Perindopril and indapamide Mylan Generics

Italy
Brand name Perindopril and indapamide Mylan Generics
Form tablets
Active substance / Dosage
PERINDOPRIL TERT-BUTYLAMINE
Prescription type Prescription only
ATC code
C09BA04
Registration number 039420
Manufacturer MYLAN S.P.A.
Perindopril and indapamide Mylan Generics tablets

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets, 4 mg/1.25 mg tablets

perindopril tert-butylamine/indapamide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Perindopril and Indapamide Mylan Generics is and what it is used for
  2. What you need to know before taking Perindopril and Indapamide Mylan Generics
  3. How to take Perindopril and Indapamide Mylan Generics
  4. Possible side effects
  5. How to store Perindopril and Indapamide Mylan Generics
  6. Contents of the pack and other information

1. WHAT PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS IS AND WHAT IT IS USED FOR

Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets
Perindopril and Indapamide Mylan Generics is a combination of two active substances, perindopril and indapamide.
It is an antihypertensive medicine used to treat high blood pressure (hypertension).

Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets
Perindopril and Indapamide Mylan Generics is a combination of two active substances, perindopril and indapamide.
It is an antihypertensive medicine used to treat high blood pressure (hypertension) in patients
in whom blood pressure is not adequately controlled with perindopril alone.

Perindopril belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. These work by dilating blood vessels, making it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine produced. Each of the two active substances helps reduce blood pressure, and they work together to control your blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS

Do not take Perindopril and Indapamide Mylan Generics:

  • if you are taking medicines that cause a type of rapid heartbeat (torsades de pointes). Ask your doctor which medicines these are.
  • if you are allergic to perindopril or any other ACE inhibitor;
  • if you are allergic to indapamide or any other sulfonamide;
  • if you are allergic to any of the other ingredients of this medicine (see section 6);
  • if you have previously experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rashes after treatment with an ACE inhibitor, or if you or a family member has had these symptoms under any other circumstances (a condition called angioedema);
  • if you suffer from severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disorder);
  • if you have severe kidney disease or severe renal disease where blood supply to the kidneys is reduced (renal artery stenosis);
  • if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Perindopril and Indapamide Mylan Generics may not be suitable for you.
  • if your blood potassium levels are low;
  • if it is suspected that you may have decompensated heart failure (symptoms may include severe fluid retention and breathing difficulties);
  • if you are more than three months pregnant (it is best to avoid Perindopril and Indapamide Mylan Generics even in early pregnancy – see section Pregnancy);
  • if you are breastfeeding;
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril and Indapamide Mylan Generics:

  • if you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
  • if you have any other heart or kidney problems; if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism);
  • if you have liver problems;
  • if you have collagen disorders such as systemic lupus erythematosus (a specific type of chronic inflammation) or scleroderma;
  • if you have atherosclerosis (hardening of the arteries);
  • if you have hyperparathyroidism (a condition in which your parathyroid gland does not function properly);
  • if you suffer from gout;
  • if you have diabetes;
  • if you are elderly;
  • if you are of Black origin, as you may have a higher risk of angioedema, and therefore this medicine may be less effective at lowering blood pressure compared to non-Black patients;
  • if you are on a low-sodium diet or using salt substitutes containing potassium;
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
    • aliskiren;
  • if you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) increases:
    • racecadotril (used to treat diarrhoea)
    • medicines used to prevent organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus)
    • vildagliptin, a medicine used to treat diabetes. Your doctor may monitor your kidney function, blood pressure, blood sugar levels, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the section “Do not take Perindopril and Indapamide Mylan Generics”
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Perindopril and Indapamide Mylan Generics is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken during this period (see section Pregnancy).
When taking Perindopril and Indapamide Mylan Generics, you should also inform your doctor or hospital staff if:

  • you are due to undergo anaesthesia and/or surgery;
  • you have recently had diarrhoea or vomiting or are dehydrated;
  • you are due to undergo dialysis or LDL cholesterol apheresis (removal of cholesterol from your body via a machine);
  • you are undergoing desensitisation treatment or immunotherapy with venom to reduce the effects of allergy to bee or wasp stings;
  • you are due to receive, or will receive, heparin injections to reduce or prevent blood clots;
  • you are due to undergo medical tests requiring injection of an iodinated contrast medium (a substance that makes certain organs such as kidneys or stomach visible on X-rays).
  • you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to weeks after taking Perindopril and Indapamide Mylan Generics. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or a sulfonamide, you may be at greater risk of developing this condition. Stop taking Perindopril and Indapamide Mylan Generics and contact your doctor immediately.

