Zopranol

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOPRANOL 7.5 mg, 15 mg, 30 mg, 60 mg film-coated tablets

(Zofenopril calcium)
Please 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 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:

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

1. WHAT ZOPRANOL IS AND WHAT IT IS USED FOR
ZOPRANOL contains 7.5 mg, 15 mg, 30 mg, or 60 mg of zofenopril calcium, which belongs to a group of medicines that lower blood pressure, called angiotensin-converting enzyme (ACE) inhibitors.
ZOPRANOL is used to treat the following conditions:

• High blood pressure (hypertension).
• Heart attack (acute myocardial infarction) in patients who may or may not show signs and symptoms of heart failure, and who have not received treatment to dissolve blood clots (thrombolytic therapy).

2. WHAT YOU SHOULD KNOW BEFORE TAKING ZOPRANOL

Do not take ZOPRANOL if:

• you are allergic to zofenopril calcium or to any of the other ingredients of this medicine (listed in Section 6);
• you have previously experienced allergic reactions to another ACE inhibitor, such as captopril or enalapril;
• you have previously experienced severe episodes of swelling and itching of the face, nose, and throat (angioedema) associated with prior treatment with ACE inhibitors, or if you suffer from hereditary/idiopathic angioedema (rapid swelling of the skin, tissues, gastrointestinal tract, and other organs);
• you have severe liver problems;
• you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat);
• you have narrowing of the arteries supplying the kidneys;
• you are more than three months pregnant (it is advisable to avoid taking ZOPRANOL even during early pregnancy – see section: Pregnancy);
• you are a woman of childbearing age unless you are using effective contraceptive methods;
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking ZOPRANOL.
Tell your doctor if:

• you have high blood pressure and problems with your liver or kidneys;
• your high blood pressure is due to kidney disease or narrowing of the renal artery (renovascular hypertension);
• you have recently undergone a kidney transplant;
• you are on dialysis;
• you are undergoing LDL-apheresis (a procedure similar to kidney dialysis that removes harmful cholesterol from your blood);
• you have abnormally high levels of the hormone aldosterone in your blood (primary hyperaldosteronism);
• you have narrowing of a heart valve (aortic stenosis) or thickening of the heart muscle walls (hypertrophic cardiomyopathy);
• you have or have had psoriasis (a skin condition characterized by scaly pink patches);
• you are receiving desensitization therapy ('allergy shots') for insect stings.
• you are taking any of the following medicines for high blood pressure: or an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes; or aliskiren.
• you are taking any of the following medicines, as the risk of angioedema (rapid subcutaneous swelling, for example in the throat) may be increased: or racecadotril, a medicine used to treat diarrhoea; or medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus); or vildagliptin, a medicine used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take ZOPRANOL”.
When taking ZOPRANOL, your blood pressure may drop too low, especially after taking the first dose (this is more likely if you are also taking diuretics, if you are dehydrated, or if you are on a low-salt diet). If this occurs, inform your doctor immediately and lie down on your back.
If you are undergoing surgery, inform the anaesthetist that you are taking ZOPRANOL before receiving anaesthesia. This will help the anaesthetist manage your blood pressure and heart rate during the procedure.
Additionally, if you have heart attacks (acute myocardial infarction) and:

• you have low blood pressure (<100 mmHg) or are in circulatory shock (resulting from your heart condition) – ZOPRANOL is not the recommended medicine for you;
• you are over 75 years old – ZOPRANOL should be used with particular caution.

You must inform your doctor if you think you are (or might be) pregnant. Use of ZOPRANOL is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to the baby if used at this stage (see section: Pregnancy).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as its safety has not been established.

