25 mg, 50 mg, 100 mg film-coated tablets
sildenafil
Sildenafil Navamedic contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). They work by making it easier for the blood vessels in your penis to dilate so that the blood can flow in when you are sexually stimulated. Sildenafil Navamedic only makes it easier to get an erection if you are sexually stimulated.
Sildenafil Navamedic is a treatment for men with erectile dysfunction, better known as impotence. This means that a man cannot get, or maintain, a hard erect penis sufficient for sexual intercourse.
Sildenafil contained in Sildenafil Navamedic may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- if you are taking medicines called nitrates, as the combination may cause a sharp drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often given to relieve angina ( angina pectoris ) or “chest pain”. If you are not sure, ask your doctor or pharmacist
- if you are taking medicines called nitric oxide donors such as amyl nitrite, as a combination of such medicines with Sildenafil Navamedic may also lead to a sharp drop in blood pressure
- if you take riociguat. 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, such as Sildenafil Navamedic, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
- if you have severe heart or liver problems
- if you have recently had a stroke or heart attack or if you have low blood pressure
- if you have certain, rare, inherited eye diseases (such as retinitis pigmentosa )
- if you have ever lost your sight due to non-arteritic anterior ischemic optic infarction/neuropathy (NAION)
Warnings and cautions
Talk to your doctor or pharmacist before taking Sildenafil Navamedic
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer), or multiple myeloma ( bone marrow cancer )
- if you have a deformed penis or any disease of the penis such as Peyronie’s disease
- if you have heart problems. In this case, your doctor should carefully check if your heart can withstand the increased effort of sexual activity.
- if you currently have a stomach ulcer or a bleeding disorder (such as hemophilia)
- if you experience sudden impairment or loss of vision, stop taking Sildenafil Navamedic and contact a doctor immediately
You should not use Sildenafil Navamedic at the same time as other ( oral or local) treatments for erectile dysfunction.
You should not use Sildenafil Navamedic at the same time as any treatment for pulmonary arterial hypertension (PAH) that contains sildenafil or any other PDE5 inhibitors.
You should not take Sildenafil Navamedic if you do not have erectile dysfunction.
You should not take Sildenafil Navamedic if you are a woman.
Especially to take into account when it comes to patients with liver or kidney problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide that your dose should be lower.
Children and young people
Sildenafil Navamedic should not be given to people under 18 years of age.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Sildenafil Navamedic tablets may affect the way some medicines are used, especially those used to treat chest pain. If you become acutely ill, you should inform the person treating your condition that you took Sildenafil Navamedic and when you did. Do not take Sildenafil Navamedic with other medicines unless your doctor tells you to.
You should not take Sildenafil Navamedic if you are taking medicines called nitrates, as they in combination with Sildenafil Navamedic can cause a sharp drop in blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines, which are often given to relieve angina pectoris or “chest pain”.
You should not take Sildenafil Navamedic if you are taking medicines called nitric oxide donors such as amyl nitrite, as a combination of such medicines with Sildenafil Navamedic may also lead to a sharp drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking a so-called protease inhibitor for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of Sildenafil Navamedic (25 mg).
Some patients taking alpha-receptor blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when you quickly sit up or stand up. Some patients have experienced these symptoms while taking Sildenafil Navamedic with alpha-receptor blockers. This is most likely to occur within 4 hours of taking Sildenafil Navamedic. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil Navamedic. Your doctor may prescribe a lower dose (25 mg) of Sildenafil Navamedic.
Sildenafil Navamedic can be taken with or without food, but if you take it with a heavy meal, it may take a little longer before it works.
Alcohol intake may temporarily reduce the ability to get an erection. To get the maximum effect from your medicine, you should not drink large amounts of alcohol before taking Sildenafil Navamedic.
Pregnancy, breastfeeding, and fertility
Sildenafil Navamedic should not be used by women.
Driving and using machines
Sildenafil Navamedic may cause dizziness and impair vision. You should be aware of how you react to Sildenafil Navamedic before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Always take Sildenafil Navamedic exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is 50 mg.
You should not take Sildenafil Navamedic more than once a day.
You should take Sildenafil Navamedic approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you have the impression that the effect of Sildenafil Navamedic is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Navamedic only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil Navamedic to work varies from person to person, but it usually takes between half and an hour. You may notice that it takes longer for Sildenafil Navamedic to work if you take it with a heavy meal.
