Co-amlessa

Package Leaflet: Information for the Patient

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

Co-Amlessa, 8 mg + 5 mg + 2.5 mg, Tablets

Tert-Butylamine Perindopril + Amlodipine + Indapamide

You Should Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

• You Should Keep this Leaflet, so that You Can Read it Again if Necessary.
• In Case of Any Doubts, You Should Consult a Doctor or Pharmacist.
• This Medication Has Been Prescribed to a Specific Person. Do Not Pass it on to Others. The Medication May Harm Another Person, Even if the Symptoms of Their Illness are the Same.
• If the Patient Experiences Any Undesirable Effects, Including Any Undesirable Effects Not Mentioned in this Leaflet, They Should Inform the 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 Using Co-Amlessa
• 3. How to Use Co-Amlessa
• 4. Possible Undesirable Effects
• 5. How to Store Co-Amlessa
• 6. Contents of the Packaging 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 May Take One Co-Amlessa Tablet Containing All Three Components Instead.
Co-Amlessa is a Combination of Three Active Substances: Perindopril, Indapamide, and Amlodipine. Perindopril Belongs to Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors).
Amlodipine is a Calcium Antagonist (Belonging to a Group of Medications Called Dihydropyridines).
Indapamide is a Diuretic.
In Patients with High Blood Pressure, Perindopril and Amlodipine Cause Relaxation of Blood Vessels, 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 Using Co-Amlessa

When Not to Use Co-Amlessa

• If the Patient is Allergic to Perindopril or Any Other ACE Inhibitor, Indapamide or Any Other Sulfonamide, Amlodipine Besylate or Any Other Dihydropyridine, or Any of the Other Components of this Medication (Listed in Section 6);
• If the Patient has Experienced Symptoms Such as Wheezing, Facial or Tongue Edema, Intense Itching, or Severe Skin Rashes During Previous Treatment with an ACE Inhibitor, or if the Patient or a Family Member has Experienced Such Symptoms in Any Other Situation (a Condition Called Angioedema);
• If the Patient has Liver Disease or a Condition Called Hepatic Encephalopathy (a Disease Causing Brain Damage);
• If the Patient has Severe Kidney Impairment (Creatinine Clearance Below 30 ml/min);
• If the Patient has Severe Kidney Disease that Reduces Blood Flow to the Kidneys (Renal Artery Stenosis). Co-Amlessa 8 mg + 5 mg + 2.5 mg is Contraindicated in Severe or Moderate Kidney Disease;
• If the Patient is Undergoing Dialysis or Blood Filtration by Other Methods. Depending on the Device Used, Co-Amlessa May Not be Suitable for the Patient;
• If the Patient has Low or High Potassium Levels in the Blood;
• If there is a Suspicion of Untreated, Uncontrolled Heart Failure (Symptoms Include Fluid Retention and Breathing Difficulties);
• If the Patient has Cardiogenic Shock (a Condition Where the Heart Cannot Supply Enough Blood to Meet the Body's Needs), Aortic Stenosis (Narrowing of the Main Blood Vessel Leaving the Heart), or Unstable Angina (Chest Pain that May Occur at Rest);
• If the Patient has Very Low Blood Pressure (Severe Hypotension);
• If the Patient has Heart Failure (the Heart is Not Able to Pump Enough Blood) After a Recent Heart Attack;
• If the Patient is Pregnant More than 3 Months (it is Also Recommended to Avoid Using Co-Amlessa in Early Pregnancy - See "Pregnancy and Breastfeeding");
• If the Patient has Diabetes or Kidney Impairment and is Being Treated with a Blood Pressure-Lowering Medication Containing Aliskiren;
• If the Patient has Taken or is Currently Taking a Combination Medication Containing Sacubitril and Valsartan (a Medication Used to Treat a Certain Type of Chronic Heart Failure in Adults), as the Risk of Angioedema (Rapid Swelling of Tissues) Increases.

