FOZIKARD PLUS 20 mg. / 12.5 mg. 30 tablets

WHAT FOZIKARD PLUS AND WHAT IT IS USED
Fozikard Plus is a combined product containing antihypertensive Pharmacovigilance Staril - angiotensin converting enzyme inhibitors and hydrochlorothiazide - a thiazide diuretic. Both components are acting alone and in combination exhibit mutually potentiated antihypertensive effect.
Fozikard Plus is used to treat arterial hypertension, when not adequately control blood pressure in treatment with fosinopril and / or in patients who achieved stabilization of blood pressure with various drugs given at the same doses.

WHAT YOU NEED TO KNOW BEFORE FOZIKARD PLUS
Shall not apply to:
- Hypersensitivity to the active substances or to any of the excipients included in the product, as well as other sulfonamides
- History of angioneurotic edema obtained by prior therapy with an ACE inhibitor or patients with congenital or idiopathic angioedema
- anuria
- Pregnancy and lactation
- children

In the application of this product, please note the following:
hypotension
Patients may develop symptomatic hypotension. This is rarely seen in uncomplicated hypertension, but is more common in disturbed water-electrolyte balance - reduced circulating volume, hyponatremia, hypochloraemic alkalosis, hypomagnesemia Ilia hypokalemia which may be caused by prior diuretic therapy, diet restriction Salk or from prolonged vomiting or disorder.
Preceding diuretic therapy should be discontinued for 2-3 days prior to treatment and need periodic monitoring of serum electrolytes.
In patients at increased risk of symptomatic hypotension, the initial period of treatment and dose adjustment should be done under medical supervision. Particular attention should be given to patients with cerebrovascular disease or ischemic heart disease because the strong reduction of blood pressure can cause ischemic brain accidents or myocardial infarction. If an hypotensive symptoms, the patient should be placed in the supine position and, if necessary to make infusions of saline.
Transient hypotensive response is not a contraindication to further treatment, temporarily may need a separate application of ingredients in the proper dose.
As with other vasodilators products, fosinopril should be used with caution in patients following heart disease - aortic stenosis and hypertrophic cardiomyopathy.
Assessment of renal function: Before initiation of therapy with Fozikard Plus must assess renal function of the patient and it is monitored regularly during treatment
Impaired renal function:
Thiazide diuretics are not particularly suitable for treatment of patients with renal impairment and are ineffective in moderate and severe renal insufficiency.
Fozikard Plus should not be administered to patients with renal insufficiency, while gradually increasing the dose of individual components demonstrates the benefit of the combination.
In some hypertensive patients without established pre-existing renal function can be slight and transient increase in serum urea and creatinine when fosinopril is given concomitantly with a diuretic. If it is determined such an increase in treatment Fozikard Plus, he should be suspended. Therapy may continue to acceptance of the individual components alone in an appropriate dose.
Liver disease:
Patients with hepatic impairment may have increased levels of fosinopril due to impaired digestion. Rarely, treatment with ACE inhibitors may occur debilitating impairment of liver function. In establishing jaundice or significant display of liver enzymes during treatment with Fozikard Plus, his administration should be discontinued.
Thiazide diuretics should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor changes in vodnoelektrolitnoto balance may precipitate hepatic coma.
surgery:
Patients subject to major surgery or during anesthesia with drugs leading to lowering of blood pressure, fosinopril can enhance hypotension symptoms, which can be corrected with an increase in volume.
Metabolic and endocrine changes:
Treatment with thiazide diuretics may increase blood glucose in diabetes mellitus available. This may require dose adjustment of glucose-lowering drugs, including insulin.
Thiazides may cause slight transient increase in serum calcium.
Treatment with thiazide diuretics can cause elevated levels of cholesterol and triglycerides.
Thiazide therapy may cause hyperuricemia and gout aggravation of existing
Hypersensitivity / antionevrotichen edema
Swelling of the face, extremities, lips, tongue and / or throat have been reported rarely in patients treated with ACE inhibitors, including fosinopril. In this case, the application of Fozikard Plus should be discontinued immediately and provide appropriate therapy and patient monitoring until complete and sustained resolution of symptoms.
Angioedema combined with swelling of the throat and vocal cords, can be fatal. When it is accompanied by airway obstruction, should immediately conduct appropriate therapy, for example. subcutaneous administration of adrenaline and / or to take the necessary measures to release the airways. The patient must remain under strict medical supervision until there is complete resolution of symptoms.
Patients with a history of prior angioedema unrelated to ACE inhibitors may be at increased risk of such therapy with an ACE inhibitor.
Upon treatment with diuretics, patients with underlying bronchial asthma may exhibit hypersensitivity reactions, as well as exacerbation or onset of systemic lupus erythematosus
Race:
Black patients are at higher risk of angioedema with ACE inhibitors.
Patients on hemodialysis:
The application of Fozikard Plus hemodialysis patients is not recommended due to existing renal insufficiency.
There have been reports of anaphylactoid reactions in hemodialysis patients treated concomitantly with ACE inhibitors. During treatment with Fozikard Plus is not recommended during haemofiltration and hemodialysis high flux membranes. In such patients should be considered for use on another type of dialysis membrane or antihypertensive drug from another class.
Changes in blood
Bone marrow suppression were observed rarely in uncomplicated patients but are more common in patients with impaired renal function, particularly in those with systemic connective tissue disease or immunosuppressive therapy. It is therefore necessary periodic monitoring of white blood cell counts in these patients. These events are transient in nature and disappear after cessation of therapy.
cough
Upon treatment with ACE inhibitors may be seen the advent of cough. Typical of it is that it is dry, long and disappears after discontinuation of treatment
Use pre children:
No studies on efficacy and safety in children

