RENAPRIL 10 mg. 28 tablets

WHAT RENAPRIL AND WHAT IT IS USED
Renapril is a medicinal product of the so-called. ACE inhibitors. It dilates blood vessels, thereby facilitating the heart to pump blood to all parts of the body. This results in lowering high blood pressure. In patients with heart failure, Renapril helps the heart to function better.

Renapril be used for:
Treatment of hypertension (high blood pressure);
Treatment of symptomatic (overt) heart failure;
Prevention of symptomatic heart failure in asymptomatic patients with impaired function of the left ventricle (ejection fraction <35%).

2. BEFORE YOU USE RENAPRIL
Do not use Renapril:
If you are allergic (hypersensitive) to the active substance or to any of the excipients;
If previous treatment with drugs like Renapril (ACE) inhibitors have received allergic reactions such as swelling of the face, lips, tongue and / or throat with difficulty in breathing and swallowing. You should not take Renapril and if you had these reactions without a known cause or if you have been diagnosed with congenital or idiopathic angioedema;
If you are pregnant more than three months. (It is advisable to avoid use of Renapril and more early pregnancy - see section. Pregnancy and lactation).
Take special care and tell the doctor the use of Renapril.
Before you start taking Renapril, tell your doctor about all your medical problems, as well as any allergies.
Tell the doctor if you have heart disease if you are on dialysis or are being treated with diuretics (drugs that increase the flow of water from the body), if you have recently had a severe and prolonged vomiting or diarrhea. You should tell also whether you are on a diet with restriction of salt, take potassium supplements, potassium-sparing drugs or potassium-containing salt substitutes if you have diabetes or kidney problems (including kidney transplantation), since they can lead to significantly increase the level of potassium in the blood, which can cause serious disturbances in the work of the heart. In these cases, you may need dose adjustment of Renapril or monitoring the level of potassium in the blood.
Tell your doctor if you notice symptoms such as nausea or dizziness, especially when standing up, talking about low blood pressure (orthostatic hypotension).
If you have diabetes or are taking oral antidiabetic drugs or insulin, make sure to monitor the level of glucose in the blood, especially during the first month of treatment with Renapril.
If you have blood disorders, such as decreased number or absence of white blood cells (neutropenia / agranulocytosis), low platelet count (thrombocytopenia) or a decreased number of red blood cells (anemia).
If you have liver problems, yet you desensitization therapy (reducing the effects of allergy, eg. From the bite of bees and wasps) are undergoing hemodialysis or treatment to remove cholesterol from your body using a machine (LDL apheresis).
Tell your doctor if you have had allergic reactions
swelling of the face, lips, tongue and / or throat with difficulty in swallowing and breathing.
Before surgery or anesthesia (even in dental treatment), tell the surgeon or dentist that you are taking Renapril. This is necessary because during anesthesia can be obtained a sudden fall in blood pressure.
Upon treatment with ACE inhibitors, including a Renapril may appear cough. It is dry, persistent and resolves after discontinuation of therapy.

Use in Elderly
Data from clinical studies for efficacy and tolerability when administered to elderly patients and younger patients showed no differences.

ethnic differences
As with other ACE inhibitors, enalapril is less effective in lowering blood pressure in black patients compared to non-black.

pregnancy
You need to tell your doctor if you think you are pregnant or planning a pregnancy. Not recommended the use of Renapril in early pregnancy. It should not be taken during pregnancy more than three months, as it may cause serious harm to your baby if used after the third month (see section. Pregnancy and lactation).

breastfeeding
Tell the doctor if you are breastfeeding or you are breast-feeding (see section. Lactation).

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.
Some medicines can affect the way other medicines.

