Prilace

Italy
Brand name Prilace
Form tablets
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 029243

Package leaflet: Information for the patient

Prilace 5 mg + 6 mg tablets

ramipril + piretanide
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, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Prilace is and what it is used for

Prilace contains the active substances ramipril and piretanide.
Ramipril belongs to a class of medicines called “ACE inhibitors” (Angiotensin-Converting Enzyme inhibitors) and works by:

  • reducing the body's production of substances that can cause an increase in blood pressure;
  • relaxing and widening blood vessels;
  • helping the heart to pump blood more easily around the body.

Piretanide belongs to a class of medicines called “diuretics”, which increase urine production and consequently reduce blood pressure.
Prilace is indicated for the treatment of high blood pressure (essential arterial hypertension) when treatment with ramipril or piretanide alone (monotherapy) has proven insufficient, or when blood pressure has been stabilized to normal levels following treatment with ramipril and piretanide administered separately at the same doses contained in Prilace.

2. What you need to know before taking Prilace

Do not take Prilace

  • if you are allergic to ramipril, piretanide, or any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other ACE inhibitors or to sulfonamides (sulfonamide antibiotics and sulfonylureas);
  • if you are currently undergoing treatment with sacubitril/valsartan, a medicine used for long-term treatment of heart failure;
  • if you have previously experienced swelling of the legs, arms, face, throat, or tongue (angioedema, for example following previous treatment with other medicines of the ACE-inhibitor class);
  • if you have severe kidney problems (severe renal failure);
  • if you have kidney problems requiring dialysis;
  • if you suffer from narrowing of the blood vessels supplying the kidneys with reduced blood flow to the kidneys (renal artery stenosis of both kidneys or of the only kidney you have);
  • if you have previously undergone kidney transplantation;
  • if you suffer from narrowing (stenosis) of heart valves (aortic or mitral) causing blood circulation problems, or from a heart disease characterized by thickening of the heart walls (hypertrophic cardiomyopathy);
  • if you have a condition called primary hyperaldosteronism, characterized by increased production of the hormone aldosterone, with symptoms such as high blood pressure, low potassium levels in the blood, muscle weakness, and increased urine output;
  • if you have severe liver problems (severe hepatic insufficiency) with disturbances in consciousness (hepatic coma or precoma) or inflammation of the liver (primary liver disease);
  • if you have abnormal levels of minerals in the body (electrolyte imbalance), for example low sodium levels in the blood (hyponatremia) or low potassium levels in the blood (hypokalemia);
  • if you have reduced blood volume (hypovolemia);
  • if you are pregnant (see "Pregnancy and breastfeeding");
  • if you are breastfeeding (see "Pregnancy and breastfeeding");
  • if you are a child or adolescent;
  • if you have low blood pressure or unstable blood pressure (hypotensive or hemodynamically unstable states);
  • if you have diabetes or kidney problems and are taking medicines containing aliskiren (used to treat high blood pressure) (see section "Other medicines and Prilace");
  • if you are scheduled for a treatment to remove cholesterol from the blood using machines (low-density lipoprotein (LDL) apheresis using dextran sulfate) or for dialysis or other blood filtration treatments (hemofiltration), because due to the equipment used, Prilace may not be suitable for you (see also "Other medicines and Prilace").

Warnings and precautions
Talk to your doctor or pharmacist before taking Prilace.
You must take Prilace under regular medical supervision.
Patients with overstimulated renin-angiotensin system
Your doctor will administer Prilace with particular caution if you have a condition called "overstimulation of the renin-angiotensin system", the hormonal mechanism regulating sodium and water excretion through the kidneys (see "How to take Prilace"). This is because a significant drop in blood pressure and serious kidney function disturbances may occur, especially when starting ACE inhibitor therapy or concomitant diuretic therapy, or when increasing the dose of these medicines for the first time. Your doctor will closely monitor your blood pressure.
You are likely to have overstimulation of the renin-angiotensin system, for example, if:

  • you have very high blood pressure (severe hypertension) or a rapid rise in blood pressure with serious organ damage (malignant hypertension). Close medical monitoring is required at the beginning of treatment;
  • you have heart problems (heart failure). If heart failure is severe, close medical monitoring is required at the beginning of treatment;
  • you have narrowing of heart valves (aortic or mitral) causing blood circulation problems (e.g., aortic or mitral valve stenosis). Close medical monitoring is required at the beginning of therapy;
  • you suffer from narrowing of the blood vessels supplying the kidneys with reduced blood flow (renal artery stenosis). Close medical monitoring is required at the beginning of treatment (see also below "Monitoring of kidney function");
  • you are taking medicines that increase urine production (diuretics). If discontinuation or dose reduction of the diuretic is not possible, close medical monitoring is required at the beginning of treatment;
  • you have lost significant body fluids or salts (volume or salt depletion) due to a low fluid or salt diet, or due to a condition such as diarrhea, vomiting, or excessive sweating without adequate fluid and salt intake.

Patients particularly at risk of excessive drop in blood pressure
If you are at high risk of experiencing an excessive drop in blood pressure, for example, if you suffer from a disease reducing blood flow to the heart or brain (coronary or cerebral vessel stenosis), close medical monitoring is required at the beginning of therapy.
Elderly
If you are elderly, your doctor will assess your kidney function before starting treatment.
Monitoring of kidney function
Your doctor will monitor your kidney function, especially during the first weeks of treatment and if:

  • you have heart problems (heart failure);
  • you have problems with the blood vessels of the kidneys, including narrowing of the renal blood vessels with reduced blood flow to the kidney (unilateral renal artery stenosis), possibly leading to reduced kidney function;
  • you have kidney problems (renal insufficiency);
  • you have undergone kidney transplantation.

Monitoring of mineral levels in the body (electrolytes)
During treatment with Prilace, your doctor will regularly order blood tests to measure levels of sodium, potassium, calcium, uric acid, and blood sugar (glucose). If your kidney function is reduced, your doctor will monitor your blood potassium levels more frequently.
Blood tests
Your doctor will monitor your white blood cell count (leukocyte count) to detect possible reduction (leukopenia), especially at the beginning of treatment and if you have reduced kidney function, suffer from diseases called "systemic lupus erythematosus or scleroderma" (which may present with skin irritation, joint pain, and fever), or are taking other medicines that may cause blood abnormalities (see "Other medicines and Prilace" and "Possible side effects").
If you experience severe protein loss in the urine (proteinuria) during treatment with Prilace, you must be under close medical supervision.
Primary hyperaldosteronism
If you suffer from a condition called primary hyperaldosteronism, characterized by increased production of the hormone aldosterone with symptoms such as high blood pressure, low potassium levels in the blood, muscle weakness, and increased urine output, your doctor will closely monitor your blood potassium levels.
Other checks
Your doctor will perform careful monitoring if:

  • you suffer from joint inflammation causing pain and swelling (gout);
  • you have reduced liver function.

Swelling of head, neck, or hands and feet (angioedema)
If during treatment with Prilace you develop swelling of the face, hands and feet, lips, tongue, or throat (angioedema), stop taking the medicine and contact your doctor or go immediately to the nearest hospital.
Do not use other medicines such as sacubitril/valsartan that may cause angioedema, a serious allergic reaction (see also sections "Do not take Prilace" and "Other medicines and Prilace").
Do not use other medicines such as temsirolimus, sirolimus, everolimus, racecadotril, and vildagliptin that may cause angioedema, a serious allergic reaction (see also section "Other medicines and Prilace").
Intestinal angioedema
If during treatment with Prilace you develop intestinal angioedema with abdominal pain (with or without nausea or vomiting), stop taking the medicine and contact your doctor or go immediately to the nearest hospital.
Concomitant use of medicines to lower blood pressure (ACE inhibitors, angiotensin II receptor antagonists, or aliskiren)
During treatment with Prilace, do not take other medicines to lower blood pressure (other ACE inhibitors, angiotensin II receptor antagonists, or medicines containing aliskiren), because this may lead to low blood pressure (hypotension), increased potassium levels in the blood (hyperkalemia), and reduced kidney function (including acute renal failure) (see "Other medicines and Prilace").
In particular, do not take ACE inhibitors and angiotensin II receptor antagonists together if you have reduced kidney function due to diabetes (diabetic nephropathy).
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and Prilace
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Prilace may affect the effects of other medicines, and other medicines may affect the effects of Prilace.
The following combinations with Prilace are contraindicated:

