AMLESA. 8 mg. 10 mg. 30 tablets
AMLESA. 8 mg. / 10 mg. 30 tablets
AMLESA WHAT IS AND WHAT IT IS USED
Amlesa is prescribed for the treatment of high blood pressure (hypertension), and / or treatment of stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked).
Patients previously receiving perindopril and amlodipine from separate tablets can instead receive one tablet Amlesa that contains both ingredients. Amlesa combination of two active substances, amlodipine and perindopril. Perindopril is an inhibitor of ACE (angiotensin converting enzyme) inhibitors (ACE inhibitor). Amlodipine is a calcium channel blocker (which belongs to the class of drugs known as dihydropyridines). Together they cause widening and relaxation of the blood vessels, so blood flows more easily through them and facilitate your heart in maintaining good blood flow.
2. BEFORE YOU TAKE AMLESA
Do not take Amlesa:
if you are allergic (hypersensitive) to perindopril tert-butylamine or any other ACE inhibitor, or to amlodipine besylate or other dihydropyridines, or any of the other ingredients of Amlesa (see section 6 for a list of ingredients);
if you are breastfeeding (see section "Pregnancy and lactation");
if you are pregnant after the third month. (It is also better to avoid Amlesa early pregnancy - see section "Pregnancy");
if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes in previous treatment with an ACE inhibitor or if you or a member of your family has had these symptoms for other conditions (called angioedema);
If you are in shock (severe decrease in blood pressure, leading to unconsciousness), including shock caused by heart problems;
if you have severe lowering of blood pressure (severe hypotension);
if you suffer from heart failure (the heart fails to pump blood effectively enough and as a result, there is shortness of breath or peripheral edema, such as swollen legs, ankles or feet) after acute myocardial infarction;
if you have narrowing of a heart artery and therefore pumping blood from the left ventricle of the heart is difficult (eg aortic stenosis).
Take special care with Amlesa
hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
any other heart problems;
if you have impaired liver function;
if you have kidney problems or are on dialysis;
if you have a collagen vascular disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
if you have diabetes;
if you are on a diet with limited content of salt or use salt substitutes that contain potassium (a well-balanced level of potassium in the blood is important).
You should tell your doctor if you think you are pregnant or might become pregnant. Amlesa not recommended in early pregnancy, and must not be taken if you are three months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
When taking Amlesa, you should also tell your doctor or medical staff:
if you are going to get general anesthesia and / or major surgery;
if you have recently had diarrhea or vomiting;
If you are due to (a) LDL apheresis (removal of cholesterol from your blood with a machine);
if you are desensitisation treatment to reduce the effects of an allergy to bee sting or wasp.
Amlesa not recommended for use in children and adolescents
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.
You should avoid concomitant administration of Amlesa with:
lithium (used to treat mania or depression);
estramustine (used in the treatment of cancer);
potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or potassium-containing salt substitutes.
Treatment with Amlesa may be affected by other drugs. Be sure to tell your doctor if you are taking / receiving any of the following as you may need special attention:
other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine excreted by the kidneys);
NSAIDs (e.g., ibuprofen) for pain relief or high doses of aspirin;
drugs for the treatment of diabetes (such as e. insulin);
drugs for the treatment of mental disorders, such as e. depression, anxiety, schizophrenia, etc. (Eg tricyclic antidepressants, antipsychotics, antidepressants Imipramine, neuroleptics);
immunosuppressives (drugs that inhibit the body's defense mechanisms), for use in treating autoimmune diseases, or after transplant surgery (e.g., cyclosporine);
allopurinol (for the treatment of gout);
procainamide (to treat irregular heartbeat);
vasodilators including nitrates (products that dilate blood vessels);
heparin (drugs to thin the blood);
ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma);
baclofen or dantrolene (infusion), both used for the treatment of muscular diseases such as hardening in multiple sclerosis, Dantrolene is also used for treatment of malignant hyperthermia during anesthesia (symptoms, including a very high body temperature, and muscular rigidity);
certain antibiotics, such as e. rifampicin;
antiepileptic agents, such as e. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
itraconazole, ketoconazole (medicines used to treat fungal infections);
alpha-blockers - used to treat enlarged prostate, such as e. prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
amifostine (used to prevent or reduce the adverse effects caused by other drugs or radiotherapy, which are used to treat cancer), corticosteroids (which are used to treat various conditions, including severe asthma, and rheumatoid arthritis);
gold salts, particularly for intravenous administration (used for the treatment of the signs of rheumatoid arthritis).
Taking Amlesa with food and drink
Amlesa should be taken before meals.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
You should tell your doctor if you think you are pregnant or might become pregnant. Your doctor will normally advise you to stop taking Amlesa before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Amlesa. Amlesa not recommended in early pregnancy, and must not be taken after the third month of pregnancy because 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 think you start to breastfeed Amlesa not recommended for mothers who are breastfeeding and your doctor should choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely .
Driving and using machines
Amlesa not affect your ability to drive, but you might feel dizzy or faint due to low blood pressure, which could affect your ability to drive or operate machinery. Do not drive a car or operate machinery until you know how it affects us taking Amlesa.
