PERINDOPRIL 2 mg /0.625 Mg Tablets

Зміст інструкції

1. Perindopril and Indapamide Mylan Generics 2 mg/0.625 mg tablets, 4 mg/1.25 mg tablets
   1. WHAT IS PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING PERINDOPRIL AND INDAPAMIDE MYLAN
   3. HOW TO TAKE PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PERINDOPRIL E INDAPAMIDE MYLAN GENERICS
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

perindopril tert-butylamine/indapamide

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 IS PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS 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 ingredients, perindopril and indapamide.
It is an antihypertensive medicine used for the treatment of 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 ingredients, perindopril and indapamide.
It is an antihypertensive medicine used for the treatment of high blood pressure (hypertension) in patients in whom
blood pressure is not adequately controlled with perindopril alone.
Perindopril belongs to a class of drugs called angiotensin converting enzyme inhibitors
(ACE inhibitors). They work by widening the 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 is different from other diuretics, because it causes only a slight
increase in the amount of urine produced. Each of the two active ingredients reduces blood pressure and they work
together to control it.

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 these medicines 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 already had symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes following treatment with an ACE inhibitor or if you or a member of your family has had these symptoms in any other circumstance (a condition called angioedema);
• if you suffer from a severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disease);
• if you suffer from severe kidney diseases or a severe kidney disease in which the 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 the levels of potassium in your blood are low;
• if you suspect you may be suffering from decompensated heart failure (symptoms may include severe water retention and difficulty breathing);
• if you are pregnant for more than three months (it is best to avoid Perindopril and Indapamide Mylan Generics even in the early stages of pregnancy - (see the Pregnancy section);
• if you are breastfeeding;
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

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

• if you suffer from aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys);
• if you suffer from any other heart or kidney problems; if you have abnormally elevated levels of a hormone called aldosterone in your blood (primary aldosteronism);
• if you suffer from liver problems;
• if you suffer from collagen diseases such as systemic lupus erythematosus (a particular type of chronic inflammation) or scleroderma;
• if you suffer from atherosclerosis (hardening of the arteries);
• if you suffer from hyperparathyroidism (a condition in which your parathyroid gland is not working properly);
• if you suffer from gout;
• if you suffer from diabetes;
• if you are elderly;
• if you are black as you may have a higher risk of angioedema and therefore this medicine may be less effective in reducing blood pressure compared to non-black patients;
• if you are following a low-sodium diet or if you are using salt substitutes that contain potassium;
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin such as in the throat) is greater:
• racecadotril (used to treat diarrhea)
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) vildagliptin, a medicine used to treat diabetes. The doctor may check your kidney function, blood pressure, blood sugar and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

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

• you are going to have anesthesia and/or surgery;
• you have recently suffered from diarrhea or vomiting or are dehydrated;
• you are going to undergo dialysis or LDL cholesterol apheresis (which is the removal of cholesterol from your body through a machine);
• you will undergo desensitization treatment or immunotherapy with venom to reduce the effects of an allergy to bee or wasp stings;
• you are going to, or will be, undergoing heparin injections to reduce or prevent blood clots
• you are going to undergo medical tests that require the injection of an iodine-containing contrast agent (a substance that makes some organs such as kidneys or stomach visible on X-rays).
• you have a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Perindopril and Indapamide Mylan Generics. This can lead to permanent vision loss if not treated. If you have had an allergy to penicillin or a sulfonamide in the past, you may be at greater risk of developing this condition. Stop taking Perindopril and Indapamide Mylan Generics and contact your doctor.

For athletes: Athletes must be informed that Perindopril and Indapamide
Mylan Generics contains an active ingredient (indapamide) that can induce a positive reaction to doping control tests. The use of the drug without therapeutic need constitutes doping and may still result in a positive doping control test.

Children and adolescents
Perindopril and Indapamide Mylan Generics should not be given to children and adolescents.

Other medicines and Perindopril and Indapamide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available 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 the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots). * estramustine (used in the treatment of cancer).