  • treatments such as dialysis, blood filtration (hemofiltration) with high-flux membranes, such as polycrylonitrile membranes, or treatment to remove cholesterol from the blood using machines (low-density lipoprotein (LDL) apheresis using dextran sulfate), because severe and rapid allergic reactions (anaphylactoid reactions) may occur (see "Do not take Prilace");
  • blood pressure-lowering medicines containing aliskiren if you have diabetes or reduced kidney function (see "Do not take Prilace" and "Warnings and precautions");
  • sacubitril/valsartan, a medicine used for long-term treatment of heart failure, which may increase the risk of angioedema (see also sections "Do not take Prilace" and "Warnings and precautions").

The following combinations with Prilace are not recommended:

  • other blood pressure-lowering medicines (other ACE inhibitors, angiotensin II receptor antagonists). The combined use of these medicines with Prilace increases the risk of adverse effects such as low blood pressure (hypotension), increased potassium levels in the blood (hyperkalemia), and reduced kidney function (including renal failure) (see "Do not take Prilace" and "Warnings and precautions");
  • potassium salts, other medicines that may increase potassium concentration in the blood, and diuretics that increase urine production without reducing potassium levels (potassium-sparing diuretics, such as spironolactone). The combined use of Prilace with these medicines may increase blood potassium levels, sometimes severely;
  • medicines that may be harmful to the ear (e.g., aminoglycoside antibiotics), because the piretanide contained in Prilace may increase the severity and frequency of hearing damage, which may also be irreversible.

The following combinations with Prilace require special caution:

  • blood pressure-lowering medicines (antihypertensives) and medicines that may also lower blood pressure (nitrates: for chest pain; tricyclic antidepressants: for treating depression; anesthetics: for surgical procedures). These medicines may enhance the blood pressure-lowering effect of Prilace (see also "Warnings and precautions", "Possible side effects", and "How to take Prilace");
  • medicines used to treat low blood pressure, circulatory failure (shock), reduced heart function (heart failure), asthma, or allergies (sympathomimetic vasoconstrictors): these medicines may reduce the blood pressure-lowering effect of Prilace and, conversely, Prilace may reduce the effects of these medicines. Your doctor will need to monitor your blood pressure;
  • allopurinol (used to reduce uric acid levels in the blood), immunosuppressants (used to prevent organ rejection after transplantation), corticosteroids (used in certain inflammatory diseases), procainamide (for treating heart rhythm problems), cytostatics (for cancer treatment), and other medicines that may affect the blood. The combined use of Prilace and these medicines increases the risk of blood-related reactions (see also "Warnings and precautions");
  • lithium salts (for treating mental illnesses): Prilace may increase lithium levels in the blood and its toxicity. Therefore, your doctor must monitor your blood lithium levels;
  • medicines for treating diabetes (antidiabetic medicines such as insulin and sulfonylureas): the ramipril contained in Prilace may reduce blood sugar levels, while the piretanide contained in Prilace may reduce the effectiveness of antidiabetic medicines. Your doctor will monitor your blood sugar levels;
  • medicines containing vildagliptin (for treating diabetes). The combined use of Prilace and these medicines increases the frequency of swelling of the face, hands and feet, lips, tongue, or throat (angioedema);
  • trimethoprim and cotrimoxazole (for bacterial infections);
  • temsirolimus (for cancer);
  • everolimus (to prevent graft rejection);
  • neprilysin enzyme inhibitors (NEP). The combined use of Prilace and neprilysin inhibitors (NEP), such as racecadotril (used to treat diarrhea), may increase the risk of angioedema.