If Sildenafil Navamedic does not help you get an erection or if an erection does not last long enough to complete sexual intercourse, tell your doctor.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital for risk assessment and advice.
You may find that the side effects and their severity increase. Doses above 100 mg do not increase the effect.
Do not take more tablets than your doctor tells you to do.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported with Sildenafil Navamedic are usually mild to moderate and last only a short time.
Stop using Sildenafil Navamedic and contact your doctor immediately if you experience any of the following severe symptoms:
- An allergic reaction – is less common (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, and swelling of the eyelids, face, lips, or throat.
- Chest pain – is less common. If this happens during or after intercourse:-Rise up in a semi-sitting position and try to relax- Do not take nitrates to treat chest pain.
- Prolonged and sometimes painful erections are – rare (may affect up to 1 in 1,000 people). If you get such an erection that lasts longer than 4 hours, you should contact your doctor immediately.
- Sudden decrease or loss of vision – rare
- Severe skin reaction – rare. Symptoms include severe dandruff and swelling of the skin, blistering of the mouth, genitals, and around the eyes, and fever.
- Seizures – rare
Other side effects:
Very common (may affect more than 1 user in 10):
- Headache.
Common (may affect up to 1 in 10 people):
- Nausea
- Blush
- Hot flashes (symptoms may include a sudden feeling of warmth in the upper body)
- Digestive problems
- Altered color vision, blurred vision, visual disturbances
- Nasal congestion
- Dizziness.
Uncommon (may affect up to 1 in 100 people):
- Vomiting
- Rash
- Eye irritation
- Bloodshot eyes / red eyes
- Eye pain
- That you see flashes of light or perceive light as very strong
- Sensitivity to light, watery eyes
- Heartbeat or fast heartbeat
- High blood pressure
- Low blood pressure
- Muscle pain
- Somnolence
- Decreased feeling
- Dizziness
- Earrings
- Dry mouth
- Blocked or blocked sinuses
- Inflammation of the mucous membrane of the nose (symptoms include runny nose, sneezing, and nasal congestion)
- Pain in the upper abdomen
- Gastroesophageal reflux disease (symptoms include heartburn)
- Presence of blood in the urine
- Pain in arms or legs
- Nosebleed
- Feeling warm
- Feeling tired
Rare (may affect up to 1 in 1,000 people):
- Fainting
- Stroke
- Heart attack, irregular heartbeat
- Temporarily reduced blood flow to parts of the brain, a feeling of congestion in the throat, numb mouth
- Bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye
- Swelling of the eye or eyelid
- Small dots or spots in the field of view, where you see a halo around light sources
- Dilated pupils are
- Discoloration of the whites of the eyes
- Bleeding in the penis, blood in the semen
- Dry nose, swelling inside the nose
- Irritability
- Sudden loss or loss of hearing
After the drug has been marketed and used by patients, rare cases of unstable angina (a type of heart problem) and sudden death have been reported. It is worth noting that most – but not all – of the men who experienced these symptoms had heart problems before taking this medication. It is impossible to say whether these events were due to sildenafil.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. or on the blister map after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is sildenafil. Each film-coated tablet contains 25, 50, or 100 mg of sildenafil (as citrate).
Other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, anhydrous calcium hydrogen phosphate, hypromellose, sodium stearyl fumarate
Film coating: hypromellose, titanium dioxide (E171), triacetin, indigo carmine, aluminum lacquer (E132).
What the medicine looks like and the contents of the pack
Sildenafil Navamedic 25 mg film-coated tablets
Blue, round (diameter about 7.1 mm), biconvex, film-coated tablets, marked with “86” on one side and smooth on the other.
Sildenafil Navamedic 50 mg film-coated tablets
Blue, round (diameter about 9.6 mm), biconvex, film-coated tablets, marked with “8” and “7” on one side and smooth on the other. The tablets can be divided into two equal doses.
Sildenafil Navamedic 100 mg film-coated tablets
Blue, round (diameter about 12.3 mm), biconvex, film-coated tablets, marked with “8” and “8” on one side and smooth on the other. The tablets can be divided into two equal doses.
Pack sizes: 2, 4, 8, 12 or 24 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Navamedic ASA
Fornebuveien 42-44
1366 Lysaker
Norway
Manufacturer
Pharma Pack Hungary Kft.
2040 Budaörs, Vasút u. 13
Hungary