RENOVIA ACE. 10 mg. 10 mg. 28 tablets
RENOVIA ACE. 10 mg. / 10 mg. 28 tablets
WHAT RENOVIA ACE AND WHAT IT IS USED
Renovia Ace is a fixed combination of an ACE inhibitor ( enalapril) and a calcium channel blocker ( lercanidipine ), two drugs that lower blood pressure.
Renovia Ace is used to treat high blood pressure ( hypertension) in patients whose blood pressure is not adequately controlled with lercanidipine 10 mg. Renovia Ace should not be used for initial treatment of hypertension.
2 . BEFORE YOU TAKE RENOVIA ACE
Do not take Renovia Ace :
if you are allergic to pharmacologically active substances ( lercanidipine or enalapril ) or any of the other ingredients of the tablets Renovia Ace ;
if you are allergic to drugs which are similar to Renovia Ace (eg amlodipine , felodipine , nifedipine , captopril, fosinopril, lisinopril , ramipril ) ;
if you are pregnant after 3 months (it is also to be avoided Renovia Ace in early pregnancy - see section "Pregnancy " ) ;
if you suffer from certain heart diseases :
untreated congestive heart failure;
obstruction of the flow of blood from the left ventricle of the heart , including the constriction of the aorta (aortic stenosis ) ;
unstable angina ( angina at rest or progressively increasing angina ) ;
within one month after it had suffered a heart attack (myocardial infarction) ;
if you have severe liver or kidney problems or if you are on dialysis ;
if you take medicines such as :
antifungals (eg, ketoconazole , itraconazole ) ;
macrolide antibiotics (e.g. erythromycin, troleandomycin ) ;
antivirals (eg, ritonavir) ;
if both a medicine known as cyclosporine (cyclosporin or ciclosporin);
with grapefruit or grapefruit juice ;
if you have ever had angioedema (swelling of face, lips, tongue and / or larynx , arms and legs) , hereditary or following previous treatment with an ACE inhibitor;
if you have a hereditary tendency to swelling of the tissues or tissue if you develop swelling of unknown cause (hereditary or idiopathic angioedema) .
Take special care with Renovia Ace
Please tell your doctor or pharmacist :
if you suffer from heart disease, including the interruption of blood flow ( ischemia ) ;
if you suffer from circulation disorder of the brain ( cerebrovascular disease ) ;
if you have kidney problems;
if your liver enzymes increase and develop jaundice
If your white blood cells are reduced in different degrees ( leukopenia , agranulocytosis ), which may lead to susceptibility to infections and severe general symptoms ;
if you suffer from certain diseases of the connective tissue with involvement of blood vessels ( collagen vascular diseases) ;
at the same time taking allopurinol ( gout medicine ) , procainamide (a medicine used for the management of abnormal heart rhythm ) or lithium (a medicine used for controlling certain types of depression) ;
If a hypersensitivity reaction or swelling of tissues (angioedema) during treatment with Renovia Ace ;
if you suffer from diabetes ;
if you develop a persistent cough ;
if you are in danger of raising the level of potassium in the blood ;
if the reduction of blood pressure is inadequate due to your ethnic origin (especially in black patients ) ;
If you think you are (or might become ) pregnant Renovia Ace is not recommended in early pregnancy, and must not be taken if you are pregnant after 3 months , as it may cause serious harm to your baby if used during this period (see section " Pregnancy " ) .
If you need desensitisation therapy against insect venom (eg bee or wasp ) Renovia Ace should be temporarily replaced by appropriate drug from another species. Otherwise can develop life-threatening joint activities . Such reactions may occur after insect bites (eg stinging bee or wasp ) .
The use of Renovia Ace during dialysis or treatment for highly elevated blood lipid levels can lead to severe hypersensitivity reactions and even life-threatening shock .
Please tell your doctor that you have received Renovia Ace or you need dialysis , so the doctor can take this into account when prescribing treatment.
If you must soon undergo surgery or anesthesia (including dental anesthetic ) , please tell your doctor that you are taking Renovia ACE as may occur a sharp drop in blood pressure during anesthesia.
Tell your doctor immediately if you develop any of these signs or symptoms:
swelling of the face , extremities, lips , mucous membranes , tongue and / or larynx or shortness of breath ;
yellowing of the skin and mucous membranes ;
fever, swollen lymph nodes and / or sore throat .
In such cases, you should stop taking Renovia Ace and your doctor will take appropriate measures.
Safety and efficacy of Renovia Ase not been established in controlled studies in children.
