Zinadril

Package leaflet: Information for the patient

ZINADRIL 10 mg film-coated tablets, 5 mg film-coated tablets

Benazepril hydrochloride
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ZINADRIL is and what it is used for

ZINADRIL contains the active substance benazepril hydrochloride, which belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) that work by dilating blood vessels, improving circulation, and lowering blood pressure.
ZINADRIL is indicated for the following conditions:

• treatment of high blood pressure (arterial hypertension);
• when the heart is unable to pump an adequate amount of blood to the body (congestive heart failure, CHF);
• as adjunctive therapy in patients with congestive heart failure (NYHA classes II - IV) in whom treatment with other medicines (digitalis and/or diuretics) is not effective.

2. What you need to know before taking ZINADRIL

Do not take ZINADRIL

• if you are allergic to benazepril, to other similar medicines, or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced an allergic reaction to another ACE inhibitor, with swelling of the face, lips, mouth, tongue, or throat, and difficulty swallowing or breathing (angioedema);
• if you are more than three months pregnant (See section “Pregnancy and breastfeeding”);
• if you have diabetes (diabetes mellitus) or impaired kidney function (glomerular filtration rate GFR < 60 ml/min/1.73 m²) and are being treated with a blood pressure-lowering medicine containing aliskiren (See section “Other medicines and ZINADRIL”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ZINADRIL.
Take this medicine with caution and inform your doctor:

• if you are on a low-sodium (sodium-restricted) diet;
• if you have severe diarrhoea or vomiting;
• if you have heart problems (severe congestive heart failure, aortic or mitral valve stenosis);
• if you have kidney problems (impaired renal function with creatinine clearance < 30 ml/min) or are undergoing mechanical blood filtration (hemodialysis with high-flux membranes) (See section “Use in patients with kidney problems”);
• if you have poor blood circulation to the kidneys (unilateral or bilateral renal artery stenosis);
• if you have a vascular collagen disease such as systemic lupus erythematosus or scleroderma;
• if you have diabetes (diabetes mellitus);
• if you have liver problems;
• if you are taking any of the following medicines (See section “Other medicines and ZINADRIL”):
• other medicines that lower high blood pressure (aliskiren, angiotensin II receptor antagonists), especially if you have kidney problems related to diabetes (diabetic nephropathy). This combination is not recommended, as it increases the risk of adverse effects. If your doctor considers it necessary to take these medicines together, you must be closely monitored and your kidney function, electrolyte levels, and blood pressure must be checked regularly;
• diuretics, which help increase urine elimination;
• medicines that increase potassium levels in the blood.

In these cases, during treatment with ZINADRIL, your doctor should monitor your kidney function
(creatinine clearance), blood pressure, blood potassium levels, blood sugar (glucose), blood nitrogen
(azotemia), liver enzymes (hepatic enzymes), or the count of a specific type of white blood cells (leucocytes).
Stop taking ZINADRIL and contact your doctor immediately if, during treatment, you experience:

• severe allergic reactions (anaphylactoid or similar reactions);
• swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema). This risk appears to be higher in people with black skin compared to those with lighter skin, and if you have had such episodes in the past (See section “Do not take ZINADRIL”);
• yellowing of the skin (cholestatic jaundice) or abnormal blood test results (elevated liver enzymes);
• persistent dry (non-productive) cough.

If you are about to undergo any of the following procedures, inform your doctor that you are being treated with ZINADRIL:

• desensitization treatment to reduce the effects of allergy to bee or wasp stings;
• a procedure called low-density lipoprotein apheresis, to remove cholesterol from the blood using machines;
• any surgical procedure or if you need anaesthetics that lower blood pressure.

You must inform your doctor if you think you are pregnant or plan to become pregnant before starting treatment with ZINADRIL, as it may cause serious harm to the unborn baby. In such a case, your doctor will immediately stop the treatment and prescribe an alternative therapy (See section “Pregnancy and breastfeeding”).
If your blood pressure drops too low, lie down and contact your doctor immediately.
Children and adolescents
This medicine is not recommended for children and adolescents (0–18 years) because safety and efficacy have not been established.
Other medicines and ZINADRIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor if you are taking any of the following medicines:

• medicines that increase urine elimination (diuretics);
• potassium-sparing diuretics, such as spironolactone, triamterene, amiloride, potassium supplements, or potassium-containing salt substitutes, as they may cause increased potassium levels in the blood (hyperkalaemia) or excessive drop in blood pressure. If these medicines need to be taken together, your doctor must carefully monitor your blood potassium levels (See section “How to take ZINADRIL”);
• lithium, used to treat certain mental disorders, as ZINADRIL may increase its toxicity. This risk is higher if you are also taking a medicine that increases urine elimination (diuretic). If you need to take these medicines together, your doctor must closely monitor your blood lithium levels;
• oral hypoglycaemic agents or insulin, used to treat diabetes, as they may cause excessive lowering of blood sugar (hypoglycaemia), especially during the first week of treatment and if you have kidney problems (impaired renal function);
• other ACE inhibitors, angiotensin II receptor antagonists, or aliskiren, used to lower blood pressure, as the risk of adverse effects such as low blood pressure (hypotension), increased blood potassium levels (hyperkalaemia), and reduced kidney function is higher (See sections “Do not take ZINADRIL” and “Warnings and precautions”);
• racecadotril (a medicine used to treat diarrhoea). In particular, you must inform your doctor or pharmacist if you are using:
• non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation (e.g., ibuprofen, indomethacin);
• aspirin (acetylsalicylic acid) when used to relieve pain and inflammation (benazepril may be used with aspirin when aspirin is taken to prevent heart attacks and strokes);
• ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection;
• heparin, a medicine used to thin the blood;
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

ZINADRIL and alcohol
Avoid drinking alcoholic beverages during treatment with ZINADRIL, as this may cause excessive lowering of blood pressure and dizziness.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are being treated with this medicine and pregnancy is confirmed, stop taking it immediately and consult your doctor for an alternative therapy.
ZINADRIL is not recommended during early pregnancy and must not be taken if you are more than three months pregnant (second and third trimesters), as it may cause serious harm to the unborn baby during this period (See section “Do not take ZINADRIL”).
If you have taken this medicine during the second or third trimester of pregnancy, the newborn must undergo an ultrasound to check kidney function and skull development, and blood pressure must be closely monitored.
Breastfeeding
This medicine is not recommended during breastfeeding, especially for babies born prematurely or during the first few weeks after birth (See section “Do not take ZINADRIL”).
Once the baby is older and your doctor considers it appropriate, you may take this medicine, but the baby must be monitored for any possible adverse effects.
Driving and using machines
As with other medicines that lower blood pressure, ZINADRIL may cause dizziness or affect your ability to concentrate. Therefore, before driving or operating machinery, you should be aware of your individual response to this medicine.
ZINADRIL contains lactose and hydrogenated castor oil
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains hydrogenated castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take ZINADRIL

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablet every day at the same time, preferably in the morning, with a glass of water.
You may take ZINADRIL before, during, or after breakfast.
The tablet may be divided into two equal halves.
Before and during treatment with ZINADRIL, your doctor must carefully monitor your blood
pressure (arterial pressure), kidney function, and blood potassium levels (see section
"Warnings and precautions").

Treatment of high blood pressure (hypertension)
At the beginning of treatment, the recommended dose is 10 mg up to a maximum of 20 mg, once daily,
with dose adjustments made at intervals of 1–2 weeks.
If the medicine's effect on blood pressure diminishes before the next dose is due, your doctor may
divide the daily dose into two equal doses.
The maximum recommended dose is 40 mg per day, either as a single dose or divided into two doses.
If further lowering of blood pressure is needed, your doctor may prescribe a low dose of another
medicine for high blood pressure (a thiazide diuretic or calcium antagonist) to be taken together with
ZINADRIL.
If you are taking medicines that increase urine elimination (diuretics) or have reduced body fluids
(dehydration), stop treatment for 2–3 days before starting ZINADRIL, and then restart if necessary,
because excessive lowering of blood pressure (hypotension) may occur.
If you cannot stop treatment, your doctor will reduce the initial dose of ZINADRIL to 5 mg.

Use in patients with kidney problems
If you have mild to moderate kidney problems (creatinine clearance ≥ 30 ml/min), no dose adjustment
is necessary.
If you have severe kidney problems (creatinine clearance < 30 ml/min), your doctor will prescribe an
initial dose of 5 mg, which may be increased up to 10 mg per day.
To further lower blood pressure, your doctor may prescribe a medicine to promote urine elimination
(non-thiazide diuretic) or another antihypertensive medicine.

Use in patients with liver problems (impaired liver function)
If you have severe liver problems (severe hepatic insufficiency), your doctor will prescribe an initial
dose of 5 mg.

Treatment of heart disorders (congestive heart failure)
At the beginning of treatment, the recommended dose is 2.5 mg per day.
Your doctor will closely monitor you after you take this medicine, as a marked reduction in blood
pressure (arterial pressure) may occur.
If you have not experienced symptom improvement and have not developed low blood pressure
(symptomatic hypotension) or other adverse effects, after 2–4 weeks of treatment your doctor may
gradually increase the dose to 5 mg or up to 20 mg, once daily, depending on your response to the
medicine.
Generally, a single daily dose is effective, but in some cases it may be necessary to divide the daily
dose into two doses.
If you have severe heart function problems (severe heart failure, NYHA class IV), your doctor will
reduce the dose.

Use in elderly patients
If you are elderly, no dose adjustment is necessary.

If you take more ZINADRIL than you should
Taking an excessive dose of this medicine may cause excessive lowering of blood pressure (marked
hypotension).
Your doctor will determine the appropriate treatment based on your symptoms.
In case of accidental overdose or ingestion of ZINADRIL, contact your doctor immediately or go to the
nearest hospital.

If you forget to take ZINADRIL
Do not take a double dose to make up for the missed tablet. Take only the next tablet at the scheduled
time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:
Common (may affect up to 1 in 10 people)

• increased awareness of heartbeats (palpitations);
• dizziness when standing up (orthostatic symptoms);
• stomach and bowel disturbances (non-specific gastrointestinal disorders);
• skin irritation (rash), redness, itching, light sensitivity reactions (photosensitivity);
• frequent need to urinate (frequent urination);
• cough;
• breathing problems (respiratory tract symptoms);
• headache (cephalalgia), dizziness, fatigue.

Uncommon (may affect up to 1 in 1,000 people)

• lowering of blood pressure (symptomatic hypotension), chest pain (thoracic pain, angina pectoris), changes in heart rhythm (arrhythmias);
• diarrhoea, constipation (stipsis), nausea, vomiting, abdominal pain (abdominal pain);
• blister formation on the skin (pemphigus);
• inflammation of the liver (hepatitis, cholestatic hepatitis), yellowing of the skin and eyes (cholestatic jaundice);
• increased levels of nitrogen in the blood (azotemia) and of creatinine in the blood (serum creatinine), a substance indicating proper kidney function. These effects disappear if ZINADRIL treatment is discontinued and are more frequent if you have kidney problems (renal artery stenosis);
• drowsiness, difficulty sleeping (insomnia), nervousness, tingling sensation in arms and legs (paraesthesiae);
• swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema, lip and/or facial oedema);
• joint pain (arthralgia), joint inflammation (arthritis), muscle pain (myalgia).

Rare (may affect up to 1 in 10,000 people)

• heart attack (myocardial infarction);
• inflammation of the pancreas (pancreatitis);
• severe skin allergic reaction (Stevens-Johnson syndrome);
• impairment of kidney function (renal dysfunction);
• reduction in the number of red blood cells in the blood (haemolytic anaemia) and in the number of platelets in the blood (thrombocytopenia);
• perception of ringing sounds in the ear (tinnitus), altered taste (dysgeusia).

Frequency not known (cannot be estimated from the available data)

• cold (rhinitis), flu-like symptoms, inflammation of the throat (pharyngitis), inflammation of nasal mucosa (sinusitis);
• feeling of uneasiness (anxiety), depression, lack of coordination (incoordination);
• sexual disorders (decreased libido, impotence);
• sweating;
• worsening of psoriasis (a skin disease causing red, itchy and scaly patches, most commonly on knees, elbows, trunk and scalp).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 ZINADRIL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from moisture.
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. Package contents and other information

What ZINADRIL contains
ZINADRIL 10 mg film-coated tablets

• The active substance is benazepril hydrochloride. Each tablet contains 10 mg of benazepril hydrochloride.
• The other components are: anhydrous colloidal silica, microcrystalline cellulose, hydrogenated castor oil, lactose, pregelatinized corn starch, crospovidone, hypromellose, yellow iron oxide (E 172), macrogol 8000, talc, titanium dioxide.

ZINADRIL 5 mg film-coated tablets

• The active substance is benazepril hydrochloride. Each tablet contains 5 mg of benazepril hydrochloride.
• The other components are: anhydrous colloidal silica, microcrystalline cellulose, hydrogenated castor oil, lactose, pregelatinized corn starch, crospovidone, hypromellose, yellow iron oxide (E 172), macrogol 8000, talc, titanium dioxide.

Description of the appearance of ZINADRIL and pack sizes
ZINADRIL 10 mg film-coated tablets
Carton pack containing 14 or 28 divisible tablets.
ZINADRIL 5 mg film-coated tablets
Carton pack containing 28 divisible tablets.

Marketing Authorization Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milano – Italy
Manufactured under license from: Meda Pharma S.p.A.
Manufacturer
FAMAR ITALIA S.p.A. – Via Zambeletti, 25 – Baranzate (MI) – Italy
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)