Perindopril Teva Generics

Patient Information Leaflet: Information for the User

Perindopril Teva Generics 4 mg tablets

Perindopril tert-butylamine
Generic medicine
Please read all of this leaflet carefully before you start 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 give it to other people, even if they have the same symptoms as you, because it could 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 Teva Generics is and what it is used for
2. What you need to know before taking Perindopril Teva Generics
3. How to take Perindopril Teva Generics
4. Possible side effects
5. How to store Perindopril Teva Generics
6. Contents of the pack and other information

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

The active substance of Perindopril Teva Generics belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.
Perindopril Teva Generics is used to treat:

• high blood pressure (hypertension),
• symptomatic heart failure (a condition in which the heart is unable to pump enough blood to meet the body’s needs),
• reduction of the risk of heart problems such as heart attacks, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked), who have previously had a heart attack and/or undergone surgery to increase blood flow to the heart by widening the blood vessels supplying it.

2. What you should know before taking Perindopril Teva Generics

Do not take Perindopril Teva Generics

• if you are allergic to perindopril, to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitors;
• if you have previously had a hypersensitivity reaction characterized by sudden swelling of the lips and face, neck, possibly also involving hands and feet, or a sensation of suffocation or hoarseness (angioedema) after taking an ACE inhibitor;
• if you have a family history of angioedema or if you have previously experienced angioedema in other circumstances;
• if you are more than three months pregnant. (It is advisable to avoid Perindopril Teva Generics even during early pregnancy – see section Pregnancy);
• 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 chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Perindopril Teva Generics may not be suitable for you, or you may need regular monitoring. Talk to your doctor or pharmacist before taking Perindopril Teva Generics:

• if you have been diagnosed with reduced or blocked blood flow to the heart (stable coronary artery disease);
• if you have been told you have dilated cardiomyopathy or have a heart valve disorder;
• if you have been diagnosed with narrowing of the artery supplying blood to the kidney (renal artery stenosis);
• if you have diabetes;
• if you have other kidney, liver, or heart problems;
• if you are on dialysis or have recently undergone a kidney transplant;
• if you have a connective tissue disease such as systemic lupus erythematosus or scleroderma;
• if you are on a low-salt diet, or have had repeated episodes of vomiting or diarrhoea, or have used medicines that increase urine output (diuretics);
• 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), 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 Teva Generics”.
• if you are taking lithium, a medicine used to treat mania or depression;
• if you are taking potassium supplements or potassium-containing salt substitutes;
• if you are taking any of the following medicines, as the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhoea,
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes. You must inform your doctor if you think you are pregnant (or if there is a possibility you could become pregnant). Perindopril Teva 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 unborn child if taken during this period (see section Pregnancy).

While taking Perindopril Teva Generics
Inform your doctor immediately if you develop any of the following symptoms:

• You feel dizzy after the first dose. Some people may experience dizziness, weakness, fainting, or general malaise after the first dose or when the dose is increased.
• Sudden swelling of the lips and face, neck, possibly also involving hands and feet, or wheezing or hoarseness. This condition is called angioedema. This can occur at any time during treatment.
• Swelling of the intestine, known as “intestinal angioedema”, which may present with symptoms such as abdominal pain, vomiting, and diarrhoea. ACE inhibitors are associated with a higher incidence of angioedema in Black patients compared to non-Black patients.
• High fever, sore throat, or mouth ulcers (these may be symptoms of infection due to a reduced white blood cell count).
• Yellowing of the skin or whites of the eyes (jaundice), which may indicate liver problems.
• A persistent, dry cough over a long period. Cases of cough have been reported with the use of ACE inhibitors, but it may also be a symptom of other upper respiratory tract diseases.

At the beginning of treatment and/or during dose adjustment, you may need more frequent medical check-ups. Do not skip appointments even if you feel well. Your doctor will determine how often you need to be monitored.
To prevent any possible complications during treatment with Perindopril Teva Generics, you must also inform your doctor that you are taking Perindopril Teva Generics tablets if:

• you are about to undergo anaesthesia and/or surgery (including dental procedures),
• you are about to undergo treatment to reduce the effects of an allergy to bee or wasp stings (desensitisation),
• you are about to undergo haemodialysis or LDL cholesterol apheresis (a procedure to remove cholesterol from your body using a machine).

