Co Amlessa 2 mg. 5 mg. 30 tablets
Co-Amlessa is prescribed for the treatment of high blood pressure (hypertension). All three substances help to control high blood pressure (hypertension). Patients already taking perindopril / indapamide and amlodipine as separate tablets may instead receive one Co-Amlesa tablet containing the three ingredients.
Co-Amlessa 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 act by relaxing the blood vessels so that blood passes through them more easily. Indadamid increases the amount of urine released by the kidneys. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.
2. What you need to know before you take Co-Amlesa
Do not take Co-Amblese:
if you are allergic to perindopril or another ACE inhibitor or to indapamide or other sulphonamides, amlodipine besylate or other dihydropyridines or any of the other ingredients of Co-Amlesa (listed in section 6)
if you have had symptoms such as wheezing, swelling of the face or tongue, severe itching or severe skin rashes in previous ACE inhibitor treatment, or if you or a member of your family have had these symptoms under other circumstances (a condition called angioedema)
if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease)
if you have severe kidney disease or if you are on dialysis treatment.
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 potassium levels in the blood,
if you have any doubt that you suffer from untreated decompensated heart failure (severe water retention, difficulty in breathing),
if you have a cardiogenic shock (when the heart is unable to deliver 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 appear during rest)
if you have severe lowering of blood pressure (hypotension),
if you suffer from heart failure (the heart can not pump enough blood, resulting in shortness of breath or peripheral edema like swelling of the feet, ankles or legs) after a severe heart attack,
if you are pregnant after 3 months (additionally, you should avoid Co-Amlesa in early pregnancy - see "Pregnancy and breast-feeding"),
if you are breast-feeding,
if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Amlessa: If you have recently suffered a heart attack,
if you have aortic stenosis (narrowing of the main blood vessel that comes out of the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies the kidneys with blood)
if you have heart failure,
if you have any other heart problems or kidney problems, if you have a severe increase in blood pressure (hypertension), if you have problems with the liver,
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 (hyperfunction of the parathyroid gland), if you suffer from gout, if you have diabetes,
if you are on a diet with limited salt intake or using substitutes on the cooker
salt, which contain potassium,
if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with Co-Amlesa 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 sartens - for example 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 titled "Do not take Co-Amblese".
if you are taking any of the following medicines, the risk of angioedema is increased: racemacotril (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 may be) pregnant.
When you drink Co-Amlesa, you should also tell your doctor or medical staff:
if you are going to have anesthesia and / or surgery,
if you have recently suffered from diarrhea or vomiting or if you are dehydrated if you are on dialysis or LDL apheresis (removal of blood cholesterol through an apparatus) if you will be subjected to a desensitization treatment to reduce the effects of allergy after stinging bees or axles ,
if you will be subjected to a medical examination that requires injection of an iodinated contrast agent (a substance that makes organs like the kidneys or the stomach visible to X-rays).
Athletes should know that Co-Amlesa contains an active ingredient (indapamide) that can give a positive reaction to doping tests.
Children and adolescents
Co-Amlesa is not recommended for use in children and adolescents.
Other Drugs and Co-Amlesa
Tell your doctor or pharmacist if you are taking, have recently taken or can take any other medicines.
You should avoid Co-Amlesa with:
lithium (used to treat depression),
potassium sparing diuretics (spironolactone, triamterene), potassium salts.
Treatment with Co-Amlesa 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,
procaine (to treat irregular heart rhythm),
allopurinol (for the treatment of 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
(eg, cyclosporin), ritonavir, indinavir, nelfinavir (the so-called protease inhibitors used to treat HIV), medicines for the treatment of cancer,
ketoconazole, itraconazole (antifungal medicines)
rifampicin, erythromycin, clarithromycin (antibiotics),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
injection gold (used to treat rheumatoid arthritis),
vincamine (used to treat symptomatic cognitive disorders in adults, including memory loss),
bepridil, verapamil, diltiazem (heart medicines),
sultopride (for the treatment of psychosis),
medicines used for heart rhythm problems (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
digoxin or other cardiac glycosides (for the treatment of heart problems), baclofen (for the treatment of muscle stiffness occurring in such diseases as multiple sclerosis),
medicines for the treatment of diabetes, such as insulin or metformin, calcium, including calcium supplements, stimulant laxatives (e.g., senna),
non-steroidal anti-inflammatory drugs (eg ibuprofen) or high doses of salicylates (eg, aspirin),
amphotericin B (for treatment of severe fungal diseases),
medicines to treat mental illnesses such as depression, anxiety, schizophrenia
(e.g., tricyclic antidepressants, neuroleptics),
tetracosactide (for treatment of crown disease),
hypericum perforatum (St. John's wort),
dentrolene (infusion at elevated temperature),
tacrolimus (a medicine that affects the function of the immune system), simvastatin (a cholesterol lowering drug), ciclosporin (immunosuppressant), anesthetics,
medicines that are most commonly used to treat diarrhea (racemacotril) or to avoid rejection of transplanted organs (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 an angiotensin II receptor blocker (ARB) or aliskiren (see also the information titled "Do not take Co-Amlesa" and "Warnings and precautions" ).
Co-Amlesa with food and beverages
It is preferable to take Co-Amlesa before a meal.
Grapefruit and grapefruit juice should not be consumed by people who take Co-Amblese. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which may cause an unpredictable increase in the effect of Co-Amlesa on lowering blood pressure.
Pregnancy and breastfeeding
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 you start taking this baby
You should tell your doctor if you think you are (or may become) pregnant, your doctor will advise you to stop taking Co-Amlesa before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Co-Amlesa. Co-Amlesa is not recommended in early pregnancy and should not be taken after the third month as it may
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 shortness of breath,
symptoms of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,
(Stevens Johnson Syndrome) or other allergic reactions, severe dizziness or fainting, severe skin reactions including severe skin rash, urticaria, redness of the whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes
heart attack, abnormally fast or uneven heart rhythm, inflammation of the pancreas, which can lead to severe abdominal pain and back pain accompanied by a feeling of being very unwell.
In descending order of frequency, side effects may include:
Very common (may affect more than 1 in 10 people):
edema (fluid retention)
Common (may affect up to 1 in 10 people):
headache, dizziness, vertigo, numbness, somnolence (sleepiness), visual disturbances (including double vision), low blood pressure, tinnitus (feeling of tinnitus), low blood pressure, palpitations (hot or hot facial waves), shortness of breath, cough, gastrointestinal disorders (nausea, pain in the epigastrum, anorexia, vomiting, abdominal pain, taste disturbance, dry mouth, changes in defecation, dyspepsia or confusion udneniya digestion, diarrhea, constipation), muscle cramps, ankle swelling, weakness, fatigue.
Uncommon (may affect up to 1 in 100 people):
allergic reactions (eg skin rashes, pruritus), mood changes, sleep disturbances, insomnia, depression, trembling, loss of pain, abnormal heart rhythm, syncope (temporary loss of consciousness), rhinitis (nasal congestion or runny nose) (such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), sweating, hair loss, red or discolored skin spots, back pain, muscles or joints, kidney problems, often urine sc, especially at night, impotence, breast enlargement in men, chest pain, pain, malaise, weight gain or reduce it.
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 blood white blood cell count, decreased platelet counts in the blood, which may lead to abnormal bruising or bleeding, high blood sugar, cardiovascular disorders (angina, myocardial infarction), eosinophilic pneumonia (rare pneumonia) bloating, gastric bloating, peripheral neuropathy (a disease that causes 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 kind of connective tissue disease), it may get worse.
Impaired liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), elevated liver enzymes, which may affect some medical tests. Inflammation of the blood vessels, often with skin rash.
Cases of photosensitivity (change in skin appearance) have been reported after exposure to sun or artificial UVA.
Not known (frequency can not be estimated from the available data):
Life-threatening arrhythmia (Torsade de pointes).
Blood, kidney, liver or pancreas can occur, and changes in laboratory performance (blood test). Your doctor may appoint blood tests to track your condition.
In case of hepatic failure (liver problems), hepatic encephalopathy (degenerative brain disease) is likely to develop. Shivering, stiff posture, facial expression (masked face), slow motion and leg drag, unsteady gait.
How to Store Co-Amlesa
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP / 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 light and moisture.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6.Containing the package and additional information
What Co-Amlessa contains
The active substances are tert-butylamine perindopril (perindopril tert-butylamine), amlodipine (amlodipine) and indapamide.
Co-Amlesa 2 mg / 5 mg / 0.625 mg
Each tablet contains 2 mg of tert-butylamine perindopril, 5 mg of amlodipine (as besylate) and 0.625 mg of indapamide.
Co-Amlesa 4 mg / 5 mg / 1.25 mg
Each tablet contains 4 mg of tert-butylamine perindopril, 5 mg of amlodipine (as besylate) and 1.25 mg of indapamide.
Co-Amlesa 4 mg / 10 mg / 1.25 mg
Each tablet contains 4 mg of tert-butylamine perindopril, 10 mg of amlodipine (as besylate) and 1.25 mg of indapamide.
Co-Amlesa 8 mg / 5 mg / 2.5 mg
Each tablet contains 8 mg of tert-butylamine perindopril, 5 mg of amlodipine (as besylate) and 2.5 mg of indapamide.
Co-Amlesa 8 mg / 10 mg / 2.5 mg
Each tablet contains 8 mg of tert-butylamine perindopril, 10 mg of amlodipine (as besylate) and 2.5 mg of indapamide.
The other ingredients are sodium bicarbonate, microcrystalline cellulose (E460), pregelatinised starch (type 1500), sodium starch glycollate (type A), silica, colloidal anhydrous magnesium stearate (E572) and calcium chloride hexahydrate.
What Co-Amlesa looks like and what the package contains
2 mg / 5 mg / 0.625 mg tablets: white to off-white, oval, biconvex tablets scored on one side and 9 mm long. The divider is only for ease of breaking, for easier swallowing, not for splitting 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 scored on one side with a length of 12 mm. The tablet can be divided into two equal doses.
8 mg / 5 mg / 2.5 mg tablets: white to off-white, round, biconvex, bevelled edges, 9 mm in diameter.
8 mg / 10 mg / 2.5 mg tablets: white to off-white, round, biconvex, scored on one side with bevelled edges, 9 mm in diameter. The tablet can
The tablets are supplied in cartons of 10, 14, 20, 28, 30, 56, 60, 84 and 90 tablets in a blister. Not all pack sizes may be marketed.