PERINDOPRIL 4 mg Tablet

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

PERINDOPRIL DOC Generici 2 mg tablets

PERINDOPRIL DOC Generici 4 mg tablets
PERINDOPRIL DOC Generici 8 mg tablets
Generic Equivalent 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PERINDOPRIL DOC Generici is and what it is used for
• 2. What you need to know before you take PERINDOPRIL DOC Generici
• 3. How to take PERINDOPRIL DOC Generici
• 4. Possible side effects
• 5. How to store PERINDOPRIL DOC Generici
• 6. Contents of the pack and other information

1. What PERINDOPRIL DOC Generici is and what it is used for

PERINDOPRIL DOC Generici is an angiotensin converting enzyme (ACE) inhibitor.
ACE inhibitors work by widening blood vessels, making it easier for the heart to pump the
blood through them.
PERINDOPRIL DOC Generici is used:

• to treat high blood pressure(hypertension),
• to treat heart failure(a condition in which the heart is unable to pump enough blood to meet the body's needs),
• to reduce the risk of cardiac events, such as a heart attack, in patients with stable coronary artery disease(a condition involving a reduction or blockage of blood supply to the heart) and who have already had a heart attack and/or surgery to improve blood supply to the heart by widening the vessels that supply it.

2. What you need to know before taking PERINDOPRIL DOC Generici

Do not take PERINDOPRIL DOC Generici

• if you are allergic to perindopril tert-butylamine or to any of the other ingredients of this medicine (listed in section 6)
• if you have experienced symptoms such as breathlessness, swelling of the face, tongue or throat, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member have experienced such symptoms in any other circumstance (a condition called angioedema).
• if you are pregnant for more than three months (It is best to avoid PERINDOPRIL DOC Generici even in the early stages of pregnancy - see the Pregnancy section),
• 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.

Warnings and precautions
If any of the following situations apply to you, speak to your doctor or pharmacist or nurse before taking PERINDOPRIL DOC Generici:

• if you have aortic stenosis (narrowing of the main artery leaving the heart) or hypertrophic cardiomyopathy (disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from other heart problems,
• if you have liver problems,
• if you have kidney problems or are undergoing dialysis,
• if you suffer from a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are following a diet with restricted salt intake or are using potassium-containing salt substitutes,
• if you are going to have anesthesia and/or surgery,
• if you are going to undergo LDL apheresis (blood purification from cholesterol using a machine),
• if you are going to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you have been diagnosed by a doctor with an intolerance to certain sugars,
• 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.
• if you are taking any of the following medicines, increases the risk of angioedema:
• racecadotril (used for the treatment of diarrhea)
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in the prevention of rejection following organ transplantation). The doctor may check your kidney function, blood pressure, 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 DOC Generici”
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing blood pressure compared to patients who are not black.

Angioedema
In patients treated with ACE inhibitors, including PERINDOPRIL DOC Generici, angioedema has been reported
(a serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). This can occur at any time
during treatment. If you develop these symptoms, you should stop taking PERINDOPRIL
DOC Generici and consult a doctor immediately. See also section 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant).
PERINDOPRIL DOC Generici 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).

Children and adolescents
PERINDOPRIL DOC Generici is not recommended for use in children and adolescents.

Other medicines and PERINDOPRIL DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Treatment with PERINDOPRIL DOC Generici can be affected by taking other
medicines. Your doctor may need to adjust your dose and/or take other
precautions. These medicines include:

• other medicines for high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also what is stated in the section “Do not take PERINDOPRIL DOC Generici” and “Warnings and precautions”), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium,
• potassium-sparing drugs used for the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• lithium for the treatment of mania or depression,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high doses of aspirin,
• medicines for diabetes (such as insulin or metformin and gliptins such as linagliptin, saxagliptin, sitagliptin, vildagliptin),
• baclofen (used for the treatment of muscle stiffness in diseases such as multiple sclerosis),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that can reduce the body's defense mechanisms) used for the treatment of autoimmune diseases or following organ transplantation (e.g. cyclosporine, tacrolimus),
• trimethoprim (for the treatment of infections),
• estramustine (used in cancer therapy),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeat),
• vasodilators including nitrates (products that dilate blood vessels),
• heparin (a medicine used to make the blood more fluid),
• medicines used in the treatment of hypotension, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline),
• gold salts especially with intravenous administration (used in the treatment of the symptoms of rheumatoid arthritis),
• medicines used more often for the treatment of diarrhea (racecadotril) or for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See the section “Warnings and precautions”.

PERINDOPRIL DOC Generici with food and drink
Drinking alcohol with PERINDOPRIL DOC Generici can cause dizziness. Check with your doctor if
you can drink alcohol while taking this medicine.
It is preferable to take PERINDOPRIL DOC Generici before meals.

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 should 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 DOC Generici before starting to become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine
instead of PERINDOPRIL DOC Generici.
PERINDOPRIL DOC Generici 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
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
PERINDOPRIL DOC Generici 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
PERINDOPRIL DOC Generici usually does not affect alertness but in some patients reactions such as dizziness or fatigue may
occur in relation to the reduction of blood
pressure. If you experience these symptoms, your ability to drive vehicles or operate machinery
may be reduced.