Discuss with your doctor if you are taking any of the following medications:
Diuretics (drugs that increase the flow of fluid from the body, including those which retain potassium);
Potassium tablets or potassium containing salt substitutes;
Other medicines for high blood pressure (antihypertensives);
Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants;
Nonsteroidal anti-inflammatory drugs (NSAIDs) which are used to treat arthritis or muscle pain;
Gold-containing agents (for the treatment of arthritis);
Medicines for insomnia and anxiety (hypnotics and sedatives);
Medicines to treat diabetes, such as insulin or medicines taken by mouth;
Drugs that stimulate the central nervous system (sympathomimetics). This includes some drugs for the treatment of coughs, colds and weight reduction;
Alcohol.
Taking Renapril with food and drink
No evidence of the need for special diets or restrictions on certain types of foods and beverages during treatment with this product. Renapril can be taken before, during or after meals.

Pregnancy and lactation
pregnancy:
You need to tell your doctor if you think you are pregnant or could become pregnant. Usually the doctor will advise you to stop taking Renapril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine replace Renapril. Renapril not recommended in the early months of pregnancy, and should not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage.

breastfeeding
Tell your doctor if you are breastfeeding or about to start breast-feeding. Not recommended for use in infants Renapril (during the first few weeks after birth), and especially in premature infants.
In older infants Your doctor will explain the benefits and risks of taking Renapril during lactation compared with other drugs.

Driving and using machines
At the beginning of treatment Renapril may experience temporary weakness and dizziness, which could affect driving or operating machinery.

Important information about some of the ingredients of Renapril
This medicine contains lactose (milk sugar). If you are advised by your doctor that you have an intolerance to some sugars, contact him before taking this medicine.

3. HOW TO TAKE RENAPRIL
Always take Renapril exactly as prescribed by your doctor. If you're not sure, ask your doctor or pharmacist!
The dosage and duration of treatment prescribed by the doctor, as are individual depending on the effect, tolerability and taking other drugs. It is before, during or after a meal orally with sufficient fluid.
Renapril treatment is usually prolonged, the duration is determined by your doctor. Do not take more than prescribed tablets.

High blood pressure:
For most patients, the recommended starting dose is typically from 5 to 20 mg, once daily. Some patients may need a lower starting dose. The usual maintenance dose for a prolonged course of treatment is 20 mg, taken once. The maximum maintenance dose for a prolonged course of treatment is 40 mg daily.

Heart failure:
The recommended initial dose is typically 2.5 mg, once daily. Your doctor will increase this amount gradually until you achieve appropriate for dosage. The usual maintenance dose for a prolonged course of treatment is 20 mg daily, administered once or in two doses. The maximum maintenance dose for a prolonged course of treatment is 40 mg daily, administered once or in two doses.
Be especially careful when you take your first dose or if your dose was increased. If you experience any symptoms such as dizziness or vertigo, tell your doctor.

Patients with kidney problems:
The dose of your medicine will be changed depending on the offense in the function of your kidneys:
Moderately impaired kidney function - of 5 mg to 10 mg daily;
Severe renal impairment - 2.5 mg daily;
If you are on dialysis - 2.5 mg on days of dialysis. Dose on days without dialysis can be changed depending on the changes in blood pressure.
Elderly:
The dose of your medicine will be determined by your doctor and will be depending on your kidney function.

children:
Experience with use in children with high blood pressure is limited. For children who can not swallow tablets, the dose is determined individually according to the child's weight and blood pressure. The usual starting doses are:
20 kg or 50 kg - 2.5 mg daily;
Over 50 kg - 5 mg daily.
The dose may be changed depending on the needs of the child:
A maximum of 20 mg per day may be used in children who weigh between 20 kg and 50kg;
A maximum of 40 mg per day may be used in children who weigh 50 kg.
Renapril not recommended for infants and children with impaired renal function.

If you take more than the amount Renapril
When taking a higher dose than prescribed, immediately contact a doctor!
The most common symptoms of overdose are dizziness, vertigo (due to a sharp and strong lower blood pressure), confusion and decreased urine output.
In case of overdose should be discontinued product gastric lavage and appoint charcoal and symptomatic means. Monitoring of the patient by a doctor until resolution of all symptoms.