Warnings and Precautions

Before Starting Co-Amlessa, the Patient Should Discuss it with Their Doctor or Pharmacist.

• If the Patient has Recently Had a Heart Attack;
• If the Patient has Aortic Stenosis (Narrowing of the Main Blood Vessel Leaving the Heart) or Hypertrophic Cardiomyopathy (a Heart Muscle Disease) or Renal Artery Stenosis (Narrowing of the Artery Supplying Blood to the Kidney);
• If the Patient has Heart Failure or Any Other Heart Disease;
• If the Patient has Kidney Disease or is Undergoing Dialysis;
• If the Patient has Experienced a Significant Increase in Blood Pressure (Hypertensive Crisis);
• If the Patient has Muscle Disorders, Including Muscle Pain, Tenderness, Weakness, or Cramps;
• If the Patient has High Levels of a Hormone Called Aldosterone in the Blood (Primary Aldosteronism);
• If the Patient has Liver Disease;
• If the Patient has Collagenosis (a Skin Disease), Such as Systemic Lupus Erythematosus or Scleroderma;
• If the Patient has Atherosclerosis (Hardening of the Arteries);
• If the Patient has Hyperparathyroidism;
• If the Patient has Gout;
• If the Patient has Diabetes;
• If the Patient is on a Low-Sodium Diet or Using Salt Substitutes Containing Potassium;
• If the Patient is Taking Lithium or Potassium-Sparing Diuretics (such as Spironolactone, Triamterene) or Potassium Supplements, as Their Use with Co-Amlessa is Not Recommended (see "Co-Amlessa and Other Medications");
• If the Patient is Elderly and Requires a Dose Increase;
• If the Patient has Experienced Hypersensitivity Reactions to Light;
• If the Patient has Experienced a Severe Allergic Reaction with Facial, Lip, Mouth, Tongue, or Throat Edema, which May Cause Difficulty Swallowing or Breathing (Angioedema). Angioedema May Occur at Any Time During Treatment. If Such Symptoms Occur, the Patient Should Stop Taking Co-Amlessa and Consult a Doctor Immediately;
• If the Patient is Taking Any of the Following Medications Used to Treat High Blood Pressure:
• Angiotensin Receptor Blockers (ARBs) (also Known as Sartans - e.g., Valsartan, Telmisartan, Irbesartan), Especially if the Patient has Kidney Impairment Related to Diabetes,
• Aliskiren. The Doctor May Monitor Kidney Function, Blood Pressure, and Electrolyte Levels (e.g., Potassium) in the Blood at Regular Intervals. See also the Information Under the Heading "When Not to Use Co-Amlessa" and "Warnings and Precautions".
• If the Patient is of Black Race - in this Case, there May be a Greater Risk of Angioedema, and the Medication May be Less Effective in Lowering Blood Pressure than in Patients of Other Races;
• If the Patient is Undergoing Dialysis Using High-Permeability Membranes;
• If the Patient is Taking Any of the Following Medications, which May Increase the Risk of Angioedema (Rapid Swelling of Tissues):
• Racecadotril (Used to Treat Diarrhea),
• Sirolimus, Everolimus, Temsirolimus, and Other mTOR Inhibitors (Used to Prevent Transplant Rejection and Treat Cancer),
• Linagliptin, Saxagliptin, Sitagliptin, Vildagliptin (Used to Treat Diabetes),
• Sacubitril (Available in a Combination Medication Containing Sacubitril and Valsartan), Used to Treat Chronic Heart Failure.