PERINDOPRIL DOC Generici contains lactose
If you have been diagnosed by a doctor with an intolerance to certain sugars, contact your doctor
before taking this medicine.

3. How to take PERINDOPRIL DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably every day at the same time, in the morning, before a meal. Your doctor will decide the appropriate dose for you.
The recommended doses are as follows:

High blood pressure: the usual initial and maintenance dose is 4 mg once a day. After one month, this dose may be increased to 8 mg once a day, if required. 8 mg per day constitutes the maximum recommended dose for the treatment of high blood pressure.
If you are over 65 years of age, the usual initial dose is 2 mg once a day. After one month this dose may be increased to 4 mg once a day and if necessary to 8 mg once a day.

Heart failure: the usual initial dose is 2 mg once a day. After two weeks, this dose may be increased to 4 mg once a day, which constitutes the maximum recommended dose for heart failure.

Stable coronary artery disease: the usual initial dose is 4 mg once a day. After two weeks, this dose may be increased to 8 mg once a day, which represents the maximum recommended dose for this indication.
If you are over 65 years of age, the usual initial dose is 2 mg once a day. After one week this dose may be increased to 4 mg once a day and after another week to 8 mg once a day.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more PERINDOPRIL DOC Generici than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or consult your doctor. The most likely effect in case of overdose is a lowering of blood pressure which can cause dizziness or fainting. In this case, it may be helpful to lie down with your legs raised.

If you forget to take PERINDOPRIL DOC Generici
It is important to take the medicine every day as regular treatment is more effective. However, if you forget to take a dose of PERINDOPRIL DOC Generici, take the next dose as usual. Do not take a double dose to compensate for the forgotten tablet.

If you stop taking PERINDOPRIL DOC Generici
Since treatment with PERINDOPRIL DOC Generici is usually lifelong, you should talk to your doctor before stopping taking this medicine.
If you have any questions about 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 everybody gets them.

Stop taking the medicine and tell your doctor immediately if you experience any of the following side effects, which may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”),
• severe dizziness or fainting due to low blood pressure,
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack,
• weakness of the arms or legs, or speech problems, which could be a sign of a possible stroke,
• sudden shortness of breath, chest pain, wheezing or difficulty breathing (bronchospasm),
• inflamed pancreas which can cause severe abdominal pain and back pain accompanied by a feeling of severe illness,
• yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis,
• skin rashes which often start with red, itchy patches on the face, arms or legs (erythema multiforme).

Stop taking the medicine and tell your doctor if you notice any of the following side effects:

• kidney problems,
• changes in blood tests such as a reversible high level of potassium when treatment is stopped, or a low level of sodium,
• chest infection (eosinophilic pneumonia),
• bruising or unexplained bleeding,
• frequent or recurring fever or infections,
• increased feeling of fatigue or shortness of breath,
• changes in blood values such as a decrease in the number of white blood cells and red blood cells, a decrease in hemoglobin, a decrease in the number of platelets.

Other side effects:

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

• headache,
• dizziness,
• vertigo,
• tingling,
• vision disorders,
• tinnitus (ringing in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste alteration, indigestion or dyspepsia, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling tired.

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

• mood changes,
• sleep disorders,
• dry mouth,
• intense itching or severe skin rashes,
• formation of clusters of blisters on the skin,
• impotence,
• sweating,
• excess of eosinophils (a type of white blood cells),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reaction (increased sensitivity of the skin to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• peripheral edema,
• fever,
• risk of falls,
• laboratory parameter changes: hypoglycemia (very low blood sugar levels) in diabetic patients, increased plasma urea and increased plasma creatinine.

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

• changes in laboratory parameters: increased levels of liver enzymes, high level of serum bilirubin,
• worsening of psoriasis.

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

• confusion,
• rhinitis (stuffy or runny nose).

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

• Abnormal color, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 DOC Generici

Keep this medicine out of the sight and reach of children. Store at
a temperature below 25  C. Store in the original package.
Do not use this medicine after the expiry date which is reported on the package after
Exp. The expiry date refers to the last day of that month.
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 DOC Generici contains

• The active ingredient is perindopril tert-butylamine.
• The other ingredients are anhydrous lactose and magnesium stearate.

Description of the appearance of PERINDOPRIL DOC Generici and contents of the pack
PERINDOPRIL DOC Generici 2 mg are white, round, biconvex tablets, with engraved
“APO” on one side and “PE2” on the other side.
PERINDOPRIL DOC Generici 4 mg are white, capsule-shaped tablets, with engraved
“APO” on one side and “PE” and “4” on the other side. The tablet can be divided into two equal
doses.
PERINDOPRIL DOC Generici 8 mg are white, capsule-shaped tablets, with engraved
“APO” on one side and “PE” and “8” on the other side. The tablet can be divided into two equal
doses.
Each dosage of PERINDOPRIL DOC Generici is available in packs of 4, 7, 14, 15, 28,
30, 50, 56, 60, 90, 100, 112, 120, 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands

PERINDOPRIL DOC Generici 4 mg and 8 mg tablets:
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano 43
24041 Brembate (Bergamo)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: PERINDOPRIL DOC Generici
Netherlands: Perindopril tert-butylamine Apotex