PERINDOPRIL 4 mg Tablet

Зміст інструкції

1. Perindopril Teva Generics 4 mg tablets
   1. What is Perindopril Teva Generics 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. Package Contents and Other Information

Perindopril Teva Generics 4 mg tablets

Perindopril tert-butylamine

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, 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 Teva Generics is and what it is used for
• 2. What you need to know before you take 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 is Perindopril Teva Generics and what it is used for

The active substance of Perindopril Teva Generics belongs to the group of drugs called angiotensin converting enzyme (ACE) inhibitors.
Perindopril Teva Generics is used for the treatment of:

• high blood pressure (hypertension),
• symptomatic heart failure (a condition in which the heart is unable to pump a sufficient amount of blood to meet the body's needs),
• reduction of the risk of cardiac disorders such as heart attacks, in patients with stable coronary artery disease (a condition in which the amount of blood supplied to the heart is reduced or blocked), and who have previously had a heart attack and/or surgery to increase blood flow to the heart by dilating the vessels that distribute it.

2. What you need to 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 characterised by sudden swelling of the lips and face, neck, with possible involvement also of hands and feet, or a feeling of suffocation or hoarseness (angioedema) after taking an ACE inhibitor;
• if there have been cases of angioedema in your family or if you have had angioedema in other circumstances;
• if you are pregnant for more than three months. (It is best to avoid Perindopril Teva Generics even in the early stages of pregnancy - see the section Pregnancy);
• 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 type of long-term (chronic) 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
It is possible that Perindopril Teva Generics is not suitable for you, or that you need to have
regular check-ups. Talk to your doctor or pharmacist before taking Perindopril Teva
Generics:

• if you have been told you have a narrowing or blockage of blood flow to the heart (stable coronary artery disease);
• if you have been told you have an enlargement of the heart muscle or a problem with your heart valves;
• if you have been told you have a narrowing of the artery supplying blood to the kidney (renal artery stenosis);
• if you suffer from diabetes;
• if you suffer from other kidney, liver or heart disorders;
• if you are on dialysis or have recently had a kidney transplant;
• if you have a connective tissue disease such as systemic lupus erythematosus or scleroderma;
• if you are following a low-salt diet, or have had repeated episodes of vomiting or diarrhoea or have used medicines that increase the amount of urine (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 - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (such as potassium) in your blood at regular intervals. See also what is stated under “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 salt substitutes containing potassium;
• if you are taking any of the following medicines, 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 tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril Teva Generics is not recommended in the early stages of pregnancy, and must 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 section Pregnancy).

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

• You experience a feeling of dizziness after the first dose. Some people experience dizziness, weakness, fainting and discomfort after the first dose or when the dose is increased.
• Sudden swelling of the lips and face, neck, with possible involvement also of hands and feet, or wheezing or hoarseness. This condition is called angioedema. This can happen at any time during treatment.
• Swelling of the intestine called “intestinal angioedema”, which manifests with symptoms such as abdominal pain, vomiting and diarrhoea. ACE inhibitors cause a higher percentage of angioedema in patients of black race than in patients of non-black race.
• High fever, sore throat or ulcers in the mouth (these may be symptoms of infection caused by a decrease in the number of white blood cells).
• Yellowing of the skin and the whites of the eyes (jaundice) which may be signs of liver disorders.
• Dry, persistent cough for a long time. Cases of cough have been reported with ACE inhibitors, but it may also be a symptom of other diseases of the upper respiratory tract.

At the beginning of treatment and/or during the dose adjustment period, it may be necessary to
increase the frequency of medical check-ups. Do not skip visits even if you feel well. Your
doctor will determine the frequency of check-ups.

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, (even by the dentist),
• 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 (which involves removing cholesterol from your body using a machine).

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

Other medicines and Perindopril Teva Generics
Tell 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 consulting your doctor. This
mainly concerns:

• cold medicines containing the active substance pseudoephedrine or phenylephrine,
• pain relievers, including acetylsalicylic acid (a substance present in many medicines used as pain relievers and to reduce fever, as well as to prevent blood clotting),
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole 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 blood clots). Tell your doctor if you are taking any of the following medicines to be sure 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 the amount of urine (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, soreness and inflammation associated with painful conditions, especially those affecting muscles, bones and joints (non-steroidal anti-inflammatory drugs - NSAIDs), such as ibuprofen, indometacin, diclofenac or acetylsalicylic acid (a substance present in many medicines used as pain relievers and to reduce fever, as well as to prevent blood clotting),
• anti-inflammatory medicines (systemic corticosteroids),
• medicines that prevent tumor growth (cytostatic agents),
• medicines that decrease the body's immune responses (immunosuppressant agents),
• medicines that have a stimulating effect on a specific part of the nervous system such as ephedrine, noradrenaline or adrenaline (sympathomimetics.),
• medicines for the treatment of mania or depression (lithium),
• potassium tablets,
• gold. Your doctor may need to adjust the dose and/or take other precautions:
• If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “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 drugs 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, in order to reduce the
influence of food on the effectiveness of the medicine. Taking alcohol at the same time as
Perindopril Teva Generics can cause dizziness or lightheadedness. Ask your doctor if you can
drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, 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 becoming
pregnant). As a rule, your doctor will advise you to stop taking Perindopril Teva Generics before
becoming pregnant or as soon as you find out you are pregnant and will advise you to take another
medicine instead of Perindopril Teva Generics. Perindopril Teva Generics is not recommended in the
early stages of pregnancy, and must 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
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
Perindopril Teva Generics is not recommended for women who are breastfeeding and your doctor
may choose another treatment if you wish to breastfeed, especially if your baby is newborn or
premature.