The use of this drug requires regular medical supervision. Therefore , please rest assured that you are doing any laboratory tests and examinations that the doctor appointments.
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.
When Renovia Ace is taken with certain other drugs , the effects of Renovia Ace or the other medicine may be strengthened or weakened , or some side effects may occur more frequently.
The effect of lowering blood pressure can be increased if you take the following medicines with Renovia Ace :
ciclosporin (a medicine that suppresses the immune system) ;
oral antifungal agents such as ketoconazole and itraconazole ;
antivirals such as ritonavir ;
macrolide antibiotics such as erythromycin or troleandomycin ;
anti-ulcer drugs cimetidine at daily doses above 800 mg;
diuretics such as hydrochlorothiazide , chlorthalidone , furosemide , triamterene , amiloride, indapamide , spironolactone or other blood pressure lowering drugs ;
some vasodilating agents such as glyceryl trinitrate and organic nitrates ( isosorbide ), or anesthetic agents ;
Some antidepressants and antipsychotic drugs ;
The effect of lowering blood pressure may be diminished if you take the following medicines with Renovia Ace :
some analgesics (e.g., acetaminophen , ibuprofen , naproxen , indomethacin, aspirin , or unless it is used in low dose) ;
drugs that act on the blood vessels (e.g., norepinephrine, isoprenaline, dopamine, salbutamol ) ;
anticonvulsants such as phenytoin and carbamazepine ;
rifampicin (a medicine used to treat tuberculosis ) .
If you are using digoxin (a medicine that affects the tone of the heart muscle) , ask your doctor about what signs to follow.
If you use potassium -sparing diuretics ( spironolactone) or potassium supplements, potassium level in the blood can increase.
Concomitant use of lithium carbonate and Renovia Ace can lead to lithium toxicity .
If you are taking immunosuppressant drugs or gout may very rarely be susceptible to serious infections.
If you have diabetes , please note that the concomitant use of Renovia Ace and insulin or oral antidiabetic agents such as sulfonylureas and biguanides may lead to hypoglycaemia (too low blood sugar) during the first month of treatment.
Please tell your doctor if you take aitihistaminovi such as terfenadine or astemizole, or antiarrhythmic agents such as amiodarone or quinidine or estramustine or gold , as there may be some drug interactions with these substances.
Taking Renovia Ace with food and drink
Renovia Ace should be taken at least 15 minutes before food.
Alcohol may increase the effects of Renovia Ace . For this reason we recommend or not to consume alcohol or strictly limit alcohol intake .
Pregnancy and lactation
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Renovia Ace before you become pregnant or as soon as you know you are pregnant and will advise you to replace it with another drug . Renovia Ace is not recommended in early pregnancy, and must not be taken if you are pregnant after 3 months , as it may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breastfeeding newborn babies ( first few weeks after birth) , especially premature babies , is not recommended while taking Renovia Ace . In older babies , your doctor should advise you on the benefits and risks of taking Renovia Ace while breastfeeding , compared with other drugs.
Ask your doctor or pharmacist before taking any medicine .
Driving and using machines
In case of dizziness , weakness, fatigue or drowsiness during treatment with this medicine , you should not drive or operate machinery.
Important information about some of the ingredients of Renovia Ace
Renovia Ace contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 . HOW TO TAKE RENOVIA ACE
Always take Renovia Ace exactly as your doctor tells you . If you are unsure , ask your doctor or pharmacist.
The usual dose is one tablet once daily at the same time each day, unless your doctor has appointed another . The tablet should be taken preferably in the morning , at least 15 minutes before breakfast . The tablet should be swallowed whole with water.
The tablets must be administered with grapefruit or grapefruit juice.
If you have the impression that the effect of Renovia Ace is too strong or too weak , please talk to your doctor.
The recommended dose is one tablet once a day, at least 15 minutes before food.
If you take more dose Renovia Ace
If you take more than the prescribed by your doctor or in case of overdose , get medical help immediately and if possible take the tablets the doctor and / or packaging.
The adoption of more than the correct dose can lead to excessive fall in blood pressure and heart beat irregularly or faster. This can cause loss of consciousness.
Furthermore , severe decreases in blood pressure may result in decreased blood flow to vital organs , cardiovascular disease , and kidney failure .
If you forget to take Renovia Ace
If you miss a dose , take the missed dose as soon as possible, unless it is almost time for your next dose . Then continue taking the tablets as usual. Do not take a double dose on the same day.
