Ofnifenil belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. You may have been prescribed it to reduce high blood pressure (hypertension), or to prevent (or treat) heart failure. Heart failure is a condition where your heart does not work as well as it should.
Before taking Ofnifenil
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking Ofnifenil it is important that your doctor knows:
- If you are pregnant or breastfeeding.
- If you have any problems with the way your k >
Before taking Ofnifenil,
- tell your doctor and pharmacist if you are allergic to Ofnifenil; other ACE inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), fosinopril (Monopril), lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); any other medications; or any ingredients in Ofnifenil tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor or pharmacist if you are taking valsartan and sacubitril (Entresto) or if you have stopped taking it within the last 36 hours. Your doctor will probably tell you not to take Ofnifenil, if you are also taking valsartan and sacubitril. Also, tell your doctor if you have diabetes and you are taking aliskiren (Tekturna, in Amturnide, in Tekamlo, in Tekturna HCT). Your doctor will probably tell you not to take Ofnifenil if you have diabetes and you are also taking aliskiren.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin (Indocin, Tivorbex); diuretics ('water pills'); lithium (Lithobid); and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had heart or kidney disease; lupus; scleroderma (a condition in which extra tissue grows on the skin and some organs); diabetes; or angioedema (a condition that causes difficulty swallowing or breathing and painful swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs).
- tell your doctor if you are breastfeeding.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Ofnifenil.
- you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting.
2. Key facts
- Ofnifenil lowers your blood pressure and makes it easier for your heart to pump blood around your body.
- Your first dose of Ofnifenil may make you feel dizzy, so it's best to take it at bedtime. After that, if you don't feel dizzy, you can take it at any time of day.
- Some people get a dry, irritating cough with Ofnifenil.
- If you get severe diarrhoea or vomiting from a stomach bug or illness, tell your doctor. You may need to stop taking Ofnifenil for a while until you feel better.
- Drinking alcohol with Ofnifenil can make you feel dizzy or light-eaded.
- Ofnifenil is also called by the brand name Innovace. When it's mixed with hydrochlorothiazide, its brand name is Innozide.
As with all vasodilators, Ofnifenil should be given with caution to patients with obstruction in the outflow tract of the left ventricle.
Do not use Ofnifenil if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.
You should not use Ofnifenil if you have ever had angioedema. Do not take Ofnifenil within 36 hours before or after taking any medicine that contains sacubatril (such as Entresto).
If you have diabetes, do not use Ofnifenil together with any medication that contains aliskiren (such as Tekturna or Tekamlo).
Ofnifenil can affect your heart or your electrolyte levels. Call your doctor if you have chest pain, pounding heartbeats or fluttering in your chest, a slow heart rate or weak pulse, a tingly feeling, muscle weakness, or muscle tightness or contraction.
Before taking Ofnifenil, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as benazepril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), high level of potassium in the blood.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
Older adults may be more sensitive to the side effects of this drug, including dizziness and increases in potassium level.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)
This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Immediate action required: Call 999 or go to A&E if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you're wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
These are not all the side effects of Ofnifenil. For a full list see the leaflet inside your medicines packet.
You can report any suspected side effect to the UK safety scheme.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
There was no evidence of a tumorigenic effect when Ofnifenil was administered for 106 weeks to male and female rats at doses up to 90 mg/kg/day or for 94 weeks to male and female mice at doses up to 90 and 180 mg/kg/day, respectively. These doses are 26 times (in rats and female mice) and 13 times (in male mice) the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis.
Neither Ofnifenil maleate nor the active diacid was mutagenic in the Ames microbial mutagen test with or without metabolic activation. Ofnifenil was also negative in the following genotoxicity studies: rec-assay, reverse mutation assay with E. coli, sister chromatid exchange with cultured mammalian cells, and the micronucleus test with mice, as well as in an in vivo cytogenic study using mouse bone marrow.
There were no adverse effects on reproductive performance of male and female rats treated with up to 90 mg/kg/day of Ofnifenil (26 times the MRHDD when compared on a body surface area basis).
Conversion from intravenous (IV) to oral dosage form
If not concurrently receiving diuretics, initiate Ofnifenil 5 mg orally once/day; if concurrently receiving diuretics and responding to 0.625 mg IV every 6 hours, initiate at 2.5 mg orally once/day; titrate upwards as necessary
¿Qué otras drogas afectarán a Ofnifenil?
Dígale a su médico acerca de todas las medicinas que usted esté usando, comience a usar, o deje de usar durante su tratamiento con Ofnifenil, especialmente:
- un diurético o "pastilla para eliminar el agua";
- inyecciones de oro para el tratamiento de la artritis; o
- antiinflamatorios no esteroides (AINE, NSAID por sus siglas en inglés) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, y otras.
Esta lista no está completa. Otras drogas pueden interactuar con Ofnifenil, incluyendo medicinas que se obtienen con o sin receta, vitaminas, y productos herbarios. No todas las interacciones posibles aparecen en esta guía del medicamento.
Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in either hypertension or congestive heart failure patients treated with VASOTEC but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia. Hemolytic anemia, including cases of hemolysis in patients with G6PD deficiency, has been reported; a causal relationship to Ofnifenil cannot be excluded.
How much to take
The dose of Ofnifenil you take depends on why you need the medicine. Take it as your doctor tells you to.
To decide the correct dose for you, your doctor will check your blood pressure and ask you if you are getting any side effects. You may also have blood tests to check how well your kidneys are working and the amount of potassium in your blood.
Depending on why you're taking Ofnifenil, the usual starting dose is between 2.5mg and 20mg once a day. This will be increased gradually over a few weeks to a usual dose of:
- 20mg once a day for high blood pressure
- 10mg once a day or 20mg once a day for heart failure
The maximum dose is 20mg twice a day.
Doses are usually lower for children or people with kidney problems.