1. What Co-Amles is and what it is used for
Co-Amles is prescribed to treat high blood pressure (hypertension). All three substances help control high blood pressure (hypertension). Patients who are already taking perindopril / indapamide and amlodipine as separate tablets may instead receive one Co-Amlesa tablet containing the three ingredients.
Co-Amlesa is a combination of three active ingredients perindopril, indapamide and amlodipine. Perindopril is an ACE (angiotensin-converting enzyme) inhibitor. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Indapamide is a diuretic.
In patients with high blood pressure, perindopril and amlodipine work by relaxing the blood vessels so that the blood can pass through them more easily. Indapamide increases the amount of urine excreted by the kidneys. Each of the active ingredients lowers blood pressure and they work together to control your blood pressure.
2. What you need to know before you take Co-Amles
Do not take Co-Amles:
if you are allergic to perindopril or another ACE inhibitor or to indapamide or other sulphonamides, amlodipine besylate or other dihydropyridines, or to any of the other ingredients of Co-Amles (listed in section 6),
if you have had symptoms such as wheezing, swelling of the face or tongue, severe itching or severe skin rash with previous treatment with an ACE inhibitor, or if you or a family member have had these symptoms in other circumstances (a condition called angioedema),
if you have severe liver disease or suffer from a condition called liver encephalopathy (degenerative brain disease),
if you have severe kidney disease, or if you are on dialysis.
Concentrations of 8 mg / 5 mg / 2.5 mg and 8 mg / 10 mg / 2.5 mg are contraindicated if you have severe and moderate kidney disease,
if you have low or high levels of potassium in your blood
if you suspect that you are suffering from untreated decompensated heart failure (severe water retention, difficulty breathing),
if you have cardiogenic shock (when the heart is unable to supply enough blood to the body), aortic stenosis (narrowing of a major blood vessel coming out of the heart) or unstable angina (chest pain that may occur during rest),
if you have a severe drop in blood pressure (hypotension),
if you suffer from heart failure (the heart cannot pump blood sufficiently, leading to shortness of breath or peripheral swelling such as swelling of the legs, ankles or legs) after an acute heart attack,
if you are more than 3 months pregnant (it is also a good idea to avoid Co-Amles in early pregnancy - see "Pregnancy and breast-feeding"),
if you are breast-feeding,
if you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Amles: if you have recently had a heart attack,
if you have aortic stenosis (narrowing of the main blood vessel coming out of the heart) or hypertrophic cardiomyopathy (heart muscle disease), or stenosis of the renal artery (narrowing of the artery that supplies blood to the kidneys),
if you have heart failure
if you have any other heart problems or kidney problems, if you have a strong rise in blood pressure (hypertensive crisis), if you have liver problems,
if you suffer from connective tissue disease (skin disease), such as systemic lupus erythematosus or scleroderma, if you have atherosclerosis (hardening of the arteries),
if you suffer from hyperparathyroidism (hyperthyroidism), if you suffer from gout, if you have diabetes,
if you are on a diet with limited salt intake or use cooking substitutes
salt containing potassium,
if you are taking lithium or potassium-storing diuretics (spironolactone, triamterene), as their use with Co-Amles should be avoided (see "Taking other medicines"), if you are elderly and your dose should be increased, if you are taking any of the following medicines used to treat high blood pressure:
angiotensin II receptor blocker (ARB) (also known as sartans - eg valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes;
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood. See also the information entitled "Do not take Co-Amles".
if you are taking any of the following medicines, the risk of angioedema increases: racecadotril (used to treat diarrhea),
sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicines called mTOR inhibitors (used to avoid rejection of transplanted organs).
You should tell your doctor if you think you are (or might become) pregnant. Co-Amlesa is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see "Pregnancy and breast-feeding"). .
When you take Co-Amles, you must also tell your doctor or medical staff:
if you are about to have anesthesia and / or surgery,
if you have recently suffered from diarrhea or vomiting, or are dehydrated, if you are on dialysis or LDL apheresis (removal of cholesterol from the blood by a device), if you will be treated for desensitization to reduce the effects of allergies after bee or wasp stings ,,
if you are going to have a medical examination that requires an injection of an iodine contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-rays).
Athletes should be aware that Co-Amlesa contains an active ingredient (indapamide) that may test positive for doping tests.
Children and adolescents
Co-Amlesa is not recommended for use in children and adolescents.
Other medicines and Co-Amles
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should avoid Co-Amles with:
lithium (used to treat depression),
potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Co-Amles treatment may be affected by other medicines.