Angioedema
Patients Treated with ACE Inhibitors, Including Co-Amlessa, have Reported Angioedema (Severe Allergic Reaction with Facial, Lip, Tongue, or Throat Edema, and Difficulty Swallowing or Breathing). This Reaction May Occur at Any Time During Treatment. If Such Symptoms Occur, the Patient Should Stop Taking Co-Amlessa and Consult a Doctor Immediately. See also Section 4.
The Patient Should Inform the Doctor About Pregnancy, Suspected Pregnancy, or Planned Pregnancy. Co-Amlessa is Not Recommended During Early Pregnancy and Should Not be Used After 3 Months of Pregnancy, as it May Seriously Harm the Fetus if Used During this Period (see "Pregnancy and Breastfeeding").
During Co-Amlessa Treatment, the Patient Should Also Inform the Doctor or Medical Staff:

• If the Patient has a Dry Cough;
• If the Patient is to Undergo General Anesthesia and/or Surgery;
• If the Patient has Recently Had Diarrhea or Vomiting, or is Dehydrated;
• If the Patient is to Undergo Dialysis or LDL Apheresis (Removal of Cholesterol from the Blood Using a Special Device);
• If the Patient is to Undergo Desensitization to Reduce Allergic Reactions in Case of Insect Stings;
• If the Patient is to Undergo Tests Requiring the Use of Contrast Agents Containing Iodine (a Substance that Makes Certain Organs, such as the Kidneys or Stomach, Visible on X-rays);
• If the Patient Experiences Vision Loss or Eye Pain. These May be Symptoms of Fluid Accumulation in the Vascular Layer Surrounding the Eye (Excessive Fluid Accumulation Between the Choroid and Sclera) or Increased Intraocular Pressure - They May Occur Within a Few Hours to Weeks After Taking Co-Amlessa. If Left Untreated, they May Lead to Permanent Vision Loss. Patients with a History of Penicillin or Sulfonamide Allergy May be More Prone to Developing this Condition. Co-Amlessa Treatment Should be Discontinued and a Doctor Consulted.

Athletes Should be Informed that Co-Amlessa Contains the Active Substance Indapamide, which May Give a Positive Result in Doping Tests.

Children and Adolescents

Co-Amlessa is Not Recommended for Use in Children and Adolescents.

Co-Amlessa and Other Medications

The Patient Should Tell the Doctor or Pharmacist About All Medications They are Currently Taking or Have Recently Taken, as Well as Any Medications They Plan to Take.
The Patient Should Avoid Taking Co-Amlessa with:

• Lithium (Used to Treat Depression);
• Aliskiren (a Medication Used to Treat High Blood Pressure) in Patients Who Do Not Have Diabetes or Kidney Impairment;
• Potassium-Sparing Diuretics (e.g., Triamterene, Amiloride), Potassium Salts, and Other Medications that May Increase Potassium Levels in the Body (e.g., Trimethoprim and Cotrimoxazole, also Known as Trimethoprim/Sulfamethoxazole, Used to Treat Bacterial Infections; Cyclosporine, an Immunosuppressant Used to Prevent Transplant Rejection and Treat Cancer, and Heparin, a Medication Used to Thin the Blood to Prevent Clots);
• Sacubitril/Valsartan (Used to Treat Chronic Heart Failure). See Sections "When Not to Use Co-Amlessa" and "Warnings and Precautions";
• Estramustine (Used to Treat Cancer);
• Other Medications Used to Treat High Blood Pressure: ACE Inhibitors and Angiotensin Receptor Blockers.

Other Medications May Affect the Action of Co-Amlessa.
The Patient Should Inform the Doctor About Taking Any of the Following Medications, as Special Care May be Necessary:

• Other Medications Used to Treat High Blood Pressure, Including Angiotensin Receptor Blockers (ARBs) or Aliskiren (see also Sections "When Not to Use Co-Amlessa" and "Warnings and Precautions"), or Diuretics (Medications that Increase Urine Production);
• Potassium-Sparing Medications Used to Treat Heart Failure: Eplerenone and Spironolactone in Doses of 12.5 mg to 50 mg per Day;
• Anesthetics;
• Contrast Agents Containing Iodine;
• Moxifloxacin, Sparfloxacin, Rifampicin, Erythromycin, Clarithromycin (Antibiotics Used to Treat Infections);
• Methadone (Used to Treat Opioid 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);
• Immunosuppressants Used to Treat Autoimmune Disorders or After Transplantation to Prevent Rejection (e.g., Cyclosporine);
• Ritonavir, Indinavir, Nelfinavir (Protease Inhibitors Used to Treat HIV Infections);
• Cancer Medications;
• Ketoconazole, Itraconazole (Antifungal Medications);
• Halofantrine (Used to Treat Certain Types of Malaria);
• Pentamidine (Used to Treat Pneumonia);
• Gold in Injectable Medications (Used to Treat Rheumatoid Arthritis);
• Vinca Alkaloids (Used to Treat Cancer);
• Bepridil, Verapamil, Diltiazem (Cardiac Medications);
• Medications 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 Digitalis Glycosides (Used to Treat Heart Conditions);
• Baclofen (Used to Treat Muscle Stiffness in Conditions Such as Multiple Sclerosis);
• Medications 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 Medications (e.g., Ibuprofen) or High Doses of Salicylates (e.g., Aspirin);
• Amphotericin B in Injectable Medications (Used to Treat Severe Fungal Infections);
• Medications Used to Treat Mental Disorders, Such as Depression, Anxiety, or Schizophrenia (e.g., Tricyclic Antidepressants, Neuroleptics);
• Tetracosactide (Used to Treat Crohn's Disease);
• Trimethoprim (Used to Treat Infections);
• Vasodilators, Including Nitrates;
• Medications 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 Regulation Disorders);
• Tacrolimus (Used to Modify the Immune System's Response);
• Simvastatin (a Medication that Lowers Cholesterol Levels);
• Cyclosporine (an Immunosuppressant);
• Medications Commonly Used to Treat Diarrhea (e.g., Racecadotril) or Prevent Transplant Rejection (e.g., Sirolimus, Everolimus, Temsirolimus, or Other mTOR Inhibitors). See Section "Warnings and Precautions".

The Doctor May Need to Adjust the Dose and/or Take Other Precautions:

• If the Patient is Taking an Angiotensin Receptor Blocker (ARB) or Aliskiren (see also Sections "When Not to Use Co-Amlessa" and "Warnings and Precautions").

Using 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 Eat Grapefruits, as They May Increase the Levels of the Active Substance Amlodipine in the Blood, Leading to Unpredictable Intensification of Co-Amlessa's Blood Pressure-Lowering Effect.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or is Planning to Have a Child, They Should Consult a Doctor or Pharmacist Before Using this Medication.

Pregnancy

The Patient Should Inform the Doctor About Pregnancy, Suspected Pregnancy, or Planned Pregnancy. The Doctor Will Usually Advise Stopping Co-Amlessa Before Planned Pregnancy or as Soon as Pregnancy is Confirmed, and Prescribe Another Medication. Co-Amlessa is Not Recommended During the First Trimester of Pregnancy and Should Not be Used After 3 Months of Pregnancy, as it May Seriously Harm the Fetus if Used During this Period.

Breastfeeding

It has Been Shown that Small Amounts of Amlodipine Pass into Human Milk.
The Patient Should Inform the Doctor About Breastfeeding or Intention to Breastfeed. Co-Amlessa is Not Recommended for Breastfeeding Women. The Doctor May Prescribe Another Medication if the Patient Wants to Continue Breastfeeding, Especially if the Baby is a Newborn or Premature. The Patient Should Consult a Doctor Immediately.

Driving and Operating Machines

Co-Amlessa Does Not Affect Concentration, but Dizziness or Weakness Due to Low Blood Pressure May Occur, Which May Affect the Ability to Drive or Operate Machines. The Patient Should Not Drive or Operate Machines Until They are Familiar with Their Individual Reaction to Co-Amlessa.

Co-Amlessa Contains Sodium

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Considered "Sodium-Free".

3. How to Use Co-Amlessa

This Medication Should Always be Used as Directed by the Doctor or Pharmacist. If the Patient is Uncertain, They Should Consult a 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 Medication in the Morning Before a Meal.
The Tablet Should be Swallowed with a Glass of Water.
The Doctor Will Decide Which Dose is Suitable for the Patient. Co-Amlessa is Recommended for Patients Already Taking Perindopril/Indapamide and Amlodipine in Separate Tablets.

Overdose of Co-Amlessa

In Case of Overdose, the Patient Should Immediately Consult a Doctor or Go to the Emergency Department of the Nearest Hospital. The Most Likely Undesirable Effect of Overdose is Hypotension. If there is a Significant Drop in Blood Pressure (Symptoms Such as Dizziness or Fainting), the Patient Should Lie Down with Their Legs Elevated.
Up to 24-48 Hours After Taking the Medication, Shortness of Breath Due to Excess Fluid Accumulation in the Lungs (Pulmonary Edema) May Occur.

Missing a Dose of Co-Amlessa

It is Essential to Take the Medication Every Day, as it Ensures the Effectiveness of the Treatment. If a Dose of Co-Amlessa is Missed, the Next Dose Should be Taken at the Usual Time.
The Patient Should Not Take a Double Dose to Make Up for a Missed Tablet.

Stopping Co-Amlessa Treatment

Since Antihypertensive Therapy is Usually Long-Term, the Patient Should Discuss Stopping the Medication with Their Doctor Before Doing So.
If the Patient has Any Further Questions About Using this Medication, They Should Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like All Medications, Co-Amlessa Can Cause Undesirable Effects, Although Not Everyone Will Experience Them.

If the Patient Experiences Any of the Following Serious Undesirable Effects, They Should Stop Taking Co-Amlessa and Consult a Doctor Immediately:

• Severe Dizziness or Fainting Due to Low Blood Pressure (Frequent - May Occur in Up to 1 in 10 Patients),
• Bronchospasm (Feeling of Compression in the Chest, Wheezing, and Shortness of Breath) (Uncommon - May Occur in Up to 1 in 100 Patients),
• Facial, Lip, Mouth, Tongue, or Throat Edema, Difficulty Swallowing (Angioedema, See Section 2 "Warnings and Precautions") (Uncommon - May Occur in Up to 1 in 100 Patients),

Undesirable Effects are Listed in Order of Decreasing 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 with a Tendency to Allergic and Asthmatic Reactions, Low Potassium Levels in the Blood, Headache, Dizziness, Balance Disorders, Tingling and Numbness, Drowsiness, Vision Disorders, Feeling of "Empty Head" Due to Low Blood Pressure, Tinnitus (Ringing in the Ears), Low Blood Pressure, Palpitations (Very Rapid Heartbeat), Flushing, Especially of the Face, Shortness of Breath, Cough, Gastrointestinal Disorders (Nausea, Vomiting, Abdominal Pain, Taste Disorders, Changes in Bowel Movements, Indigestion or Digestive Disorders, Diarrhea, Constipation), Dryness of the Mucous Membranes, Allergic Reactions (Such as Skin Rashes, Itching), Muscle Cramps, Swelling of the Ankles, Weakness, Fatigue.
• Uncommon (May Occur in Up to 1 in 100 Patients): Nasal Congestion or Runny Nose, Increased Eosinophil Count (a Type of White Blood Cell), Hypoglycemia (Very Low Blood Sugar), Changes in Laboratory Test Results: High Potassium Levels in the Blood, Transient and Reversible, Low Sodium Levels in the Blood, Which May Cause Dehydration and Low Blood Pressure, Mood Changes, Sleep Disorders, Insomnia, Depression, Tremors, Loss of Pain Sensation, Tachycardia (Rapid Heartbeat), Heart Rhythm Disorders, Vasculitis (Inflammation of Blood Vessels), Bronchospasm (Feeling of Compression in the Chest, Wheezing, and Shortness of Breath), Angioedema (See Section 2 "Warnings and Precautions"), Hives, Blistering of the Skin, Erythema Multiforme (a Skin Rash Often Starting with Red, Itchy Patches on the Face, Arms, or Legs), Pruritus (Itching), Exfoliative Dermatitis (Skin Peeling), Photosensitivity Reactions (Increased Sensitivity of the Skin to Sunlight), Back Pain, Muscle or Joint Pain, Kidney Disorders, Increased Urination Frequency (Especially at Night), Impotence (Inability to Achieve or Maintain an Erection), Gynecomastia (Breast Enlargement in Men), Chest Pain, Pain, General Malaise, 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), there May be an Exacerbation of Symptoms.