If you stop taking Renovia Ace
If you stop taking Renovia Ace , your blood pressure may increase again . Please consult with your doctor before you stop taking Renovia Ace .
If you have any further questions on the use of this product , ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Renovia Ace can cause side effects, although not everybody gets them .
The most common side effects ( 1 to 10 % incidence ) observed with Renovia Ace 10 mg/10 mg are cough , dizziness and drowsiness. All adverse events observed with Ase Renovia 10 mg/10 mg, enalapril or only with lercanidipine are listed below .
Frequencies are defined as :
very common ( affects more than 1 in 10 patients) ;
Common ( affects less than 1 in 10 patients) ;
Uncommon ( affects less than 1 in 100 patients) ;
rare ( affects less than 1 in 1000 patients) ;
very rare ( affects less than 1 in 10,000 patients).
Blood and lymphatic system disorders:
Uncommon : anemia ;
Rare: Decrease of some blood cells , reduction of certain laboratory values (hemoglobin and hematocrit) , decreased bone marrow function , swollen lymph nodes , autoimmune diseases.
Uncommon: Extremely low blood sugar.
Very common: Blurred vision .
Very common: Dizziness ;
Common: Headache, depression ;
Uncommon: confusion, drowsiness , insomnia , nervousness, abnormal sensations (such as numbness ) ;
Rare: Changed dreams, sleep disturbances .
Cardiovascular system :
Common: Extremely decrease in blood pressure , including exclusive drop in blood pressure on standing , chest pain, feeling of tightness in the chest, abnormal heart rhythm , increased heart attack or stroke , chest pain, feeling of tightness in the chest, abnormal heart rhythm , increased heart rate ;
Uncommon: ankle swelling , palpitations ;
Rare: cold hands and feet .
Respiratory tract :
Very Common: Cough ;
Common: Shortness of breath ;
Uncommon: runny nose , sore throat and hoarseness, wheezing , asthma ;
Rare: Abnormal changes in lung tissue , runny nose , inflammation of the lung.
Gastrointestinal tract :
Very common: nausea ;
Common: Diarrhoea, abdominal pain , abnormal taste;
Uncommon: Bowel obstruction , inflammation of the pancreas , vomiting, digestive disorders , constipation, loss of appetite, upset stomach , dry mouth , stomach ulcer ;
Rare: Inflammation and ulceration of the lining of the mouth , inflammation of the tongue ;
Very rare: thickening of gums , swelling of the intestines.
Liver and gallbladder :
Rare: Hepatic failure, inflammation of the liver , jaundice ( yellowing of the skin and / or whites of the eyes ) .
Skin and subcutaneous tissue disorders :
Common: flushing, redness and a feeling of warmth , skin rash, swelling of the face , lips, tongue , throat, hands ;
Uncommon : increased sweating , pruritus, urticaria, rash, hair loss ;
Rare: Severe skin reactions.
Described is a complex of symptoms that can be associated with some or all of the following side effects: fever, inflammation of mucosal surfaces , inflammation of blood vessels , muscle and joint pain / muscle and joint inflammation and some changes in laboratory values, and skin rash . May experience sensitivity to light and other skin reactions.
Kidneys and urinary tract
Uncommon: Kidney problems ;
Rare: decreased urine output , increased urine output .
Reproductive system and breast disorders :
Uncommon: impotence ;
Rare: breast enlargement in men.
Very common: Feeling weak ;
Common: Fatigue ;
Uncommon: Muscle cramps , flushing , ringing in the ears, nausea , fever .
Laboratory values :
Common: Increased level of potassium in the blood, increased level of creatinine in the blood ;
Uncommon : increased BUN, decreased level of sodium in the blood ;
Rare: Increased laboratory values ( liver enzymes , serum bilirubin) .
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 RENOVIA ACE
Keep out of reach of children .
Do not use Renovia Ace after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Your tablets Renovia Ace is best stored in the original package to protect from light and moisture. Be stored below 25 ° C.
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 . FURTHER INFORMATION
What does Renovia Ace
The active substances are enalaprilov maleate and lerkanidipinov hydrochloride.
Each tablet contains : 10 mg of enalaprilov maleate (equivalent to 7,64 mg of enalapril ) , and 10 mg lerkanidipinov hydrochloride (equivalent to 9,44 mg of lercanidipine ) .
Other ingredients are :
Core: lactose monohydrate , microcrystalline cellulose , sodium starch glycolate, povidone , sodium hydrogencarbonate, magnesium stearate.
Film coating : hypromellose , titanium dioxide ( E171), talc , macrogol 6000.