VAZOPREN table. 5 mg. 28 tablets
VAZOPREN table. 5 mg. 28 tablets
VAZOPREN WHAT IS AND WHAT IT IS USED FOR ?
Vazopren contains active substance enalaprilov maleate, which relates to the antihypertensive ( blood pressure lowering ) drugs called angiotensin converting enzyme ( ACE) inhibitors . The drugs in this group inhibit the activity of this enzyme , resulting in decreased blood pressure , improves the overall activity of the cardiovascular system . Vazopren is used to treat hypertension (high blood pressure ), congestive heart insufficiency (weakness of the heart function ) , in violation of the function of the left ventricle .
2 . BEFORE YOU TAKE VAZOPREN
Do not take Vazopren :
if you are allergic (hypersensitive ) to the active substance or to any of the ingredients of the product;
if the previous treatment with ACE the inhibitory you experience an allergic reaction such as swelling of the face , lips , tongue and / or throat with difficulty in breathing and swallowing ;
if you had any hypersensitivity reactions of unknown cause or if Bit is diagnosed with hereditary or idiopathic angioedema ;
the last six months of pregnancy ( Vazopren use is not recommended in the first trimester of pregnancy - see section "Pregnancy and lactation " ) .
Take special care with Vazopren
Before starting treatment with Vazopren tell your doctor :
- If there is a risk of excessive fall in blood pressure due to impaired water-salt balance , e. treatment with diuretics ( water tablets ) , diet , limiting salt or as a result of vomiting or diarrhea ;
- If you have a narrowing of the aorta (aortic stenosis), renal artery or increased thickness of the heart muscle ( hypertrophic myocardiopathy ) if you have a heart problem , liver or kidney problems , if you have recently had a kidney transplant ;
- If you have previously experienced an allergic reaction with swelling of the face , lips and tongue with difficulty in swallowing or breathing ;
- If you have a disease of the immune system , diabetes, an all - infectious inflammatory diseases ( sore throat , fever and the like . )
- If you are being treated with allopurinol , procainamide , or potassium- sparing diuretics, potassium supplements , potassium-containing salts and other drugs associated with increases in serum potassium levels ;
- Before surgery or anesthesia , tell your doctor that you are taking enalapril, as you may have seen a sharp drop in blood pressure;
- If you are desensitization treatment against insect venom ( bee or wasp ) . Desensitization treatment can sometimes increase the risk of anaphylactoid reactions when co-administered with ACE inhibitors;
- If you are receiving treatment called LDL- apheresis with dextran sulfate ( purification of low-density lipoproteins from the blood high cholesterol ) ;
- If hemodialysis with high-flux membranes ( polyacrylonitrile ), if you think you are (or might become) pregnant . Vazopren use is not recommended during the first three months of pregnancy. The product should not be used after the third month of pregnancy , since administration in this period can cause serious harm to your baby ( see below section "Pregnancy and lactation " ) .
If during treatment with Vazopren show any of these symptoms , tell your doctor :
- Jaundice ( yellowing of the skin and whites of the eyes ), persistent dry irritating cough . Use of this drug requires regular monitoring by your doctor. Therefore, you must follow the laboratory studies and surveys that your doctor has appointed .
There is limited experience of the use of Vazopren in children over 6 years of age with hypertension. No data available for use in other indications. The use of the drug is not recommended in neonates and in children with reduced renal function.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines , including medicines obtained without a prescription such as diuretics ( water pills ) such as furosemide ;
potassium-sparing diuretics such as spironolactone, triamterene, or amiloride , potassium preparations and potassium-containing salt substitutes ;
medicines to treat cardiovascular diseases such as drugs that lower blood pressure, nitroglycerin and other nitrates, or other drugs to dilate blood vessels ( vasodilators ) , procainamide , digoxin ;
anti-inflammatory drugs ( indomethacin, diclofenac and others. ) drugs for treatment of gout ( allopurinol) , probenecid ;
drugs for the treatment of low blood pressure, shock , asthma , allergies such as noradretsalin , adrenaline , systemic corticosteroids , lithium salts ;
drugs that suppress the immune system ( immunosuppressants ), antidiabetic agents , medications for depression such as amitriptyline ;
antacids (for excess acid in the stomach) ;
Aspirin ( acetylsalicylic acid - in cardiac doses) , thrombolytics ( drugs to break down blood clots) and beta- blockers ( medicines for the treatment of certain heart conditions) may be applied simultaneously with Vazopren .
Taking Vazopren with food and drink
During treatment with Vazopren not recommended due to alcohol as enhancing the effect of the drug.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Vazopren use is not recommended during the first three months of pregnancy. If you are pregnant , planning to become pregnant or suspect that you are pregnant , please consult with your doctor to change your treatment .
Vazopren should not be used during the last six months of pregnancy because it may cause serious harm to your baby.
Vazopren use is not recommended by mothers of premature infants , and during the first few weeks after birth .
In older infants use Vazopren the mother may be considered , where appropriate, in tracking child for adverse reactions.
Driving and using machines
Vazopren can cause hypotension ( blood pressure lowering ) in some patients , especially early in treatment , which must be taken into account when driving or operating machinery.
3 . HOW TO TAKE VAZOPREN ?
Always take Vazopren exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Vazopren taken orally 1 or 2 times per day before, during or after meals. Hypertension (high blood pressure ) : The recommended starting dose is 10 mg to 20 mg a day depending on the degree of hypertension. In mild hypertension , the recommended starting dose is 10 mg of 1 or 2 times daily. Some patients may need a lower starting dose. For other degrees of hypertension starting dose is 20 mg daily. The usual maintenance dose is 20 mg of 1 or 2 times daily.
Heart failure: Generally the recommended starting dose is 2,5 mg once daily. The dose should be increased gradually depending on the individual response to a regular maintenance dose of 20 mg, taken once or in 2 divided doses .
Patients with impaired renal function
Your doctor will decide the dose depending on the degree of disability. Hypertensive children
There is limited clinical trial experience of the use of enalapril in hypertensive children . For children who can not swallow tablets , the dose should be individualized . The recommended starting dose is 2,5 mg once daily in patients weighing 20 to 50 kg and 5 mg once daily in patients weighing over 50 kg.
If you take more dose Vazopren
In cases of administration of very high doses may occur dizziness due to a sharp drop in blood pressure. Tell your doctor immediately or contact your nearest emergency room.
If you forget to take Vazopren
If you miss a dose, take it as soon as possible . If almost time for your next dose , take it as usual. Do not take a double dose to make up for a missed dose. Continue taking your medicine as prescribed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Vazopren can cause side effects, although not everybody gets them . Vazopren usually well tolerated.
You may experience the following side effects:
It is vital to stop taking Vazopren and seek immediate medical attention if you experience any of the following symptoms:
- Allergic reaction - itching, difficulty breathing, hoarseness, swelling of the hands , mouth , throat, face.
Stop taking Vazopren and tell your doctor if you experience any of these side effects:
- Severe dizziness , lightheadedness , especially early in treatment , increasing the dose or upon standing , severe redness , blistering of the skin to peel off the skin.