H. HOW TO TAKE AMLESA
Always take Amlesa exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Swallow your tablets with a glass of water, preferably at the same time every day, in the morning before eating. Your doctor will decide what is the right dose for you. The usual dose is usually one tablet per day.
Amlesa usually prescribed to patients already taking perindopril and amlodipine from separate tablets.
If you take use more dose Amlesa
If you take too many tablets, contact your nearest emergency facility or tell your doctor immediately. The most likely effect of overdose is lower blood pressure, which can make you feel dizziness or faint. If this happens, can help filling a horizontal position with raised legs.
If you forget to take Amlesa
It is important to take your medicine every day as regular treatment has a better effect. However, if you forget to take a dose Amlesa, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Amlesa
Since treatment with Amlesa is usually for life, you should discuss this with your doctor before you stop taking your tablets.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlesa can cause side effects, although not everybody gets them.
Adverse reactions are classified into the following groups depending on the frequency.
Very common: occurs in more than 1 in 10 users;
Common: occurs in 1 to 10 users in 100;
Uncommon: occurs in 1 to 10 of 1000 users;
Rare occurs in 1 to 10 per 10 000 users
Very rare: it manifests itself in less than 1 in 10,000 users;
Not known: frequency can not be predicted from the available data.
If any of these side effects, stop taking the drug immediately and tell your doctor immediately:
symptoms of allergic reactions such as swelling of the face, lips, mouth, tongue or throat, difficulty breathing;
severe dizziness or fainting;
unusually fast or irregular heartbeat.
Other side effects are:
Common adverse reactions (occurring in more than 1 out of 10 users, but more than 1 in 100 users):
headache, dizziness, vertigo, numbness, drowsiness, visual disturbances, tinnitus, palpitations (rapid heartbeat), flushing (feeling of warmth or heat on the face), loss of balance due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste perversion, indigestion or difficulty in swallowing, diarrhea, constipation, allergic reactions (such as. rashes, itching), muscle cramps, fatigue, edema (swelling of the legs or ankles ).
Uncommon side effects (occurring in less than 1 in 100 users, but more than 1 in 1,000 users):
rapid changes in mood, sleep disturbance, shivering, syncope (temporary loss of consciousness), loss of sensation of pain, rhinitis (stuffy or runny nose), changes in bowel habits, hair loss, red or discolored spots on the skin, sore back, muscle or joint pain, chest pain, frequent urination especially at night, malaise, bronchospasm (constriction of the chest, wheezing and shortness of breath), dry mouth, angioneurotic edema, symptoms such as wheezing, swelling of the face or language), kidney problems, impotence, increased potlivost, breast enlargement in men, gain or weight loss.
Very rare side effects (occurring in less than 1 in 10,000 users):
confusion, cardiovascular disorders (irregular heartbeats, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), erythema multiforme (a skin rash that often begins with red itchy spots on the face, arms or legs), blood disorders , pancreatic, gastric, or liver, peripheral neuropathy (disease causing loss of sensation, pain, inability to control muscles), pathologically increased muscle tone, vasculitis (inflammation of blood vessels in the skin), gum swelling, high blood sugar.
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. STORAGE AMLESA
Keep out of the reach of children.
Amlesa not use after the expiry date stated on the carton and container. The expiry date refers to the last day of that month.
Do not store above 30 ° C. Store in the original package to protect from moisture.
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 Amlesa
The active compounds are tert-butylamine perindopril and amlodipine besylate.
Amlesa 4 mg / 5 mg: tablets
One tablet contains 4 mg of perindopril tert-butylamine (perindopril tert-butylamine) and 5 mg amlodipine besylate (amlodipine (as besilate)).
Amlesa 4 mg/10 mg tablets
One tablet contains 4 mg of perindopril tert-butylamine (perindopril tert-butylamine) and 10 mg amlodipine (as besilate).
Amlesa 8 mg / 5 mg tablets
One tablet contains 8 mg of perindopril tert-butylamine (perindopril tert-butylamine) and 5 mg amlodipine besylate (amlodipine (as besilate)).
Amlesa 8 mg/10 mg tablets
One tablet contains 8 mg of perindopril tert-butylamine (perindopril tert-butylamine) and 10 mg amlodipine besylate (amlodipine (as besilate)).
Other substances are microcrystalline cellulose (E460), calcium chloride hexahydrate, sodium hydrogen carbonate, pregelatinized starch, sodium starch glycolate (type A), magnesium stearate (K572), and silica colloidal anhydrous.
Almesa looks like and contents of pack
Amlesa 4 mg / 5 mg: White to off-white, round, slightly biconvex tablets with bevelled edges.
Amlesa 4 mg/10 mg: White to off-white, oblong, biconvex tablets scored on one side. The scoreline is not intended to divide the tablet into two equal parts.
Amlesa 8 mg / 5 mg: White to off-white, round, biconvex tablets with bevelled edges.
Amlesa 8 mg/10 mg: White to off-white, round, biconvex tablets with bevelled edges and scored on one side. The tablet can be divided into equal halves.