Patient Information Leaflet: Information for the User

QUINAZIL 5 mg film-coated tablets, 20 mg film-coated tablets

Quinapril hydrochloride
Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could 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:

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

1. WHAT QUINAZIL IS AND WHAT IT IS USED FOR

QUINAZIL contains the active substance quinapril hydrochloride (belonging to the pharmacological class
of ACE inhibitors, medicines used to lower blood pressure).
QUINAZIL is used in adults for the treatment:

of systemic arterial hypertension (elevated blood pressure due to causes not yet identified);
of congestive heart failure (fluid accumulation due to the heart's inability to function properly).

2. WHAT YOU NEED TO KNOW BEFORE TAKING QUINAZIL

Do not take QUINAZIL

if you are allergic to the active substance (quinapril hydrochloride), to any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced angioedema (sudden swelling of subcutaneous and submucosal tissues) associated with prior therapy with ACE inhibitors;
if you have hereditary/idiopathic angioedema (of unknown origin);
if you are in the second or third trimester of pregnancy (see "Pregnancy, breastfeeding and fertility");
if you have diabetes mellitus or impaired renal function and are being treated with medicinal products 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, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking QUINAZIL:

if you are taking any of the following medicines used to treat high blood pressure:
an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
aliskiren (see “Do not take QUINAZIL”), a medicine used to treat high blood pressure.
if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, for example in the throat) may be increased:
Racecadotril, a medicine used to treat diarrhoea.
Medicines used to prevent organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus and everolimus).
Vildagliptin, a medicine used to treat diabetes.

Your doctor may check your kidney function, blood pressure and levels of electrolytes
(for example potassium) in your blood at regular intervals.
See also the information under “Do not take QUINAZIL”.
In case of:
Ethnic differences
If you are of Black ethnicity, this medicine may be less effective in lowering your
blood pressure and may increase the risk of you developing severe allergic reactions
(angioedema).
Surgery/anaesthesia
Before undergoing surgery and/or general anaesthesia, inform your doctor that you are
taking ACE inhibitors. In patients undergoing major surgery or during treatment with
anaesthetics known to cause a decrease in blood pressure, hypotension or hypotensive shock may occur.
In such cases, expansion of blood or plasma volume may be required.
Aortic stenosis / hypertrophic cardiomyopathy
Use ACE inhibitors with caution if you have a valvular obstruction or obstruction of the left ventricular outflow tract (one of the four chambers into which the heart is divided).
Renovascular hypertension/renal impairment
If you have renovascular hypertension and pre-existing bilateral or unilateral renal artery stenosis, you may be at increased risk of severe hypotension and renal failure; treatment with diuretics may contribute to increasing this risk. Loss of renal function may occur even with slight changes in serum creatinine concentrations, even in patients with unilateral renal artery stenosis.
Some patients treated with quinapril without apparent pre-existing renovascular disease have shown increases in blood urea nitrogen (BUN) and serum creatinine, generally mild and temporary, particularly when quinapril is administered together with a diuretic. In such cases, dosage reduction may be required. Your kidney function will be monitored continuously.
As a consequence of inhibition of the renin-angiotensin-aldosterone system, changes in kidney function may be expected in certain individuals (e.g. those with a single kidney).
If you have severe heart failure with kidney function dependent on the activity of the renin-angiotensin-aldosterone system, treatment with an ACE inhibitor, including quinapril, may be associated with oliguria (reduced urine output) and/or progressive uraemia (presence of urea in the blood) and, rarely, potentially fatal acute renal failure.
If you have hypertension with unilateral or bilateral renal artery stenosis, your kidney function should be monitored during the first weeks of treatment with ACE inhibitors. Clinical studies in patients under such conditions have shown increases in BUN and serum creatinine in some cases after ACE inhibitor therapy, almost always reversible upon discontinuation of treatment.
Some patients with hypertension or heart failure without apparent pre-existing renovascular disease have shown increases in BUN and serum creatinine, generally minor and temporary, particularly when quinapril is administered together with a diuretic.
This may occur more easily in patients with pre-existing renal impairment. In such cases, reduction or discontinuation of QUINAZIL may be required.
Although clinical studies have indicated that in patients with renal impairment, quinapril generally does not induce further worsening of pre-existing conditions, periodic monitoring of renal function parameters is recommended in such patients.

During treatment with QUINAZIL, the following may occur:
Allergic reactions
These may manifest as red-brown spots on the skin, excessive reddening of the skin following exposure to sunlight, urticaria, inflammation of blood vessels possibly leading to tissue death, or serious lung problems.
Hypotension
Symptomatic hypotension (low blood pressure) has rarely been observed in patients with uncomplicated hypertension. Symptomatic hypotension may result from ACE inhibitor therapy in patients depleted of salt and/or volume (reduction in the amount of salt and water in the body), such as those being treated with diuretics, on a low-salt diet, or undergoing haemodialysis (a physical therapy replacing kidney function).
If you have congestive heart failure, you may be at risk of excessive drop in blood pressure; in this case, treatment with QUINAZIL should be initiated with the lowest recommended dose and you should be closely monitored during the first two weeks of treatment and each time the QUINAZIL dose is increased.
Symptomatic hypotension is more likely to occur if you have severe heart failure, with or without severe renal impairment, during treatment with high doses of loop diuretics, if you have hyponatraemia (low sodium concentration in the blood) or impaired renal function.
If hypotension develops, you should be placed in a supine position and, if necessary, your blood volume should be restored via intravenous infusion of saline solution.
A temporary hypotensive response is not a contraindication to continuing therapy; however, if such an event occurs, consideration should be given to reducing the dose of QUINAZIL.
You should be advised to report any sensation of dizziness, especially during the first days of treatment with QUINAZIL. If syncope occurs, discontinue treatment until you consult your doctor.
Inadequate fluid intake, excessive sweating and dehydration, as well as vomiting and diarrhoea, may promote excessive drop in blood pressure due to reduced fluid volume; in such cases, consult your doctor.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Concomitant use of ACE inhibitors, angiotensin II receptor antagonists (medicines used to treat hypertension) or aliskiren increases the risk of hypotension, hyperkalaemia (increased potassium levels in the blood) and leads to reduced kidney function (including acute renal failure). Dual blockade of the RAAS through combined use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is therefore not recommended (see “Do not take QUINAZIL” and “Other medicines and QUINAZIL”).
If dual blockade treatment is considered absolutely necessary, it should only be carried out under the supervision of a specialist physician with close and frequent monitoring of kidney function, electrolytes and blood pressure.
ACE inhibitors and angiotensin II receptor antagonists should not be used simultaneously in patients with diabetic nephropathy (kidney damage due to diabetes).
Anaphylactoid reactions during exposure to high-flux dialysis membranes
In haemodialysed patients (undergoing physical therapy replacing kidney function) using high-flux polycrylonitrile membranes (i.e. capable of removing medium-sized toxins), anaphylactoid reactions such as swelling, flushing, hypotension and dyspnoea have been reported within minutes of starting haemodialysis. In these patients, consider using different types of dialysis membranes or different classes of antihypertensive drugs.
Hepatic impairment
Use QUINAZIL with caution in combination with a diuretic if you have impaired liver function or progressive liver disease, as even minor disturbances in fluid and electrolyte balance may worsen the onset of hepatic coma.
The conversion of quinapril into quinaprilat, the active substance acting on blood pressure, occurs in the liver; therefore, this conversion is altered in patients with hepatic impairment due to cirrhosis.
Angioedema of the face and neck
Immediately discontinue treatment with QUINAZIL if laryngeal stridor (a sound accompanying inspiration) or angioedema of the face, tongue or glottis occurs, and seek appropriate treatment; you should remain under observation until the swelling resolves.
If you are taking an ACE inhibitor (such as QUINAZIL), especially during the first weeks of treatment and after the first dose, angioedema may occur in the extremities, face, lips, mucous membranes, tongue, glottis or larynx. In rare cases, long-term treatment with ACE inhibitors may lead to a severe form of angioedema.
Angioedema involving the tongue, glottis or larynx may be fatal. Emergency treatment (e.g. injection of adrenaline solution) must be initiated.
In cases where swelling is limited to the face and lips, it usually resolves without treatment, although antihistamines may help relieve symptoms.
Therefore, immediately report any signs or symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue, difficulty swallowing or breathing) and do not take the medicine again before consulting your doctor.
An increased risk of orolingual angioedema has been observed in patients with acute ischaemic stroke treated with alteplase concomitantly with ACE inhibitors.
The risk of developing angioedema is higher if you are being treated with temsirolimus (a medicine used against certain types of tumour) or vildagliptin (a medicine used against diabetes) (see section “Other medicines and QUINAZIL”).
Intestinal angioedema
Intestinal angioedema, with abdominal pain (with or without nausea or vomiting), has been rarely reported in patients treated with ACE inhibitors; in some cases, there was no history of facial angioedema and C-1 esterase levels (a parameter for diagnosing hereditary angioedema) were normal.
Angioedema may be diagnosed via abdominal CT scan or ultrasound, or during surgery, and symptoms may resolve after discontinuation of the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients treated with ACE inhibitors who present with abdominal pain.
Cough
A non-productive (dry), persistent cough has been reported with the use of ACE inhibitors, which resolves upon discontinuation of treatment (see section 4 “Possible side effects”).
Hyperkalaemia (elevated potassium levels in the blood)
In some patients treated with QUINAZIL, increased blood potassium levels have been observed. Patients at risk of developing hyperkalaemia include those with renal and/or cardiac impairment, those receiving concomitant treatment with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes or other medicines associated with increased potassium levels. If the use of these substances is considered appropriate, regular monitoring of blood potassium levels is recommended.
In elderly patients or those with impaired renal function, co-administration of an ACE inhibitor with sulfamethoxazole/trimethoprim has been associated with severe hyperkalaemia believed to be due to trimethoprim. Medicinal products containing quinapril and trimethoprim should therefore be administered with caution and with adequate monitoring of serum potassium.
Neutropenia/agranulocytosis
During treatment with ACE inhibitors, including quinapril, agranulocytosis (severe decrease in the number of granulocytes, a type of white blood cell, in the blood) and bone marrow depression (reduced production of blood components in the bone marrow) may rarely occur in uncomplicated patients, more frequently in patients with renal impairment, especially in the presence of vascular collagenoses, e.g. systemic lupus erythematosus, scleroderma (a chronic connective tissue disease), and in patients receiving immunosuppressive therapy. The effect is reversible upon discontinuation of the ACE inhibitor.
As with other ACE inhibitors, periodic monitoring of white blood cell counts is advisable in patients with vascular collagenoses and/or nephropathy treated with QUINAZIL.
Promptly inform your doctor if you develop an infection (e.g. sore throat or fever) that does not resolve within two or three days.
Proteinuria
Proteinuria (presence of protein in urine) may occur, particularly if you have pre-existing renal dysfunction or are receiving relatively high doses of ACE inhibitors.
Elderly
Some elderly patients may be more responsive to ACE inhibitors than younger individuals. Therefore, lower initial doses are recommended and renal function should be evaluated at the start of therapy.
Your doctor should be cautious when initiating cotrimoxazole treatment in patients over 66 years of age who are receiving ACE inhibitors and angiotensin receptor antagonists.
Children and adolescents
Current data do not allow for any recommendations.
Other medicines and QUINAZIL
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:
Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride) and other medicines may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clot formation).
If concomitant use is indicated due to manifest hypokalaemia, these should be used with caution and with frequent monitoring of blood potassium levels (see “Warnings and precautions”).
Medicines that increase the risk of angioedema
Concomitant use of ACE inhibitors and sacubitril/valsartan is contraindicated as it increases the risk of angioedema.
Concomitant use of ACE inhibitors and racecadotril (a medicine mainly used to treat diarrhoea) and mTOR inhibitors (medicines used to prevent rejection after organ transplantation such as sirolimus, everolimus, temsirolimus) may increase the risk of angioedema.
Sulfamethoxazole/trimethoprim (used against certain types of bacterial infections)
In elderly patients or those with impaired renal function, co-administration of an ACE inhibitor with sulfamethoxazole/trimethoprim has been associated with severe hyperkalaemia believed to be due to trimethoprim. Medicinal products containing quinapril and trimethoprim should therefore be administered with caution and with adequate monitoring of serum potassium.
Diuretics
Treatment with diuretics may lead to excessive reduction in blood pressure (see “Warnings and precautions”). Hypotensive effects may be reduced by discontinuing the diuretic, increasing fluid volume or salt intake, or starting therapy with low doses of quinapril.
If discontinuation of the diuretic is not possible, you should be monitored medically for at least one hour after the initial dose of QUINAZIL. QUINAZIL may attenuate potassium loss caused by thiazide diuretics.
Tetracyclines (antibiotics) and other drugs interacting with magnesium
Concomitant administration of QUINAZIL and tetracyclines reduces the absorption of the latter due to the presence of magnesium carbonate as an excipient in the formulation of QUINAZIL.
Lithium
Increased lithium concentrations in blood and lithium toxicity have been reported during concomitant administration of lithium and ACE inhibitors. Careful monitoring of blood lithium levels should be frequently performed if such combination is necessary.
Anaesthetics
ACE inhibitors may enhance the hypotensive effects of certain anaesthetics (see “Warnings and precautions”).
Narcotics/Antipsychotics/Barbiturates
Orthostatic hypotension may occur during concomitant use with quinapril.
Other antihypertensives
Concomitant use of quinapril and antihypertensive medicines may lead to additive or enhanced effects, resulting in greater reduction in blood pressure.
ACE inhibitors, angiotensin II receptor antagonists or aliskiren
Concomitant use of ACE inhibitors and angiotensin II receptor antagonists or aliskiren is associated with a higher frequency of adverse effects such as hypotension, hyperkalaemia and reduced kidney function (including acute renal failure).
Temsirolimus/Vildagliptin
The risk of developing angioedema is higher if you are being treated with temsirolimus (a medicine used against certain types of cancer) or vildagliptin (a medicine used against diabetes).
Allopurinol (a medicine that reduces uric acid formation), procainamide (a medicine used to treat cardiac rhythm abnormalities), cytostatics (anticancer drugs that inhibit and combat tumour development) or immunosuppressive agents (medicines that reduce or block immune response), systemic corticosteroids (anti-inflammatory medicines).
Concomitant administration of ACE inhibitors may lead to an increased risk of leucopenia (reduced level of white blood cells in the blood).
Non-steroidal anti-inflammatory drugs (NSAIDs)
When ACE inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (e.g. selective COX-2 inhibitors such as celecoxib or valdecoxib, acetylsalicylic acid at doses ≥ 325 mg/day, and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of worsening kidney function, including possible acute renal failure, and increased blood potassium levels, especially in patients with pre-existing impaired renal function.
Use QUINAZIL with caution, especially if you are elderly. You should be adequately hydrated and monitoring of kidney function should be considered at the start of concomitant therapy.
In some patients, administration of non-steroidal anti-inflammatory agents may reduce the antihypertensive effect of ACE inhibitors.
Furthermore, it has been reported that NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, and may cause deterioration of kidney function. These effects are usually reversible and occur particularly in patients with impaired renal function.
Sympathomimetics
These may reduce the antihypertensive effects of ACE inhibitors; patients should be monitored carefully.
Alteplase
Use caution in patients taking alteplase. An increased risk of orolingual angioedema has been observed in patients with acute ischaemic stroke treated with alteplase concomitantly with ACE inhibitors.
Antidiabetics
Concomitant administration of ACE inhibitors and antidiabetic medicines (oral hypoglycaemics or insulin) may enhance the hypoglycaemic effect of the latter, increasing the risk of hypoglycaemia, especially during the first weeks of combination therapy and in patients with impaired renal function.
Adjustment of the antidiabetic medicine dosage may be required.
Antacids
Concomitant use of QUINAZIL and antacid medicines (used to counteract stomach acidity) may reduce the effect of quinapril.
Other medicines
No clinically significant interactions have been observed with concomitant administration of quinapril and propranolol, digoxin, hydrochlorothiazide, warfarin and cimetidine.
QUINAZIL and alcohol
Consumption of alcohol during treatment with QUINAZIL may enhance orthostatic hypotension.
QUINAZIL and food
It is recommended to take QUINAZIL away from meals, as reduced effectiveness of the medicine may occur (see section 3 “How to take QUINAZIL”).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take QUINAZIL during the second and third trimesters of pregnancy (see “Do not take QUINAZIL”).
Use of ACE inhibitors is not recommended during the first trimester of pregnancy.
Evidence regarding teratogenic risk (abnormal fetal development during pregnancy) following exposure to ACE inhibitors during the first trimester of pregnancy has not yielded conclusive results; however, a small increased risk cannot be excluded.
Do not start therapy with QUINAZIL if you are pregnant.
When pregnancy is diagnosed, treatment with ACE inhibitors must be immediately discontinued and, if appropriate, alternative therapy should be initiated.
It is known that exposure to ACE inhibitors in women during the second and third trimesters causes fetal toxicity (reduced renal function, oligohydramnios, i.e. reduced amount of amniotic fluid, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia, i.e. increased potassium levels in the blood).
If exposure to an ACE inhibitor occurs from the second trimester of pregnancy, ultrasound monitoring of renal and skull development is recommended.
Newborns whose mothers have taken ACE inhibitors should be closely monitored for hypotension (see “Do not take QUINAZIL”).
Breastfeeding
Use of QUINAZIL during breastfeeding is not recommended for preterm infants and during the first weeks after delivery, due to the hypothetical risk of cardiovascular and renal effects and because there is insufficient clinical experience.
In older infants, if considered necessary for the mother, QUINAZIL may be taken during breastfeeding, but in this case the infant should be monitored for possible adverse effects.
Fertility
If you are planning a pregnancy, you should switch to alternative antihypertensive treatments with a proven safety profile during pregnancy, unless continuation of therapy with an ACE inhibitor is considered essential.
Driving and use of machines
Especially at the beginning of treatment with QUINAZIL, your ability to drive or operate machinery may be impaired.
QUINAZIL 5 mg film-coated tablets and QUINAZIL 20 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please contact him/her before taking this medicine.

3. HOW TO TAKE QUINAZIL

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will individually assess the dosage of the medicine based on your clinical response.

Adults
Hypertension

Monotherapy: The recommended initial dose in patients not taking a diuretic is 10 mg once daily. The dose may then be adjusted according to clinical response up to 20–40 mg daily, administered as a single dose or divided into two doses. Most patients are maintained on a single daily dose. Some patients have been treated with QUINAZIL doses up to 80 mg daily.
Concomitant diuretic therapy: The recommended starting dose is 5 mg in order to monitor for excessive hypotension. The dose should then be adjusted to achieve optimal response.
Renal impairment (creatinine clearance less than 40 ml/min) and elderly patients: The recommended initial dose is 5 mg once daily, followed by dose adjustment based on response.

Congestive heart failure
The recommended initial dose is 5 mg once daily; you must be closely monitored to determine the initial effect on blood pressure.
The daily dose may then be adjusted up to 40 mg, administered in two divided doses.
If you are taking diuretics and/or digitalis, the recommended daily dose may range from 10 mg to 20 mg.

Concomitant use with diuretics
If you are already being treated with a diuretic, symptomatic hypotension may occur after the first dose of quinapril, alone or in combination. Therefore, it is important, whenever possible, to discontinue the diuretic at least 2–3 days before starting QUINAZIL. If this is not possible, begin with low doses of QUINAZIL as directed by your doctor.

In patients with congestive heart failure, with or without renal impairment, ACE-inhibitor therapy may cause excessive drop in blood pressure.
In general, since QUINAZIL may cause symptomatic hypotension, especially after the first dose, in both complicated and uncomplicated hypertensive patients—including those with reduced salt/volume status, such as those with congestive heart failure—therapy should be initiated under medical supervision, and patients should be carefully monitored for the first two weeks of treatment and whenever the dose is increased (see “Warnings and precautions”).

Method of administration
Take QUINAZIL at the same time each day, independent of meals.

Duration of treatment
As prescribed by the physician.

Use in children
Current data do not allow for any dosage recommendations.

If you take more QUINAZIL than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital.
There are no available data regarding QUINAZIL overdose in humans, nor specific information on its treatment.
Treatment should be symptomatic and supportive, in accordance with standard medical practice, including discontinuation of QUINAZIL therapy and careful patient monitoring.
The most likely clinical manifestation attributable to quinapril overdose in monotherapy would be severe hypotension, which should be treated with intravenous infusion of physiological saline solution.
Haemodialysis and peritoneal dialysis have minimal effect on removing the drug.

If you forget to take QUINAZIL
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (may affect up to 1 in 10 patients)

Hyperkalaemia ##, gout #, hyperuricaemia #
Insomnia
Dizziness #, headache #, somnolence #
Angina pectoris#, tachycardia#, palpitations#
Vasodilatation#
Cough#
Abdominal pain#, diarrhoea#, dyspepsia#, nausea# and vomiting#
Back pain#, myalgia#
Asthenia#, chest pain#, fatigue#
Increased blood creatinine #, increased blood urea#
Bronchitis, upper respiratory tract infection, pharyngitis #, rhinitis #
Decreased sodium concentrations in the blood

Uncommon adverse reactions (may affect up to 1 in 100 patients)

Glucose intolerance
Depression, confusion, nervousness
Paraesthesia #, transient ischaemic attacks #
Syncope #, dysgeusia #
Amblyopia#
Dizziness # and tinnitus#
Myocardial infarction#
Hypotension#
Dyspnoea#, dry throat#
Flatulence#, dry mouth#
Alopecia#, photosensitivity reactions#, pruritus#, rash#, angioedema#, hyperhidrosis#.
Arthralgia#
Renal dysfunction#, proteinuria
Erectile dysfunction#
Pyrexia#, generalized oedema#, peripheral oedema#
Viral infection, urinary tract infection, sinus

Rare adverse reactions (may affect up to 1 in 1,000 patients)

Constipation#, glossitis#
Skin disorders may be associated with fever, muscle and joint pain (myalgia, arthralgia, arthritis), vascular inflammation (vasculitis), psoriasiform dermatitis #

Very rare adverse reactions (may affect up to 1 in 10,000 patients)

Disturbance in balance
Blurred vision#
Eosinophilic pneumonia#, airway obstruction due to angioedema (which could be fatal)#
Ileus#, angioedema of the small intestine#

Adverse reactions with unknown frequency (frequency cannot be determined from the available data)

Agranulocytosis ##, haemolytic anaemia #, neutropenia ##, thrombocytopenia #, eosinophilia#
Anaphylactoid reaction#
Cerebrovascular accidents
Arrhythmia#
Orthostatic hypotension#
Bronchospasm#
Pancreatitis#
Hepatitis#, cholestatic jaundice#
Toxic epidermal necrolysis #, erythema multiforme #, exfoliative dermatitis #, pemphigus #,
Systemic lupus erythematosus#
Tubulointerstitial nephritis
Serositis
Increased blood cholesterol #, increased blood triglycerides#, decreased haematocrit#, increased liver enzymes, increased blood bilirubin, increased antinuclear antibodies#, increased erythrocyte sedimentation rate.
Dark urine, nausea, vomiting, muscle cramps, confusion and convulsions. These could be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Psoriasis or worsening of existing psoriasis (a skin disease characterized by red patches covered with silvery scales).

Adverse reactions associated with the quinapril component, frequencies observed during treatment with quinapril and hydrochlorothiazide.

Adverse reactions associated with the active substance quinapril in monotherapy.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE QUINAZIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What QUINAZIL contains
QUINAZIL 5 mg film-coated tablets
Each tablet contains:
Active substance: quinapril hydrochloride 5.416 mg (equivalent to 5 mg of quinapril).
Other components: heavy magnesium carbonate, lactose, gelatin, crospovidone, magnesium stearate,
hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide (E171), red iron oxide (E172), candelilla wax.

QUINAZIL 20 mg film-coated tablets
Each tablet contains:
Active substance: quinapril hydrochloride 21.664 mg (equivalent to 20 mg of quinapril).
Other components: heavy magnesium carbonate, lactose, gelatin, crospovidone, magnesium stearate,
hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide (E171), red iron oxide (E172), candelilla wax.

Description of the appearance of QUINAZIL and contents of the pack
QUINAZIL 5 mg film-coated tablets
Film-coated tablets, oval, with a break line on one side, brownish-red in colour.
Pack containing 28 5 mg tablets in a blister.

QUINAZIL 20 mg film-coated tablets
Film-coated tablets, round, biconvex, with a break line on both sides, brownish-red in colour.
Pack containing 14 20 mg tablets in a blister.
Pack containing 28 20 mg tablets in a blister.

Marketing Authorization Holder
MALESCI Istituto Farmacobiologico SpA - via Lungo L’Ema 7, Bagno a Ripoli (FI).

Manufacturer
A. Menarini Manufacturing Logistics and Services srl – Campo di Pile, L’Aquila.
Menarini Von Heyden GmbH, Leipziger Strasse 7-13, Dresden (Germany).

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Quinazil