PRILACE 5 mg/6 mg Tablets

Зміст інструкції

1. Prilace 5 mg + 6 mg tablets
   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

Prilace 5 mg + 6 mg tablets

ramipril + piretanide

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 pass it on to others, even if their symptoms are the same as yours, 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 Prilace is and what it is used for
• 2. What you need to know before you take 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 it works:

• by reducing the production by the body of substances that can cause an increase in blood pressure;
• by relaxing and widening blood vessels;
• by making it easier for the heart to pump blood around the body.

Piretanide belongs to a class of medicines called “diuretics”, which promote the production
of urine, 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 at normal values following
treatment with ramipril and piretanide administered separately and 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 sulfonamides (sulfonamide antibiotics and sulfonylureas);
• if you are taking sacubitril/valsartan, a medicine used to treat long-term 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 from the ACE inhibitor family);
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you have kidney problems that require dialysis;
• if you suffer from a narrowing of the blood vessels of the kidneys with reduced blood flow to the kidneys (renal artery stenosis of both kidneys or the only kidney you have);
• if you have had a kidney transplant in the past;
• if you suffer from narrowing (stenosis) of the heart valves (aorta or mitral) which causes problems with blood circulation or a heart disease characterized by thickening of the heart walls (hypertrophic cardiomyopathy);
• if you have a disease called primary hyperaldosteronism characterized by an increase in the production of the hormone aldosterone with disorders such as high blood pressure, low levels of potassium in the blood, muscle weakness and increased urine output;
• if you suffer from severe liver problems (severe hepatic insufficiency) with changes in consciousness (hepatic coma or precoma) or liver inflammation (primary liver disease);
• if you have abnormal amounts of minerals in your body (electrolyte imbalance) for example reduced levels of sodium in the blood (hyponatremia) or reduced amounts of potassium in the blood (hypokalaemia);
• if you have a reduction in 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 fluctuations in blood pressure (hypotensive states or haemodynamically unstable);
• 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 to undergo treatment to remove cholesterol from the blood by machinery (low-density lipoprotein (LDL) apheresis with dextran sulfate) or dialysis or other blood filtration treatment (haemofiltration), as the machinery used may make the use of Prilace unsuitable 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 an excessively stimulated renin-angiotensin system
Your doctor will administer Prilace with particular caution if you have a condition called
“excessive stimulation of the renin-angiotensin system”, the hormonal mechanism that regulates
the elimination of sodium and water through the kidneys (see “How to take Prilace”). This is because
a significant drop in blood pressure and severe changes in
kidney function may occur, especially if you are given the ACE inhibitor or a
concurrent diuretic therapy for the first time or if the dose of these medicines is increased for the first time. Your
doctor will carefully monitor your blood pressure.
You are likely to develop excessive stimulation of the renin-angiotensin system for example
if:

• you have very high blood pressure (severe hypertension) or a rapid increase in blood pressure with severe damage to organs (malignant hypertension). You must be under close medical supervision at the start of treatment;
• you have heart problems (heart failure). If the heart failure is severe, you must be under close medical supervision at the start of treatment;
• you have narrowing of the heart valves (aorta or mitral) which causes problems with blood circulation (e.g. aortic or mitral valve stenosis). You must be under close medical supervision at the start of therapy;
• you suffer from narrowing of the blood vessels of the kidneys with reduced blood flow to the kidneys (renal artery stenosis). You must be under close medical supervision at the start of treatment (see also below “Control of renal function”);
• you are taking medicines that promote urine production (diuretics). If it is not possible to stop or reduce the dose of the diuretic, you must be under close medical supervision at the start of treatment;
• you have lost a lot of fluids or salts from your body (dehydration or salt depletion) due to a low-fluid or low-salt diet or due to an illness such as diarrhoea, vomiting or excessive sweating without adequate intake of fluids and salts.

Patients particularly at risk for an excessive drop in blood pressure
If you are at high risk of having an excessive drop in blood pressure, for example
you suffer from a disease that reduces blood flow to the heart or brain (stenosis of the coronary arteries or vessels that supply the brain), you must be under close medical supervision at the start of therapy.

Elderly
If you are elderly, your doctor will assess your kidney function before starting treatment.

Control of renal function
Your doctor will check your kidney function, especially during the first few weeks of
treatment and if:

• you have heart problems (heart failure)
• you have blood vessel disorders of the kidneys, including narrowing of the blood vessels of the kidneys with reduced blood flow to the kidney (renal artery stenosis) with possible reduction of kidney function
• you have kidney problems (renal insufficiency)
• you have had a kidney transplant.

Control of minerals in the body (electrolytes)
During treatment with Prilace, your doctor will regularly prescribe blood tests to
measure the levels of sodium, potassium, calcium, uric acid and sugars (glycaemia). If your
kidney function is reduced, your doctor will check your potassium levels in the blood more frequently.

Blood tests
Your doctor will check the number of white blood cells in your blood (leukocyte count) to be able to
detect a possible reduction (leukopenia), especially at the start of treatment and if you have
reduced kidney function or suffer from diseases called “systemic lupus erythematosus or
scleroderma” (which can manifest with skin irritation, joint pain and fever) or
take other medicines that can cause changes in the blood (see “Other medicines and
Prilace” and “Possible side effects”).
If you have severe protein loss with your urine (proteinuria) during treatment with Prilace, you
must be under close medical supervision.

Primary hyperaldosteronism
If you suffer from a disease called primary hyperaldosteronism, characterized by an increase in the
production of the hormone aldosterone with disorders such as high blood pressure, low levels of
potassium in the blood, muscle weakness and increased urine output, your doctor will carefully monitor your potassium levels in the blood.

Other checks
Your doctor will subject you to careful checks if:

• you suffer from an inflammation of the joints that causes pain and swelling (gout)
• you have reduced liver function.

Swelling of the head, neck or hands and feet (angioedema)
If you experience swelling of the face, hands and feet, lips, tongue or throat (angioedema) during treatment with Prilace, stop taking the medicine and seek immediate medical attention or the nearest hospital.
Do not use other medicines at the same time, such as sacubitril/valsartan, which can cause
angioedema, a serious allergic reaction (see also sections “Do not take Prilace” and “Other
medicines and Prilace”).
Do not use other medicines at the same time, such as temsirolimus, sirolimus, everolimus, racecadotril
and vildagliptin, which can cause angioedema, a serious allergic reaction (see also
section “Other medicines and Prilace”).

Intestinal angioedema
If you experience intestinal angioedema with abdominal pain (with or
without nausea or vomiting) during treatment with Prilace, stop taking the medicine and seek immediate medical attention or the nearest hospital.

Concomitant use of medicines to lower blood pressure (ACE inhibitors, angiotensin II receptor antagonists or aliskiren)
During therapy with Prilace, do not take other medicines to lower blood pressure (other
medicines from the ACE inhibitor group, angiotensin II receptor antagonists or medicines
containing aliskiren) as low blood pressure (hypotension),
increased levels of potassium in the blood (hyperkalaemia) and reduced kidney function
(including acute renal failure) may occur (see “Other medicines and Prilace”).
In particular, do not take ACE inhibitors and angiotensin II receptor antagonists at the same time if you have reduced kidney function caused by diabetes (diabetic nephropathy).

Children and adolescents
This medicine should not be used in children and adolescents under 18
years of age.

Other medicines and Prilace
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Prilace can influence the effects of other medicines and other medicines can influence the effects of Prilace.

The combination between Prilace and the following medicines is contraindicated:

• treatments such as dialysis, blood filtration (hemofiltration) with high-flux membranes, such as polyacrylonitrile membranes, or treatment to remove cholesterol from the blood by machinery (low-density lipoprotein apheresis using dextran sulfate) as severe and rapid allergic reactions (anaphylactoid reactions) may occur (see “Do not take Prilace”);
• medicines to lower blood pressure 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 the long-term treatment of heart failure, may increase the risk of angioedema (see also paragraphs “Do not take Prilace” and “Warnings and precautions”).

The combination between Prilace and the following medicines is not recommended:

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

The combination between Prilace and the following medicines requires particular caution:

• medicines to lower blood pressure (antihypertensives) and medicines that can also lower blood pressure (nitrates: for chest pain; tricyclic antidepressants: for treating depression; anaesthetics: for surgical procedures). These medicines can increase the blood pressure lowering effect of Prilace (see also “Warnings and precautions”, “Possible side effects” and “How to take Prilace”);
• medicines used for the treatment of low blood pressure, circulatory failure (shock), reduced heart function (heart failure), asthma or allergies (sympathomimetic vasopressors): these medicines can reduce the blood pressure lowering effects of Prilace and, in turn, Prilace can reduce the effects of these medicines. Your doctor will need to check 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), cytotoxic agents (for cancer treatment) and other medicines that can alter the blood. The combined use of Prilace and these medicines increases the risk of blood reactions (see also “Warnings and precautions);
• lithium salts (for the treatment of mental illnesses): Prilace may increase lithium levels in the blood and its toxicity. The doctor must therefore check your lithium levels in the blood;
• medicines for the treatment of diabetes (antidiabetic medicines such as insulins and sulfonylureas): ramipril contained in Prilace may cause a reduction in blood sugar and the piretanide contained in Prilace may reduce the effects of antidiabetic medicines. The doctor will check your blood sugar levels;
• medicines containing vildagliptin (for the treatment of 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 infections caused by bacteria);
• temsirolimus (for cancer);
• everolimus (to prevent graft rejection);
• inhibitors of the neprilysin enzyme (NEP). The combined use of Prilace and neprilysin (NEP) inhibitors, such as racecadotril (used for the treatment of diarrhoea) may increase the risk of angioedema.

The combination between Prilace and the following medicines requires particular attention:

• non-steroidal anti-inflammatory drugs (for the treatment of pain and inflammation, also known as NSAIDs, such as indometacin, acetylsalicylic acid) :these medicines can reduce the blood pressure lowering effect of Prilace, worsen the impairment of kidney function (acute renal failure) and increase potassium levels in the blood, especially if your kidney function is already reduced. The doctor will administer this combination with caution especially if you are elderly. You must drink and take enough fluids and the doctor will check your kidney function at the beginning of this treatment;
• heparin (to thin the blood): the combination with Prilace may increase potassium levels in the blood (kalaemia);
• probenecid (to reduce uric acid levels in the blood): this medicine can reduce the blood pressure lowering effects 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), large consumption of liquorice, prolonged use of laxatives (to promote bowel movements) and other medicines that can reduce potassium levels in the blood: the combined use of Prilace may reduce potassium levels in the blood (hypokalaemia);
• digitalis (used for heart diseases): the combined use of Prilace and these medicines may increase the toxicity of digitalis due to changes in mineral salt levels in the blood (reduction of potassium levels - hypokalaemia, reduction of magnesium levels in the blood - hypomagnesaemia);
• curariform muscle relaxants (to relax muscles during surgical procedures): the combined use with Prilace may increase and prolong the effects of muscle relaxation;
• medicines that can damage the kidneys: the combination may increase the harmful effect on the kidneys (due to piretanide);
• desensitization therapies: if you have to undergo therapies to reduce allergy to insect stings, tell your doctor that you are taking Prilace because there is a greater possibility of experiencing serious and rapid allergic reactions (anaphylactic or anaphylactoid reactions).

Prilace with food and alcohol
Food intake does not influence the activity of Prilace.
A diet high in salt may reduce the blood pressure lowering effect of Prilace.
Prilace increases the effects of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Prilace during pregnancy.
You must exclude a possible pregnancy before starting treatment.
During treatment with Prilace you must use adequate contraceptive measures.
If it is not possible to switch to a therapy without ACE inhibitors and diuretics, avoid pregnancy as Prilace can harm the foetus.

Breastfeeding
Do not take Prilace if you are breastfeeding.
If an alternative treatment to Prilace is not possible, stop breastfeeding.

Driving and operating machinery
Due to the possible occurrence of certain side effects (e.g. some disorders due to the lowering of blood pressure, such as dizziness and lightheadedness) that can interfere with your ability to concentrate and react, Prilace may impair your ability to drive vehicles or operate machinery.

For those who play sports
The use of the medicine without therapeutic need constitutes doping and may still result in positive doping tests.

3. How to take Prilace

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is 1 Prilace tablet per day.

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

Use in patients already being treated with diuretics
If you are taking other medicines that promote urine production (diuretics), the treatment with the
diuretic must be stopped at least 2-3 days before starting therapy with Prilace or its dose must
at least be reduced.
Follow your doctor's instructions carefully; the recommended initial dose is ½ Prilace tablet per
day.
Method of administration
Preferably take the recommended dose in a single administration in the morning.
Take the tablets with an adequate amount of liquid (at least ½ glass).
Do not chew or crush the tablets.
You can take Prilace before, during or after meals.
The doctor will establish how long you must take Prilace.

If you take more Prilace than you should
An excessive dose of Prilace may cause increased urine production, significant
lowering of blood pressure, shock, slowed heartbeat (bradycardia),
alterations in the levels of fluids and mineral salts in the body, kidney problems (renal insufficiency),
alterations in heart rhythm, reduction or loss of consciousness up to coma, convulsions,
decreased motility (paresis), cessation of stool and gas emission from the intestine (paralytic ileus), and
difficulty urinating and excessive increase in bladder volume, especially in case of obstruction
of the urinary tract (for example due to enlargement of the prostate - prostatic hyperplasia).
In case of accidental ingestion/taking of an excessive dose 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 doubts 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 everyone will experience 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
• dizziness (feeling lightheaded)
• dry cough, which worsens at night or when lying down, and which occurs especially in women and non-smokers
• bronchial inflammation (bronchitis)
• inflammation of the nasal sinuses (sinusitis)
• difficulty breathing (dyspnea)
• inflammation of the stomach and intestines
• digestive disturbances
• abdominal pain
• digestive disorders (dyspepsia)
• diarrhea
• nausea
• vomiting
• skin rash, especially 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 getting up or after being seated 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)
• fast heartbeat (tachycardia)
• heart rhythm disturbances (arrhythmia)
• irregular or strong heartbeat (palpitations)
• fluid accumulation with swelling in various parts of the body (peripheral edema)
• increase in a type of white blood cells (eosinophilia)
• dizziness (vertigo)
• altered skin sensitivity, tingling (paresthesia)
• loss of taste (ageusia)
• altered or reduced sense of taste (dysgeusia)
• visual disturbances, including blurred vision
• constriction of the bronchi, making it difficult to breathe (bronchospasm)
• worsening of asthma
• swelling of the inner wall of the nose (nasal congestion)
• inflammation of the pancreas (pancreatitis) sometimes fatal
• alteration of blood tests specific for monitoring the pancreas (increased levels of pancreatic enzymes)
• swelling and pain in the first part of the intestine (small intestinal angioedema)
• stomach pain
• inflammation of the stomach lining (gastritis)
• constipation
• dry mouth
• reduced kidney function (renal insufficiency)
• increased urine output
• worsening of protein loss in the urine (proteinuria)
• increased urea in the blood
• increased creatinine in the blood
• severe allergic reaction with swelling of the face, hands and feet, lips, tongue or throat, difficulty swallowing and breathing (angioedema) which can be fatal. Black patients have a higher risk of developing this type of reaction with the use of ACE inhibitors
• itching
• excessive sweating (hyperhidrosis)
• joint pain (arthralgia)
• loss of appetite (anorexia)
• decreased appetite (inappetence)
• hot flashes
• fever
• alteration of blood tests specific for monitoring the liver (increased levels of liver enzymes and/or conjugated bilirubin)
• temporary inability to achieve or maintain an erection (erectile dysfunction)
• 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 (neutropenia and agranulocytosis), decreased number of red blood cells, decreased hemoglobin in the blood, decreased number of platelets in the blood. These effects are more likely in patients with kidney problems or with diseases such as lupus erythematosus or scleroderma or with other medicines that can alter blood values
• tremors
• altered or lost sense of balance (instability)
• red and swollen eyes (conjunctivitis)
• hearing disturbances
• feeling ringing or whistling inside the ear (tinnitus)
• inflammation of the tongue (glossitis)
• skin inflammation with scaling (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)
• confusional state

