Co-Amlessa 8 mg. / 5 mg. / 2.5 mg. 30 tablets

What Co-Amlessa is and what it is used for
Co-Amlessa is prescribed for the treatment of high blood pressure (hypertension). All three substances help control high blood pressure (hypertension). Patients already taking perindopril / indapamide and amlodipine as separate tablets may instead receive one Co-Amlesa tablet that contains 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 lowers blood pressure and they act simultaneously to control your blood pressure.

2. What you need to know before you take Co-Amlessa
Do not take Co-Amblessa:

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 pruritus or severe skin rashes with 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 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 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 a severe decrease in 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, it is better to avoid Co-Amlesa in early pregnancy - see "Pregnancy and breast-feeding");
If you are breastfeeding.
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);
if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (a 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 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 (hyperfunction of the parathyroid gland);
if you suffer from gout;
if you have diabetes;
if you are on a low-salt diet or use potassium salt substitutes that 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.
You should tell your doctor if you think you are (or may be) pregnant. Co-Amlesa is not recommended in early pregnancy and should not be taken if you are pregnant after 3 months because it can cause serious harm to your baby if used during this period (see "Pregnancy and breast-feeding") .

When you are taking Co-Amlesa, you should also tell your doctor or health care professional:

if you are going 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 (removing blood cholesterol through an apparatus);
if you will be subjected to a desensitization treatment to reduce the effects of allergy after bee or axle stings;
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 stomach visible on X-rays).
Athletes should know that Co-Amlesa contains an active ingredient
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 may have used 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 for the treatment of high blood pressure;
Procainamide (for the treatment of 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 transplantation to prevent rejection (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 polyarthritis);
Vincamine (used to treat symptomatic cognitive disorders in adults, including memory loss);
Bepridil, verapamil, diltiazem (heart medicines);
Sulpride (for the treatment of psychosis);
Medicines used for heart rhythm problems (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
Digoxin or other cardiac glycosides (to treat heart problems);
Baclofen (for the treatment of muscle stiffness occurring in such diseases as multiple sclerosis);
Medicines to treat diabetes such as insulin or metformin;
Calcium, including calcium supplements;
Stimulating laxatives (for example, senna);
Non-steroidal anti-inflammatory drugs (eg ibuprofen) or high doses of salicylates (eg aspirin);
Amphotericin B (for the treatment of severe fungal diseases);
Medicines for the treatment of mental illnesses such as depression, anxiety, schizophrenia (eg tricyclic antidepressants, neuroleptics);
Tetracosactide (for the treatment of Crohn's disease);
Hypericum perforatum (St. John's Wort);
Dannrol (infusion at elevated temperature);
Simvastatin (cholesterol-lowering medicines);
Anesthetics.
Co-Amlesa with food and beverages
It is preferable to take Co-Amblese before a meal.

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 taking this medicine.

Pregnancy
You should tell your doctor if you think you are pregnant (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 during early pregnancy and should 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 breast-feeding or intend to breast-feed. Co-Amlesa is contraindicated for mothers who are breast-feeding and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is newborn or premature. Visit your doctor immediately.

Driving and using machines
Co-Amlesa does not affect alertness, but you may experience dizziness or weakness due to low blood pressure, which may affect the ability to drive and use machines. It is not recommended to drive or use machines until you know how your Co-Amblese works.
How to take Co-Amlesa
Always take this medicine exactly as your doctor or pharmacist has told you. Check with 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.

If necessary, Co-Amlesa 4 mg / 10 mg / 1.25 mg and Co-Amlesa 8 mg / 10 mg / 2.5 mg can be divided into two equal doses. You can separate Co-Ammesa 4 mg / 10 mg / 1.25 mg or Co-Amlesa 8 mg / 10 mg / 2.5 mg tablet, placing it on the face with the score line up. Then, press two fingers on both sides of the tablet.
Your doctor will evaluate the dose you need. Co-Amlesa is prescribed to patients already taking perindopril / indapamide and amlodipine as single tablets.

If you take more Co-Amlesa than you should
If you have taken too many tablets, contact your doctor or nearest hospital immediately! The most likely effect in case of overdose is a decrease in blood pressure.
If you develop a low blood pressure (symptoms such as dizziness or fainting), it can help if you lie down with raised legs.

If you forget to take Co-Amblese
It is important to take your medicine every day because regular treatment is more effective.
However, if you miss a dose of Co-Amlesa, take the next dose at the usual time.
Do not take a double dose to make up for the missed tablet.

If you stop taking Co-Amblese
Since high blood pressure is usually life-long, you should discuss 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 everyone gets them.

If you experience any of the following, stop taking the medicine immediately and tell your doctor:

Symptoms of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty in breathing;
Severe dizziness or fainting;
Unusually fast or uneven heartbeat.
In descending order of frequency, side effects may include:
Common (may affect up to 1 in 10 people):

headache, dizziness, dizziness, 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, dyspepsia or dyspepsia). digestive difficulties Here, diarrhea, constipation), cramps, edema (swelling of the feet or ankles), feeling tired.
Uncommon (may affect up to 1 in 100 people):

allergic reactions (eg skin rashes, pruritus), mood swings, sleep disturbances, insomnia, depression, trembling, loss of pain, syncope (temporary loss of consciousness), rhinitis (nasal congestion or runny nose), bronchospasm abdominal pain (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 decrease.
Very rare (may affect up to 1 in 10,000 people):

high blood sugar, confusion, cardiovascular disorders (irregular heartbeat, angina pectoris, myocardial infarction), eosinophilic pneumonia (rare pneumonia), swollen gums, abdominal (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 kind of connective tissue disease), it may get worse;
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 disease and changes in laboratory parameters (blood test) may occur. Your doctor may appoint blood tests to track your condition;
In case of hepatic failure (liver problems), hepatic encephalopathy (degenerative brain disease
6. Package Contents and Additional Information
What Co-Amlesa contains
The active substances are: tert-butylamine perindopril, 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 indiaamide.

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 a beigelate) 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.

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