Package leaflet: Information for the user

QUINAZIDE 20 mg + 6.25 mg film-coated tablets, 20 mg + 12.5 mg film-coated tablets

quinapril hydrochloride + hydrochlorothiazide
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT QUINAZIDE IS AND WHAT IT IS USED FOR

QUINAZIDE contains the active substances quinapril hydrochloride (belonging to the pharmacological class of ACE inhibitors, medicines used to lower blood pressure) and hydrochlorothiazide (a diuretic medicine belonging to the sulfonamides, which increases urine production).
QUINAZIDE is used in adults for the treatment of hypertension (high blood pressure) in patients for whom combination therapy with an ACE inhibitor and a diuretic is appropriate.

2. WHAT YOU NEED TO KNOW BEFORE TAKING QUINAZIDE

Do not take QUINAZIDE

if you are allergic to quinapril hydrochloride or any other ACE inhibitor; if you are allergic to hydrochlorothiazide or other sulfonamide-derived drugs, 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 or idiopathic (unknown origin) angioedema;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in the throat);
if you have anuria (inability to excrete urine);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing the active substance aliskiren;
if you are in the second or third trimester of pregnancy (see "Pregnancy, breastfeeding and fertility").

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

if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking QUINAZIDE;
if you are taking any of the following medicines for high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
aliskiren (see "Do not take QUINAZIDE").
if you are taking any of the following medicines, the risk of angioedema may be increased:
Racecadotril, a medicine used to treat diarrhoea.
Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
Vildagliptin, a medicine used to treat diabetes.
if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after starting QUINAZIDE. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may regularly check your kidney function, blood pressure, and levels of electrolytes
(such as potassium) in your blood.
See also information under "Do not take QUINAZIDE".
In case of:
Renovascular hypertension (high blood pressure due to reduced blood flow to one or both kidneys) or renal failure
Take QUINAZIDE with caution if you have severe nephropathy; thiazide diuretics may cause an increase in blood urea nitrogen (azotemia).
If you have renovascular hypertension with pre-existing bilateral or unilateral renal artery stenosis, you may be at increased risk of severe hypotension and renal failure; treatment with diuretics may further increase this risk. Loss of kidney function may occur even with minor changes in serum creatinine levels, even in patients with unilateral renal artery stenosis.
Some hypertensive patients treated with quinapril without apparent pre-existing renovascular disease have shown increases in azotemia and serum creatinine, usually mild and transient, particularly when quinapril is administered together with a diuretic. This is more likely if you have pre-existing renal impairment; in such cases, dose reduction or discontinuation of QUINAZIDE may be required. Your kidney function will be continuously monitored.
As a consequence of inhibition of the renin-angiotensin-aldosterone system (RAAS), changes in kidney function may be expected in certain individuals.
If you have severe heart failure with kidney function dependent on RAAS activity, treatment with ACE inhibitors, including quinapril, may be associated with oliguria (reduced urine output) and/or progressive uremia, and rarely, acute renal failure which may be potentially fatal.
If you have hypertension with unilateral or bilateral renal artery stenopenia, your kidney function should be monitored during the first weeks of treatment with ACE inhibitors. Clinical studies in patients under these conditions have shown increases in azotemia and serum creatinine in some cases after ACE inhibitor therapy, almost always reversible upon discontinuation of treatment.
Although clinical studies have indicated that in patients with renal impairment, quinapril generally does not cause further worsening of pre-existing conditions, periodic monitoring of renal function parameters is recommended in such patients.

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 blood), and reduced kidney function (including acute renal failure). Dual blockade of RAAS through combined use of ACE inhibitors, angiotensin II receptor antagonists, or aliskiren is therefore not recommended (see "Do not take QUINAZIDE" and "Other medicines and QUINAZIDE").
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).

Liver impairment
Due to the presence of the diuretic, take QUINAZIDE with caution if you have impaired liver function or progressive hepatopathy, as even minor disturbances in fluid and electrolyte balance may worsen the onset of hepatic coma.
Quinaprilat concentrations are reduced in patients with hepatic cirrhosis (chronic liver inflammation) due to reduced activation of quinapril.

Hypoglycaemia and Diabetes
If you have diabetes and have previously been treated with oral antidiabetics or insulin, your blood glucose levels (blood sugar concentration) may decrease; therefore, they should be carefully monitored. If you have diabetes, adjustment of insulin or oral hypoglycaemic agent dosage (medicines taken by mouth to treat diabetes) may be required. Latent (hidden) diabetes may become apparent during treatment with thiazide diuretics.

Surgery/anaesthesia
Before undergoing surgery and/or general anaesthesia, inform your doctor that you are taking ACE inhibitors. Hypotension or hypotensive shock may occur in patients undergoing major surgery or receiving anaesthetics. In such cases, expansion of blood or plasma volume may be required.

Aortic stenosis / hypertrophic cardiomyopathy
Use ACE inhibitors with caution if you have valvular obstruction or left ventricular outflow tract obstruction (one of the four chambers of the heart).

During treatment with QUINAZIDE, the following may occur:

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 who are salt/volume depleted (reduced salt and water content in the body), such as those on diuretic therapy, on a low-salt diet, or undergoing haemodialysis (a physical therapy replacing kidney function) (see "Other medicines and QUINAZIDE").
Symptomatic hypotension is more likely if you have severe heart failure, with or without severe renal failure, during treatment with high doses of loop diuretics, if you have hyponatraemia (low sodium concentration in blood), or impaired kidney function.
If hypotension develops, you should be placed in a supine position and, if necessary, blood volume should be restored via intravenous saline infusion.
A temporary hypotensive response is not a contraindication to continuing therapy; however, if such an event occurs, dose reduction of QUINAZIDE should be considered.
You should be warned to report any sensation of dizziness, especially during the first days of QUINAZIDE therapy. If syncope occurs, discontinue treatment until you consult your doctor.
Inadequate fluid intake, excessive sweating, dehydration, vomiting, and diarrhoea may lead to excessive drop in blood pressure due to reduced fluid volume; in such cases, consult your doctor.

Anaphylactoid reactions during exposure to high-flux dialysis membranes
Anaphylactoid reactions such as swelling, flushing, hypotension, and dyspnoea have been reported in haemodialysed patients (undergoing physical therapy replacing kidney function) using high-flux polycrylonitrile membranes (capable of removing medium-sized toxins) within minutes of starting haemodialysis. In such patients, consider using different types of dialysis membranes or different classes of antihypertensive drugs.

Angioedema of the face and neck
Immediately discontinue treatment with QUINAZIDE if laryngeal stridor or angioedema of the face, tongue, or glottis occurs, and seek appropriate treatment; you will remain under observation until the swelling resolves.
If you are taking an ACE inhibitor (such as QUINAZIDE), especially during the first weeks of treatment and after the first dose, angioedema may occur in the extremities, face, lips, mucous membranes, tongue, glottis, including laryngeal oedema. Rarely, 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. adrenaline injection) must be initiated.
If oedema 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.
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) (see section "Other medicines and QUINAZIDE").

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 on ACE inhibitors presenting with abdominal pain.

Cough
A non-productive (dry), persistent cough has been reported with ACE inhibitor use, which resolves upon discontinuation of therapy (see section 4 "Possible side effects").

Neutropenia/agranulocytosis
During treatment with ACE inhibitors, including quinapril, agranulocytosis (severe decrease in granulocyte count, a type of white blood cell) and bone marrow depression (reduced blood cell production in the bone marrow) may occur, rarely in uncomplicated patients, more frequently in patients with renal impairment, especially in the presence of vascular collagen diseases (e.g. systemic lupus erythematosus, scleroderma) and 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 collagen disease and/or nephropathy treated with QUINAZIDE.
Promptly inform your doctor if you develop an infection (e.g. sore throat or fever) that does not resolve within two to three days.

Proteinuria
Proteinuria (presence of protein in urine) may occur, particularly if you have pre-existing renal dysfunction or are on relatively high doses of ACE inhibitors.

Elderly
Some elderly patients may be more responsive to ACE inhibitors than younger patients. Therefore, lower initial doses are recommended, and renal function should be evaluated at the start of therapy.

Alterations in blood electrolytes / Metabolic and endocrine disturbances
Periodic determination of electrolytes in blood and urine at appropriate intervals is important during treatment with QUINAZIDE, especially in cases of severe vomiting and parenteral fluid therapy.
As with other ACE inhibitors, patients treated with quinapril monotherapy may experience increased blood potassium levels, especially in the presence of renal and/or cardiac failure, diabetes mellitus, or concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.
If concomitant use of these agents is considered appropriate, initial and periodic monitoring of blood potassium and other electrolytes is required.
Since QUINAZIDE contains hydrochlorothiazide, adding a potassium-sparing diuretic is not recommended.
Patients should be warned not to use potassium-containing salt substitutes without consulting their doctor.
Thiazide diuretics, including hydrochlorothiazide, may cause fluid and electrolyte imbalance, including hypokalaemia (decreased potassium levels in blood), hyponatraemia (decreased sodium levels in blood), and hypochloraemic alkalosis (decreased blood acidity due to reduced chloride levels). However, since quinapril reduces aldosterone production, its combination with the diuretic attenuates potassium loss induced by the latter.
In some patients on thiazide diuretics, hyperuricaemia or gout attacks may occur; however, combination with quinapril may attenuate the hyperuricaemic effect of hydrochlorothiazide.
Thiazide diuretics may increase urinary magnesium excretion, leading to hypomagnesaemia, and reduce urinary calcium excretion, causing intermittent and mild elevation of serum calcium levels in the absence of confirmed calcium metabolism disorders. Marked hypercalcaemia may indicate latent hyperparathyroidism (increased parathyroid function). Thiazide treatment should be discontinued before performing parathyroid function tests.
Thiazide diuretic therapy may be associated with increased plasma cholesterol and triglyceride levels.

Children and adolescents
The use of QUINAZIDE is not recommended in children, as efficacy and tolerability have not been established in this population.

Other medicines and QUINAZIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:
Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting)
Sulfamethoxazole/Trimethoprim (used against certain types of bacterial infections);
In elderly patients or those with impaired kidney function, co-administration of an ACE inhibitor with sulfamethoxazole/trimethoprim has been associated with severe hyperkalaemia believed to be due to trimethoprim. Medicines containing quinapril/hydrochlorothiazide and trimethoprim should therefore be administered with caution and with adequate monitoring of serum potassium.
Tetracyclines (antibiotics) and other drugs interacting with magnesium
Concurrent administration of QUINAZIDE and tetracyclines reduces absorption of the latter, due to the presence of magnesium carbonate as an excipient in the formulation of QUINAZIDE.
Other diuretics
Since QUINAZIDE already contains a diuretic, concomitant use of another diuretic may have an additive effect; patients on diuretics, especially salt/volume-depleted patients, may experience excessive reduction in blood pressure at the start of therapy or upon dose increase of the ACE inhibitor (see "Warnings and precautions").
Lithium
Increased blood lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium and ACE inhibitors or lithium and thiazide diuretics. Careful monitoring of blood lithium levels should be performed frequently if combination therapy 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
Concurrent use of QUINAZIDE 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 arrhythmias), 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 white blood cell count).
Corticosteroids and ACTH increase electrolyte depletion, particularly reduction in blood potassium levels.
Antidiabetics
Concomitant administration of ACE inhibitors and antidiabetic medicines (oral hypoglycaemics or insulin) may require adjustment of antidiabetic medicine dosage.
Non-depolarizing muscle relaxants (used to relieve muscle spasms, e.g. tubocurarine)
Their effects may be potentiated by hydrochlorothiazide.
Digitalis glycosides, e.g. Digoxin (medicines used to treat heart diseases) or other medicines affecting heart rhythm:
The likelihood of adverse effects may be increased when taken together with QUINAZIDE.
Antigout medicines (allopurinol, uricosurics, xanthine oxidase inhibitors, medicines used to reduce uric acid in blood such as probenecid):
Thiazide-induced hyperuricaemia may compromise the effectiveness of gout treatment with allopurinol and probenecid. Concomitant administration of hydrochlorothiazide and allopurinol may increase the incidence of allergic reactions to allopurinol.
Inform your doctor if you are taking the following medicines, as they may reduce the effect of QUINAZIDE:

non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used against pain and inflammation);
antacids (medicines used against heartburn);
sympathomimetics (e.g. noradrenaline)

QUINAZIDE with food and alcohol
It is recommended to take QUINAZIDE away from meals, as the medicine's activity may be reduced (see section 3 "How to take QUINAZIDE").
Alcohol and barbiturate use during treatment with QUINAZIDE may enhance orthostatic hypotension.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
QUINAPRIL
Do not take QUINAZIDE during the second and third trimesters of pregnancy (see "Do not take QUINAZIDE").
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 in the first trimester is inconclusive; however, a small increased risk cannot be excluded.
Do not start therapy with QUINAZIDE 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 induces fetal toxicity (reduced kidney function, oligohydramnios, i.e. reduced amniotic fluid volume, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia, i.e. increased potassium levels in blood).
If exposure to an ACE inhibitor occurs from the second trimester of pregnancy, an ultrasound evaluation of kidney function and skull development is recommended.
Newborns whose mothers took ACE inhibitors should be closely monitored for hypotension, oliguria, and hypercalcaemia (see "Do not take QUINAZIDE"). If oliguria occurs, measures to support blood pressure and renal perfusion should be implemented.
Fertility
If you are planning a pregnancy, you should switch to alternative antihypertensive treatments with a proven safety profile during pregnancy, unless continuation of ACE inhibitor therapy is considered essential.

HYDROCHLOROTHIAZIDE
There is limited experience with hydrochlorothiazide during pregnancy, especially in the first trimester. Animal studies are insufficient.
Hydrochlorothiazide crosses the placenta. Based on its mechanism of action, use of hydrochlorothiazide during the second and third trimesters of pregnancy may impair fetoplacental perfusion and may cause fetal and neonatal effects such as jaundice (yellowing of the skin, sclerae, and mucous membranes), electrolyte imbalance, and thrombocytopenia (decreased platelet count in blood).
Do not take hydrochlorothiazide for treatment of:

gestational oedema (fluid accumulation occurring during pregnancy), gestational hypertension, or pre-eclampsia (a serious pregnancy complication affecting both mother and fetus, characterised by oedema, hypertension, and proteinuria, i.e. loss of protein in urine), due to the risk of reduced blood volume and placental hypoperfusion (reduced blood flow to the placenta) without beneficial effect on disease course;
hypertension, if you are pregnant, except in rare situations where no other treatment could be used.

Breastfeeding
Use of QUINAZIDE during breastfeeding is not recommended. If QUINAZIDE is taken during breastfeeding, doses should be kept as low as possible.
QUINAPRIL
Limited data show very low concentrations of quinapril in breast milk.
Although these concentrations appear to be clinically irrelevant, use of QUINAZIDE 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 lack of sufficient clinical experience.
In older infants, if deemed necessary for the mother, QUINAZIDE may be taken during breastfeeding, but the infant should be monitored for possible adverse effects.
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide is excreted in breast milk in small amounts. High-dose thiazide diuretics cause intense diuresis which may inhibit milk production.

Driving and using machines
As with other antihypertensives, your ability to drive or operate machinery may be impaired, especially at the beginning of treatment with QUINAZIDE.

QUINAZIDE contains lactose.
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE QUINAZIDE

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
If you are not currently on diuretic therapy, the recommended initial dose is half a tablet taken once
daily.
The usual maintenance dose is one tablet daily.
If necessary, the dose may be increased up to 2 tablets taken once daily.
If you are currently on diuretic therapy, it is advisable to initiate treatment with a single dose of 5 mg of quinapril
to minimize the risk of excessive hypotension, then adjust the dosage until the optimal response is achieved. If this response is achieved with the same dose contained in the combination product, you may switch to QUINAZIDE therapy.
Patients already receiving diuretic therapy may develop symptomatic hypotension after the first dose of quinapril, whether administered alone or in combination. In patients receiving diuretics, it is important, whenever possible, to discontinue the diuretic at least 2–3 days before starting QUINAZIDE.
If this is not feasible, initiate therapy with low doses of QUINAZIDE.
In patients with heart failure, with or without renal impairment, ACE inhibitor therapy may cause excessive drop in blood pressure.
In general, since QUINAZIDE may cause symptomatic hypotension, especially after the first dose, in both complicated and uncomplicated hypertensive patients, including those who are volume- or salt-depleted, treatment should be initiated under medical supervision, and patients should be closely monitored during the first two weeks of treatment and whenever the dose is increased.
Elderly patients
In elderly patients, the initial dose should not exceed 5 mg of quinapril and must be carefully determined by the doctor.
The dose should be kept as low as possible while still achieving adequate blood pressure control.
Patients with renal impairment or undergoing dialysis
When quinapril in combination with a diuretic is required in patients with severe renal impairment (creatinine clearance less than 30 mL/min), a loop diuretic is preferred over a thiazide diuretic; therefore, QUINAZIDE is not recommended in these patients.
Use in children
The use of QUINAZIDE is not recommended, as efficacy and tolerability have not been established in children.
Method of administration
Take QUINAZIDE at the same time each day, on an empty stomach.
Treatment duration
As prescribed by the physician.
If you take more QUINAZIDE than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital.
There are no available data regarding QUINAZIDE overdose in humans, nor specific information on its management.
Treatment should be symptomatic and supportive, in accordance with standard medical practice, including discontinuation of QUINAZIDE therapy and careful patient monitoring.
Quinapril: 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.
Hemodialysis and peritoneal dialysis have minimal effect on removing the drug.
Hydrochlorothiazide: the most commonly observed signs and symptoms attributable to hydrochlorothiazide overdose in monotherapy are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis (fluid loss).
If you are also receiving digitalis therapy, hypokalemia may increase the risk of cardiac arrhythmias.
If you forget to take QUINAZIDE
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of 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.
The most frequently reported adverse reactions are headache, dizziness, cough, and fatigue; these are generally mild and transient.
The adverse reactions most commonly leading to discontinuation of therapy are headache, followed by cough, nausea, and vomiting.

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

Thrombocytopenia (decrease in the number of platelets in the blood).
Anaphylactoid reactions (severe allergic reactions).
Nervousness.
Paresthesia, somnolence, insomnia, dizziness.
Palpitations, tachycardia, vasodilation.
Hypotension, postural hypotension, syncope.
Sinusitis, dyspnea (difficulty breathing), upper respiratory tract infections, pharyngitis, bronchitis, rhinitis.
Dry mouth, flatulence (excessive air in the gastrointestinal tract), nausea, vomiting, diarrhea, dyspepsia (difficulty in digestion), constipation.
Hepatitis.
Photosensitivity, pruritus, rash (sudden reddening of the skin).
Myalgia (muscle pain), joint pain, chest pain, abdominal pain, lumbago.
Urinary tract infections, urinary abnormalities, dysuria (difficulty in passing urine), pollakiuria (frequent urination).
Impotence.
Peripheral edema (fluid accumulation), viral infections, fever, malaise, asthenia (lack of strength).
Laboratory test abnormalities: increased creatinine, increased blood urea nitrogen (azotemia), serum electrolytes (see "Warnings and precautions").

Other adverse reactions reported with the individual active ingredients are as follows:
QUINAPRIL: angina pectoris, depression, increased sweating, angioedema (see "Warnings and precautions").
HYDROCHLOROTHIAZIDE: anorexia, gastric irritation, cramps, intrahepatic cholestatic jaundice (jaundice due to altered bile flow), pancreatitis (inflammation of the pancreas), sialadenitis (inflammation of the salivary glands), leukopenia, agranulocytosis, thrombocytopenia, aplastic and hemolytic anemia, muscle spasms, agitation, renal failure, renal dysfunction, interstitial nephritis, xanthopsia (visual disturbance characterized by yellow vision of white objects), purpura, photosensitivity, urticaria, necrotizing vasculitis (inflammation of blood vessels), respiratory distress, pneumonia, and pulmonary edema, anaphylactic reactions, acute myopia, visual impairment or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Frequency “not known”: skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following website: 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 QUINAZIDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What QUINAZIDE contains
QUINAZIDE 20 mg + 6.25 mg
One tablet contains:
Active substances: quinapril hydrochloride 21.7 mg (equivalent to 20 mg of quinapril) + hydrochlorothiazide 6.25 mg.
Other components: magnesium carbonate, lactose, povidone, crospovidone, magnesium stearate, hypromellose, titanium dioxide, hydroxypropylcellulose, macrogol 400, yellow iron oxide, candelilla wax.

QUINAZIDE 20 mg + 12.5 mg
One tablet contains:
Active substances: quinapril hydrochloride 21.7 mg (equivalent to 20 mg of quinapril) + hydrochlorothiazide 12.5 mg.
Other components: magnesium carbonate, lactose, povidone, crospovidone, magnesium stearate, hypromellose, titanium dioxide, hydroxypropylcellulose, macrogol 400, red iron oxide, yellow iron oxide, candelilla wax.

Description of the appearance of QUINAZIDE and pack contents
QUINAZIDE 20 mg + 6.25 mg film-coated tablets
Film-coated tablets, yellow in colour, round, biconvex, with a cross-shaped break line.
Carton pack containing 14 divisible tablets in blister.

QUINAZIDE 20 mg + 12.5 mg film-coated tablets
Film-coated tablets, pink in colour, round, biconvex, with a central break line and lateral score marks on both sides.
Carton pack containing 14 divisible tablets in blister.
Carton pack containing 28 divisible tablets in blister.

Marketing Authorization Holder
MALESCI Istituto Farmacobiologico S.p.A. - Via Lungo l’Ema, 7 - Bagno a Ripoli (FI).

Manufacturer
A. Menarini Manufacturing Logistics and Services srl - L’Aquila.

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Quinazide