If you forget to take Renapril
Do not take a double dose to make up the missed dose. Do this in the next regular intake.

If you stop taking Renapril
Do not stop taking Renapril unless your doctor has told you to do this.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Renapril can cause side effects, although not everybody gets them. If you are not sure what the following side effects, ask your doctor to explain them.

Stop taking Renapril and seek medical advice immediately if you notice any of the following serious side effects that can be life threatening:
allergic reactions - swelling / swelling of the face, eyes, lips or throat with difficulty in swallowing or breathing;
swelling in hands, feet or ankles;
the occurrence of skin rash and itching.
Stop taking Renapril and contact your doctor if you notice any of the following side effects:
pronounced dizziness and fainting, especially at the beginning of treatment or when increasing the dose, and when standing; strong skin redness, blistering, severe peeling of the skin.
Other possible side effects:
Very common (occurring in more than 1 in 10 people):
blurred vision, dizziness, cough, nausea, weakness.
Common (affects less than 1 in 10 people):
headache, depression;
hypotension, syncope (fainting), chest pain, heart rhythm disorders, angina, heart rate;
shortness of breath;
diarrhea, abdominal pain, changes in taste;
rash, hypersensitivity / angioneurotic edema (severe life-threatening allergic reaction); angioneurotic edema (swelling) of the face, extremities, lips, tongue, throat, causing difficulty in swallowing and shortness of breath;
fatigue;
increase in the potassium content in the blood, increased creatinine in the blood.
Uncommon (affects less than 1 in 100 people):
anemia, hypoglycemia (low blood sugar);
confusion, drowsiness, sleep disturbances, nervousness, numbness and tingling, dizziness;
low blood pressure (which can cause dizziness when standing up), palpitations, heart attack or stroke (in patients at high risk);
runny nose, sore throat and hoarseness, wheezing or asthma;
impaired patency of the intestine (ileus), pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer;
excessive sweating, itching, hives, hair loss;
impaired renal function, renal failure, protein in the urine (shown with relevant test);
impotence;
muscle cramps, flushing, tinnitus, malaise, fever;
urea increased and decreased sodium in the blood (shown by tests).
Rare (affects less than 1 in 1000 people):
changes in the number of various blood cells (decrease in red and white blood cells and platelets), enlarged lymph nodes, suppression of bone marrow function, autoimmune diseases;
unusual dreams, trouble sleeping;
reduced blood flow to the fingers and toes, leading to redness and pain (Raynaud's syndrome);
inflammatory changes in the lung, nasal discharge, eosinophilic pneumonia (expressed in cough, fever and difficulty breathing);
pain, swelling or ulceration of the mouth and tongue;
liver dysfunction or hepatitis, which can cause yellow skin (jaundice);
excessive skin redness, blistering, severe peeling of the skin, as a manifestation of severe skin disorders (erythema multiforme, Stevens-Johnson, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma);
reduced amount of urine;
breast enlargement in men;
increases in liver enzymes or bilirubin (blood indicators of liver damage).
Very rare (affects less than 1 in 10,000 people):
swelling of the intestinal wall (intestinal angioedema) presenting with abdominal pain, malaise and vomiting.
Others (it is not known how many people might show):
There have been reports and complex side effects, which may include some or all of the following symptoms:
fever, inflammation of vessels, pain and inflammation of muscles or joints;
blood disorders (settling by blood tests);
rash, photosensitivity and other skin manifestations.
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 RENAPRIL
At temperatures below 25 ° C.
Keep out of reach of children!
Do not use Renapril after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of in 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 Renapril
The active substance is enalaprilov maleate (enalapril maleate) 5 mg and 10 mg.
The other ingredients are ludipres (lactose monohydrate, povidone, crospovidone); cellulose, microcrystalline; magnesium stearate