Other medicines and ZOPRANOL
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting);
• lithium (used to treat mood disorders);
• anaesthetics;
• narcotic drugs (such as morphine);
• antipsychotic drugs (used to treat schizophrenia and similar conditions);
• antidepressants or tricyclics, e.g. amitriptiline and clomipramine;
• other medicines for high blood pressure and vasodilators (including beta-blockers, alpha-blockers, and diuretics such as hydrochlorothiazide, furosemide, torasemide); Your doctor may consider it necessary to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take ZOPRANOL” and “Warnings and precautions”);
• nitroglycerin and other nitrates used for chest pain (angina);
• antacids including cimetidine (used to treat heartburn and stomach ulcers);
• cyclosporine (used after organ transplantation) and other immunosuppressants (drugs that suppress the body's immune defenses);
• allopurinol (used to treat gout);
• insulin and other oral antidiabetic medicines;
• cytostatic agents (used to treat cancer or immune system disorders);
• corticosteroids (potent anti-inflammatory drugs);
• procainamide (used to control irregular heartbeat);
• non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin or ibuprofen);
• sympathomimetic drugs (drugs acting on the nervous system, including some
• drugs used to treat asthma or hay fever and pressor amines such as adrenaline);
• racecadotril (a medicine used to treat diarrhoea), drugs commonly used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus), and vildagliptin (a medicine used to treat diabetes). The risk of angioedema may be increased. Sacubitril/valsartan, medicines used to treat a type of chronic heart failure in adults. See section “Do not take ZOPRANOL”.

ZOPRANOL with food, drinks, and alcohol
ZOPRANOL can be taken with or without food, but it is preferable to take the tablet with water. Alcohol enhances the blood pressure-lowering effect of ZOPRANOL (further lowering blood pressure); consult your doctor for further advice on alcohol consumption while taking this medicine.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking ZOPRANOL before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. ZOPRANOL is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. ZOPRANOL is not recommended during breastfeeding, and your doctor may choose another suitable medicine if you wish to continue breastfeeding, particularly if you are breastfeeding a premature infant.

Driving and using machines
This medicine may cause dizziness or fatigue. If this occurs, do not drive or operate machinery until symptoms resolve.

ZOPRANOL contains lactose
This product contains lactose. If you know you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE ZOPRANOL

Always take ZOPRANOL exactly as directed by your doctor. If you have any doubts, consult your doctor.
ZOPRANOL may be taken with food or on an empty stomach. It is preferable to take the tablet with water.
ZOPRANOL 15mg, 30mg, 60mg
The tablet may be divided into two equal doses.
Treatment of high blood pressure (hypertension)
The usual starting dose of ZOPRANOL is 15 mg once daily. Your doctor will gradually adjust the dose (usually at four-week intervals) to find the most appropriate dose for you. Long-term antihypertensive effects are generally achieved with a daily dose of 30 mg of ZOPRANOL taken once daily. The maximum dose is 60 mg per day, which may be taken as a single dose or in two separate doses.
If you are dehydrated, have a salt deficiency, or are taking diuretics, treatment may need to start with 7.5 mg of ZOPRANOL.
Liver or kidney problems
If you have mild to moderate hepatic impairment or moderate to severe renal impairment, your doctor will start treatment with half the normal therapeutic dose of ZOPRANOL (15 mg). If you are on dialysis, treatment should be started with a quarter of the normal therapeutic dose (7.5 mg).
Heart attack (acute myocardial infarction)
Treatment with ZOPRANOL should begin within the first 24 hours after symptom onset.
Take ZOPRANOL tablets twice daily, in the morning and evening, as follows:

• 7.5 mg twice daily on the first and second day of treatment;
• 15 mg twice daily on the third and fourth day of treatment;
• from the fifth day onward, the dose should be increased to 30 mg twice daily;
• your doctor may adjust the dose or maximum dose you receive, based on blood pressure measurements;
• treatment will then continue for six weeks or longer if symptoms of heart failure persist.

If you take more ZOPRANOL than you should
If you accidentally take more tablets than you should, contact your doctor or the nearest emergency department immediately (bring any remaining tablets, the packaging, or this leaflet with you if possible). The most common symptoms and signs of overdose are low blood pressure with fainting (hypotension), very slow heart rate (bradycardia), changes in blood tests (electrolytes), and kidney dysfunction.
If you forget to take ZOPRANOL
If you forget to take a dose, take your usual dose the next day. However, if the delay is very long (e.g., several hours) and the time for your next dose is approaching, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed tablet.
If you stop taking ZOPRANOL
Always consult your doctor before stopping treatment with ZOPRANOL, whether you are taking it for high blood pressure or following a heart attack.
If you have any questions about the use of ZOPRANOL, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ZOPRANOL can cause side effects, although not everyone experiences them.
Most of the side effects associated with ACE inhibitors are reversible and disappear at the end of treatment.