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

Other medicines and Perindopril Teva Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take over-the-counter medicines without first consulting your doctor. This particularly includes:

• cold remedies containing pseudoephedrine or phenylephrine,
• painkillers, including acetylsalicylic acid (a substance found in many medicines used as painkillers and fever reducers, and also to prevent blood clotting),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting). Inform your doctor if you are taking any of the following medicines to ensure it is safe to take Perindopril Teva Generics at the same time:
• other medicines for treating high blood pressure and/or heart failure, including medicines that increase urine output (diuretics),
• medicines for treating irregular heartbeat (procainamide),
• medicines for treating diabetes (insulin or oral antidiabetics),
• medicines for treating gout (allopurinol),
• medicines used to relieve pain, stiffness, and inflammation associated with painful conditions, particularly those affecting muscles, bones, and joints (non-steroidal anti-inflammatory drugs - NSAIDs), such as ibuprofen, indomethacin, diclofenac, or acetylsalicylic acid (a substance found in many medicines used as painkillers and fever reducers, and also to prevent blood clotting),
• anti-inflammatory medicines (systemic corticosteroids),
• medicines that inhibit tumour growth (cytostatic agents),
• medicines that reduce the body's immune responses (immunosuppressants),
• medicines that stimulate a specific part of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics),
• medicines for treating mania or depression (lithium),
• potassium tablets,
• gold. Your doctor may consider it necessary to adjust your dose and/or take other precautions:
• If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Perindopril Teva Generics” and “Warnings and precautions”).
• Medicines commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Perindopril Teva Generics with food, drinks, and alcohol
It is recommended to take Perindopril Teva Generics before meals to minimize the influence of food on the medicine’s effectiveness. Taking alcohol together with Perindopril Teva Generics may cause dizziness or lightheadedness. Ask your doctor for advice on whether you can consume alcoholic beverages.

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

Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Perindopril Teva Generics before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Perindopril Teva 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 unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Perindopril Teva Generics is not recommended for women who are breastfeeding. 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
Dizziness may occasionally occur (especially at the start of treatment, when the dose is increased, or if alcohol is consumed), which may affect your ability to drive or operate machinery.

Perindopril Teva Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Perindopril Teva Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Perindopril Teva Generics

Take Perindopril Teva Generics exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for the treatment of hypertension is 4 mg of perindopril (1 tablet of 4 mg Perindopril Teva Generics) once daily. When necessary, this dose may be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril Teva Generics) once daily.
The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril (half a 4 mg tablet of Perindopril Teva Generics) once daily; if necessary, the daily dose may be increased to 4 mg of perindopril (1 tablet of 4 mg Perindopril Teva Generics) once daily.
The recommended initial dose for the treatment of stable coronary artery disease is 4 mg of perindopril (1 tablet of 4 mg Perindopril Teva Generics) once daily; if well tolerated, the dose may be increased to 8 mg of perindopril (2 tablets of 4 mg Perindopril Teva Generics) once daily.
Take the tablet with a glass of water, preferably at the same time every day, in the morning, before a meal.
During treatment, your doctor will adjust the dose according to the treatment's effectiveness and your individual needs.
The dose may be lower than usual and will be determined by your doctor:

• in elderly patients,
• in patients with renal impairment,
• in patients with hypertension caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension),
• in patients being treated simultaneously with drugs that increase urine output (diuretics),
• in hypertensive patients for whom diuretic treatment cannot be discontinued,
• in patients with severe heart failure, and
• in patients treated with drugs that dilate blood vessels (vasodilators).

Your doctor will determine the duration of treatment based on your medical condition.
The efficacy and safety of use in children and adolescents (under 18 years of age) have not been established. Therefore, use in children and adolescents is not recommended.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Perindopril Teva Generics than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other symptoms may include rapid or slow heart rate, unpleasant sensations of irregular and/or excessive heartbeats, increased rate and depth of breathing, dizziness, anxiety, and/or cough.
If blood pressure drops significantly, you should lie down, elevate your legs, and use only a small pillow to support your head.

If you forget to take Perindopril Teva Generics
It is important to take the medicine every day. However, if you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for the forgotten dose. If you forget more than one dose, take the missed dose as soon as you remember, then continue as prescribed.

If you stop taking Perindopril Teva Generics
After stopping treatment, blood pressure may rise again, increasing the risk of complications due to hypertension, especially affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen to the extent that hospitalization may be required. Therefore, if you are considering stopping treatment with Perindopril Teva Generics, you must first discuss this with your doctor.

If you have any questions about the use of 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.
Possible side effects:
Common: may affect up to 1 in 10 people
headache, dizziness, sensation of dizziness (vertigo), tingling or pins and needles in the hands and
feet (paraesthesia), vision disturbance, ringing, buzzing, whooshing, crackling in the ears, etc.
(tinnitus), low blood pressure (hypotension) and effects related to hypotension, cough, shortness
of breath (dyspnoea), feeling unwell (nausea), malaise (vomiting), abdominal pain,
taste disturbances (dysgeusia), sensation of gurgling in the stomach (dyspepsia), diarrhoea and
constipation, skin rash, itching, muscle cramps, weakness (asthenia).
Uncommon: may affect up to 1 in 100 people
mood or sleep disturbances, narrowing of the airways due to muscle spasms
(bronchospasm), dry mouth, hypersensitivity reaction with sudden swelling of the face, neck, lips,
mucous membranes, tongue, glottis and/or larynx (with hoarseness or suffocation), possibly also
swelling of the hands and feet (angioedema), urticaria, reduced kidney function, inability to
achieve or maintain penile erection (impotence), sweating.
Rare: may affect up to 1 in 1,000 people
In rare cases, increased activity of liver enzymes and increased levels of serum bilirubin (an orange-yellow pigment in bile) have been reported; worsening of psoriasis.
Very rare: may affect up to 1 in 10,000 people
Very rarely, a decrease in the substance in red blood cells that carries oxygen to body tissues (haemoglobin), and in the relative amount of red blood cells in the blood (haematocrit), an unusually low number of platelets in the blood (cells responsible for blood clotting) (thrombocytopenia), an abnormal reduction in white blood cell count (leucopenia), a decrease in the number of a certain type of white blood cells - neutrophils (neutropenia), and cases of marked reduction in the number of certain types of white blood cells - granulocytes (agranulocytosis), or an abnormal deficiency of all blood cells (red blood cells, white blood cells and platelets - pancytopenia) have been reported.
Confusion, abnormal heart rhythm (arrhythmia), chest pain (angina pectoris), heart attack, likely due to excessive lowering of blood pressure in high-risk patients, lung inflammation associated with accumulation of certain blood cells (eosinophils) in lung tissue (eosinophilic pneumonia), inflammation of the nasal mucous membrane (rhinitis), inflammation of the pancreas (pancreatitis), allergic reaction of the small intestine (intestinal angioedema), inflammation of the liver (hepatitis), allergic rash characterised by flat pink-red spots (erythema multiforme), acute kidney failure.
Not known: frequency cannot be estimated from the available data
In patients with a congenital deficiency of certain enzymes (glucose-6-phosphate dehydrogenase - G-6PDH), very rare cases of anaemia (lack of red blood cells) have been reported, resulting from destruction of red blood cells (haemolytic anaemia).
Low blood sugar level (hypoglycaemia), inflammation of blood vessels (vasculitis), abnormal colour, numbness and pain in fingers of hands or feet (Raynaud's phenomenon).
Increases in waste products (plasma urea and plasma creatinine) and high levels of potassium (hyperkalaemia) may occur; these are reversible upon discontinuation of treatment, particularly in patients with impaired renal function, severe heart failure, and high blood pressure caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via 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 Teva Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Perindopril Teva Generics contains

• The active substance is perindopril tert-butylamine.
  Perindopril Teva Generics 4 mg tablets:
• Each tablet contains 4 mg of perindopril tert-butylamine salt, equivalent to 3.34 mg of perindopril.
• The other components are monohydrate lactose, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Perindopril Teva Generics and pack sizes
The 4 mg tablets are white, oblong, biconvex with bevelled edges and a score line on one side. The tablet can be divided into equal doses.
Pack sizes of 7, 10, 14, 20, 28, 30, 50, 60, 90 or 100 tablets in blisters are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco Strasse 3, 89079 Ulm (Germany)
Manufacturer
Merckle GmbH, Ludwig-Merckle Strasse 3, 89134 Blaubeuren (Germany)
Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto (Slovenia)
Krka Polska Sp.z.o.o. Ul Równoległa 5 02-235 Warsaw (Poland)

This medicinal product is authorised in the European Economic Area countries under the following names:
Perindopril 4 mg tablets:
Czech Republic: Perindopril-ratiopharm 4mg
Finland: Perindopril ratiopharm 4 mg tabletti
Hungary: Perindopril-Teva 4 mg tabletta
Italy: Perindopril Teva Generics 4 mg tablets
Netherlands: Perindopril tert-butylamine Teva 4 mg, tabletten
Portugal: Perindopril ratiopharm 4 mg comprimidos
Slovak Republic: Perindopril ratiopharm 4 mg