For athletes:
Athletes should be aware that Perindopril and Indapamide Mylan Generics contains an active substance (indapamide) that may cause a positive result in doping control tests. Use of the drug without therapeutic need constitutes doping and may result in a positive doping test regardless.

Children and adolescents
Perindopril and Indapamide Mylan Generics must not be administered to children or adolescents.

Other medicines and Perindopril and Indapamide Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

You must avoid taking Perindopril and Indapamide Mylan Generics with:

  • lithium (used to treat depression);
  • potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene, amiloride), and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting);
  • estramustine (used in cancer treatment).

Inform your doctor if you are taking any of the following medicines, as they may interact with Perindopril and Indapamide Mylan Generics:

  • other medicines for treating high blood pressure, such as other ACE inhibitors;
  • other diuretics;
  • procainamide (for treating irregular heartbeat);
  • allopurinol (for treating gout);
  • terfenadine, astemizole, mizolastine (antihistamines for hay fever and other allergies);
  • corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis;
  • immunosuppressants used to treat autoimmune diseases or to prevent organ transplant rejection (e.g., cyclosporine, tacrolimus);
  • medicines for treating cancer;
  • intravenous erythromycin (an antibiotic);
  • halofantrine (used to treat certain types of malaria);
  • cisapride or difemanil (used to treat gastrointestinal disorders);
  • sparfloxacin or moxifloxacin (antibiotics used to treat infections);
  • methadone;
  • pentamidine (used to treat pneumonia);
  • vincamine (used to treat memory loss in the elderly);
  • bepridil (used to treat angina pectoris);
  • medicines for treating heart rhythm problems (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium);
  • digoxin or other cardiac glycosides (for treating heart problems);
  • baclofen (for treating muscle stiffness occurring in diseases such as multiple sclerosis);
  • medicines for treating diabetes such as insulin, metformin, or gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin);
  • calcium, including calcium supplements;
  • stimulant laxatives (e.g., senna);
  • non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high-dose salicylates (e.g., acetylsalicylic acid);
  • intravenous amphotericin B (to treat serious fungal infections);
  • medicines for treating neurological disorders such as depression, anxiety, and schizophrenia, including tricyclic antidepressants (such as imipramine) and neuroleptics (such as chlorpromazine, carbamazepine, levomepromazine, thioridazine, trifluoperazine, pimozide, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
  • tetracosactide (for treating Crohn's disease);
  • injectable gold (for treating arthritis), also known as sodium aurothiomalate;
  • trimethoprim (used to treat infections);
  • vasodilators, including nitrates (used to dilate blood vessels);
  • heparin (used to thin the blood);
  • medicines used to lower blood pressure, treat shock, or asthma (ephedrine, epinephrine, or norepinephrine).

Treatment with Perindopril and Indapamide Mylan Generics may be affected by other medicines.
Your doctor may consider it necessary to adjust the dose and/or take other precautions. These include:

  • if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Perindopril and Indapamide Mylan Generics” and “Warnings and precautions”).
  • if you are taking neprilysin inhibitors (NEP) such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril (often used to treat diarrhoea), or medicines used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTOR inhibitor class). The risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) may increase. See sections “Do not take Perindopril and Indapamide Mylan Generics” and “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Perindopril and Indapamide Mylan Generics before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Perindopril and Indapamide Mylan Generics is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
You must not take Perindopril and Indapamide Mylan Generics while breastfeeding. Inform your doctor immediately if you are breastfeeding or about to start breastfeeding. Perindopril and Indapamide Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Perindopril and Indapamide Mylan Generics usually does not affect reaction times, but in some patients, side effects such as dizziness or weakness related to low blood pressure may occur. Before driving or operating machinery, ensure you are not affected by these side effects.

Perindopril and Indapamide Mylan Generics contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Perindopril and Indapamide Mylan Generics contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. HOW TO TAKE PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS

Take Perindopril and Indapamide Mylan Generics exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults, including elderly patients
Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets
The recommended dose is one tablet once daily. Your doctor may decide to increase the dose
to 2 tablets per day.
Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets
The recommended dose is one tablet once daily.
Patients with kidney problems
Your doctor may decide to adjust the dose if you have kidney problems.
How to take the medicine
It is preferable to take the tablet in the morning and before a meal.
Swallow the tablet with a glass of water.
If you take more Perindopril and Indapamide Mylan Generics than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
The most likely effect in case of overdose is low blood pressure (symptoms include dizziness or fainting). Other effects may also include nausea or vomiting, muscle cramps, drowsiness, confusion, or reduced urine production. If a marked drop in blood pressure occurs, lying down with your feet raised may be helpful.
If you forget to take Perindopril and Indapamide Mylan Generics
It is important to take your medicine every day, as regular treatment is more effective.
However, if you forget to take a dose of Perindopril and Indapamide Mylan Generics, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Perindopril and Indapamide Mylan Generics
Since treatment for high blood pressure usually lasts a lifetime, you must speak with your doctor before stopping treatment.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported in patients treated with perindopril and/or indapamide.
If you experience any of the following adverse reactions, stop taking the medicine immediately,
inform your doctor and go to the nearest emergency room:

Common (may affect up to 1 in 10 people):

  • if you notice any changes in vision or pain in one or both eyes. This may be a sign of increased pressure in the eye or eyes (glaucoma),
  • allergic skin reactions (such as rashes, itching) or redness in patients with a known history of allergic and respiratory problems (such as asthma),
  • headache, dizziness, vertigo, lightheadedness, especially when standing. These may be signs of low blood pressure.

Uncommon (may affect up to 1 in 100 people):

  • swelling of the face, lips, mouth, tongue, and trachea, which may cause severe breathing difficulties;

Very rare (may affect up to 1 in 10,000 people):

  • severe skin reactions such as widespread rash with red spots and itching on the face, arms or legs (erythema multiforme). You may develop blisters and bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome) and widespread peeling of the skin (toxic epidermal necrolysis).
  • increased number of infections you may get, such as fever, severe chills, sore throat or mouth ulcers. This may be a sign of low white blood cell count.
  • bruising or bleeding more easily than usual. This may be a sign of low platelet count in the blood.
  • weakness, fatigue, headache, shortness of breath on exertion with dizziness and pale or yellowish skin and/or whites of the eyes. These may be signs of low red blood cell levels.
  • low levels of all types of blood cells, which may lead to increased infections, easy bruising or bleeding, and weakness, fatigue and breathlessness.
  • collapse, numbness or weakness in arms or legs, confusion, difficulty speaking or vision problems. These may be signs of stroke and may occur after signs of low blood pressure.
  • an unusually fast, slow or irregular heartbeat, which may be seen on an electrocardiogram (ECG);
  • a sensation of heaviness or tightness in the chest with chest pain and increased breathlessness on exertion (may be signs of heart problems such as angina).
  • sudden chest pain that may spread to the neck or arm, with breathlessness and a feeling of cold sweat. These may be signs of a heart attack and may occur after signs of low blood pressure.
  • cough, fever, increased breathlessness and night sweats, which may be due to lung problems called eosinophilic pneumonia (a rare type of pneumonia);
  • severe stomach pain that may radiate to the back. This may be a sign of inflammation of the pancreas (pancreatitis);
  • inflammation of the liver (hepatitis). Signs include feeling unwell (nausea) or being unwell (vomiting), loss of appetite, general malaise, fever, itching, yellowing of the skin and/or eyes (jaundice), pale stools and dark urine, reduced urine output, cloudy urine or blood in the urine, pain during urination or back pain. These may be signs of serious kidney problems.

