Perindopril indapamide Ratiopharm: detailed information

Package leaflet: Information for the user

Perindopril Indapamide ratiopharm 2 mg/0.625 mg tablets, 4 mg/1.25 mg tablets

Generic medicine
perindopril tert-butylamine and indapamide
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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Perindopril Indapamide ratiopharm is and what it is used for
What you need to know before taking Perindopril Indapamide ratiopharm
How to take Perindopril Indapamide ratiopharm
Possible side effects
How to store Perindopril Indapamide ratiopharm
Contents of the pack and other information

1. What Perindopril Indapamide ratiopharm is and what it is used for

What Perindopril Indapamide ratiopharm is
Perindopril Indapamide ratiopharm is a combination of two active substances, perindopril and
indapamide. The medicine is an antihypertensive and is used in the treatment of high blood
pressure (hypertension).
What Perindopril Indapamide ratiopharm is used for
Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the
blood vessels, thereby allowing the heart to pump blood more easily.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys.
However, indapamide differs from other diuretics in that it causes only a slight increase in the
amount of urine produced. Each of the active substances reduces blood pressure, and together
they act to control your blood pressure level.

2. What you need to know before taking Perindopril Indapamide ratiopharm

Do not take Perindopril Indapamide ratiopharm:

If you are allergic to perindopril (or to any other ACE inhibitor, e.g. ramipril, lisinopril, fosinopril), to indapamide (or to other sulfonamides, e.g. cotrimoxazole, sulfadiazine), 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, facial or tongue swelling, severe itching, or serious skin rash during prior treatment with ACE inhibitors, or if you have ever had these symptoms under any circumstances (a condition called angioedema);
If you have severe liver problems or a disease called hepatic encephalopathy (a degenerative brain disorder);
If you have severe kidney problems or are on dialysis;
If you have low levels of potassium in your blood;
If you suspect you have untreated decompensated heart failure (severe fluid retention, difficulty breathing);
If you are more than 3 months pregnant (it is advisable to avoid use of Perindopril Indapamide ratiopharm even in early pregnancy – see “Pregnancy, breastfeeding and fertility”);
If you are breastfeeding;
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, e.g. in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Indapamide ratiopharm 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 have aortic stenosis (narrowing of the main blood vessel leaving 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 or kidney disorders;
You have a connective tissue disease such as systemic lupus erythematosus or scleroderma;
You have atherosclerosis (hardening of the arteries);
You have gout;
You have diabetes;
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), especially 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 Indapamide ratiopharm”.
You are on a low-salt diet or use potassium-containing salt substitutes;
You are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with Perindopril Indapamide ratiopharm should be avoided (Other medicines and Perindopril Indapamide ratiopharm);
You experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to weeks after taking Perindopril Indapamide ratiopharm. This condition may lead to permanent vision loss if untreated. If you have previously

had allergic reactions to penicillin or sulfonamides, you may be at higher
risk of developing this condition.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Perindopril Indapamide ratiopharm 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 child if taken during this period (see
section “Pregnancy, breastfeeding and fertility”).
While taking Perindopril Indapamide ratiopharm, inform your doctor or healthcare provider if:

You are due to undergo anaesthesia and/or surgery;
You have recently had diarrhoea or vomiting, or are dehydrated;
You are scheduled for LDL apheresis (i.e. removal of cholesterol from the blood using a machine);
You are due to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
You are scheduled for a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-rays).

Athletes should be aware that Perindopril Indapamide ratiopharm contains
an active ingredient (indapamide) that may lead to a positive result in doping tests.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping
and may result in a positive doping test.

Children and adolescents
This medicine must not be used in children.

Other medicines and Perindopril Indapamide ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

You must avoid Perindopril Indapamide ratiopharm with:

Lithium (used to treat depression);
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 transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

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

Other medicines for treating high blood pressure;
Procainamide (for treating irregular heartbeat);
Allopurinol (for treating gout);
Terfenadine or astemizole (antihistamines for hay fever or allergies);
Corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis;
Immunosuppressants used to treat autoimmune diseases or to prevent organ transplant rejection (e.g. cyclosporine);
Medicines for treating cancer;
Intravenous erythromycin (an antibiotic);
Halofantrine (used to treat certain types of malaria);
Pentamidine (used to treat pneumonia);
Injectable gold (used to treat rheumatoid arthritis);
Vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
Bepridil (used to treat angina pectoris);
Sultopride (for treating psychosis);
Medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
Digoxin or other cardiac glycosides (for treating heart problems);
Baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis);
Medicines used to treat diabetes (such as insulin or metformin);
Calcium, including calcium supplements;
Stimulant laxatives (e.g. senna);
Non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. aspirin);
Intravenous amphotericin B (for treating serious fungal infections);
Medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
Tetracosactide (for treating Crohn's disease);
Medicines usually used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the mTOR inhibitor class). See section “Warnings and precautions”. 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 sections “Do not take Perindopril Indapamide ratiopharm” and “Warnings and precautions”).

Perindopril Indapamide ratiopharm with food and drink
It is preferable to take Perindopril Indapamide ratiopharm before a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, plan 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 Indapamide ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
Perindopril Indapamide ratiopharm 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 child if taken beyond the third month of pregnancy.

Breastfeeding
Do not take Perindopril Indapamide ratiopharm if you are breastfeeding.
Inform your doctor if you are breastfeeding or planning to breastfeed.
Contact your doctor immediately.

Driving and using machines
Perindopril Indapamide ratiopharm generally does not affect alertness; however, in some patients, side effects such as dizziness or weakness related to lowered blood pressure may occur. If you experience these, your ability to drive or operate machinery may be impaired.