The following combinations with Prilace require special attention:

  • non-steroidal anti-inflammatory medicines (for treating pain and inflammation, also known as NSAIDs, such as indometacin, acetylsalicylic acid): these medicines may reduce the blood pressure-lowering effect of Prilace, worsen kidney function disturbances (acute renal failure), and increase potassium levels in the blood, especially if your kidney function is already reduced. Your doctor will prescribe this combination cautiously, particularly if you are elderly. You should drink sufficient fluids, and your doctor will monitor your kidney function at the start of treatment;
  • heparin (to thin the blood): combination with Prilace may increase blood potassium levels (kalemia);
  • probenecid (to reduce uric acid levels in the blood): this medicine may reduce the blood pressure-lowering effect of Prilace;
  • salicylates (used for pain): Prilace may increase the effects and toxicity of salicylates;
  • corticosteroids, ACTH (hormone), amphotericin B (for treating fungal infections), carbenoxolone (for treating stomach ulcers), excessive consumption of licorice, prolonged use of laxatives (to promote bowel evacuation), and other medicines that may reduce potassium levels in the blood: the combined use of Prilace may reduce blood potassium levels (hypokalemia);
  • digitalis (used for heart diseases): the combined use of Prilace and these medicines may increase digitalis toxicity due to disturbances in mineral levels in the blood (reduced potassium levels - hypokalemia, reduced magnesium levels in the blood - hypomagnesemia);
  • curare-type muscle relaxants (to relax muscles during surgery): combined use with Prilace may increase and prolong muscle relaxation effects;
  • medicines that may damage the kidneys: the combination may increase kidney damage (due to piretanide);
  • desensitization therapies: if you are scheduled for therapies to reduce allergy to insect stings, inform your doctor that you are taking Prilace, as there is an increased risk of serious adverse effects and rapid allergic reactions (anaphylactic or anaphylactoid reactions).

Prilace with food and alcohol
Taking food does not affect the activity of Prilace.
A high-salt diet may reduce the blood pressure-lowering effect of Prilace.
Prilace increases the effects of alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Prilace during pregnancy.
You must rule out possible pregnancy before starting treatment.
During treatment with Prilace, you must use adequate contraceptive measures.
If switching to a treatment without ACE inhibitors and diuretics is not possible, avoid pregnancy because Prilace may harm the fetus.
Breastfeeding
Do not take Prilace if you are breastfeeding.
If an alternative treatment to Prilace is not possible, discontinue breastfeeding.
Driving and using machines
Due to the possible occurrence of certain side effects (e.g., disturbances due to low blood pressure such as dizziness and lightheadedness) that may interfere with your ability to concentrate and react, Prilace may impair your ability to drive vehicles or operate machinery.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Prilace

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet of Prilace daily.

Use in patients with kidney problems (moderate renal impairment) and in elderly patients
If you have kidney problems or are elderly, your doctor will determine the dose with great caution.
The maintenance dose is ½ tablet of Prilace daily. Do not exceed the maximum dose of 1 tablet of Prilace per day.

Use in patients already being treated with diuretics
If you are taking other medicines that increase urine production (diuretics), treatment with the diuretic should be stopped at least 2–3 days before starting therapy with Prilace, or at least the dose should be reduced.
Follow your doctor’s instructions carefully; the recommended initial dose is ½ tablet of Prilace daily.

Method of administration
Take the recommended dose as a single administration, preferably in the morning.
Take the tablets with an adequate amount of liquid (at least ½ glass).
Do not chew or crush the tablets.
You may take Prilace before, during, or after meals.
Your doctor will decide how long you should continue taking Prilace.

If you take more Prilace than you should
An overdose of Prilace may cause increased urine production, a marked drop in blood pressure, shock, slow heart rate (bradycardia), disturbances in fluid and electrolyte levels in the body, kidney problems (renal failure), irregular heart rhythm, reduced or loss of consciousness up to coma, seizures, reduced motility (paresis), intestinal obstruction preventing the passage of stools and gas (paralytic ileus), and difficulty urinating with excessive bladder distension, especially in case of urinary tract obstruction (e.g. due to enlarged prostate – prostatic hyperplasia).
In case of accidental ingestion or overdose of Prilace, contact your doctor immediately or go to the nearest hospital.