Not known (frequency cannot be estimated from available data):

  • you feel weak and notice your heartbeat is faster and/or irregular. This may be due to reduced potassium levels in the blood (this is more common in elderly, malnourished patients, or those with heart failure, or liver or kidney problems).
  • hepatic encephalopathy, with symptoms such as fatigue, irritability and forgetfulness with confusion, tremor, seizures, unconsciousness and coma due to brain swelling (more frequent if you have liver problems).
  • decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other possible adverse reactions:
Common (may affect up to 1 in 10 people):

  • headache;
  • visual disturbances;
  • dizziness;
  • bad or metallic taste in the mouth;
  • tinnitus (ringing in the ears);
  • a sensation of dizziness when standing up or sitting down (vertigo);
  • tingling;
  • itching, skin rash;
  • breathlessness;
  • dry cough;
  • feeling unwell or being unwell (nausea and vomiting);
  • stomach pain;
  • dry mouth;
  • indigestion, diarrhoea, constipation;
  • muscle cramps;
  • feeling of weakness.

Uncommon (may affect up to 1 in 100 people):

  • increased number of white blood cells (eosinophilia);
  • low blood sugar levels, low blood sodium levels;
  • low blood potassium levels, which improve when treatment is stopped;
  • mood changes;
  • sleep disturbances, drowsiness;
  • fainting;
  • fast heart rate (tachycardia), rapid heartbeats felt as a pounding in the chest (palpitations);
  • inflammation of blood vessels (vasculitis);
  • small red spots on the skin (purpura);
  • chest tightness, wheezing and breathlessness (bronchospasm);
  • urticaria;
  • increased skin sensitivity to sunlight;
  • muscle or joint pain;
  • other kidney problems;
  • sweating;
  • inability to achieve or maintain an erection (impotence);
  • middle or upper chest pain (chest pain);
  • general feeling of malaise, fever;
  • swelling in hands, ankles or feet (fluid retention);
  • increased levels of urea and creatinine in the blood, detectable by a blood test;
  • falls.

Rare (may affect up to 1 in 1,000 people):

  • worsening of psoriasis;
  • fatigue;
  • increased levels of bilirubin or liver enzymes in the blood, detectable by a blood test.

Very rare (may affect up to 1 in 10,000 people):

  • confusion;
  • blocked and runny nose (rhinitis);
  • a rapid increase in blood calcium (detectable by blood tests). This may cause increased urine production, feeling unwell or being unwell with stomach pain;
  • abnormal liver function;
  • reduced haemoglobin and haematocrit levels, detectable by a blood test.

Not known (frequency cannot be estimated from available data):

  • if you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen;
  • increased levels of urea and blood sugar, detectable by a blood test.
  • discoloration/numbness and pain in fingers and toes (Raynaud's phenomenon); concentrated urine (dark in colour), feeling or being sick, muscle cramps, confusion and seizures (convulsions) which may be caused by inappropriate ADH (antidiuretic hormone) secretion may occur with ACE inhibitors. If you experience these symptoms, contact your doctor immediately.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS

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

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Perindopril and Indapamide Mylan Generics contains
The active substances are perindopril tert-butylamine and indapamide.
Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets
Each tablet contains 2 mg of perindopril tert-butylamine, equivalent to 1.67 mg of perindopril and 0.625 mg
of indapamide.
Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets
Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.34 mg of perindopril and 1.25 mg
of indapamide.
The excipients are: microcrystalline cellulose, monohydrate lactose (see section 2 "Perindopril and Indapamide Mylan Generics contains lactose"), sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Perindopril and Indapamide Mylan Generics and packaging contents
Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets
Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets are oblong, white, slightly biconvex tablets with bevelled edges.
Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets
Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets are oblong, white, slightly biconvex tablets with bevelled edges.
PVC/PE/PVDC/Al blister packs of 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in a cardboard box.
OPA/Al/PVC/Al blister packs of 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturers responsible for batch release
KRKA Polska Sp. Z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia