Noliprel

Package Leaflet: Information for the Patient

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

Noliprel, 2.5 mg + 0.625 mg, Film-Coated Tablets
Perindopril Arginine + Indapamide

You Should Carefully Read the Contents of This Leaflet Before Taking the Medication, as It Contains Important Information for the Patient.

• You Should Keep This Leaflet, so You Can Read It Again if You Need to.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass It on to Others. The Medication May Harm Others, 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 Noliprel and What is it Used For
• 2. Important Information Before Taking Noliprel
• 3. How to Take Noliprel
• 4. Possible Side Effects
• 5. How to Store Noliprel
• 6. Contents of the Packaging and Other Information

1. What is Noliprel and What is it Used For

Noliprel is a Combination Medication Containing Two Active Substances: Perindopril and Indapamide.
This is an Antihypertensive Medication Used to Treat High Blood Pressure in Adults.
Perindopril Belongs to a Group of Medications Called Angiotensin-Converting Enzyme (ACE) Inhibitors. These Medications Work by Dilating Blood Vessels, Making it Easier for the Heart to Pump Blood.
Indapamide is a Diuretic. Diuretics Increase the Amount of Urine Excreted by the Kidneys. Indapamide Differs from Other Diuretics in that it Only Slightly Increases Urine Excretion.
Both Active Substances Lower Blood Pressure and Work Together to Normalize the Patient's Blood Pressure.

2. Important Information Before Taking Noliprel

When Not to Take Noliprel:

• If You are Allergic to Perindopril or Other ACE Inhibitors, to Indapamide or Other Sulfonamides, or to Any of the Other Components of This Medication (Listed in Section 6);
• If You Have Experienced Symptoms Such as Wheezing, Swelling of the Face or Tongue, Intense Itching, or Severe Skin Rashes When Taking an ACE Inhibitor in the Past, or if You Have Experienced Such Symptoms in Any Other Situation (a Condition Called Angioedema);
• If You Have Diabetes or Kidney Problems and are Being Treated with a Blood Pressure-Lowering Medication Containing Aliskiren;
• If You Have Severe Liver Disease or a Condition Called Hepatic Encephalopathy (a Disease that Damages the Brain);
• If You Have Severe Kidney Disease that Reduces Blood Flow to the Kidneys (Renal Artery Stenosis);
• If You are Undergoing Dialysis or Blood Filtration by Any Other Method. Depending on the Device Used, Noliprel May Not be Suitable for You.
• If You Have Low Potassium Levels in Your Blood;
• If You Have Untreated, Uncontrolled Heart Failure (Severe Fluid Retention, Breathing Difficulties);
• If You are Pregnant More Than 3 Months (It is Also Recommended to Avoid Taking Noliprel in Early Pregnancy - See "Pregnancy and Breastfeeding");
• If You Have Taken or are Currently Taking a Combination Medication Containing Sacubitril and Valsartan, Used to Treat Heart Failure, as the Risk of Angioedema (Rapid Swelling of Tissues Under the Skin in the Throat Area) Increases (See "Warnings and Precautions" and "Noliprel and Other Medications").

Warnings and Precautions

Before Starting to Take Noliprel, Discuss the Following with Your Doctor or Pharmacist:

• If You Have Aortic Stenosis (Narrowing of the Main Blood Vessel Carrying Blood from the Heart) or Hypertrophic Cardiomyopathy (a Heart Muscle Disease) or Renal Artery Stenosis (Narrowing of the Blood Vessel Supplying the Kidney);
• If You Have Heart Failure or Any Other Heart Conditions;
• If You Have Kidney Problems or are Undergoing Dialysis;
• If You Experience Vision Loss or Eye Pain. These May be Symptoms of Fluid Accumulation in the Vascular Layer of the Eye (Choroidal Effusion) or Increased Eye Pressure, Which Can Occur Within Hours or Weeks of Taking Noliprel. If Left Untreated, These Symptoms Can Lead to Permanent Vision Loss. If You Have Previously Been Allergic to Penicillin or Sulfonamides, You are at Greater Risk of Developing These Conditions.
• If You Have Muscle Disorders, Including Pain, Tenderness, Weakness, or Muscle Cramps;
• If You Have Elevated Levels of a Hormone Called Aldosterone in Your Blood (Primary Aldosteronism);
• If You Have Liver Disease;
• If You Have Collagenosis (a Skin Disease), Such as Systemic Lupus Erythematosus or Scleroderma;
• If You Have Atherosclerosis (Hardening of the Arteries);
• If You Have Hyperparathyroidism (a Condition Affecting the Parathyroid Glands);
• If You Have Gout;
• If You Have Diabetes;
• If You are on a Low-Salt Diet or Using Salt Substitutes Containing Potassium;
• If You are Taking Lithium or Potassium-Sparing Medications (Spironolactone, Triamterene), or Potassium Supplements - You Should Avoid Taking These Medications While Taking Noliprel (See "Noliprel and Other Medications");
• If You are Elderly;
• If You Have Had Allergic Reactions to Light;
• If You Experience Severe Allergic Reactions with Swelling of the Face, Lips, Mouth, Tongue, or Throat, Which Can Cause Difficulty Swallowing or Breathing (Angioedema) - Swelling Can Occur at Any Time During Treatment. If You Experience Such Symptoms, Stop Taking Noliprel and Consult Your Doctor Immediately;
• If You are Taking Any of the Following Medications Used to Treat High Blood Pressure:
• An Angiotensin II Receptor Antagonist (AIIRA), Also Known as a Sartan - for Example, Valsartan, Telmisartan, Irbesartan, Especially if You Have Diabetic Kidney Problems;
• Aliskiren. Your Doctor May Recommend Regular Monitoring of Kidney Function, Blood Pressure, and Electrolyte Levels (Such as Potassium) in Your Blood. See Also the Subsection "When Not to Take Noliprel".
• If You are 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 You are Undergoing Dialysis Using High-Permeability Membranes;
• If You are Taking Any of the Following Medications, Which Increase the Risk of Angioedema:
• Racecadotril (Used to Treat Diarrhea);
• Sirolimus, Everolimus, Temsirolimus, and Other Medications Belonging to the Group of Medications Called mTOR Inhibitors (Used to Prevent Transplanted Organ Rejection and to Treat Cancer);
• Sacubitril (Available in a Combination Medication Containing Sacubitril and Valsartan), Used to Treat Chronic Heart Failure;
• Linagliptin, Saxagliptin, Sitagliptin, Vildagliptin, and Other Medications Belonging to the Group of Medications Called Gliptins (Used to Treat Diabetes).

Angioedema
Patients Treated with ACE Inhibitors, Including Noliprel, Have Reported Angioedema (Severe Allergic Reaction with Swelling of the Face, Lips, Tongue, or Throat, and Difficulty Swallowing or Breathing). This Reaction Can Occur at Any Time During Treatment. If You Experience Such Symptoms, Stop Taking Noliprel and Consult Your Doctor Immediately. See Also Section 4.
You Should Inform Your Doctor About Pregnancy, Suspected Pregnancy, or Planned Pregnancy. Usually, Your Doctor Will Advise You to Stop Taking Noliprel Before Becoming Pregnant or as Soon as You Find Out You are Pregnant, and Will Prescribe Another Medication Instead of Noliprel. It is Not Recommended to Take Noliprel in Early Pregnancy and It Must Not be Taken After 3 Months of Pregnancy, as It Can Cause Serious Harm to the Baby (See "Pregnancy and Breastfeeding").
When Taking Noliprel, You Should Also Inform Your Doctor or Medical Staff:

• If You are to Undergo Anesthesia and (or) Surgery;
• If You Have Recently Experienced Diarrhea or Vomiting, or if You are Dehydrated;
• If You are to Undergo Dialysis or LDL Apheresis (Removal of Cholesterol from the Blood Using a Special Device);
• If You are to Undergo Desensitization Treatment to Reduce Allergic Reactions to Bee or Wasp Stings;
• If You are to Undergo a Test Requiring the Administration of a Contrast Agent Containing Iodine (a Substance that Allows Organs Such as the Kidney or Stomach to be Seen on an X-Ray);
• If You Experience Vision Loss or Eye Pain While Taking Noliprel. These May be Symptoms of Glaucoma or Increased Eye Pressure. You Should Stop Taking Noliprel and Consult Your Doctor.

