RENAPRIL 20 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, facilitating the heart to pump blood to all parts of the body. This leads to lower 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 are diagnosed with congenital or idiopathic angioedema;
If you are pregnant more than 3 months. (It is advisable to avoid the use of Renapril and in 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 strong and prolonged vomiting or diarrhea. You can also tell whether you are on a diet with salt restriction, take potassium supplements, potassium-sparing drugs or potassium-containing salt substitutes if you have diabetes or kidney problems (including kidney transplantation), as they may lead to significantly increase the level of potassium in the blood, which can cause serious malfunctions of the heart. In these cases it may be necessary to adjust the dose of Renapril or tracking the levels of potassium in the blood.
Tell your doctor if you notice symptoms such as fainting or dizziness, especially when getting up, talking about low blood pressure (orthostatic hypotension).
If you have diabetes or if you are taking oral antidiabetic drugs or insulin, monitor regularly the level of glucose in the blood, especially during the first month of treatment with Renapril.
If you have blood disorders, such as a reduced number or lack of white blood cells (neutropenia / agranulocytosis), low platelet count (thrombocytopenia) or a decreased number of red blood cells (anemia).
If you have liver problems, you are going to desensitization treatment (reduces effects of allergy, eg. By 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 ever had an allergic reaction to
swelling of face, lips, tongue and / or throat with difficulty in swallowing and breathing.
Before surgery or anesthesia (even at the 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 patients
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 than in non-black.

Pregnancy
It is necessary to inform your doctor if you think you are pregnant or planning a pregnancy. Not recommended to use Renapril in early pregnancy. It should not be taken during pregnancy over 3 months, as it may cause serious harm to your baby if used after the third month (see section. Pregnancy and lactation).

Breastfeeding
Tell your doctor if you are breastfeeding or if 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 potassium-sparing diuretics);
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 (sedatives and tranquilizers);
Medicines to treat diabetes, such as insulin or medicines taken by mouth;
Drugs that stimulate the central nervous system (sympathomimetic). This includes a number of drugs for the treatment of cough, colds, and weight loss;
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:
It is necessary to inform 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 in place of 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 occur temporary fatigue and dizziness, which could affect driving or operating machinery.

Important information about some of the ingredients of Renapril
This medicinal product 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 are not sure, ask your doctor or pharmacist!
The dosage and duration of treatment prescribed by a physician, as are individual depending on the effect, tolerability and concomitant medications. It is prior to, during or after meals by mouth with a sufficient amount of liquid.
Renapril treatment is usually long, the length is determined by your doctor. Do not take more than the prescribed tablets.

High blood pressure:
For most patients, the recommended starting dose is usually 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 a day. Your doctor will increase this amount gradually until it reaches an appropriate dosage for you. The usual maintenance dose for a prolonged course of treatment is 20 mg daily, administered once or in two divided doses. The maximum maintenance dose for a prolonged course of treatment is 40 mg daily, administered once or in two divided 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:
Moderate renal impairment - 5 mg to 10 mg daily;
Severe renal impairment - 2.5 mg daily;
If you are on dialysis - 2.5 mg in the days of dialysis. The dose in non-dialysis days 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 individually adjusted according to the child's weight and blood pressure. The usual starting doses are:
Between 20 kg and 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;
Maximum 40 mg per day may be used in children who weigh 50 kg.
Renapril not recommended in neonates and children with impaired renal function.

If you take more dose Renapril
When taking a higher dose than prescribed, immediately contact a doctor!
The most common symptoms of overdose include dizziness, vertigo (due to a sharp and very low blood pressure), confusion and decreased urine output.
In case of overdose, it is necessary to discontinue the product, gastric lavage and appoint charcoal and symptomatic agents. Monitoring of the patient by the doctor to 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 to you.

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 of the hands, feet or ankles;
develop skin rash and itching.
Renapril stop taking and consult your doctor if you notice any of these side effects:
strong dizziness and fainting, especially at the beginning of treatment or when increasing the dose, and when standing; strong skin redness, blistering, severe skin peeling.
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 of the blood, increase in blood creatinine levels.
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 (high-risk);
fever, sore throat and hoarseness, difficulty breathing 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 the relevant test);
impotence;
muscle cramps, flushing, tinnitus, malaise, fever;
raising the urea and reducing the sodium in the blood (shown by means of the tests).
Rare (affects less than 1 in 1000 people):
changes in the number of various cells (decrease of white and red blood cells and platelets), lymph node enlargement, inhibition 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 yellowing of the skin (jaundice);
excessive redness of the skin, blisters, severe skin peeling, 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;
increase 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) manifested by abdominal pain, malaise and vomiting.
Other (not known in how many people may show):
There have been reports of a complex of 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;
syndrome caused by inadequate secretion of antidiuretic syndrome.
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!
Renapril not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.