Perindopril Indapamide ratiopharm contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Perindopril Indapamide ratiopharm

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
The usual dose is one tablet once daily. Your doctor may decide to adjust the
dosing regimen if you have renal impairment. Take the tablet preferably in the
morning and before a meal. Swallow the tablet with a glass of water.
Perindopril Indapamide ratiopharm 2 mg/0.625 mg tablets:
The score line on the tablet is intended to facilitate swallowing by allowing the tablet to be broken, but it is not intended for dividing the tablet into equal doses.
Perindopril Indapamide ratiopharm 4 mg/1.25 mg tablets:
The tablet can be divided into two equal halves.
If you take more Perindopril Indapamide ratiopharm than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. In case of overdose, the most likely adverse effect is low blood pressure. If a marked drop in blood pressure occurs (symptoms such as dizziness or fainting), it may be helpful to lie down with your legs elevated.
If you forget to take Perindopril Indapamide ratiopharm
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 Indapamide ratiopharm, take the next dose at your usual time. DO NOT take a double dose to make up for the missed dose.
If you stop taking Perindopril Indapamide ratiopharm
Since high blood pressure treatment usually needs to be continued for life, you must discuss with your doctor before stopping this medicine.
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 everybody gets them.
If you experience any of the following side effects, stop taking the tablets immediately and inform your doctor straight away:

swelling of the face, lips, mouth, tongue or throat with difficulty in breathing;
severe dizziness or feeling faint;
unusually fast or irregular heartbeat.

In order of decreasing frequency, possible side effects may include:

Common: (may affect up to 1 in 10 people) headache, dizziness, vertigo, tingling sensations, visual disturbances, tinnitus (ringing in the ears), lightheadedness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, epigastric pain, loss of appetite, vomiting, abdominal pain, altered taste, dry mouth, indigestion or digestive problems, diarrhoea, constipation), allergic reactions (such as skin rash, itching), muscle cramps, feeling of fatigue.
Uncommon: (may affect up to 1 in 100 people) mood swings, sleep disorders, depression, bronchospasm (chest tightness, breathlessness and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), kidney problems, impotence, sweating. If you suffer from systemic lupus erythematosus (a type of collagen disease), your condition may worsen.
Rare: (may affect up to 1 in 1,000 people) dark-coloured urine, feeling unwell (nausea) or being unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). Flushing, worsening of psoriasis, reduced or absent urine output, acute renal failure.
Very rare: (may affect up to 1 in 10,000 people) confusion, cardiovascular disorders (irregular heartbeat, angina, heart attack), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), allergic reaction in the small intestine (intestinal angioedema), severe skin reactions such as erythema multiforme. In addition, cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA have been reported.
Not known: (frequency cannot be estimated from the available data) decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), feeling faint, abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon), potentially life-threatening irregular heartbeat (torsades de pointes), abnormal ECG, increased liver enzyme levels.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may decide to carry out blood tests to monitor your condition.
In case of hepatic impairment (liver problems), there is a risk of developing hepatic encephalopathy (a degenerative brain disease).

Reporting of side effects
If you get any side effects, 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 Indapamide ratiopharm

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 blister or outer packaging after "Exp.". The expiry date refers to the last day of that month.
Perindopril Indapamide ratiopharm 2 mg/0.625 mg tablets
Do not store above 25°C.
Perindopril Indapamide ratiopharm 4 mg/1.25 mg tablets
Do not store above 30°C.
Do not dispose of any medicine via wastewater. 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 Indapamide ratiopharm contains
The active substances are perindopril tert-butylamine and indapamide.
Perindopril Indapamide ratiopharm 2 mg/0.625 mg tablets
Each tablet contains 1.669 mg of perindopril equivalent to 2 mg of perindopril tert-
butylamine and 0.625 mg of indapamide.
Perindopril Indapamide ratiopharm 4 mg/1.25 mg tablets
Each tablet contains 3.338 mg of perindopril equivalent to 4 mg of perindopril tert-
butylamine and 1.25 mg of indapamide.
The excipients are:
monohydrate lactose, microcrystalline cellulose (E460i), anhydrous hydrophobic colloidal silica,
magnesium stearate.

Description of the appearance of Perindopril Indapamide ratiopharm and contents of the
pack
The tablets are white, capsule-shaped, with a score line on both sides, marked with an 'L' (for the 2 mg/0.625 mg strength) or an 'H' (for the 4 mg/1.25 mg strength) on both sides of the score line on one side of the tablet, and smooth on the opposite side.
Perindopril Indapamide ratiopharm is available in packs with blisters containing 14, 20, 28, 30, 50, 56, 60, 90, 100 and 500 tablets.
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 – 89143 Blaubeuren, Germany
Specifar S.A. 1, 28 Octovriou Str. 12351 Agia Varvara, Athens, Greece

This medicinal product is authorised in the European Economic Area countries under
the following names:
Germany: Perindopril/Indapamid ratiopharm comp. 2 mg/0.625 mg Tabletten
Perindopril/Indapamid ratiopharm comp. 4 mg/1.25 mg Tabletten
Latvia: Perindap 4 mg/1.25 mg tabletes
Lithuania: Perindap 4 mg/1.25 mg tabletės
Italy: Perindopril Indapamide ratiopharm 2 mg/0.625 mg compresse
Perindopril Indapamide ratiopharm 4 mg/1.25 mg compresse
Netherlands: Perindopril tert-butylamine / indapamide Teva 2 mg/0.625 mg
Perindopril tert-butylamine / indapamide Teva 4 mg/1.25 mg
Portugal: Perindopril + Indapamida Ratiopharm
Czech Republic: Perinpa 4 mg/1.25 mg
Slovakia: Perindocombi 2 mg/0.625 mg
Perindocombi 4 mg/1.25 mg