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WHAT Amlessa IS AND WHAT IT IS USED
Amlessa is prescribed for the treatment of high blood pressure (hypertension) and / or treatment of stable coronary artery disease (a condition where blood supply to the heart is reduced or blocked).
Patients who previously received perindopril and amlodipine in separate tablets may instead receive one Amlesa tablet that contains both ingredients. Amlesa is a combination of two active substances, perindopril and amlodipine. Perindopril is an inhibitor of ACE (angiotensin converting enzyme) (ACE inhibitor). Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they cause the blood vessels to expand and relax, so the blood passes through them more easily and makes your heart easier to maintain good blood flow.
2. BEFORE YOU TAKE Amlessa
Do not take Amlessa:
if you are allergic (hypersensitive) to tert-butylamine perindopril or any other ACE inhibitor or to amlodipine besylate or other dihydropyridines or any of the other ingredients of Amlesa (see section 6 for the list of excipients);
if you are breast-feeding (see section "Pregnancy and breast-feeding");
if you are pregnant after the third month. (It is also better to avoid Amlesa in early pregnancy - see section "Pregnancy");
if you have experienced symptoms such as whistling, swelling of the face or tongue, severe itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family experienced such symptoms under other circumstances (a condition called angioneurotic edema);
if you are in shock (severe lowering of blood pressure leading to unconsciousness), including shock caused by heart problems;
if you have a severe decrease in blood pressure (severe hypotension);
if you suffer from heart failure (the heart fails to pump the blood efficiently and as a result, there is shortness of breath or peripheral edema, such as swelling of the feet, ankles or legs) after an acute heart attack;
if you have a narrowing of the heart artery, so 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 that supplies the kidney with blood);
any other heart problems;
if you suffer from impaired hepatic function;
if you have kidney problems or are on dialysis;
if you have vascular collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
if you have diabetes;
if you are on a diet with a low salt content or using potassium salt substitutes that contain potassium (a well-balanced blood potassium level is important).
You should tell your doctor if you think you are pregnant or could become pregnant. Amlesa is not recommended during early pregnancy and should not be taken if you are pregnant after the third month as it may cause serious harm to your baby if used during this period (see section on pregnancy).
When you are taking Amlessa, you should also tell your doctor or health care professional:
if you are going to get general anesthesia and / or a major surgery;
if you have recently had diarrhea or vomiting;
if you have to undergo LDL apheresis (removing cholesterol from your blood with a machine);
if you are going to have desensitization treatment to reduce the effects of allergy to bee sting or bee stings.
Amlesa is 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 taking Amlessa together 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.
Amlesa treatment may be affected by other medicines. Be sure to tell your doctor if you are taking / taking any of the following medicines, as special care may be necessary:
other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys);
non-steroidal anti-inflammatory drugs (eg ibuprofen) to relieve pain or high doses of aspirin;
medicines to treat diabetes (such as insulin);
medicines for the treatment of psychiatric disorders such as, for example, depression, anxiety, schizophrenia, etc. (eg tricyclic antidepressants, antipsychotics, imipramine antidepressants, neuroleptics);
immunosuppressants (medicines that suppress the body's defense mechanisms) used to treat autoimmune diseases or after transplant surgery (eg cyclosporin);
allopurinol (for treating gout);
procaine (for the treatment of non-cardiac heart disease);
vasodilators, including nitrates (products that enlarge 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 to treat 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);
some antibiotics such as, for example, rifampicin;
antiepileptics, such as e.g. carbamazepine, phenobarbital, phenytoin, phosphinothione, primidone;
itraconazole, ketoconazole (medicines used to treat fungal infections);
alpha-blockers - used to treat enlarged prostate, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
amifostine (used to prevent or reduce side 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, especially when given intravenously (used to treat rheumatoid arthritis).
Take Amlesa with food and drink
Amlesa should be taken before a meal.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should tell your doctor if you think you are pregnant or could 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 is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breastfeeding or think you start to breastfeed Amlesa not recommended for mothers who are breastfeeding and your doctor must choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely .
Driving and using machines
Amlesa 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. You should not drive a car or operate machinery until you know how Amlesa is affected.
H. HOW TO TAKE AMLESA
Always take Amlesa exactly as your doctor has told you. 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 a meal. Your doctor will decide which dose is right for you. The usual dose is usually one tablet a day.
Amlesa is usually prescribed to patients already taking perindopril and amlodipine in separate tablets.
If you have taken more Amlesa than you should
If you take too many tablets, contact your nearest hospital emergency department or tell your doctor immediately. The most likely effect in case of overdose is a decrease in blood pressure, which may make you feel dizzy or faint. If this happens, it can help to take up a horizontal position with raised lower limbs.
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 one dose of Amlesa, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Amlesa
Because Amlesa is usually life-threatening, you should discuss this with your doctor before stopping 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 everyone gets them.
Adverse reactions are classified into the following groups depending on the frequency.
Very common: occurs in more than 1 user in 10;
Often: occurs in between 1 and 10 users per 100;
Uncommon: occurs in between 1 and 10 per 1,000 users;
Rarely: occurs in between 1 and 10 users in 10,000
Very rare: occurs in less than 1 in 10,000 users;
Not known: frequency can not be predicted from available data.
If you experience any of the following 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 in breathing;
severe dizziness or fainting;
abnormally fast or uneven heartbeat.
Other side effects are:
Common side effects (occurring in less than 1 user in 10 but more than 1 in 100 users):
headache, dizziness, vertigo, numbness, drowsiness, visual disturbance, tinnitus, palpitation (very rapid heartbeat), redness (sensation of heat or heat on the face), loss of balance due to low blood pressure, cough, nausea, vomiting, abdominal pain, perversion, dyspepsia or difficulty in swallowing, diarrhea, constipation, allergic reactions (such as skin rashes, pruritus), muscle cramps, tiredness, swelling (swelling of the lower limbs or ankles ).
Uncommon side effects (affects less than 1 user in 100 but more than 1 in 1,000 users):
mood swings, sleep disturbances, trembling, syncope (temporary loss of consciousness), loss of sense of pain, rhinitis (stuffy nose or runny nose), changes in defecation, hair loss, red or discolored skin spots, back pain, muscle or joints, chest pain, more frequent urination especially at night, malaise, bronchospasm (chest tightness, swirling breathing and shortness of breath), dry mouth, angioneurotic edema, symptoms such as whistling, swelling of the face or language), kidney problems, impotence dw increased potlivost, enlarged breasts in men, weight gain or weight loss.
Very rare side effects (occurring in less than 1 in 10,000 users):
confusion, cardiovascular disorders (irregular heartbeat, chest tooth, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), erythema multiforme (skin rash often beginning with red itchy spots on the face, arms or lower limbs) , pancreatic, stomach or liver, peripheral neuropathy (a disease causing loss of sensation, pain, inability to control muscles), pathologically increased muscle tone, vasculitis (inflammation of the blood vessels of the skin), swelling of Enzymes, increased blood sugar.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORAGE OF AMLESA
Keep out of the reach and sight of children.
Do not use Amlesa after the expiry date which is stated on the carton and the 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Amlesa contains
The active substances are tert-butylamine perindopril and amlodipine besylate.
Ammesa 4 mg / 5 mg: tablets
One tablet contains 4 mg of tert-butylamine perindopril (perindopril tert-butylamine) and 5 mg of amlodipine besilate (amlodipine (as besilate)).
Amlesa 4 mg / 10 mg tablets
One tablet contains 4 mg of tert-butylamine perindopril (perindopril tert-butylamine) and 10 mg of amlodipine (as besylate).
Amlesa 8 mg / 5 mg tablets
One tablet contains 8 mg of tert-butylamine perindopril (perindopril tert-butylamine) and 5 mg of amlodipine besilate (amlodipine (as besilate)).
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