Common side effects (may affect up to 1 in 10 people):

• fatigue
• nausea and/or vomiting
• dizziness
• headache
• cough

Uncommon side effects (may affect up to 1 in 100 people):

• general weakness
• muscle cramps
• skin rash

Rare side effects (may affect up to 1 in 1,000 people):

• rapid swelling and itching, particularly of the face, mouth, and throat, possibly causing breathing difficulties

In addition to the side effects reported for ZOPRANOL, the following side effects have generally been reported for ACE inhibitors:

• severe drop in blood pressure at the start of treatment or with dose increase, causing dizziness, blurred vision, or fainting (syncope);
• increased or irregular heart rate, palpitations, and chest pain (heart attack or angina pectoris);
• loss of consciousness, sudden dizziness, sudden blurred vision, weakness and/or loss of sensation on one side of the body (transient ischemic attack or stroke);
• peripheral edema (swollen limbs due to fluid accumulation), low blood pressure when standing, chest pain, muscle pain and/or cramps;
• reduced kidney function, changes in daily urine output, presence of protein in urine (proteinuria), impotence;
• abdominal pain, diarrhea, constipation, dry mouth;
• allergic reactions such as skin rash, hives, itching, skin peeling, redness, skin loosening, and blistering (toxic epidermal necrolysis), worsening of psoriasis (a skin disease characterized by scaly pink areas), hair loss (alopecia);
• increased sweating and hot flushes;
• mood changes, depression, sleep disturbances, altered skin sensations such as burning, tingling, or prickling (paresthesia), balance disorders, confusion, ringing in the ears (tinnitus), taste disturbances, blurred vision;
• breathing difficulties, narrowing of the airways in the lungs (bronchospasm), sinusitis, nasal congestion (rhinitis), inflammation of the tongue (glossitis), bronchitis;
• yellowing of the skin (jaundice), inflammation of the liver or pancreas (hepatitis, pancreatitis), obstruction of the small intestine (ileus);
• changes in blood tests such as red blood cell, white blood cell, or platelet counts, or a reduction in all blood cells (pancytopenia). Contact your doctor if you notice easy bruising or develop an unexplained sore throat or fever;
• increased blood levels of liver enzymes (transaminases) and bilirubin, increased blood urea and creatinine levels;
• anemia due to destruction of red blood cells (hemolytic anemia), which may occur if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency;
• hypoglycemia

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

5. HOW TO STORE ZOPRANOL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
Do not dispose of medicines via wastewater. 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 ZOPRANOL contains

The active substance is zofenopril calcium 7.5 mg, 15 mg, 30 mg, 60 mg.
The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, hypromellose, titanium dioxide (E 171), macrogol 400, and macrogol 6000 (see section 2 “ZOPRANOL contains lactose”).

Description of the appearance of ZOPRANOL and contents of the pack

ZOPRANOL 7.5 is available as white, film-coated, round, convex-faced tablets in packs of 12, 14, 15, 28, 30, 48, 50, 56, 90 or 100 tablets, and in unit-dose divisible blister packs of 50 and 56.
ZOPRANOL 15 is available as white, film-coated, oval tablets in packs of 12, 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in unit-dose divisible blister packs of 50 and 56.
ZOPRANOL 30 is available as white, film-coated, oval tablets in packs of 7, 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in unit-dose divisible blister packs of 50 and 56.
ZOPRANOL 60 is available as white, film-coated, oval tablets in packs of 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in unit-dose divisible blister packs of 50 and 56.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Laboratori Guidotti S.p.A. - Via Livornese 897, PISA – La Vettola
Marketing Authorization Holder for Sales: A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 - Florence
Manufacturer
A. MENARINI Manufacturing Logistics and Services Srl
Campo di Pile - L'Aquila - Italy.
MENARINI Von Heyden GmbH
Leipziger Strasse 7-13
01097 – Dresden (Germany).

This patient information leaflet was last updated on