Athletes Should be Aware that Noliprel Contains the Active Substance Indapamide, Which Can Cause a Positive Result in a Doping Test.

Children and Adolescents

Noliprel Should Not be Used in Children and Adolescents.

Noliprel and Other Medications

You Should Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
You Should Avoid Taking Noliprel with:

• Lithium (Used to Treat Mania or Depression);
• Aliskiren (a Medication 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, or Other Medications that Can Increase Potassium Levels in the Body (Such as Heparin, a Medication Used to Thin the Blood to Prevent Blood Clots; Trimethoprim and Cotrimoxazole, Also Known as a Combination Medication Containing Trimethoprim and Sulfamethoxazole, Used to Treat Bacterial Infections);

Estramustine (Used to Treat Cancer);

• Other Medications Used to Treat High Blood Pressure: ACE Inhibitors and Angiotensin II Receptor Antagonists. The Use of Other Medications May Affect Treatment with Noliprel. Your Doctor May Recommend a Dose Change and (or) Take Other Precautions. You Should Tell Your Doctor About Taking Any of the Following Medications, as Special Precautions May be Necessary:
• Other Medications Used to Treat High Blood Pressure, Including Angiotensin II Receptor Antagonists (AIIRA) or Aliskiren (See Also Subsections "When Not to Take Noliprel" and "Warnings and Precautions"), or Diuretics (Medications that Increase Urine Production);
• Potassium-Sparing Medications Used to Treat Heart Failure: Eplerenone and Spironolactone at Doses of 12.5 mg to 50 mg per Day;
• Medications Used to Treat Diarrhea (Racecadotril) or to Prevent Transplanted Organ Rejection (Sirolimus, Everolimus, Temsirolimus, and Other Medications Belonging to the Group of Medications Called mTOR Inhibitors). See Section "Warnings and Precautions".
• A Combination Medication Containing Sacubitril and Valsartan (Used to Treat Chronic Heart Failure). See Sections "When Not to Take Noliprel" and "Warnings and Precautions".
• Anesthetics;
• Contrast Agents Containing Iodine;
• Antibiotics Used to Treat Bacterial Infections (Such as Moxifloxacin, Sparfloxacin, Erythromycin Injected);
• 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 (Such as Mizolastine, Terfenadine, Astemizole);
• Corticosteroids Used to Treat Various Diseases, Including Severe Asthma and Rheumatoid Arthritis;
• Immunosuppressive Medications Used to Treat Autoimmune Diseases or After Organ Transplantation to Prevent Rejection (Such as Cyclosporine, Tacrolimus);
• Halofantrine (Used to Treat Certain Types of Malaria);
• Pentamidine (Used to Treat Pneumonia);
• Gold Salts Injected (Used to Treat Rheumatoid Arthritis);
• Vinca Alkaloids (Used to Treat Cancer);
• Bepridil (Used to Treat Angina Pectoris);
• Medications Used to Treat Heart Rhythm Disorders (Such as Quinidine, Hydroquinidine, Dyzopiramid, Amiodarone, Sotalol, Ibutilide, Dofetilide, Digitalis Preparations, 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 Diseases Such as Multiple Sclerosis);
• Medications Used to Treat Diabetes, Such as Insulin, Metformin, or Gliptins;
• Calcium, Including Calcium Supplements;
• Laxatives with a Stimulant Effect (Such as Senna);
• Non-Steroidal Anti-Inflammatory Medications (Such as Ibuprofen) or High Doses of Salicylates (Such as Acetylsalicylic Acid (a Substance Found in Many Medications, Used as a Pain Reliever and to Reduce Fever, as Well as to Prevent Blood Clots));
• Ambotericin B Injected (Used to Treat Severe Fungal Infections);
• Medications Used to Treat Mental Disorders, Such as Depression, Anxiety, Schizophrenia (Such as 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;
• Medications Used to Treat Low Blood Pressure, Shock, or Asthma (Such as Ephedrine, Noradrenaline, or Adrenaline).

