PERINDOPRIL MYLAN GENERICS

Package leaflet: Information for the patient

Perindopril Mylan Generics 5 mg film-coated tablets, 10 mg film-coated tablets

perindopril arginine
Equivalent 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Perindopril Mylan Generics is and what it is used for

Perindopril Mylan Generics belongs to a group 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.
Perindopril Mylan Generics is used to:

• treat high blood pressure (hypertension)
• treat heart failure (a condition in which the heart is unable to pump blood strongly enough to meet the body’s needs) [5 mg dosage only]
• reduce the risk of cardiac events, such as heart attacks, in patients with stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked) who have previously had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the vessels supplying it.

2. What you need to know before taking Perindopril Mylan Generics

Do not take Perindopril Mylan Generics:

• if you are allergic to perindopril, to any other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6),
• if you have previously experienced symptoms such as shortness of breath, swelling of the face, tongue or throat, severe itching or severe skin rash during previous treatment with ACE inhibitors, or if a member of your family has had these symptoms under any circumstances (a condition called angioedema),
• if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, for example in the throat). Treatment with sacubitril/valsartan must not be started within 36 hours of taking the last dose of Perindopril Mylan Generics. Treatment with Perindopril Mylan Generics must not be started until at least 36 hours have passed since the last dose of sacubitril/valsartan (see sections “Warnings and precautions” and “Other medicines and Perindopril Mylan Generics”),
• if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Perindopril Mylan Generics may not be suitable for you,
• if you have kidney problems causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are more than 3 months pregnant (It is advisable to avoid using Perindopril Mylan Generics even during early pregnancy – see section “Pregnancy”),
• Perindopril Mylan Generics contains soybean oil. If you are allergic to peanuts or soybeans, do not use this medicine,
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Mylan Generics if any of the following apply to you:

• you have aortic stenosis (narrowing of the main blood vessels of the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• you have any other heart problems,
• you have liver problems,
• you have kidney problems or are undergoing dialysis,
• you have abnormally high levels in the blood of a hormone called aldosterone (primary hyperaldosteronism),
• you have collagen vascular diseases (connective tissue diseases) such as systemic lupus erythematosus or scleroderma,
• you have diabetes,
• you are on a low-salt diet or use salt substitutes containing potassium,
• you are scheduled to undergo anaesthesia and/or major surgery,
• you are undergoing LDL apheresis (a procedure in which cholesterol is removed from the blood using a special machine),
• you are scheduled to undergo desensitisation treatment to reduce the effects of allergy to bee or wasp stings,
• you have recently had diarrhoea or vomiting or if you are dehydrated,
• your doctor has told you that you have an intolerance to certain sugars,
• you are taking any of the following medicines used to treat high blood pressure:
  • an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
  • aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Perindopril Mylan Generics”.
• if you are of Black origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-Black patients,
• if you are taking any of the following medicines, your risk of angioedema may be increased:
  • racecadotril, a medicine used to treat diarrhoea,
  • medicines used to prevent organ transplant rejection or for cancer (e.g. temsirolimus, sirolimus, everolimus),
  • linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class known as gliptins (medicines used to treat diabetes),
  • sacubitril/valsartan (used to treat chronic heart failure). See section “Do not take Perindopril Mylan Generics”.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindopril Mylan Generics. This may occur at any time during treatment. If you develop such symptoms, you must stop taking Perindopril Mylan Generics and contact a doctor immediately. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril Mylan Generics is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn baby if used during this period (see section “Pregnancy”).

Children and adolescents
Perindopril Mylan Generics is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Perindopril Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Perindopril Mylan Generics may affect how other medicines work, and some medicines may affect the action of Perindopril Mylan Generics. Your doctor may need to adjust your dose and/or take other precautions. In particular, inform your doctor if you are taking any of the following medicines:

• other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. triamterene or amiloride), and other medicines that may increase potassium levels in the blood

(such as trimethoprim and co-trimoxazole, for bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots),

• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
• lithium (a medicine used to treat mental health conditions),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used to treat pain, or high-dose aspirin, a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting,
• medicines used to treat diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body’s immune defences), used to treat autoimmune diseases or after organ transplant surgery (e.g. cyclosporine, tacrolimus),
• trimethoprim (used to treat infections),
• estramustine (used in cancer therapy),
• medicines used mainly to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”,
• medicines used to treat gout (e.g. allopurinol),
• medicines used to treat irregular heartbeat (e.g. procainamide),
• medicines that widen blood vessels (e.g. vasodilators, including nitrates),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis).