pregnancy
Before taking any medicine, consult a doctor. The application of Fozikard Plus is contraindicated during pregnancy and it should be terminated if it is suspected.
breastfeeding
Fizinopril and hydrochlorothiazide passes into breast milk. Due to the potential risk of serious harm to the infant must decide or discontinue breast-feeding or discontinuation of therapy with Fozikard Plus.

Driving and using machines:
At the beginning of treatment may be a temporary occurrence of fatigue and dizziness, which affect the ability to drive and use machines.
Important information about some of the ingredients:
This medicinal product contains lactose as an excipient, which makes it unsuitable for patients with lactase intolerance.

HOW TO TAKE FOZIKARD PLUS
Adults:
The daily dose is one tablet once per day.
Patients with renal insufficiency:
Not suitable as initial therapy in patients with renal insufficiency. If such patients pending the realization of a treatment with this combination, it must first determine the degree of renal failure and start initial treatment with fosinopril under strict control of serum urea and creatinine.
Fozikard Plus can be used in patients with a creatinine kliryns between 30 and 80 ml / min, but only after prior determination the dosage of the individual components.
Thiazides are not particularly suitable for diuretic therapy in patients with compromised renal function and are ineffective at creatinine clearance values lower than 30 ml / min.
children:
This product is not recommended for children. In nyah safety and efficacy have not been established.
Tablets should be taken with enough water regardless of food intake, preferably in the morning.

POSSIBLE SIDE EFFECTS
General:
Anaphylactoid reactions, chest discomfort, fever, flushing, malaise, fatigue
Cardiovascular:
In high-risk patients with a salt deficit and / or dehydration, and also in patients with heart failure, severe or renal fipertoniya may occur hypotension or orthostatic, especially early in treatment.
Respiratory system:
Dry irritating cough, swelling of the nasal mucosa, sinusitis, bronchitis, shortness of breath, rarely bronchospasm.
Gastrointestinal:
Dry mouth, nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, loss of appetite.
Genitourinary:
In separate cases, the occurrence of oliguria, proteinuria, progressive urea increased, interstitial nephritis, acute renal failure.
Hypersensitivity / angioneurotic edema:
Angioneurotic edema in the extremities, face, lips, tongue, throat and / or larynx occurs very rarely.
skin:
Rash, urticaria, pruritus, photosensitivity and severe skin reactions.
Hematologic:
Rarely observed bone marrow suppression, manifested by a reduced number of cells of different cell lines. There are rare reports of agranulocytosis, although no causal relationship.
Neurological / Psychiatric:
Dizziness, svetovartuzh, headache, fatigue, depression, drowsiness, insomnia, nervousness, mental confusion, impaired vision, ringing in the ears, decreased libido.