20 mg film-coated tablets
WHAT ORISILD IS AND WHAT IT IS USED FOR
Orisild contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Orisild lowers blood pressure in the lungs by dilating the blood vessels in the lungs.
Orisild is used to treat adults and children and adolescents from 1 to 17 years of age with high blood pressure in the blood vessels in the lungs ( pulmonary arterial hypertension ).
Sildenafil contained in Orisild 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.
BEFORE YOU USE ORISILD
Do not use Orisild
- if you are allergic to sildenafil or any of the other ingredients of
- if you are taking medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medications are often given to relieve angina (or angina pectoris ). Orisild may cause a severe increase in the effect of these medicines. Tell your doctor if you are taking any of these medicines. If you are not sure, ask your doctor or pharmacist.
- 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 Orisild have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are unsure talk to your doctor.
- if you have recently had a stroke , heart attack, severe liver disease or very low blood pressure (<90/50 mmHg)
- if you are taking medicines containing ketoconazole or itraconazole to treat fungal infections or medicines containing ritonavir (for HIV )
- if you have ever before lost your sight due to a problem with the blood flow to the nerve in the eye called non-arteritic anterior ischemic optic infarction / neuropathy (NAION).
Take special care with Orisild
Talk to your doctor before taking Orisild if you:
- have a disease due to a blocked or narrowed vein in the lung, rather than a blocked or narrowed artery
- have severe heart problems
- have problems with the chambers of the heart
- have high blood pressure in the blood vessels of the lungs
- have low blood pressure at rest
- loses a large amount of body fluids ( dehydration ) which can occur if you sweat a lot or do not drink enough fluid. This can happen if you are sick with fever, vomiting or diarrhea.
- have a rare inherited eye disease ( retinitis pigmentosa )
- have abnormal red blood cells (sickle cell anemia), blood cell cancer ( leukemia ), bone marrow cancer (multiple myeloma ), any disease of the penis or deformed penis
- right now have stomach ulcers or a bleeding disorder (such as hemophilia ) or problems with nosebleeds
- uses drugs for erectile dysfunction .
When used to treat male erectile dysfunction (ED), the following side effects on vision have been reported with PDE5 inhibitors, including sildenafil, at an unknown frequency: partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes.
If you experience sudden visual impairment or loss of vision, stop taking Orisild and contact your doctor immediately (see also section 4).
Prolonged and sometimes painful erections have been reported in men after using sildenafil. If you get an erection that lasts longer than 4 hours, stop taking Orisild and contact your doctor immediately (see also section 4).
Especially to take into account for patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Orisild should not be given to children under 1 year of age.
Other medicines and Orisild
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- drugs containing nitrates, or nitric oxide donors such as amyl nitrite. These medicines are often given to relieve angina pectoris or angina (see section 2. Before you take Orisild).
- tell your doctor or pharmacist if you are already taking riociguat
- treatment for pulmonary hypertension (eg bosentan , iloprost)
- medicines containing St. John ‘s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy )
- blood-thinning drugs (eg warfarin ) even if they did not show any side effects
- medicines containing erythromycin, clarithromycin, telithromycin ( antibiotics for the treatment of specific bacterial infections ), saquinavir (for the treatment of HIV ) or nefazodone (for depression), as your dose may need to be adjusted
- alpha-receptor blockers (eg doxazosin ) for the treatment of high blood pressure or prostate problems, as the combination of the two drugs can cause symptoms that lead to a decrease in your blood pressure (eg dizziness and dizziness).
Intake of Orisild with food and drink
You should not drink grapefruit juice while you are being treated with Orisild.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Orisild should be used during pregnancy only when needed.
Orisild should not be given to women of childbearing potential unless appropriate contraception is used.
Orisild passes into breast milk in very small amounts and is not expected to harm the baby.
Driving and using machines
Orisild can cause dizziness and affect vision. You should be aware of how you react to the medicine 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. 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.
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
HOW TO USE ORISILD
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For adults, the recommended dose is one 20 mg three times daily (taken at 6 to 8-hour intervals) with or without food.
Use in children and adolescents
For children and adolescents between 1 year and 17 years of age, the recommended dose is either 10 mg three times daily for children and adolescents weighing 20 kg or less, or 20 mg three times daily for children and adolescents weighing more than 20 kg. Taken with or without food. Higher doses should not be used in children. This medicine should only be used when administering 20 mg 3 times daily. Other forms of medicine are more suitable for the treatment of patients weighing less than 20 kg, as well as for younger patients who can not swallow tablets.
If you use more Orisild than you should
Do not take more medicines than your doctor tells you to do. 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. Taking more Orisild than you should increase the risk of known side effects.
If you forget to take Orisild
If you forget to take Orisild, take a dose as soon as you remember. Then continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop using Orisild
Sudden discontinuation of Orisild treatment may make your symptoms worse. Do not stop taking Orisild unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping completely.
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.
If you experience any of the following side effects, stop taking Orisild and contact your doctor immediately (see also section 2):
- if you experience a sudden deterioration or loss of vision (no known frequency).
- if you have an erection that lasts longer than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (no known frequency).
The side effects reported as very common ( may affect more than 1 in 10 people ) were: headache, flushing, digestive problems, diarrhea, and pain in the arms and legs.
Side effects that were reported as common ( may affect up to 1 in 10 people ) were: subcutaneous infection, flu-like symptoms, sinusitis, decreased red blood cell count ( anemia ), fluid retention in the body, difficulty sleeping, anxiety, migraines, tremors, numbness and tingling, burning sensation, decreased sensitivity of the skin, bleeding in the back of the eye, effects on vision, blurred vision and light shading, effect on color vision, eye irritation, bloodshot eyes / red eyes, dizziness, tracheal cataracts, nosebleeds, runny nose, cough, nasal congestion, stomach intestinal inflammation, heartburn, hemorrhoids, distended abdomen, dry mouth, hair loss, reddening of the skin, night sweats, muscle aches, back pain, and increased body temperature.
Side effects that were reported as uncommon ( may affect up to 1 in 100 people ) were: decreased visual acuity, double vision, abnormal sensation in the eyes, bleeding in the penis, presence of blood in semen and/or urine, and breast enlargement in men.
Skin rash and sudden loss or loss of hearing and decreased blood pressure have also been reported with an unknown frequency ( occurring in an unknown number of users ).
Children and young people
The following serious side effects have been reported commonly ( may affect up to 1 in 10 people ): pneumonia, heart failure, right ventricular failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory tract infection, tracheal inflammation, gastrointestinal and intestinal viral infection caries.
The following serious side effects were considered treatment-related and have been reported as uncommon ( may affect up to 1 in 100 people ): allergic reactions (such as rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing), convulsions, irregular heartbeat, hearing loss, shortness of breath, inflammation of the stomach and intestines, wheezing due to obstructed airflow.
Side effects reported as very common ( may affect more than 1 in 10 people ) were: headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.
Side effects reported as common ( may affect up to 1 in 10 people ) were: nausea, increased erection, pneumonia, and runny nose.
HOW TO STORE ORISILD
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. 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.
The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (in the form of citrate).
Other ingredients are:
- Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, hypromellose, sodium stearyl fumarate.
- Film coating: hypromellose 2910, titanium dioxide (E171) and triacetin.
What the medicine looks like and contents of the pack
White to off-white, round, 6.8 mm in diameter, biconvex film-coated tablets marked with “85” on one side and smooth on the other side.
The tablets are supplied in blister packs containing 10, 90, or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation Orion Pharma
Orion Corporation Orion Pharma
For further information on this medicine, please contact your local doctor