CO AMLESSA 8 mg. / 10 mg. /. 30 tablets

What is Co-Amlessa and what it is used
Co-Amlessa is prescribed for the treatment of high blood pressure (hypertension). All three substances help to control high blood pressure (hypertension). Patients already receiving perindopril / indapamide and amlodipine from separate tablets can instead receive one tablet Co-Amlessa which contains three components.
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 blood vessels so that the blood flows through them more easily. Indapamide increases the amount of urine excreted by the kidneys. Each of the active ingredients reduces blood pressure and they work simultaneously to control your blood pressure.

2. What you need to know before taking Co-Amlessa
Do not take Co-Amlessa:
If you are allergic to perindopril or any other ACE inhibitor, or to indapamide or other sulfonamides, amlodipine besylate or other dihydropyridines or any of the other ingredients of Co-Amlessa (listed in section 6);
If you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous treatment with an ACE inhibitor, or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema);
If you have 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, concentrations of 8 mg / 5 mg / 2.5 mg and 8 mg / 10 mg / 2.5 mg is contraindicated if you have severe and moderate renal disease;
If you have low or high levels of potassium in the blood;
If you suspect that you suffer 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 the main blood vessel leaving the heart) or unstable angina (chest pain that can occur during the holiday);
If you have very low blood pressure (hypotension);
If you suffer from heart failure (the heart can not pump blood adequately, leading to shortness of breath or peripheral edema such as swollen legs, ankles or feet) after acute myocardial infarction;
If you are pregnant after 3 months (it is also better to avoid Co-Amlessa in early pregnancy - see "Pregnancy and lactation");
If you are breastfeeding.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Co-Amlessa:
if you have recently had a heart attack;
if you have aortic stenosis (narrowing of the main blood vessel that exits the heart);
if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (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;
you have a very high blood pressure (hypertensive crisis);
if you have liver problems;
if you have a connective tissue disease (a skin disease), such as systemic lupus erythematosus or scleroderma;
if you have atherosclerosis (hardening of the arteries);
if you suffer from hyperparathyroidism (overactive parathyroid gland);
if you suffer from gout;
if you have diabetes;
if you are on a diet with limited salt intake or use salt substitutes that contain potassium;
if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Co-Amlessa should be avoided (see. "Taking other medicines");
if you are elderly and your dose needs to be increased.
You should tell your doctor if you think you are (or might become) pregnant. Co-Amlessa not recommended in early pregnancy and must not be taken if you are pregnant after 3 months, as it may cause serious harm to your baby if used at that stage (see "Pregnancy and lactation") .
When taking co-Amlessa, you should also tell your doctor or medical staff:
if you are 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 through the apparatus);
if you are undergoing treatment for desensitization to reduce the effects of an allergy after a sting from bees or wasps;
if you will be subjected to medical examination, which requires injection of iodinated contrast agent (a substance that makes organs like kidney or stomach visible on X-rays).
Athletes should be aware that the Co-Amlessa contains an active ingredient (indapamide) which may give a positive reaction in doping tests.

Children and adolescents
Co-Amlessa not recommended for use in children and adolescents.

Other medicines and Co-Amlessa
Tell your doctor or pharmacist if you are taking, have recently taken or may have used other drugs.

You should avoid co-Amlessa with:
Lithium (used to treat depression);
Potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Co-treatment with Amlessa can be affected by other drugs.
You should tell your doctor if you are taking any of these medicines as may be required special attention:
Other drugs for the treatment of high blood pressure;
Procainamide (to treat irregular heart beat);
Allopurinol (for 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 the transplantation to prevent rejection (eg. Cyclosporin);
Ritonavir, indinavir, nelfinavir (so called protease inhibitors used for the treatment of HIV);
Medicines to treat cancer;
Ketoconazole, itraconazole (antifungal medicines);
Rifampicin, erythromycin, clarithromycin (antibiotics);
Halofantrine (used to treat certain types of malaria);
Pentamidine (used for the treatment of pneumonia);
Injectable gold (used to treat rheumatoid arthritis);
Vincamine (used to treat symptomatic cognitive disorders in adults, including memory loss);
Bepridil, verapamil, diltiazem (heart medicine);
Sultopride (to treat psychosis);
Drugs used for heart rhythm problems (eg. Quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
Digoxin or other cardiac glycosides (for the treatment of heart disease);
Baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis);
Medicines to treat diabetes, such as insulin or metformin;
Calcium, including calcium supplements;
Stimulant laxatives (eg senna);
Nonsteroidal anti-inflammatory agents (eg., Ibuprofen), or high doses of salicylates (eg. Aspirin);
Amphotericin B for injection (for the treatment of serious fungal diseases);
Medicines to treat psychiatric disorders such as depression, anxiety, schizophrenia (eg. Tricyclic antidepressants);
Tetracosactide (for the treatment of Crohn's disease);
Hypericum perforatum (St. John's Wort);
Dantrolene (infusion for fever);
Simvastatin (cholesterol lowering drugs);
Anesthetics.
Co-Amlessa with food and drink
Preferably Co-Amlessa be taken before meals.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist before you start taking this medicine.

pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking Co-Amlessa before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Co-Amlessa. Co-Amlessa not recommended in early pregnancy and must not be taken after the third month, as it may cause serious harm to your baby if used after the third month of pregnancy.

breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Co-Amlessa is contraindicated for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely. Visit your doctor immediately.

Driving and using machines
Co-Amlessa not affect alertness but you may feel dizziness or weakness due to low blood pressure, which can affect the ability to drive and use machines. It is not recommended to drive or operate machinery until you know how you act Co-Amlessa.

3. How to take Co-Amlessa
Always take this medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once daily. It is preferable to take the tablet in the morning before eating. Swallow the tablet with a glass of water.

If necessary, co-Amlessa 4 mg / 10 mg / 1,25 mg and the Co-Amlessa 8 mg / 10 mg / 2,5 mg could be divided into two equal doses. You can divide Co-Amlessa 4 mg / 10 mg / 1,25 mg or Co-Amlessa 8 mg / 10 mg / 2,5 mg tablet, putting it on the surface with the score facing upwards. Then press with two fingers from both sides of the tablet.
Your doctor will decide the right dose for you. Co-Amlessa be prescribed to patients already receiving perindopril / indapamide and amlodipine from separate tablets.

If you take more than the amount of co-Amlessa
If you take too many tablets, contact your doctor or nearest hospital immediately! The most likely effect in case of overdose, lowering blood pressure.
If you develop low blood pressure (symptoms such as dizziness or faintness), can help you if you lie down with legs raised.

If you forget to take Co-Amlessa
It is important to take your medicine every day as regular treatment is more effective.
However, if you forget to take a dose of Co-Amlessa, 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-Amlessa
As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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 feel something of the following, stop taking the medicine and tell your doctor:
Symptoms of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty breathing;
Severe dizziness or fainting;
Unusually fast or irregular heart beat.
In decreasing order of frequency, side effects can include:
Common (may affect up to 1 in 10 people):
headache, feelings of dizziness, vertigo, pins and needles, somnolence (sleepiness), visual disturbances (including diplopia), fainting due to low blood pressure, tinnitus (sensation of tinnitus), low blood pressure, palpitations (very fast heartbeat), flushing (hot or warm flush on the face), shortness of breath, cough, gastrointestinal disturbances (nausea, pain epigastruma, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhea, constipation), cramps, edema (swelling of the feet or ankles), feeling tired.
Uncommon (may affect up to 1 in 100 people):
allergic reactions (such as skin rashes, itching), mood swings, sleep disturbances, insomnia, depression, tremors, loss of sensation of pain, syncope (temporary loss of consciousness), rhinitis (nasal congestion or runny nose), bronchospasm (tightness of the chest, wheezing and shortness of breath), changes in bowel habits, angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), sweating, hair loss, red or discolored skin patches, back pain, muscle or joint pain, kidney problems, frequent urination, especially at night, impotence, breast enlargement in men, chest pain, pain, malaise, weight gain or reduction.
Very rare (may affect up to 1 in 10,000 people):
high blood sugar, confusion, cardiovascular disorders (irregular heart beat, angina, myocardial infarction), eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, bloating (gastritis), 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 type of connective tissue disease), it could be worse;
Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA.
Not known (frequency can not be estimated from available data):
life-threatening arrhythmia (Torsade de pointes);
May develop a blood disorder, kidney, liver or pancreas and changes in laboratory parameters (blood tests). Your doctor may order blood tests to monitor your condition;
In case of hepatic insufficiency (liver problems) are likely to develop hepatic encephalopathy (degenerative brain disease).
If you get any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Co-Amlessa
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the pack after EXP. 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 light and moisture.