Driving and using machines
Dizziness may occasionally occur (especially at the beginning of treatment, when the
dose is increased or if you drink alcohol at the same time), which may impair your ability to
drive and use machines.

Perindopril Teva Generics contains lactose
If you have been diagnosed with an intolerance to certain sugars, contact your doctor 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 always exactly as your doctor or pharmacist has told you.
If you have doubts, ask your doctor or pharmacist.
The recommended dose for the treatment of hypertension is 4 mg of perindopril (1 tablet of 4 mg of
Perindopril Teva Generics) once a day. When necessary, this can be increased to 8 mg
of perindopril (2 tablets of 4 mg of Perindopril Teva Generics) once a day.
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 a day; if necessary, the daily dose
can be increased to 4 mg of perindopril (1 tablet of 4 mg of Perindopril Teva
Generics) once a day.
The initial recommended dose for the treatment of stable coronary artery disease is 4 mg of perindopril (1
tablet of 4 mg of Perindopril Teva Generics) once a day; if well tolerated, the dose can
be increased to 8 mg of perindopril (2 tablets of 4 mg of Perindopril Teva Generics) once
a day.
Take the tablet with a glass of water, preferably every day at the same time, in the morning,
before a meal.
During the treatment, your doctor will adjust the dose based on the effectiveness of the treatment and your
needs.
The dose may be lower than usual and will be determined by your doctor:

• in elderly patients,
• in patients with kidney damage,
• in patients with high blood pressure caused by a narrowing of the arteries that supply blood to the kidneys (renovascular hypertension),
• in patients treated simultaneously with drugs that increase the amount of urine (diuretics),
• in hypertensive patients for whom diuretic treatment cannot be interrupted,
• 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 the 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, seek immediate medical attention or contact your pharmacist.
The most likely symptom of an overdose is a sudden drop in blood pressure
(hypotension). Other symptoms may include a fast 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, raise your lower limbs, and
use only a small pillow as a headrest.

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, continue
with the next dose as usual. Do not take a double dose to make up for a
missed dose. If you forget to take more than one dose, take another as soon as you
remember and then continue as prescribed.

If you stop taking Perindopril Teva Generics
Following discontinuation of treatment, blood pressure may rise again, and this may
increase the risk of complications due to hypertension, especially to the heart, brain and kidneys.
The condition of patients with heart failure may worsen to the extent that hospitalisation is justified.
Therefore, if you are considering stopping treatment with
Perindopril Teva Generics, you should talk to your doctor first.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may occur:

Common: may affect up to 1 in 10 people
Headache, dizziness, feeling of spinning (vertigo), tingling or pins and needles in the hands and
feet (paresthesia), visual impairment, tinnitus, buzzing, crackling, popping in the ears, etc.
(tinnitus), low blood pressure (hypotension) and effects related to hypotension, cough, shortness of
breath (dyspnea), feeling unwell (nausea), general feeling of discomfort (vomiting), abdominal pain,
altered taste (dysgeusia), sensation of gurgling in the stomach (dyspepsia), diarrhea 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 spasms of the muscles
(bronchospasm), dry mouth, hypersensitivity reaction with sudden swelling of the face, neck, lips,
mucous membranes, tongue, glottis and/or larynx (with hoarseness
or suffocation), with possible swelling also of the hands and feet (angioedema), urticaria,
reduced kidney function, inability to achieve or maintain a penile erection (impotence),
sweating.

Rare: may affect up to 1 in 1,000 people
In rare cases, an increase in liver enzyme activity and serum bilirubin levels (orange-yellow pigment in bile) has been reported;
worsening of psoriasis.

Very rare: may affect up to 1 in 10,000 people
Very rarely, a decrease in the substance contained in red blood cells that
carries oxygen to the body's tissues (hemoglobin), and the relative amount of red blood cells in the blood
(hematocrit) has been reported, an unusually low number of platelets in the blood (cells that allow
blood clotting) (thrombocytopenia), an abnormal reduction in the count of white blood cells
(leukopenia), a decrease in the number of a certain type of white blood cells - neutrophils
(neutropenia), and cases of marked decrease in the number of some types of white blood cell cells -
granulocytes (agranulocytosis) or abnormal deficiency of all blood cells (red blood cells and white
blood cells and platelets - pancytopenia).
Confusion, abnormal heart rhythm (arrhythmia), chest pain (angina pectoris), heart attack,
likely due to excessively low blood pressure in high-risk patients, lung inflammation associated with the accumulation of certain blood cells (eosinophils) in the
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 characterized by flat, pink-red spots (erythema multiforme), acute renal failure.

Not known: frequency cannot be estimated based on available data
In patients with a congenital deficiency of certain enzymes (glucose-6-phosphate dehydrogenase - G-
6PDH), very rare cases of anemia (deficiency of red blood cells) have been reported, as a result of
red blood cell destruction (hemolytic anemia).
Low blood sugar (hypoglycemia), inflammation of blood vessels (vasculitis),
abnormal color, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).
Increases in waste products (plasma urea and plasma creatinine) and high
levels of potassium (hyperkalemia) may occur, reversible with 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 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 Teva 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 and blister after
”Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30° C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in waste water. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Perindopril Teva Generics Contains

• The active ingredient 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 ingredients are lactose monohydrate, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate.

Description of the Appearance of Perindopril Teva Generics and Package Contents
The 4 mg tablets are white, oblong, biconvex with bevelled edges and a fracture line on
one side. The tablet can be divided into equal doses.
Packs 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 Równolegla 5 02-235 Warsaw (Poland)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

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 compresse
Netherlands: Perindopril tert-butylamine Teva 4 mg, tabletten
Portugal: Perindopril ratiopharm 4 mg comprimidos
Slovak Republic: Perindopril ratiopharm 4 mg