Perindopril Doc Generici: detailed information

Patient Information Leaflet

PERINDOPRIL DOC Generici 2 mg tablets, 4 mg tablets, 8 mg tablets

Generic Medicine
Please read all of 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 side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PERINDOPRIL DOC Generici is and what it is used for
What you need to know before taking PERINDOPRIL DOC Generici
How to take PERINDOPRIL DOC Generici
Possible side effects
How to store PERINDOPRIL DOC Generici
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 dilating blood vessels, making it easier for the heart to pump 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 heart attack, in patients with stable coronary artery disease (a condition involving reduced or blocked blood supply to the heart) who have already had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the vessels that supply it.

2. What you should 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 previously experienced symptoms such as breathlessness, swelling of the face, tongue or throat, severe itching or serious skin rashes related to prior treatment with ACE inhibitors, or if you or a family member have ever had such symptoms under any circumstances (a condition called angioedema)
if you are more than three months pregnant (PERINDOPRIL DOC Generici should also be avoided 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.

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

if you have aortic stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys)
if you have other heart problems
if you have liver problems
if you have kidney problems or are on 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 on a low-salt diet or use potassium-containing salt substitutes
if you are due to undergo anaesthesia and/or surgery
if you are scheduled for LDL apheresis (blood purification to remove cholesterol using a machine)
if you are undergoing desensitisation treatment to reduce allergic reactions to bee or wasp stings
if you have recently had diarrhoea or vomiting, or if you are dehydrated
if your doctor has diagnosed you 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 (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
- aliskiren
if you are taking any of the following medicines, which increase the risk of angioedema:
- racecadotril (used to treat diarrhoea)
- sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection)
  Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals. See also 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 lowering blood pressure compared to non-Black patients.

Angioedema
Angioedema (a serious allergic reaction causing swelling of the face, lips, tongue or throat, with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL DOC Generici. This may occur at any time during treatment. If you develop such symptoms, you must stop taking PERINDOPRIL DOC Generici and seek immediate medical attention. See also section 4.
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 during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if taken during this period (see section Pregnancy).

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 may be affected by concomitant use of other medicines. Your doctor may need to adjust your dose and/or take additional precautions. These include:

other blood pressure-lowering medicines, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also “Do not take PERINDOPRIL DOC Generici” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys)
potassium-sparing agents (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes
potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily
lithium, used to treat mania or depression
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief, or high-dose aspirin
medicines for diabetes (such as insulin or metformin, and gliptins such as linagliptin, saxagliptin, sitagliptin, vildagliptin)
baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis)
medicines for mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics)
immunosuppressants (medicines that reduce the body’s immune defences) used to treat autoimmune diseases or after surgical organ transplantation (e.g. ciclosporin, tacrolimus)
trimethoprim (for treating infections)
estramustine (used in cancer therapy)
allopurinol (for treating gout)
procainamide (for treating irregular heartbeat)
vasodilators including nitrates (substances that dilate blood vessels)
heparin (a medicine used to thin the blood)
medicines used more commonly to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”.

PERINDOPRIL DOC Generici with food and drink
Drinking alcohol with PERINDOPRIL DOC Generici may cause dizziness. Check with your doctor whether 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, think you may be pregnant, are 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 if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking PERINDOPRIL DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
PERINDOPRIL DOC Generici is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
PERINDOPRIL DOC Generici 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
PERINDOPRIL DOC Generici generally does not affect alertness, but in some patients, side effects such as dizziness or fatigue may occur due to lowered blood pressure. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

PERINDOPRIL DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PERINDOPRIL DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablet with a glass of water, preferably at the same time each day, 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 starting and maintenance dose is 4 mg once daily. After one month, this dose may be increased to 8 mg once daily, if needed. 8 mg per day is the maximum recommended dose for the treatment of high blood pressure.
If you are over 65 years of age, the usual starting dose is 2 mg once daily. After one month, this dose may be increased to 4 mg once daily and, if necessary, to 8 mg once daily.
Heart failure: The usual starting dose is 2 mg once daily. After two weeks, this dose may be increased to 4 mg once daily, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: The usual starting dose is 4 mg once daily. After two weeks, this dose may be increased to 8 mg once daily, which is the maximum recommended dose for this indication.
If you are over 65 years of age, the usual starting dose is 2 mg once daily. After one week, this dose may be increased to 4 mg once daily, and after another week to 8 mg once daily.

Use in children and adolescents
The use of this medicine is not recommended in children and adolescents.

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 department or contact your doctor. The most likely effect of an overdose is a drop in blood pressure, which may cause dizziness or fainting. In this case, lying down with your legs raised may be helpful.

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 make up for the missed tablet.

If you stop taking PERINDOPRIL DOC Generici
Since treatment with PERINDOPRIL DOC Generici is usually lifelong, you should speak to your doctor before stopping this medicine.

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 everybody gets them.
Stop taking the medicine and inform 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 in arms or legs, or difficulty speaking, which could be signs of a possible stroke,
sudden shortness of breath, chest pain, difficulty breathing or breathlessness (bronchospasm),
inflamed pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of severe illness,
yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis,
skin rashes that often begin with red, itchy spots on the face, arms or legs (erythema multiforme).

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

kidney problems,
changes in blood tests such as high potassium levels (reversible upon discontinuation of treatment), or low sodium levels,
chest infection (eosinophilic pneumonia),
appearance of unexplained bruising or bleeding,
fever or recurring infections,
unusual tiredness or breathlessness,
changes in blood values such as a decrease in white blood cells and red blood cells, a decrease in haemoglobin, or a decrease in platelet count.

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

headache,
dizziness,
vertigo,
tingling,
visual disturbances,
tinnitus (ringing or other noise in the ears),
cough,
shortness of breath (dyspnea),
gastrointestinal disorders (nausea, vomiting, abdominal pain, altered taste, dyspepsia or indigestion, diarrhoea, constipation),
allergic reactions (such as skin rash, itching),
muscle cramps,
feeling of fatigue.

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

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

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

changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels,
worsening of psoriasis.

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

confusion,
rhinitis (stuffy or runny nose).

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
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 not exceeding 25 °C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the pack after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 DOC Generici contains

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

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Italy: PERINDOPRIL DOC Generici
Netherlands: Perindopril tert-butylamine Apotex