• Rare (May Occur in Up to 1 in 1000 Patients): Disorientation, Exacerbation of Psoriasis, Acute Kidney Failure, Decreased 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): Blood Test Abnormalities, Such as Decreased White Blood Cell, Red Blood Cell, or Platelet Count, Decreased Hemoglobin or Hematocrit, High Blood Sugar (Hyperglycemia), Cardiovascular Disorders (e.g., Angina, Heart Attack, Stroke), Eosinophilic Pneumonia (a Rare Type of Pneumonia), Gum Hypertrophy (Gum Overgrowth), Pancreatitis (Inflammation of the Pancreas), Abdominal Distension (Stomach Swelling), Gastritis (Inflammation of the Stomach), Peripheral Neuropathy (a Disease Causing Loss of Sensation, Pain, or Inability to Control Muscles), Severe Skin Reactions (e.g., Erythema Multiforme). Abnormal Liver Function, Hepatitis, Jaundice, Increased Liver Enzyme Activity, Detected in Blood Tests.
• Unknown Frequency (Cannot be Estimated from Available Data): Abnormal Heart Function Detected in ECG, Changes in Laboratory Test Results: High Uric Acid Levels, Myopia (Nearsightedness), Blurred Vision, Vision Loss or Eye Pain Due to Increased Intraocular Pressure - These May be Symptoms of Fluid Accumulation in the Vascular Layer Surrounding the Eye (Excessive Fluid Accumulation Between the Choroid and Sclera) or Acute Angle-Closure Glaucoma. Life-Threatening Heart Rhythm Disorders (Torsades de Pointes). In Patients with Liver Impairment (Liver Disease), there is a Risk of Hepatic Encephalopathy (a Disease Causing Brain Damage). Tremors, Rigidity, Mask-Like Facial Expression, Slow Movements, and Shuffling Gait. Cyanosis, Numbness, and Pain in the Fingers or Toes (Raynaud's Phenomenon).

Reporting Undesirable Effects

If the Patient Experiences Any Undesirable Effects, Including Any Undesirable Effects Not Mentioned in this Leaflet, They Should Inform the Doctor or Pharmacist. Undesirable Effects Can be Reported Directly to the Department of Drug Safety, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
By Reporting Undesirable Effects, More Information on the Safety of this Medication Can be Collected.

5. How to Store Co-Amlessa

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
Do Not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
Store at a Temperature Below 30°C.
Store in the Original Packaging to Protect from Light and Moisture.
Medications Should Not be Disposed of in Sewers or Household Waste. The Patient Should Ask the Pharmacist How to Dispose of Unused Medications. This Will Help Protect the Environment.

6. Contents of the Packaging 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 8 mg of Perindopril tert-Butylamine, 5 mg of Amlodipine (as Amlodipine Besylate), and 2.5 mg of Indapamide.
• Other Ingredients are: Microcrystalline Cellulose (E 460), Corn Starch, Calcium Chloride Hexahydrate, Sodium Hydrogen Carbonate, Colloidal Silica, Magnesium Stearate (E 470b). See Section 2 "Co-Amlessa Contains Sodium".

What Co-Amlessa Looks Like and Contents of the Packaging

White to Almost White, Round, Biconvex Tablets with Beveled Edges, 9 mm in Diameter.
Packaging:30 and 60 Tablets in OPA/Al/PVC/Al Blisters, in a Cardboard Box.
For More Detailed Information, the Patient Should 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:14-0028

Parallel Import Authorization Number: 302/24

Date of Approval of the Leaflet: 25.07.2024

[Information about the Trademark]