Other possible side effects:
Very common (affects more than 1 in 10 people)
blurred vision, cough, nausea , asthenia ( weakness). Common ( affects less than 1 in 10 people)
headaches, depression , low blood pressure , fainting , chest pain, changes in heart rate , pain behind the breastbone , rapid heartbeat , shortness of breath ;
changes in taste , abdominal pain, diarrhea , edema, affecting different parts of the body , fatigue ;
rash, hypersensitivity reactions hypersensitivity / angioneurotic edema : swelling of the face , extremities, lips, tongue , glottis and / or larynx ;
potassium and increase in serum creatinine . Uncommon (affects less than 1 in 100 people)
anemia ( reduction in red blood cells, which can lead to pallor , weakness or shortness of breath ) , hypoglycemia ( low blood sugar) , confusion, drowsiness , insomnia , nervousness, numbness in the fingers of the extremities , dizziness ;
orthostatic hypotension ( drop in blood pressure , especially when you stand from a lying or sitting position, causing dizziness, light-headedness or fainting) , feeling unusually rapid or irregular heartbeat, myocardial infarction or cerebrovascular accident ( in high-risk patients) ;
runny nose , sore throat and hoarseness, bronchospasm ;
dry mouth , indigestion, anorexia, gastric irritation , vomiting , constipation, pancreatitis ( inflammation of the pancreas ) , sudden severe abdominal pain, ulcers, increased sweating , pruritus, urticaria, alopecia ( hair loss , most often the head ) , proteinuria ( presence of protein in the urine) , impaired renal function , renal failure ;
impotence , muscle cramps, flushing, tinnitus , malaise, increased body temperature , myalgia (muscle pain ), hyponatremia (decreased sodium ), a rise in blood urea .
Rare (affects less than 1 in 1000 people) sleep disorder , abnormal dreams ;
decreases in hemoglobin, hematocrit , leukopenia (decreased numbers of white blood cells , increasing the likelihood of infection ) , neutropenia, agranulocytosis ( a strong decrease in the number of white blood cells , increasing the likelihood of infection ), thrombocytopenia (decreased numbers of platelets , which increases risk of bleeding or bruising ) , pancytopenia (severe reduction in the number of blood cells that can cause weakness , bruising or increased likelihood of infection ) , bone marrow suppression , lymphadenopathy ( swollen lymph units ) , autoimmune diseases ;
elevated serum bilirubin, elevated liver enzymes , hypoglycaemia ( very low blood sugar) ;
reduced blood flow in the limbs due to vasospasm ( Raynaud's syndrome ) affects the lungs ( pulmonary infiltrates ) , allergic inflammation of the lungs ( allergic alveolitis / eosinophilic pneumonia ) ;
inflammation of the oral mucosa with ulcers (stomatitis / aphthous ulcers ), inflammation of the tongue ( glossitis ) , decreased urine output ( oliguria ) ;
liver failure , jaundice, inflammation of the liver (hepatitis ), erythema multiforme, incl. Stevens -Johnson syndrome ( a severe illness accompanied by blistering of the skin, mouth, eyes and genitals ) , exfoliative dermatitis , toxic epidermal necrolysis (severe illness accompanied by blistering of the skin), purpura ( multiple small hemorrhages skin and mucous membranes ) , cutaneous lupus erythematosus, bullous pemphigus ( a disease characterized by blistering of the skin and mucous membranes , which are easily cleaved to form a painful erosions ) , erythroderma ( abnormal redness of the skin) ;
gynecomastia ( breast enlargement in men ) . Very rare (occurring in more than 1 out of 10 000 people )
Intestinal angioedema (swelling of the intestinal mucosa) . Other ( not known )
syndrome of inappropriate antidiuretic hormone.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE VAZOPREN ?
Store in original container in a dry and dark place at
temperature below 25 ° C.
Keep out of reach of children.
Vazopren not use after the expiry date stated on the pack . The expiry date refers to the last day of that 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.
6 . ADDITIONAL INFORMATION
What does Vazopren ?
The active substance is enalaprilov maleate 5 mg, 10 mg or 20 mg per tablet . The other ingredients are mannitol , microcrystalline cellulose , hydroxypropylcellulose , sodium bicarbonate , sodium starch glycolate , silica, colloidal anhydrous ;
magnesium stearate , red iron oxide ( 10 mg tablets and 20 mg), yellow iron oxide ( tablet 20 mg), talc .
Vazopren looks like and contents of the pack ?
Tablets 5 mg: round, flat tablets with white , with bilateral facet and scored on one side , diameter of 6 mm.
Tablets 10 mg: round, flat tablets with a light pink color mosaic with bilateral facet and scored on one side , diameter of 7 mm.
Tablets 20 mg: round, flat tablets with a beige color, with bilateral facet and scored on one side and a diameter of 8 mm.