PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

QUINAPRIL ZENTIVA 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets

Generic medicinal product

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of willness are the same as yours. - - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet: 1.What QUINAPRIL ZENTIVA is and what it is used for 2. What you need to know before you use QUINAPRIL ZENTIVA 3. How to use QUINAPRIL ZENTIVA 4. Possible side effects 5. How to store QUINAPRIL ZENTIVA 6. Contents of the pack and other information

1. What QUINAPRIL ZENTIVA is and what it is used for

QUINAPRIL ZENTIVA belongs to a group of medicines called ACE-inhibitors. It contains quinapril, which inhibits the production of certain substances present in the body that cause a rise in blood pressure . Treatment with QUINAPRIL ZENTIVA causes the blood vessels to dilate and consequently lowers blood pressure. QUINAPRIL ZENTIVA is used to treat high blood pressure and congestive heart failure.

2. What you need to know before you use QUINAPRIL ZENTIVA

Do not use QUINAPRIL ZENTIVA: - If you are allergic to quinapril or other ACE-inhibitors or any of the other ingredients of QUINAPRIL ZENTIVA. - If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. - If you suffer from hereditary or idiopathic angioneurotic oedema. - If in the past you have had episodes of angio-oedema (swelling of the legs, arms, face, mucosae or tongue) related to treatment with ACE-inhibitors. - If you are more than three months pregnant (it is also recommended to avoid using QUINAPRIL ZENTIVA during early pregnancy – see the paragraph on Pregnancy). - If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.

Warning and precautions Please tell your doctor about any health problems you may have or have had in the past, particularly impaired renal function (including kidney transplant), dialysis, blood disorders, diabetes, liver problems, other types of heart disease (for example heart valve defects) and allergies. It is particularly important to tell your doctor if you have ever had allergic reactions that have caused swelling, for example of your face, tongue and/or throat (reactions to food and/or wasp or bee stings). Please tell your doctor if you experience excessive vomiting or diarrhoea, you are taking potent diuretics, potassium supplements, potassium-saving medications, culinary salt substitutes containing potassium or if you are on a low-sodium diet, as all of these may influence the effect of the medicinal product. Severe allergic reactions may occur when QUINAPRIL ZENTIVA is administered during treatment for hypersensitivity to bee or wasp stings (hyposensitisation) or during LDL apheresis. You should therefore tell your doctor if you are taking any of these treatments. Before any surgical procedure or anaesthesia (including for dental treatment) your doctor/dentist should be informed you are under treatment with QUINAPRIL ZENTIVA , as there is a risk of an excessive drop in blood pressure during anaesthesia. It is important to remember that patients with primary hyperaldosteronism (known also as Conn’s syndrome) – an adrenal gland disorder in which there is excessive production of the hormone aldosterone – usually do not respond to ACE-inhibitors.

Talk to your doctor or pharmacist before taking Quinapril Zentiva:

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) is increased: - sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs); - racecadotril and other medicines belonging to the class of neprilydin (NEP) inhibitors.

- concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema (See Do not use QUINAPRIL ZENTIVA and Other medicines and QUINAPRIL ZENTIVA)

 if you are taking any of the following medicines used to treat high blood pressure: - an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems; - aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not use Quinaprl Zentiva”

QUINAPRIL ZENTIVA is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe damage to your baby if taken in this period (see the paragraph on Pregnancy).

Other medicines and QUINAPRIL ZENTIVA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This applies in particular if you are also taking: - Medicines which are most often used to avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”. Sacubitril/valsartan – a medicine used for treating a type of long-term (chronic) heart failure in adults (see also information under the headings “Do not take QUINAPRIL ZENTIVA and Warning and precautions”); - Medicines as racecadotril used against diarrhea (medicines belonging to the class of neprilydin (NEP) inhibitors. See section “Warnings and precautions”). - An angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not use Quinapril Zentiva” and “Warnings and precautions”). - Antibiotics belonging to the tetracycline family because QUINAPRIL ZENTIVA contains magnesium, which delays their absorption. Consequently, tetracycline should not be taken whilst taking QUINAPRIL ZENTIVA. - Medicines containing lithium because they may only be taken at the same time as QUINAPRIL ZENTIVA if the concentration of lithium in the blood is carefully monitored by your doctor. - Potassium-saving medicines, potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in particular those so called potassium sparing), treatments for gout (allopurinol), medicines for controlling diabetes (oral glycaemia- lowering agents or insulin) and other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole). QUINAPRIL ZENTIVA may reduce the excretion of potassium from the body and consequently mineral salts containing potassium or medicines that increase the level of potassium may only be taken under doctor’s orders.

It is also important for your doctor to know if you are taking anti-hypertension medications, antiacids, anaesthetics, cytostatics or immunosuppressants, systemic corticosteroids, procainamide, trimethoprim, anti-inflammatory analgesics or medications for depression or mental disorders.

It is important to know that consumption of alcohol, barbiturates or narcotics may cause a rise in orthostatic hypotension.

QUINAPRIL ZENTIVA with food and drink QUINAPRIL ZENTIVA must not be taken with alcoholic beverages.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy ACE-inhibitor treatment must not be started during pregnancy. QUINAPRIL ZENTIVA is contraindicated during the second and third trimesters of pregnancy.

You must tell your doctor if you think you may be pregnant (or if it is possible that you may become pregnant). Your doctor will probably recommend you stop taking QUINAPRIL ZENTIVA before becoming pregnant or as soon as you know you are pregnant and will recommend you take another medicine instead of QUINAPRIL ZENTIVA . QUINAPRIL ZENTIVA is not recommended at the beginning of a pregnancy and you must not take it if you are more than three months pregnant, as it may cause severe damage to your baby if taken after the third month of pregnancy.

In the event of exposure to quinapril after the third month of pregnancy, an ultrasound scan of the kidneys and head are recommended.

Newborns whose mothers have taken quinapril must be kept under close observation.

Breast-feeding Please tell your doctor if you are breast-feeding or are about to start breast-feeding. Breast-feeding newborns (in the first few weeks after birth) and particularly premature babies is not recommended whilst taking QUINAPRIL ZENTIVA. In the case of older babies, your doctor will advise you about the risks and benefits of taking QUINAPRIL ZENTIVA whilst breast-feeding, compared to other treatments.

Driving and using machines Treatment with QUINAPRIL ZENTIVA may cause dizziness or tiredness in some patients. These effects may influence your ability to drive or use machines. Please observe your personal reaction.

3. How to use QUINAPRIL ZENTIVA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Essential hypertension Monotherapy: Depending on clinical response, the dosage may be adjusted, as indicated by your doctor, up to a maintenance dose of between 20 and 40 mg/day, taken as 1 or 2 separate administrations. The usual maximum maintenance dose is 40 mg/day.

Concomitant diuretic therapy: You may develop symptomatic hypotension after starting treatment with quinapril. This is much more likely to happen in patients treated with diuretics. If possible, the diuretic should be suspended 2-3 days before the start of treatment with quinapril. The starting dose is 2.5 mg of QUINAPRIL ZENTIVA in patients who have been treated with diuretics. The dose of QUINAPRIL ZENTIVA tablets should subsequently be adjusted, according to your doctor’s orders, to achieve optimal response.

Congestive heart failure The initial individual dose is 2.5 mg. In patients under treatment with diuretic and/or cardiac glycoside, the dose must subsequently be adjusted, according to doctor’s orders, to an efficacious dose: the efficacious dose is usually between 10 and 20 mg/day, taken as 1 or 2 administrations. The maximum daily dose of 40 mg must not be exceeded.

Patients considered to be at high risk should start treatment in hospital conditions.

Elderly patients (>65) Treatment in elderly patients should take into account that renal function tends to worsen with age. A starting dose of 2.5 mg, subsequently adjusted to achieve optimal response is recommended.

Renal function impairment: The starting dose of quinapril must be reduced in patients with impaired renal function. This must also be taken into consideration for elderly patients, as renal function tends to worsen with age. The recommended posology is as follows:

Creatinine clearance Recommended maximum daily (ml/min) starting dose (mg) > 60 10 30-60 5 10-30 2.5 < 10 Inadequate evidence

Children and adolescents: Use in children and adolescents is not recommended.

Please contact your doctor or pharmacist if you think that the effect of QUINAPRIL ZENTIVA is too strong or too weak.

If you take more QUINAPRIL ZENTIVA than you should If you accidentally take too many tablets or if a child swallows some tablets, contact a doctor or hospital. Overdose may cause a drop in blood pressure, with dizziness and fainting.

If you forget to take QUINAPRIL ZENTIVA Take the next dose as prescribed. Do not take a double dose to make up for a forgotten dose.

If you stop taking QUINAPRIL ZENTIVA Do not stop taking your tablets, even if you are feeling well, unless your doctors tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine cause side effects, although not everybody gets them.

Common: less than 1 in 10 patients, but more than 1 in 100 patients Uncommon: less than 1 in 100 patients, but more than 1 in 1,000 patients Rare: less than 1 in 1,000 patients, but more than 1 in 10,000 patients Very rare: less than one in 10,000 patients, including isolated reports

Psychiatric disorders: Uncommon: Sleeping disorders, irritability. Rare: Depression, mental confusion.

Nervous system disorders: Common: Dizziness. Uncommon: Paraesthesia (numbness or pins and needles), drowsiness. Rare: Balance disorders, neuropathy (altered sensitivity due to nerve defects).

Eye disorders: Rare: Blurred vision, amblyopia (reduction in visual acuity).

Ear and labyrinth disorders: Rare: Tinnitus (sounds in the ear).

Cardiac disorders: Uncommon: Palpitations, chest pain, angina pectoris (cardiac spasms). Rare: Tachycardia, syncope (fainting), myocardial infarction, transient ischaemic attack (TIA), brain haemorrhage.

Vascular disorders: Common: Hypotension. Uncommon: Postural hypotension.

Blood and lymphatic system disorders: Uncommon: Neutropoenia. Rare: Agranulocytosis.

Respiratory, thoracic and mediastinal disorders: Common: Coughing. Uncommon: Sinusitis,Cough. laryngitis, upper airway infections. Rare: Bronchospasm, dyspnoea (difficulty breathing), bronchitis, rhinitis, asthma exacerbations. Very rare: Allergic alveolitis, anaphylactic reactions.

Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea. Uncommon: Dyspepsia (benign gastric disorder), abdominal pain, flatulence and dry mouth and throat. Rare: Taste alterations, pancreatitis, glossitis, inflammation of the ileum. Very rare: Intestinal angio-oedema.

Hepatobiliary disorders: Rare: Hepatic function alterations. Very rare: Cholestatic jaundice, hepatitis.

Skin and subcutaneous tissue disorders: Uncommon: Itchiness, rash, exfoliative dermatitis, increased perspiration, exanthema, hives. Very rare: Polymorphous erythema (skin and mucosal lesions), Stevens Johnson syndrome (bullous lesions), epidermal necrolysis, psoriasis-like marks, hair loss, pemphigus (a group of autoimmune diseases that affect the skin and mucosae), photosensitivity.

Musculoskeletal and connective tissue disorders: Rare: Joint and muscle pain, backache.

Renal and urinary disorders: Uncommon: Proteinuria (loss of proteins in the urine, sometimes associated with renal function impairment). Rare: Renal function impairment, hyperpotassaemia. Very rare: Kidney failure.

Reproductive system and breast disorders: Uncommon: Impotence.

General disorders: Common: Headache, tiredness. Uncommon: Asthenia (condition of great fatigue), vertigo, angio-oedema (with swelling of the limbs, face, lips, tongue, pharynx, glottis and/or larynx).

Laboratory parameters: increases (>1.25 times the upper limit of normal) have been reported in blood creatinine and nitrogen of 3% and 4% respectively, in patients under monotherapy. It is far more likely that these increases will occur in patients on concomitant treatment with diuretics than in patients under QUINAPRIL ZENTIVA monotherapy. The increases observed often normalise without interrupting treatment.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V<[To be completed nationally]>. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store QUINAPRIL ZENTIVA

Do not store QUINAPRIL ZENTIVA above 25°C.

Keep this medicine out of the sight and reach of children.

Attention: Do not use QUINAPRIL ZENTIVA after the expiry date which is stated on the pack.

For environmental and safety reasons, unused or expired medicines should be returned to the pharmacy for disposal.

6. Contents of the pack and other information What QUINAPRIL ZENTIVA contains - The active substance is 5 mg, 10 mg, 20 mg or 40 mg of quinapril (in the form of hydrochloride salt). - The other ingredients are: Core of the tablet: heavy magnesium carbonate, anhydrous dibasic calcium phosphate, pregelatinised corn starch, croscarmellose sodium, magnesium stearate. Coating film: hypromellose, hydroxy propyl cellulose, macrogol 400, titanium dioxide (E171) and red ferrous oxide (E172).

What QUINAPRIL ZENTIVA looks like and contents of the pack Quinapril Zentiva 5 mg is an oval, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Size 4.5 x 8.7 mm. Quinapril Zentiva 10 mg is an oval, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "L" on one side. Size 5.8 x 11.3 mm. Quinapril Zentiva 20 mg is a round, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Diameter 7 mm. Quinapril Zentiva 40 mg is an oval, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Size 6.5 x 12.7 mm.

All the tablets can be divided into equal doses.

Pack sizes: Blister: 10, 14, 28, 30, 50, 56, 98, 100 and 500 tablets Tablet container: 250 tablets in bottle

Not all pack sizes may be marketed.

Marketing authorisation holder and Manufacturer Marketing authorisation holder Zentiva Italia S.r.l., Viale Bodio 37/b - 20158 Milan

Manufacturer Actavis hf - Reykjavikurvegur, 78 - IS-220 Hafnarfjördur (Iceland)

This leaflet was last revised in: