AMLESSA 8 mg. 10 mg. 30 tablets
Amlessa 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 Amlessa which contains both ingredients. Amlessa is a combination of two active ingredients, perindopril and amlodipine. Perindopril is an inhibitor of ACE (angiotensin converting enzyme) inhibitors (ACE inhibitor). Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they cause expansion 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 AMLESSA
Do not take Amlessa:
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 Amlessa (see section 6 for a list of excipients);
if you are breastfeeding (see section "Pregnancy and lactation");
if you are pregnant after the third month. (It is also better to avoid Amlessa in early pregnancy - see "Pregnancy");
if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family has had these symptoms in any other circumstances (a condition called angioedema);
if you are in shock (severe decrease in blood pressure, leading to unconsciousness), including shock caused by heart problems;
if you have a serious decrease in blood pressure (severe hypotension);
if you suffer from heart failure (heart fails to pump blood efficiently 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 a narrowing of a heart artery and thus pumping blood from the left ventricle of the heart is difficult (eg., aortic stenosis).
Take special care with Amlessa
hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);
any other heart problems;
if you suffer from impaired liver function;
if you have kidney problems or are on dialysis;
if you have a collagen vascular disease (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 containing 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. Amlessa 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 Amlessa, 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 need to be subjected to (a) of LDL apheresis (removal of cholesterol from your blood by a machine);
if you are desensitisation treatment to reduce the effects of an allergy to bee stings or wasp.
Amlessa 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 Amlessa with:
lithium (used to treat mania or depression);
estramustine (used to treat cancer);
potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or potassium-containing salt substitutes.
Treatment with Amlessa can be affected by other drugs. Be sure to tell your doctor if you are taking / receiving any of the following medicines 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 (eg., ibuprofen) for pain relief or high dose 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, Imipramine antidepressants);
immunosuppressants (drugs that inhibit the body's defense mechanisms), used to treat autoimmune diseases, or after transplant surgery (eg. cyclosporin);
allopurinol (for gout);
procainamide (to treat irregular heartbeat);
vasodilators, including nitrates (products that widen blood vessels);
heparin (medicines for blood thinning);
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 rigidity in diseases such as multiple sclerosis, Dantrolene is also used for treatment of malignant hyperthermia during anesthesia (symptoms including very high body temperature, and muscular rigidity);
certain antibiotics, eg. rifampicin;
antiepileptic agents, such as. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
itraconazole, ketoconazole (medicines used to treat fungal infections);
alpha-blockers - used to treat an enlarged prostate, such as. 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 (used to treat various conditions, including severe asthma and rheumatoid arthritis);
gold salts, particularly in intravenous administration (used for the treatment of the symptoms of rheumatoid arthritis).
Taking Amlessa with food and drink
Amlessa 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 Amlessa before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Amlessa. Amlessa 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 Amlessa not recommended for mothers who are breastfeeding and your doctor should choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely .
Driving and using machines
Amlessa not affected the ability to drive, but you could feel dizziness or weakness 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 Amlessa.
H. HOW TO TAKE AMLESSA
Always take Amlessa exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Swallow your tablets with a glass of water, preferably at the same time each 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.
Amlessa usually prescribed for patients already taking perindopril and amlodipine from separate tablets.
If you take use more than the amount Amlessa
If you take too many tablets, contact the nearest emergency facility or tell your doctor immediately. The most likely effect in case of overdose, lowering blood pressure, which may make you feel dizziness or faint. If this happens, can help filling horizontally with legs raised.
If you forget to take Amlessa
It is important to take your medicine every day as regular treatment works better action. However, if you forget to take a dose Amlessa, take the next dose at the usual time. Do not take a double dose to make up the missed dose.
If you stop taking Amlessa
Since treatment with Amlessa 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, Amlessa 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;
Often, occurs in 1 to 10 users in 100;
Uncommon: occurs in 1 to 10 of 1000 users;
Rare occurs in 1 to 10 10 000 users
Very rare: it manifests itself in less than 1 in 10,000 users;
Not known: frequency can not be made from the available data.
If any of these side effects, stop taking the medicine 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 side effects (occurring in less than 1 in 10 users but in more than 1 in 100 users):
headache, dizziness, vertigo, pins and needles, drowsiness, visual disturbances, tinnitus, palpitations (rapid heartbeat), flushing (feeling of warmth and heat of 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 (eg. skin 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 disturbances, tremor, syncope (temporary loss of consciousness), loss of pain sensation, 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 heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), erythema multiforme (skin rash that often starts with itchy red spots on the face, arms or legs), blood disorders , pancreas, stomach or liver, peripheral neuropathy (a disease causing loss of sensation, pain, inability to control muscles), abnormally increased muscle tone, vasculitis (inflammation of blood vessels in the skin), swelling of the gums, increased blood sugar.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AMLESSA
Keep out of the reach of children.
Amlessa 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 in order to protect from moisture.