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

• allergy to light (photosensitivity reactions)

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

• bone marrow depression
• decreased number of all blood cells (pancytopenia)
• breakage of red blood cells (hemolytic anemia)
• decreased or interrupted blood flow to the brain (cerebral ischemia)
• blockage of blood vessels in the brain (ischemic stroke)
• temporary interruption of blood flow to the brain (transient ischemic attack)
• altered ability to move and react (dizziness and reduced ability to react)
• burning sensation
• disturbances of the sense of smell (parosmia)
• common cold (rhinitis)
• inflammation of the mouth with sores (aphthous stomatitis)
• severe skin lesions, mouth and other parts of the body with blisters, fever, vomiting, diarrhea and joint pain (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• one or more target-like lesions on the skin, with a target-like appearance (erythema multiforme)
• skin and mucous membrane lesions with blisters (pemphigus)
• worsening of psoriasis, a skin disease characterized by silvery-white scaling
• skin irritation similar to psoriasis (psoriasiform dermatitis)
• skin irritation characterized by the appearance of irregular red spots (exanthem)
• localized irritation of the mucous membranes and characterized by the appearance of blisters or scaly patches (pemphigoid or lichenoid enanthem)
• hair loss (alopecia)
• concentrated urine (dark colored), feeling unwell or malaise, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly
• decreased sodium levels in the blood, especially due to a low-salt diet
• disease characterized by a transient narrowing of blood vessels with a decrease in blood flow to the fingers and toes which become white and bluish for a short period and, when circulation returns to normal, become red, pulsate and hurt (Raynaud's syndrome)
• allergic reactions ( anaphylactic or anaphylactoid reactions). The possibility of severe allergic reactions to insect venom or other allergens may be increased during therapy with ACE inhibitors
• increased levels of antibodies that the body produces against itself due to autoimmune diseases (antinuclear antibodies)
• severe liver problems (hepatic failure)
• inflammation of the liver (cholestatic or cytolytic hepatitis) exceptionally with fatal outcome
• enlargement of the breasts in men (gynecomastia)
• attention disorders

Other side effects due to piretanide are:

• increased concentration of red blood cells (hemoconcentration)
• onset or intensification of disorders in patients who have difficulty draining urine (e.g. patients with bladder emptying problems, prostatic hypertrophy, urethral narrowing); in these cases, urinary retention with excessive bladder distension may occur
• reduction of fluid volume in the body (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 elimination of calcium and magnesium
• decreased potassium levels in the blood
• increased uric acid levels in the blood (which can cause gout attacks, especially if you already have high uric acid levels in the blood)
• reduced tolerance to sugars (worsening of diabetes or onset of previously unknown diabetes)
• increased thirst
• formation of blood clots in blood vessels (thrombosis)
• hearing disorders, such as ringing or buzzing (tinnitus) and sometimes irreversible deafness.

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
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

Store in the original package to protect the medicine from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the box and on the blister 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 Prilace contains

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

Description of the appearance of Prilace and contents of the pack
Prilace is available in the form of divisible tablets in packs of 14 tablets.

Marketing Authorisation 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)