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

• other medicines for the treatment of high blood pressure, such as other ACE inhibitors;
• other diuretics;
• procainamide (for the treatment of irregular heartbeat);
• allopurinol (for the treatment of 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 following organ transplantation to prevent rejection (e.g. cyclosporine, tacrolimus);
• medicines for the treatment of cancer;
• erythromycin for injection (an antibiotic);
• halofantrine (used to treat some 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 the treatment of heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium);
• digoxin or other cardiac glycosides (for the treatment of heart problems);
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis);
• medicines for the treatment of 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 salicylates at high doses (e.g. acetylsalicylic acid);
• amphotericin B for injection (to treat serious illnesses caused by fungi);
• medicines for the treatment of neurological disorders such as depression, anxiety and schizophrenia including tricyclic antidepressants (such as imipramine) and neuroleptics (such as chlorpromazine, fluphenazine, levomepromazine, thioridazine, trifluoperazine, pimozide, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• tetracosactide (for the treatment of Crohn's disease);
• gold for injection (for the treatment of arthritis), which may also be called 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, shock or asthma (ephedrine, epinephrine or norepinephrine).

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

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the 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 diarrhea) or medicines used for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the mTOR inhibitors class). The risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase. See the 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 tell your doctor if you think you may be pregnant (or if there is a possibility of starting a
pregnancy). As a rule, your doctor will advise you to stop taking Perindopril and Indapamide
Mylan Generics before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Perindopril and Indapamide Mylan
Generics.
Perindopril and Indapamide Mylan Generics is not recommended in early pregnancy, and should not be
taken if you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
Do not take Perindopril and Indapamide Mylan Generics if you are breastfeeding. Tell
your doctor immediately if you are breastfeeding or are about to start breastfeeding. Perindopril and Indapamide Mylan
Generics is not recommended for mothers who are breastfeeding, and your doctor may choose another
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 alertness, but in some
patients, various reactions such as dizziness or weakness related to a decrease in
blood pressure may occur. Before driving vehicles or using machines, you must make sure you are not subject to such
effects.

Perindopril and Indapamide Mylan Genericscontains lactose.
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

Perindopril and Indapamide Mylan Generics contains less than 1 mmol of sodium (23 mg) per tablet,
that is to say it is essentially “sodium-free”.

3. HOW TO TAKE PERINDOPRIL AND INDAPAMIDE MYLAN GENERICS

Take Perindopril and Indapamide Mylan Generics following your doctor's or pharmacist's instructions exactly.
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 a day. Your doctor may decide to increase the dose
to 2 tablets a day.
Perindopril and Indapamide Mylan Generics 4 mg/1.25 mg tablets
The recommended dose is one tablet once a day.
Patients with kidney problems
Your doctor may decide to adjust the dose if you suffer from kidney problems.
Taking 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 Genericsthan you should
If you take too many tablets, contact your doctor immediately or the emergency room of the nearest hospital.
The most likely effect of an overdose is a lowering of blood pressure (symptoms include
dizziness or fainting). Other effects may also include nausea or vomiting, muscle cramps, drowsiness,
confusion or decreased urine production. If a marked drop in blood pressure occurs
it may be helpful to lie down with your feet raised in the air.

If you forget to take Perindopril and Indapamide Mylan Generics
It is important that you 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 the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Perindopril and Indapamide Mylan Generics
As treatment for high blood pressure usually lasts a lifetime, you should talk to your doctor before
stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported in patients treated with perindopril and/or indapamide.

If you experience any of the following side effects, stop taking the medicine and
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 skin rashes, itching) or redness in patients with a known history of allergic and respiratory problems (such as asthma),
• headache, feeling dizzy, vertigo, lightheadedness, especially when standing up. These may be signs of low blood pressure. Uncommon(may affect up to 1 in 100):
• swelling of the face, lips, mouth, tongue and trachea, which can cause great difficulty in breathing;