Noliprel with Food and Drink

It is Recommended to Take Noliprel Before a Meal.

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 Medication.

Pregnancy

You Should Inform Your Doctor About Pregnancy, Suspected Pregnancy, or Planned Pregnancy. Your Doctor Will Usually Advise You to Stop Taking Noliprel Before Becoming Pregnant or as Soon as You Find Out You are Pregnant, and Will Prescribe Another Medication Instead of Noliprel. It is Not Recommended to Take Noliprel in Early Pregnancy and It Must Not be Taken After 3 Months of Pregnancy, as It Can Cause Serious Harm to the Baby.

Breastfeeding

Noliprel Should Not be Taken if You are Breastfeeding.
You Should Immediately Tell Your Doctor if You are Breastfeeding or Plan to Breastfeed.
You Should Consult Your Doctor Immediately.

Driving and Using Machines

Noliprel Usually Does Not Affect the Ability to Drive or Use Machines, However, Some Patients May Experience Dizziness or Fatigue Related to Low Blood Pressure.
In Such Cases, the Ability to Drive or Use Machines May be Impaired.

Noliprel Contains Lactose Monohydrate

If You Have Been Told You Have an Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking This Medication.

Noliprel Contains Sodium

Noliprel Contains Less Than 1 mmol of Sodium (23 mg) per Tablet, Which Means the Medication is Considered "Sodium-Free".

3. How to Take Noliprel

This Medication Should Always be Taken Exactly as Prescribed by Your Doctor or Pharmacist.
If You are Uncertain, Consult Your Doctor or Pharmacist.
The Recommended Dose is One Tablet per Day. Your Doctor May Decide to Increase the Dose to 2 Tablets per Day or Modify the Dosage if You Have Kidney Problems.
The Tablet Should be Taken Preferably in the Morning, Before a Meal. The Tablet Should be Swallowed with a Glass of Water.
The Score Line on the Tablet is Not Intended for Breaking the Tablet.

Overdose of Noliprel

If You Have Taken Too Many Tablets, Consult Your Doctor or Go to the Emergency Department of the Nearest Hospital Immediately. The Most Common Symptom of Overdose is Low Blood Pressure.
If You Experience Severe Low Blood Pressure (with Accompanying Nausea, Vomiting, Cramps, Dizziness, Drowsiness, Disorientation, and Changes in Urine Production), Lying Down with Your Legs Raised May Help.

Missing a Dose of Noliprel

It is Important to Take the Medication Every Day, as Regular Use is Most Effective.
If You Miss a Dose of Noliprel, Take the Next Dose at the Usual Time.
Do Not Take a Double Dose to Make Up for a Missed Dose.

Stopping Noliprel Treatment

Treatment of High Blood Pressure is Long-Term, So Before Stopping Noliprel, Consult Your Doctor.
If You Have Any Further Questions About Taking This Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Noliprel Can Cause Side Effects, Although Not Everybody Gets Them.

If You Experience Any of the Following Serious Side Effects, Stop Taking Noliprel and Consult Your Doctor Immediately:

• Severe Dizziness or Fainting Due to Low Blood Pressure (Common - May Occur in Less Than 1 in 10 Patients);
• Bronchospasm (Feeling of Tightness in the Chest, Wheezing, and Shortness of Breath; Uncommon - May Occur in Less Than 1 in 100 Patients);
• Swelling of the Face, Lips, Mouth, Tongue, or Throat, Difficulty Breathing (Angioedema, See Section "Warnings and Precautions" in Section 2); Uncommon - May Occur in Less Than 1 in 100 Patients;
• Severe Skin Reactions, Including Erythema Multiforme (a Skin Rash Often Starting with Red, Itchy Spots on the Face, Arms, or Legs) or Severe Skin Rashes, Hives, Redness of the Skin, Intense Itching, Blisters, Peeling, and Swelling of the Skin, Inflammation of the Mucous Membranes (Stevens-Johnson Syndrome) or Other Allergic Reactions (Rare - May Occur in Less Than 1 in 10,000 Patients);
• Cardiovascular Disorders (Heart Rhythm Disorders, Angina Pectoris (Chest Pain Radiating to the Jaw and Back, Caused by Physical Effort), Myocardial Infarction; Rare - May Occur in Less Than 1 in 10,000 Patients);
• Weakness or Numbness of the Arms or Legs, or Speech Disorders, Which May be Symptoms of a Stroke (Rare - May Occur in Less Than 1 in 10,000 Patients);
• Pancreatitis, Which Can Cause Severe Abdominal Pain and Very Poor General Condition (Rare - May Occur in Less Than 1 in 10,000 Patients);
• Jaundice (Yellowing of the Skin or Eyes), Which May be a Symptom of Hepatitis (Rare - May Occur in Less Than 1 in 10,000 Patients);
• Life-Threatening Heart Rhythm Disorders (Frequency Not Known);
• Brain Disease Caused by Liver Disease (Hepatic Encephalopathy; Frequency Not Known); Muscle Weakness, Cramps, Tenderness, or Pain, Especially if You Feel Unwell or Have a High Fever, Which May be Caused by Abnormal Muscle Breakdown (Frequency Not Known).

The Following Side Effects, Grouped by Decreasing Frequency, May Occur:

• Common (May Occur in Less Than 1 in 10 Patients): Skin Reactions in Patients with a Tendency to Allergic and Asthmatic Reactions, Headache, Dizziness of Central Origin, Dizziness of Vestibular Origin, Tingling, Vision Disorders, Tinnitus (Feeling of Hearing Sounds), Cough, Shortness of Breath, Gastrointestinal Disorders (Nausea, Vomiting, Abdominal Pain, Taste Disorders, Indigestion or Digestive Disorders, Diarrhea, Constipation), Allergic Reactions (Such as Skin Rashes, Itching), Muscle Cramps, Fatigue.
• Uncommon (May Occur in Less Than 1 in 100 Patients): Mood Swings, Sleep Disorders, Hives, Purpura (Red Spots on the Skin), Blistering, Kidney Diseases, Impotence, Excessive Sweating, Increased Eosinophil Count (a Type of White Blood Cell), Changes in Laboratory Test Results: High Potassium Levels in the Blood that are Reversible After Stopping Treatment, Low Sodium Levels in the Blood, Drowsiness, Fainting, Palpitations (Feeling of Heartbeats), Tachycardia (Fast Heart Rate), Hypoglycemia (Very Low Blood Sugar) in Diabetic Patients, Vasculitis (Inflammation of Blood Vessels), Dryness of the Mucous Membranes of the Mouth, Photosensitivity Reactions (Increased Sensitivity of the Skin to Sunlight), Joint Pain, Muscle Pain, Chest Pain, Poor General Condition, Peripheral Edema, Fever, Increased Urea Levels in the Blood, Increased Creatinine Levels in the Blood, Falls.
• Rare (May Occur in Less Than 1 in 1,000 Patients): Exacerbation of Psoriasis, Changes in Laboratory Test Results: Increased Liver Enzyme Activity, High Bilirubin Levels in the Blood; Fatigue.
• Very Rare (May Occur in Less Than 1 in 10,000 Patients): Disorientation, Eosinophilic Pneumonia (a Rare Type of Pneumonia), Rhinitis (Nasal Congestion or Runny Nose), Severe Kidney Diseases, Changes in Blood Parameters, Such as Decreased White Blood Cell Count and Red Blood Cell Count, Decreased Hemoglobin Levels, Decreased Platelet Count, High Calcium Levels in the Blood, Liver Function Disorders.
• Frequency Not Known (Cannot be Estimated from Available Data): Abnormal Heart Function Detected by ECG, Changes in Laboratory Test Results: Low Potassium Levels, High Uric Acid Levels, and High Blood Sugar Levels, Myopia (Nearsightedness), Blurred Vision, Vision Disorders, Worsening of Vision or Eye Pain Due to High Pressure (Possible Symptoms of Choroidal Effusion or Acute Glaucoma), Cyanosis (Blue Discoloration of the Skin), Numbness, and Pain in the Fingers or Toes (Raynaud's Phenomenon). If You Have Systemic Lupus Erythematosus (a Type of Collagenosis), Your Symptoms May Worsen. Blood, Kidney, Liver, or Pancreas Disorders, as Well as Changes in Laboratory Test Results, May Occur. Your Doctor May Recommend Blood Tests to Monitor Your Health.