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

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take Perindopril Mylan Generics” and “Warnings and precautions”).
• sacubitril/valsartan (a medicine used to treat chronic heart failure) is contraindicated (see section “Do not take Perindopril Mylan Generics” and “Warnings and precautions”). Treatment with sacubitril/valsartan must not be started within 36 hours of taking the last dose of Perindopril Mylan Generics. Treatment with perindopril arginine must not be started within 36 hours of taking the last dose of sacubitril/valsartan.

Perindopril Mylan Generics with food and drinks
It is recommended to take Perindopril Mylan Generics before a meal.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will normally advise you to stop taking Perindopril Mylan Generics before pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Perindopril Mylan Generics is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the first trimester.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. The use of Perindopril Mylan Generics is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, particularly if the baby is a newborn or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Perindopril Mylan Generics usually does not affect concentration. However, in some patients, dizziness or weakness due to low blood pressure may occur. If this happens, your ability to drive or operate machinery may be impaired.

Perindopril Mylan Generics contains lactose, sodium and soybean oil
If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact your doctor before taking this medicine.
If you are allergic to peanuts or soybeans, do not use this medicine (see “Do not take Perindopril Mylan Generics”).
This product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Perindopril Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, at the same time each day, preferably in the
morning, before a meal. Your doctor will determine the correct dose for you.
The recommended dose of Perindopril Mylan Generics is:
High blood pressure:
The recommended initial and maintenance dose is 5 mg once daily. After one month, this
dose may be increased, if necessary, to 10 mg once daily. The 10 mg daily dose is the maximum
recommended dose for hypertension.
If you are 65 years of age or older, treatment usually starts with a dose of 2.5 mg once daily. After one
month, this dose may be increased to 5 mg once daily, and then, if necessary, to 10 mg once
daily.
Heart failure [only for the 5 mg dosage]
The recommended dose is 2.5 mg once daily. After two weeks, this may be increased
to 5 mg once daily, which is the maximum recommended dose for heart failure.
Stable coronary artery disease:
The recommended initial dose is 5 mg once daily. After two weeks, this may be
increased to 10 mg once daily, which is the maximum recommended dose for this indication.
If you are 65 years of age or older, the recommended initial dose is 2.5 mg once daily. After one week,
this may be increased to 5 mg once daily, and after another week to 10 mg once
daily.
Use in children and adolescents
Use in children and adolescents is not recommended.
If you take more Perindopril Mylan Generics than you should
Contact the nearest hospital emergency department or speak to your doctor immediately. The most likely
effect in case of overdose is hypotension, which may cause dizziness or fainting. If this
happens to you, it may help to lie down with your legs raised.
If you forget to take Perindopril Mylan Generics
It is important to take the medicine every day, as regular treatment works best.
However, if you have forgotten to take a dose of Perindopril Mylan Generics, take the next
dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you stop taking Perindopril Mylan Generics
Since treatment with Perindopril Mylan Generics is usually long-term, you must discuss stopping this
medicine with your doctor beforehand.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking the medicine immediately and
contact your doctor straight away, as these side effects may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• sudden breathlessness, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people),
• severe skin disease with blisters and sores (bullous pemphigoid) (uncommon - may affect up to 1 in 100 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare - may affect up to 1 in 10,000 people),
• weakness in arms or legs or speech problems which could be signs of a possible stroke (very rare - may affect up to 1 in 10,000 people),
• inflamed pancreas which may cause severe abdominal pain and back pain accompanied by severe malaise (very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people),
• skin rashes that often start with red, itchy spots on the face, arms or legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people).

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

• headache, dizziness, vertigo, tingling sensations
• vision disturbances
• tinnitus (sensation of noise in the ears)
• cough, difficulty breathing (dyspnoea)
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty digesting, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• fatigue.

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

• mood changes, sleep disturbances
• dry mouth
• intense itching or severe skin rash
• kidney problems
• impotence
• sweating
• changes in blood test results including increased potassium (hyperkalaemia, reversible upon discontinuation of the medicine), low sodium levels, very low blood sugar levels in diabetic patients (hypoglycaemia), increased blood urea and increased creatinine
• feeling drowsy (somnolence)
• fainting
• palpitations
• rapid heartbeat (tachycardia)
• excessive sweating (hyperhidrosis)
• skin sensitivity to light (photosensitivity)
• muscle pain (myalgia)
• joint pain and soreness (arthralgia)
• chest pain
• malaise
• fever
• falls
• peripheral oedema
• vasculitis (inflammation of blood vessels)
• elevated eosinophils (a type of white blood cells)
• depression

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

• worsening of psoriasis
• changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels
• dark-coloured urine, feeling unwell (nausea) or malaise (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). If you experience these symptoms, consult your doctor as soon as possible
• reduced or absent urine output
• flushing
• acute kidney failure.

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

• confusion
• eosinophilic pneumonia (a very rare type of pneumonia)
• rhinitis (blocked or runny nose)
• changes in blood values such as decreased numbers of white blood cells and red blood cells, decreased haemoglobin, decreased platelet count.

If you experience these symptoms, contact your doctor immediately.
Frequency not known (frequency cannot be estimated from the available data):

• abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting system at http://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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle,
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Perindopril Mylan Generics contains
The active substance is perindopril arginine.
One 5 mg tablet contains 5 mg of perindopril arginine, equivalent to 3.395 mg of perindopril.
One 10 mg tablet contains 10 mg of perindopril arginine, equivalent to 6.790 mg of perindopril.
The other components are:
Tablet core:
Monohydrate lactose (see section 2 “Perindopril Mylan Generics contains lactose, sodium and soybean oil”), magnesium stearate, maltodextrin, anhydrous colloidal silica, sodium starch glycolate (type A), povidone (K 30).
Film coating:
Soybean lecithin (E322) (see section 2 “Perindopril Mylan Generics contains lactose, sodium and soybean oil”), partially hydrolysed polyvinyl alcohol, talc (E553b), titanium dioxide (E171), xanthan gum (E415), quinoline yellow (E104) - aluminium lake, FD & C Blue No. 1 / Brilliant Blue FCF aluminium lake (E133), yellow iron oxide (E172).

Description of the appearance of Perindopril Mylan Generics and pack contents
Perindopril Mylan Generics 5 mg film-coated tablets: green, capsule-shaped, biconvex, film-coated tablets with bevelled edges, engraved with “PA2” on one side and “M” on the other. The tablet can be divided into two equal doses.
Perindopril Mylan Generics 10 mg film-coated tablets: green, round, biconvex, film-coated tablets, engraved with “PA3” on one side and “M” on the other.
Perindopril Mylan Generics tablets are available in blisters of 10, 14, 30, 60, 90 and 100 tablets and in plastic bottles containing 30, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, Mylan Utca 1, Komárom, 2900, Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
BE: Perindopril Viatris 2.5 mg, 5 mg, 10 mg filmomhulde tabletten
CZ: Perindopril Arginin Mylan 5 mg and 10 mg potahované tablety
FR: Perindopril Arginine Viatris 2.5 mg, 5 mg, 10 mg comprimé pelliculé
IT: Perindopril Mylan Generics
LU: Perindopril Viatris 2.5 mg, 5 mg, 10 mg comprimés pelliculés
NL: Perindopril arginine Viatris 2.5 mg, 5 mg, 10 mg filmomhulde tabletten
PT: Perindopril Anova 2.5 mg 5 mg, 10 mg comprimidos revestidos por película
RO: Perindopril arginină Viatris 2.5 mg 5 mg, 10 mg comprimate filmate
UK(NI): Perindopril arginine 2.5 mg and 5 mg film-coated tablets