If you forget to take Prilace
Do not take a double dose to make up for the missed tablet.
If you have any questions 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.
The following side effects may occur with the following frequency:

Side effects due to ramipril:

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

  • headache (cephalalgia)
  • dizziness (light-headedness)
  • dry cough, which worsens at night or when lying down, and occurs particularly in women and non-smokers
  • inflammation of the bronchi (bronchitis)
  • inflammation of the sinuses (sinusitis)
  • difficulty breathing (dyspnoea)
  • inflammation of the stomach and intestine
  • digestive disorders
  • abdominal pain
  • indigestion (dyspepsia)
  • diarrhoea
  • nausea
  • vomiting
  • skin rash, particularly with redness and swelling (maculopapular rash)
  • muscle spasms (muscle cramps)
  • muscle pain (myalgia)
  • increased potassium levels in the blood
  • low blood pressure
  • sudden drops in blood pressure when standing up or after sitting or lying down (orthostatic hypotension)
  • loss of consciousness (syncope)
  • chest pain
  • fatigue

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

  • decreased or interrupted blood flow to the heart (myocardial ischemia)
  • chest pain (angina pectoris)
  • heart attack (myocardial infarction)
  • rapid heartbeat (tachycardia)
  • irregular heartbeat (arrhythmia)
  • irregular or forceful heartbeat (palpitations)
  • fluid accumulation causing swelling in various parts of the body (peripheral oedema)
  • increase in a type of white blood cells (eosinophilia)
  • dizziness (vertigo)
  • altered skin sensation, tingling (paraesthesia)
  • loss of taste (ageusia)
  • altered or reduced sense of taste (dysgeusia)
  • vision disturbances, including blurred vision
  • narrowing of the bronchi making breathing difficult (bronchospasm)
  • worsening of asthma
  • swelling of the inner nasal wall (nasal congestion)
  • inflammation of the pancreas (pancreatitis), sometimes fatal
  • changes in blood tests specific for monitoring the pancreas (increased levels of pancreatic enzymes)
  • swelling and pain in the first part of the intestine (angioedema of the small intestine)
  • stomach pain
  • inflammation of the stomach lining (gastritis)
  • constipation (stipsis)
  • dry mouth
  • reduced kidney function (renal failure)
  • increased urine output
  • worsening of protein loss in the urine (proteinuria)
  • increased blood urea
  • increased blood creatinine
  • severe allergic reaction with swelling of the face, hands and feet, lips, tongue or throat, difficulty swallowing and breathing (angioedema), which may be fatal. Patients of black race have a higher risk of this type of reaction when using ACE inhibitors
  • itching
  • excessive sweating (hyperhidrosis)
  • joint pain (arthralgia)
  • loss of appetite (anorexia)
  • decreased appetite (inappetence)
  • hot flushes
  • fever
  • changes in blood tests specific for monitoring the liver (increased serum levels of liver enzymes and/or conjugated bilirubin)
  • temporary inability to achieve or maintain an erection (erectile impotence)
  • reduced sexual desire
  • depression, anxiety, nervousness, agitation
  • sleep disturbances, including drowsiness

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

  • decreased number of white blood cells in the blood (neutropenia and agranulocytosis), decreased number of red blood cells, decreased haemoglobin, decreased number of platelets. These effects are more likely in patients with kidney problems or diseases such as systemic lupus erythematosus or scleroderma, or who are taking other medicines that may affect blood values
  • tremors
  • altered or loss of balance (sense of instability)
  • red and swollen eyes (conjunctivitis)
  • hearing disturbances
  • ringing or buzzing in the ear (tinnitus)
  • inflammation of the tongue (glossitis)
  • skin inflammation with peeling (exfoliative dermatitis)
  • urticaria
  • nail changes (onycholysis)
  • narrowing of blood vessels (vascular stenosis)
  • reduced blood flow to organs (hypoperfusion)
  • inflammation of blood vessels (vasculitis)
  • muscle weakness (asthenia)
  • yellowing of the skin and eyes (cholestatic jaundice)
  • damage to liver cells (hepatocellular damage)
  • confusion

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

  • light sensitivity (photosensitization reactions)

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

  • bone marrow depression
  • decreased number of all blood cells (pancytopenia)
  • breakdown of red blood cells (haemolytic anaemia)
  • decreased or interrupted blood flow to the brain (cerebral ischemia)
  • blockage of blood vessels in the brain (ischaemic stroke)
  • temporary interruption of blood flow to the brain (transient ischaemic attack)
  • altered ability to move and react (dizziness and reduced reaction capacity)
  • burning sensation
  • disturbances of the sense of smell (parosmia)
  • cold (rhinitis)
  • inflammation of the mouth with sores (aphthous stomatitis)
  • severe skin, mouth and other body lesions with blisters, bullae, high fever, vomiting, diarrhoea and joint pain (toxic epidermal necrolysis, Stevens-Johnson syndrome)
  • one or more target-like skin lesions (erythema multiforme)
  • skin and mucous membrane lesions with blisters (pemphigus)
  • worsening of psoriasis, a skin disease characterized by silvery-white scaling
  • psoriasis-like skin irritation (psoriasiform dermatitis)
  • skin irritation characterized by irregular red patches (exanthema)
  • localized mucosal irritation with blisters or scaly plaques (pemphigoid or lichenoid enanthema)
  • hair loss (alopecia)
  • concentrated urine (dark-coloured), feeling unwell or malaise, muscle cramps, confusion and seizures which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor immediately
  • decreased sodium levels in the blood, especially due to a low-salt diet
  • condition characterized by temporary narrowing of blood vessels, reducing blood flow to fingers and toes, which become pale and bluish for a short time, and when circulation returns to normal, become red, pulsating and painful (Raynaud's syndrome)
  • allergic reactions (anaphylactic or anaphylactoid reactions). The risk of severe allergic reactions to insect venom or other allergens may be increased during ACE inhibitor therapy
  • increased levels of antibodies that the body produces against itself due to immune system disorders (antinuclear antibodies)
  • severe liver problems (liver failure)
  • inflammation of the liver (cholestatic or cytolytic hepatitis), exceptionally with fatal outcome
  • breast enlargement in men (gynaecomastia)
  • attention disturbances

Other side effects due to piretanide are:

  • increased concentration of red blood cells in the blood (haemoconcentration)
  • onset or worsening of disorders in patients with problems in urine outflow (e.g. patients with bladder emptying problems, prostatic hypertrophy, urethral stricture); in these cases urinary retention with excessive bladder distension may occur
  • reduction in body fluid volume (especially in the elderly and if fluid loss is not replenished through adequate diet)
  • muscle weakness
  • syndrome characterized by muscle cramps, spasms, involuntary muscle contractions and muscle tremors (tetany)
  • increased levels of fats in the blood (cholesterol and triglycerides)
  • changes in blood acidity (metabolic alkalosis)
  • increased excretion of calcium and magnesium
  • decreased potassium levels in the blood
  • increased uric acid levels in the blood (which may cause gout attacks, especially if you already have high uric acid levels)
  • reduced glucose tolerance (worsening of diabetes or onset of previously undiagnosed diabetes)
  • increased thirst
  • formation of blood clots in blood vessels (thrombosis)
  • hearing disturbances, such as ringing or buzzing (tinnitus) and sometimes irreversible hearing loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prilace

Keep in the original packaging to protect the medicine from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after
"Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Prilace contains

  • The active substances are: ramipril and piretanide. Each tablet contains 5 mg of ramipril and 6 mg of piretanide.
  • The other components are: hypromellose, pregelatinized starch, microcrystalline cellulose, magnesium stearate.

Description of the appearance of Prilace and contents of the pack
Prilace is available as divisible tablets in packs containing 14 tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa n 7
20121 Milano
Manufacturer
Sanofi S.r.l.
S.S. n. 17, km 22 – 67019 Scoppito (AQ)