After Taking ACE Inhibitors, Urine Concentration (Dark Urine), Nausea, or Vomiting, Muscle Cramps, Disorientation, and Seizures May Occur, Which May be Caused by Inappropriate Antidiuretic Hormone Secretion. If You Experience Such Symptoms, Consult Your Doctor as Soon as Possible.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. You Can Report Side Effects Directly to the Department of Drug Monitoring, 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 Side Effects, You Can Help Provide More Information on the Safety of This Medication.

5. How to Store Noliprel

Keep the Medication Out of Sight and Reach of 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.
Keep the Container Tightly Closed to Protect from Moisture.
Medications Should Not be Disposed of in Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications That are No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Packaging and Other Information

What Noliprel Contains

• The Active Substances of Noliprel are Perindopril and Indapamide. One Film-Coated Tablet Contains 2.5 mg of Perindopril Arginine (Equivalent to 1.6975 mg of Perindopril) and 0.625 mg of Indapamide.
• Other Ingredients of the Tablet Core: Lactose Monohydrate, Magnesium Stearate, Maltodextrin, Silica Colloidal Anhydrous, Sodium Carboxymethylcellulose (Type A); Ingredients of the Film Coating: Glycerol, Hypromellose, Macrogol 6000, Magnesium Stearate, Titanium Dioxide (E 171).

What Noliprel Looks Like and Contents of the Packaging

Noliprel is a White, Prolonged Film-Coated Tablet with a Score Line on Both Sides. One Film-Coated Tablet Contains 2.5 mg of Perindopril Arginine and 0.625 mg of Indapamide.
Tablets are Available in a Packaging of 30 Tablets.
For More Detailed Information, Consult the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Lithuania, Country of Export:

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer:

ANPHARM Pharmaceutical Company S.A., ul. Annopol 6B, 03-236 Warsaw, Poland
Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France
Servier Ireland Industries Ltd, Gorey Road, Arklow – Co. Wicklow, Ireland

Parallel Importer:

InPharm Ltd., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Ltd. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Lithuanian Marketing Authorization Number, Country of Export: LT/1/07/0667/004
Parallel Import Authorization Number:178/17

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria

PRETERAX-ARGININ

Belgium

PRETERAX 2,5 mg/0,625 mg

Cyprus

COVERSYL PLUS ARGININE 2.5 mg/0.625 mg

Estonia

NOLIPREL ARGININE

Finland

PRETERAX NOVUM

France

PRETERAX 2,5mg/0,625mg

Germany

PRETERAX N 2,5 mg/ 0,625 mg Filmtabletten

Greece

PRETERAX 2,5 mg/0,625 mg

Ireland

COVERSYL ARGININE PLUS 2.5mg/0.625mg

Italy

PRETERAX 2,5 mg/0,625 mg

Latvia

NOLIPREL ARGININE 2.5mg/0.625mg apvalkotās tabletes

Lithuania

NOLIPREL 2,5 mg/0,625 mg tabletès

Luxembourg

PRETERAX 2,5 mg/0,625 mg

Malta

PRETERAX ARGININE 2.5mg/0.625mg

Poland

NOLIPREL

Portugal

PRETERAX 2,5 mg/0,625 mg

Romania

NOLIPREL ARG 2,5 mg/ 0,625 mg

Slovakia

NOLIPREL A

Slovenia

BIONOLIPREL 2.5mg/0.625mg filmsko obložene tablete

Translation of Day of the Week Symbols on the Immediate Packaging:

• P.– Monday, A.– Tuesday, T.– Wednesday, K.– Thursday, Pn.– Friday, Š.– Saturday,
• S.– Sunday.

Date of Leaflet Approval: 25.04.2022