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (can be experienced as runny nose, sneezing and stuffy nose)
Rare (may affect up to 1 in 1,000 people): Ÿ presence of blood in urine
Ÿ fainting, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Ÿ sudden unexpected death caused by loss of heart function (sudden cardiac arrest), stroke, heart attack, chest pains (angina), irregular heartbeat, temporary decreased blood flow to parts of the brain discolouration of the white of the eye penile bleeding, presence of blood in semen Ÿ feeling of tightening of the throat, numb mouth
Ÿ bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye,
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or
Apple App Store. By
reporting side effects you
can help provide more
information on the safety of
this medicine.
5. How to store Simarax
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Simarax contains
The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
The other ingredients are
Tablet Core: Microcrystalline cellulose, Calcium hydrogen phosphate dihydrate, Croscarmellose sodium, Hypromellose & Magnesium stearate. Film Coat: Hypromellose 6cP, Titanium Dioxide (E171), Triacetin & Indigo carmine Aluminum lake (E132).
What Simarax looks like and contents of the pack
The tablets are provided in blister packs. Blue coloured, diamond shaped, film coated tablets debossed with “CL 36” on one side and plain on the other side.
Pack sizes:
2, 4, 8 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham,
TS22 5TB, United Kingdom
PL 34771/0259