25 mg, 50 mg, 100 mg tablet
sildenafil
What Sildenafil 1A Farma is and what it is used for
Sildenafil 1A Farma contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). It works 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 1A Farma only makes it easier to get an erection if you are sexually stimulated.
Sildenafil 1A Farma is a treatment for adult men with erectile dysfunction, better known as impotence. This means that a man can not get, or maintain, a hard
erect penis sufficient for sexual intercourse.
Sildenafil contained in Sildenafil 1A Farma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sildenafil 1A Farma
Do not take Sildenafil 1A Farma
- 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 in combination with Sildenafil 1A Farma 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 (“poppers”), a combination of such medicines with Sildenafil 1A Farma 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 1A Farma, 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 specific, 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 1A Farma
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer), 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. Your doctor will carefully check if your heart can tolerate the increased effort that sexual activity entails.
- if you currently have a stomach ulcer or a bleeding disorder (such as hemophilia)
- if you experience a sudden deterioration or loss of vision, stop taking Sildenafil 1A Farma and contact a doctor immediately.
You should not use Sildenafil 1A Farma at the same time as any other ( oral or topical) treatment for erectile dysfunction.
You should not use Sildenafil 1A Farma while taking any treatment for pulmonary arterial hypertension (PAH) that contains sildenafil or any other PDE5 inhibitors.
You should not take Sildenafil 1A Farma if you do not have an erection problem ( erectile dysfunction ).
You should not take Sildenafil 1A Farma 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 1A Farma should not be given to people under 18 years of age.
Other medicines and Sildenafil 1A Farma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil 1A Farma tablets may affect the way some medicines are used, especially those used to treat chest pain. If you become acutely ill, you should inform your doctor, pharmacist, or nurse that you have taken Sildenafil 1A Farma and when. Do not take Sildenafil 1A Farma with other medicines unless your doctor tells you to.
You should not take Sildenafil 1A Farma if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often given to relieve angina pectoris or “chest pain”.
You should not take Sildenafil 1A Farma if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), as these two in combination can cause a potentially dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking so-called protease inhibitors for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of Sildenafil 1A Farma (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 1A Farma with alpha-receptor blockers. This is most likely to occur within 4 hours of taking Sildenafil 1A Farma. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil 1A Farma. Your doctor may prescribe a lower dose (25 mg) of Sildenafil 1A Farma.
Sildenafil 1A Farm with food, drink, and alcohol
Sildenafil 1A Farma 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 1A Farma.
Pregnancy, breastfeeding, and fertility
Sildenafil 1A Farma should not be used by women.
Driving and using machines
Sildenafil 1A Farma may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil 1A Farma before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. The description 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.
Sildenafil 1A Farma contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Sildenafil 1A Farma
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The recommended starting dose is 50 mg.
You should not take Sildenafil 1A Farma more than once a day.
Do not take Sildenafil 1A Farma tablets together with orodispersible tablets containing sildenafil.
You should take Sildenafil 1A Farma approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
Sildenafil 1A Farma 25 mg:
The switch is not for dividing the tablet into equal doses, but only for easier swallowing.
Sharing the tablet
Place the tablet on an even, hard surface with the break notched up. Press with your thumb in the middle of the tablet, so that the tablet is divided into two equal doses. For a minimum effective dose, both halves must be taken.
Sildenafil 1A Farma 50 mg:
The tablet can be divided into four equal doses. For a minimum effective dose, at least two quarters (equivalent to 25 mg) must be taken.
Sharing the tablet
Place the tablet on an even, hard surface with the break notched up. Press with your thumb in the middle of the tablet, so that the tablet is divided into four equal doses.
Sildenafil 1A Farma 100 mg:
The tablet can be divided into four equal doses.
Sharing the tablet
Place the tablet on an even, hard surface with a deeper notch upwards. Press with your thumb in the middle of the tablet, so that the tablet is divided into four equal doses.
If you have the impression that the effect of Sildenafil 1A Farma is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil 1A Farma only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil 1A Farma to work varies from person to person, but normally it takes between half and an hour. You may notice that it takes longer for Sildenafil 1A Farma to work if you take it with a heavy meal.
If Sildenafil 1A Farma 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 take more Sildenafil 1A Farma than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, 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 impact.
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, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported with the use of Sildenafil 1A Farma are usually mild to moderate and last only a short time.
Stop using Sildenafil 1A Farma 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 may include sudden wheezing, difficulty breathing or dizziness, and swelling of the eyelids, face, lips, or throat.
- Chest pain – is less common this happens during or after intercourse:- Get up in a semi-sitting position and try to relax.- Do not take nitrates to treat chest pain.
- Prolonged and sometimes painful erections – 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 a doctor immediately.
- Sudden decrease or loss of vision – rare.
- Severe skin reactions – rare symptoms may include severe scaling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, and fever.
- Seizures – rare
Other side effects are
Very common (may affect more than 1 user in 10):
- headache.
Common (may affect up to 1 in 10 people):
- nausea
- flushing
- 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 eye, eye pain, seeing flashes of light or perceiving light as very strong, photosensitivity, watery eyes
- palpitations, rapid heartbeat
- high blood pressure, low blood pressure
- muscle pain
- somnolence
- decreased sensation
- dizziness
- earrings
- dry mouth
- blocked or blocked sinuses, inflammation of the lining 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 of warmth
- 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 tightness in the throat
- numb mouth
- bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, swelling in the eye or eyelid, small dots or spots in the visual field, that you see a halo around light sources, dilated pupils, discoloration of the whites of the eyes
- bleeding in the penis
- blood in the semen
- dry nose
- swelling inside the nose
- irritability
- sudden decrease 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.
How to store Sildenafil 1A Farma
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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. One tablet contains 25 mg, 50 mg, or 100 mg of sildenafil (as citrate).
- The other ingredients are anhydrous calcium hydrogen phosphate, microcrystalline cellulose, copovidone, croscarmellose sodium, magnesium stearate, saccharin sodium, indigo carmine aluminum lacquer (E132).
What the medicine looks like and the contents of the pack
Sildenafil 1A Farma 25 mg tablets are light blue, round, slightly speckled tablets with a notch on one side and marked with “25” on the other side.
Sildenafil 1A Farma 50 mg tablets are light blue, round, slightly speckled tablets with two intersecting fractures on one side and marked with “50” on the other side.
Sildenafil 1A Farma 100 mg tablets are light blue, round, slightly speckled tablets with two intersecting fractures on both sides of the tablet and marked with “100” on one side.
Sildenafil 1A Farma tablets are packaged in blister packs of 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia
Sildenafil 1A Farma