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

• severe skin reactions such as widespread rashes 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 exfoliation of the skin (toxic epidermal necrolysis).
• a greater number of infections that you may contract such as fever, severe chills, sore throat or mouth ulcers. This may be a sign of a low number of white blood cells.
• bruising or bleeding more easily than usual. This may be a sign of a low number of platelets in the blood.
• weakness, fatigue, headache, shortness of breath on exertion with dizziness and pale or yellow skin and/or white of the eyes. These may be signs of low levels of red blood cells.
• low levels of all types of blood cells which can cause an increase in infections, formation of bruises or bleeding more easily than usual and weakness, fatigue and shortness of breath.
• collapse, numbness or weakness in arms or legs, confusion, difficulty speaking or vision problems. These may be signs of a stroke and can occur after signs of low blood pressure.
• an unusually fast, slow or irregular heartbeat which can be seen on an electrocardiogram (ECG);
• a feeling of heaviness or tightness in the chest with chest pain and increased breathlessness on exertion (these may be signs of heart problems such as angina).
• sudden chest pain that may spread to the neck or arm, with shortness of breath and a feeling of cold sweat. These may be signs of a heart attack and can occur after signs of low blood pressure.
• suffering from cough, fever, increased shortness of breath and night sweats which may be due to problems with the lungs 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). The signs include feeling unwell (nausea) or being unwell (vomiting), with loss of appetite, general feeling of being unwell, with fever, itching, yellowing of the skin and/or eyes (jaundice) with pale stools and dark urine, poor urine production

of urine, cloudy urine or blood in the urine, pain when urinating or lower back pain. These
may be signs of serious problems with the kidneys.

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

• you feel weak and notice that the heartbeat is faster and/or irregular. This may be due to a decrease in potassium levels in the blood (this is more common in elderly patients, malnourished patients, patients with heart failure or liver or kidney problems).
• hepatic encephalopathy, with symptoms such as fatigue, irritability and memory loss with confusion, tremors, convulsions, unconsciousness and coma due to swelling of the brain (more frequent if you suffer from 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 side effects:
Common(may affect up to 1 in 10 people):

• headache;
• vision disturbances;
• dizziness;
• bad or metallic taste in the mouth;
• tinnitus (ringing in the ears);
• a feeling of dizziness when getting up or sitting down (postural hypotension);
• tingling;
• itching, rash;
• shortness of breath;
• dry cough;
• feeling sick (nausea) and being sick (vomiting);
• stomach pain;
• dry mouth;
• indigestion, diarrhoea, constipation;
• muscle cramps;
• feeling weak.

Uncommon(may affect up to 1 in 100):

• increased number of white blood cells (eosinophilia);
• low blood sugar levels, low sodium levels in the blood;
• low potassium levels in the blood, which improve when stopping treatment;
• mood changes;
• sleep disturbances, drowsiness;
• fainting;
• fast heart rate (tachycardia), fast heartbeats that can be felt as a fluttering in the chest (palpitations);
• inflammation of blood vessels (vasculitis);
• small red dots on the skin (purpura);
• chest tightness, wheezing and shortness of breath (bronchospasm);
• urticaria;
• increased sensitivity of the skin to sunlight;
• muscle or joint pain;
• other kidney problems;
• sweating;
• inability to have or maintain an erection (impotence);
• moderate or upper chest pain (precordial pain);
• feeling generally unwell, fever;
• swelling in the 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):

• 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):

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

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

• if you suffer from systemic lupus erythematosus (a type of connective tissue disease), this could worsen;
• increased levels of urea and sugar in the blood, detectable by a blood test.
• discoloration/numbness and pain of the fingers of the hands and feet (Raynaud's phenomenon); concentrated urine (dark in color), feel or are unwell, have muscle cramps, confusion and seizures (convulsions) which may be caused by inappropriate secretion of ADH (anti-diuretic hormone) may occur with ACE inhibitors. If you have these symptoms, contact your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE PERINDOPRIL E 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 at a temperature below 30° C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Perindopril and Indapamide Mylan Generics contains
The active ingredients are perindopril tert-butylamine and indapamide.
Perindopril and Indapamide Mylan Generics 2 mg/0.625 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 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, lactose monohydrate (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 Genericsand contents of the pack
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 with rounded edges.
Perindopril and Indapamide Mylan Generics 4 mg/1.25 tablets
Perindopril and Indapamide Mylan Generics 4 mg/1.25 tablets are oblong, white, slightly
biconvex with rounded edges.
PVC/PE/PVDC/Al blisters of 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in a cardboard box.
OPA/Al/PVC/Al blisters of 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

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

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