You should tell your doctor if you are taking any of the following medicines, as special care may be required:
other medicines to treat high blood pressure,
procainamide (used to treat irregular heart rhythms),
allopurinol (used to treat gout),
terfenadine or astemizole (antihistamines for hay fever or allergies), corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis,
immunosuppressants used to treat autoimmune diseases or after
transplantation to prevent rejection (eg cyclosporine), ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV), medicines to treat cancer,
ketoconazole, itraconazole (antifungal drugs)
rifampicin, erythromycin, clarithromycin (antibiotics),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
injectable gold (used to treat rheumatoid arthritis),
vincamine (used to treat symptomatic cognitive impairment in adults, including memory loss),
bepridil, verapamil, diltiazem (heart medicines),
sultopride (used to treat psychosis),
medicines used for heart rhythm problems (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
digoxin or other cardiac glycosides (used to treat heart problems), baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
medicines to treat diabetes, such as insulin or metformin, calcium, including calcium supplements that stimulate laxatives (eg hay),
non-steroidal anti-inflammatory drugs (eg ibuprofen) or high doses of salicylates (eg aspirin),
injectable amphotericin B (used to treat severe fungal diseases),
drugs to treat mental illness such as depression, anxiety, schizophrenia
(eg tricyclic antidepressants, neuroleptics),
tetracosactide (used to treat crown disease),
hypericum perforatum (St. John's wort),
dantrolene (infusion at elevated temperature),
tacrolimus (a medicine that affects the function of the immune system), simvastatin (a medicine that lowers cholesterol), cyclosporine (an immunosuppressant), anesthetics,
medicines that are most commonly used to treat diarrhea (racecadotril) or to avoid organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicines called mTOR inhibitors). See section "Warnings and precautions".
Your doctor may need to change your dose and / or take other precautions: if you are taking angiotensin II receptor blocker (ARB) or aliskiren (see also the information entitled "Do not take Co-Amles" and "Warnings and precautions"). ).
Co-Amlesa with food and drink
It is preferable to take Co-Amlesa before meals.
Grapefruit and grapefruit juice should not be consumed by people taking Co-Amles. This is because grapefruit and grapefruit juice can increase the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the effect of Co-Amles on lowering blood pressure.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking Co-Amles before you become pregnant or as soon as you know you are pregnant and will advise you to take another drug instead of Co-Amles. Co-Amlesa is not recommended in early pregnancy, and must not be taken when more than 3 months old, as 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 planning to breast-feed. Co-Amlesa is contraindicated for breastfeeding mothers and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or born prematurely. See your doctor immediately.
Driving and using machines
Co-Amlesa does not affect alertness, but you may feel dizzy or weak due to low blood pressure, which may affect your ability to drive and use machines. It is not recommended to drive or use machines until you understand how Co-Amles works for you.
Co-Amlesa contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially 'sodium-free'. it can be said that it contains practically no sodium.
3. How to take Co-Amles
Always take this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once a day. It is preferable to take the tablet in the morning before meals. Swallow the tablet with a glass of water.
Co-Amlsa 4 mg / 10 mg / 1.25 mg and Co-Amlsa 8 mg / 10 mg / 2.5 mg tablets
If necessary, Co-Amlesa 4 mg / 10 mg / 1.25 mg or Co-Amlesa 8 mg / 10 mg / 2.5 mg tablets can be divided into 2 doses.
You can divide Co-Amlesa 4 mg / 10 mg / 1.25 mg or Co-Amlesa 8 mg / 10 mg / 2.5 mg tablets by placing it on a flat surface with the score line facing up. Then press with two fingers on both sides of the tablet.
Your doctor will decide on the right dose for you. Co-Amlesa is prescribed to patients who are already taking perindopril / indapamide and amlodipine as separate tablets.
If you take more Co-Amles than
you should If you take too many tablets, contact your doctor or nearest hospital immediately! The most likely effect in case of overdose is lowering blood pressure. If you develop a condition of low blood pressure (symptoms such as dizziness or lightheadedness), it may help to lie down with your legs raised.
If you forget to take Co-Amles
It is important that you take your medicine every day, as regular treatment is more effective. However, if you forget to take one dose of Co-Amles, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Co-Amles
As the treatment for high blood pressure is usually lifelong, you should discuss this with your doctor before stopping this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking the medicine immediately and tell your doctor:
sudden wheezing, chest pain, shortness of breath or difficulty breathing,
symptoms of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty breathing,
severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, severe itching, blisters, scaling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions, severe dizziness or nausea,
heart attack, abnormally fast or irregular heartbeat, inflammation of the pancreas, which can lead to severe abdominal pain and back pain, accompanied by a feeling of severe malaise.
In descending order of frequency, side effects may include:
Very common (may affect more than 1 in 10 people):
swelling (fluid retention)
Common (may affect up to 1 in 10 people):
headache, dizziness, vertigo, tingling in the extremities, somnolence (drowsiness), visual disturbances (including double vision), fainting due to low blood pressure, tinnitus (tinnitus), low blood pressure, palpitations rapid heartbeat), flushing (hot or hot flushes), shortness of breath, cough, gastrointestinal upset (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, changes in defecation, dyspepsia or indigestion, diarrhea, constipation), muscle cramps, swelling of the ankles, weakness, feeling tired.
Uncommon (may affect up to 1 in 100 people):
allergic reactions (eg skin rash, itching), mood swings, sleep disturbances, insomnia, depression, tremors, loss of pain, irregular heartbeat, syncope (temporary loss of consciousness), rhinitis (nasal congestion or runny nose) , bronchospasm (chest tightness, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), sweating, hair loss, red or discolored spots on the skin, back pain, muscles or joints, kidney problems, frequent urination, especially at night, impotence, breast enlargement in men, chest pain, pain, general malaise, weight gain or weight loss.
Rare (may affect up to 1 in 1,000 people):
worsening of psoriasis.
Very rare (may affect up to 1 in 10,000 people):
decreased number of white blood cells, decreased number of platelets in the blood, which can lead to unusual bruising or easier bleeding, high blood sugar, cardiovascular disorders (angina, myocardial infarction), eosinophilic pneumonia (rare type of pneumonia), swelling of the gums, bloating (gastritis), peripheral neuropathy (a disease that leads to loss of sensation, pain, inability to control muscles), increased muscle tension, severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of connective tissue disease), it can get worse.
Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), elevated liver enzymes, which may affect some medical tests. Inflammation of the blood vessels, often with a skin rash.
Cases of photosensitivity (change in the appearance of the skin) have been reported after sun exposure or artificial UVA.
Not known (frequency cannot be estimated from the available data):
Life-threatening arrhythmia (Torsade de pointes).
Diseases of the blood, kidneys, liver or pancreas and changes in laboratory parameters (blood tests) may occur. Your doctor may order blood tests to monitor your condition.
In case of liver failure (liver problems), hepatic encephalopathy (degenerative brain disease) is likely to develop. Shivering, stiff posture, mask-like facial expression (masked face), slow movements and dragging of the legs, unstable gait.
Reporting of suspected side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet . You can also report side effects directly via the Bulgarian Drug Agency,
8 Damyan Gruev Str.
Tel .: +35 928903417
By reporting side effects, you can contribute to receiving more information on the safety of this medicine.
5. How to store Co-Amles
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 30 ° C.
Store in the original package in order to protect from protect from light and moisture
Do not throw away any medicines 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. Contents of the package and additional information
What Co-Amlesa contains
The active substances are perindopril terind-butylamine, amlodipine and indapamide.
Co-Amles 2 mg / 5 mg / 0.625 mg
Each tablet contains 2 mg tert-butylamine perindopril, 5 mg amlodipine (as besylate) and 0.625 mg indapamide.
Co-Amles 4 mg / 5 mg / 1.25 mg
Each tablet contains 4 mg tert-butylamine perindopril, 5 mg amlodipine (as besylate) and 1.25 mg indapamide.
Co-Amles 4 mg / 10 mg / 1.25 mg
Each tablet contains 4 mg tert-butylamine perindopril, 10 mg amlodipine (as besylate) and 1.25 mg indapamide.
Co-Amles 8 mg / 5 mg / 2.5 mg
Each tablet contains 8 mg tert-butylamine perindopril, 5 mg amlodipine (as besylate) and 2.5 mg indapamide.
Co-Amles 8 mg / 10 mg / 2.5 mg
Each tablet contains 8 mg tert-butylamine perindopril, 10 mg amlodipine (as besylate) and 2.5 mg indapamide.
The other ingredients are sodium bicarbonate, microcrystalline cellulose (E460), pregelatinised starch (type 1500), sodium starch glycolate (type A), silica, colloidal anhydrous magnesium stearate (E572) and calcium chloride hexahydrate.
What Co-Amlesa looks like and contents of the pack
2 mg / 5 mg / 0.625 mg tablets: white to off-white, oval, biconvex tablets with a score line on one side and a length of 9 mm. The dividing line is only to facilitate breakage, to be easier to swallow, not to divide into equal doses.
4 mg / 5 mg / 1.25 mg tablets: white to off-white, round, slightly biconvex tablets with bevelled edges, 7 mm in diameter
4 mg / 10 mg / 1.25 mg tablets: White to off-white, oval, biconvex tablets with a score line of 12 mm on one side. The tablet can be divided into two equal doses.
8 mg / 5 mg / 2.5 mg tablets: white to off-white, round, biconvex tablets with bevelled edges, 9 mm in diameter.
8 mg / 10 mg / 2.5 mg tablets: White to off-white, round, biconvex tablets with a score line on one side with bevelled edges, 9 mm in diameter. The tablet can
The tablets are available in boxes of 10, 14, 20, 28, 30, 56, 60, 84 and 90 tablets in a blister. Not all pack sizes may be marketed.
Marketing Authorization Holder
KRKA, dd, Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia