Co-amlessa

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language

Co-Amlessa, 4 mg + 5 mg + 1.25 mg, Tablets

tert-Butylamine perindopril + Amlodipine + Indapamide

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Co-Amlessa and what is it used for
• 2. Important information before taking Co-Amlessa
• 3. How to take Co-Amlessa
• 4. Possible side effects
• 5. How to store Co-Amlessa
• 6. Contents of the pack and other information

1. What is Co-Amlessa and what is it used for

Co-Amlessa is used to treat high blood pressure (hypertension). All three active substances help control high blood pressure. Patients already taking perindopril/indapamide and amlodipine in separate tablets can take one Co-Amlessa tablet instead, which contains all three components.
Co-Amlessa is a combination of three active substances: perindopril, indapamide, and amlodipine. Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines).
Indapamide is a diuretic.
In patients with high blood pressure, perindopril and amlodipine cause blood vessels to relax, making it easier for blood to flow through them. Indapamide increases the amount of urine excreted by the kidneys. Each active substance lowers blood pressure, and together they effectively control it.

2. Important information before taking Co-Amlessa

When not to take Co-Amlessa

Warnings and precautions

Before taking Co-Amlessa, discuss it with your doctor or pharmacist.

• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals. See also the information under the heading "When not to take Co-Amlessa" and "Warnings and precautions".
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitors (used to prevent organ rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, vildagliptin (used to treat diabetes),
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Co-Amlessa. This reaction can occur at any time during treatment. If such symptoms occur, stop taking Co-Amlessa and consult your doctor immediately. See also section 4.
Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Co-Amlessa is not recommended during pregnancy and should not be taken after 3 months of pregnancy, as it can seriously harm the baby if taken during this period (see "Pregnancy and breastfeeding").
While taking Co-Amlessa, also inform your doctor or medical staff:

Athletes should be informed that Co-Amlessa contains an active substance (indapamide) that can give a positive result in doping tests.

Children and adolescents

Co-Amlessa is not recommended for children and adolescents.

Co-Amlessa with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Co-Amlessa should be avoided with:

• lithium (used to treat depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, and other medicines that can increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection and treat cancer, and heparin, a medicine used to thin the blood and prevent clots);
• sacubitril/valsartan (used to treat chronic heart failure). See sections "When not to take Co-Amlessa" and "Warnings and precautions";
• estrustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin receptor blockers.

Other medicines may affect the action of Co-Amlessa.
Tell your doctor if you are taking any of the following medicines, as special care may be required:

• other medicines used to treat high blood pressure, including angiotensin receptor blockers (ARBs) or aliskiren (see also sections "When not to take Co-Amlessa" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• anesthetics;
• iodine-containing contrast agents;
• moxifloxacin, sparfloxacin, rifampicin, erythromycin, clarithromycin (antibiotics used to treat infections);
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, or astemizole);
• corticosteroids (used to treat various conditions, including asthma and rheumatoid arthritis);
• immunosuppressive medicines used to treat autoimmune disorders or prevent organ rejection (e.g., cyclosporine);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infections);
• cancer medicines;
• ketoconazole, itraconazole (antifungal medicines);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold injections (used to treat rheumatoid arthritis);
• vincamine (used to treat cognitive disorders in the elderly, including memory disorders);
• bepridil, verapamil, diltiazem (heart medicines);
• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used to treat heart conditions);
• baclofen (used to treat muscle stiffness, e.g., in multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives that stimulate intestinal peristalsis (e.g., senna);
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) or high doses of salicylates (e.g., aspirin);
• amphotericin B injections (used to treat severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• tetracosactide (used to treat Crohn's disease);
• trimethoprim (used to treat infections);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• Hypericum perforatum(St. John's Wort);
• dantrolene (used to treat severe body temperature disorders);
• tacrolimus (used to modify the immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporine (an immunosuppressive medicine);
• medicines commonly used to treat diarrhea (racecadotril) or prevent organ rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See the "Warnings and precautions" section.

Your doctor may need to change the dose and/or take other precautions:

Taking Co-Amlessa with food and drink

It is recommended to take Co-Amlessa before a meal.
Patients taking Co-Amlessa should not consume grapefruit juice or grapefruits, as they can increase the levels of the active substance amlodipine in the blood, which can lead to unforeseen intensification of the action of Co-Amlessa, lowering blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Your doctor will usually recommend stopping Co-Amlessa before planned pregnancy or as soon as pregnancy is detected and will recommend taking another medicine. Co-Amlessa is not recommended during the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it can seriously harm the baby if taken during this period.

Breastfeeding

It has been shown that small amounts of amlodipine pass into breast milk.
Inform your doctor about breastfeeding or intending to breastfeed. Co-Amlessa is not recommended for breastfeeding women. Your doctor may recommend another medicine if you want to continue breastfeeding, especially if the baby is a newborn or premature.
Consult your doctor immediately.

Driving and using machines

Co-Amlessa does not affect concentration, but dizziness or weakness due to low blood pressure may occur, which can affect the ability to drive and use machines. Do not drive or operate machinery until you know how Co-Amlessa affects you.

Co-Amlessa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Co-Amlessa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Co-Amlessa is available in the following strengths: 2 mg + 5 mg + 0.625 mg; 4 mg + 5 mg + 1.25 mg; 4 mg + 10 mg + 1.25 mg; 8 mg + 5 mg + 2.5 mg; 8 mg + 10 mg + 2.5 mg.
The recommended dose is one tablet per day. It is recommended to take the medicine in the morning before breakfast.
Swallow the tablet with a glass of water.
Your doctor will decide which dose is suitable for you. Co-Amlessa is recommended for patients already taking perindopril/indapamide and amlodipine in separate tablets.

Overdose of Co-Amlessa

If you have taken more than the prescribed dose, contact your doctor or go to the emergency department of the nearest hospital immediately. The most likely side effect of overdose is low blood pressure. If you experience a significant drop in blood pressure (symptoms such as dizziness or fainting), lie down with your legs raised.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missed dose of Co-Amlessa

It is important to take the medicine every day, as this ensures the effectiveness of the treatment. If you miss a dose of Co-Amlessa, take the next dose at the usual time.
Do not take a double dose to make up for the missed tablet.

Stopping Co-Amlessa treatment

Since antihypertensive therapy is usually long-term, consult your doctor before stopping the 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, Co-Amlessa can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Co-Amlessa and contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (frequent - may occur in up to 1 in 10 patients),
• bronchospasm (feeling of chest tightness, wheezing, and shortness of breath) (uncommon - may occur in up to 1 in 100 patients),
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema, see section 2 "Warnings and precautions") (uncommon - may occur in up to 1 in 100 patients),
• severe skin reactions, including erythema multiforme (a skin rash often starting with red, itchy patches on the face, arms, or legs) or severe skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (very rare - may occur in up to 1 in 10,000 patients),
• cardiovascular disorders (heart rhythm disorders, angina pectoris, heart attack) (very rare - may occur in up to 1 in 10,000 patients),
• weakness or numbness of the arms or legs, or speech disorders, which can be symptoms of a stroke (very rare - may occur in up to 1 in 10,000 patients),
• pancreatitis, which can cause severe abdominal pain radiating to the back with very poor general condition (very rare - may occur in up to 1 in 10,000 patients),
• jaundice (yellowing of the skin or eyes), which can be a sign of liver inflammation (very rare - may occur in up to 1 in 10,000 patients),
• life-threatening heart rhythm disorders (frequency not known),
• liver disease that causes brain damage (hepatic encephalopathy) (frequency not known),
• muscle weakness, cramps, tenderness, or pain, especially if you also feel unwell or have a high temperature, which can be caused by abnormal muscle breakdown (frequency not known).

Side effects are listed below by frequency:

• Very common (may occur in more than 1 in 10 patients): edema (fluid retention).
• Common (may occur in up to 1 in 10 patients): skin reactions in patients prone to allergic or asthmatic reactions, low potassium levels in the blood, headache, dizziness, balance disorders, tingling or numbness, drowsiness, vision disturbances, feeling of "emptiness" in the head due to low blood pressure, tinnitus (ringing in the ears), low blood pressure, palpitations (very rapid heart rate), flushing (especially of the face), shortness of breath, cough, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, changes in bowel movements, indigestion or digestive disorders, diarrhea, constipation), dryness of the mucous membranes of the mouth, allergic reactions (such as skin rashes, itching), muscle cramps, swelling of the ankles, weakness, feeling of tiredness.
• Uncommon (may occur in up to 1 in 100 patients): nasal congestion (nasal stuffiness or runny nose), increased eosinophil count (a type of white blood cell), hypoglycemia (very low blood sugar levels), changes in laboratory test results: high potassium levels in the blood, which usually return to normal after stopping the treatment, low sodium levels in the blood, which can cause dehydration and low blood pressure, mood changes, sleep disturbances, insomnia, depression, tremors, loss of pain sensation, tachycardia (rapid heart rate), heart rhythm disorders, inflammation of blood vessels, bronchospasm (constriction of the airways), angioedema (see section 2 "Warnings and precautions"), hives, blistering, redness of the skin, increased sweating, hair loss, red or discolored patches on the skin, hypersensitivity reactions to sunlight (increased skin sensitivity to the sun), back pain, muscle or joint pain, kidney problems, increased urination (especially at night), impotence (inability to achieve or maintain an erection), breast enlargement in men, chest pain, pain, general poor condition, fever, increased urea levels in the blood, increased creatinine levels in the blood, weight gain or loss, falls, fainting.

In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.

• Rare (may occur in up to 1 in 1,000 patients): disorientation, worsening of psoriasis, acute kidney failure, reduced or absent urine production, changes in laboratory test results: high calcium levels, increased liver enzyme activity, high bilirubin levels in the blood, dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion), low chloride levels in the blood, low magnesium levels in the blood.
• Very rare (may occur in up to 1 in 10,000 patients): changes in blood parameters, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin and hematocrit values, decreased platelet count, high blood sugar levels (hyperglycemia), cardiovascular disorders (such as angina or heart attack), eosinophilic pneumonia (a rare type of pneumonia), gum swelling, pancreatitis, liver dysfunction, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzyme activity. Liver dysfunction can cause serious side effects, including liver failure.
• Frequency not known: abnormal heart rhythm, changes in laboratory test results: high uric acid levels, short-sightedness, blurred vision, eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute glaucoma), life-threatening heart rhythm disorders (torsades de pointes type tachycardia). In patients with liver dysfunction (liver problems), there is a risk of developing hepatic encephalopathy (a condition that causes brain damage). Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Co-Amlessa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store below 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Co-Amlessa contains

• The active substances of Co-Amlessa are perindopril tert-butylamine, amlodipine (as amlodipine besylate), and indapamide. Each tablet contains 4 mg of perindopril tert-butylamine, 5 mg of amlodipine (as amlodipine besylate), and 1.25 mg of indapamide.
• The other ingredients are: microcrystalline cellulose (E 460), maize starch, sodium chloride, sodium hydrogen carbonate, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2 "Co-Amlessa contains sodium".

What Co-Amlessa looks like and contents of the pack

White to almost white, round, slightly convex tablets with beveled edges, 7 mm in diameter.
Packaging:30 and 60 tablets in OPA/Al/PVC/Al blisters, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:14-0026

Parallel import authorization number: 303/24

Date of approval of the leaflet: 25.07.2024

[Information about the trademark]