Zantipres: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZANTIPRES 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. Do not give it to others, even if their symptoms are the same as yours, because 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 ZANTIPRES is and what it is used for
What you need to know before taking ZANTIPRES
How to take ZANTIPRES
Possible side effects
How to store ZANTIPRES
Contents of the pack and other information

1. WHAT ZANTIPRES IS AND WHAT IT IS USED FOR
ZANTIPRES 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.
ZANTIPRES 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 ZANTIPRES

Do not take ZANTIPRES if:

you are allergic to calcium zofenopril 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 had severe episodes of swelling and itching of the face, nose, and throat (angioedema) associated with prior therapy 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 chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g., in the throat)
you suffer from renal artery stenosis (narrowing of the arteries to the kidneys)
you are more than three months pregnant (it is better to avoid taking ZANTIPRES even in 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 ZANTIPRES.
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 the blood (primary hyperaldosteronism) or low levels of the hormone aldosterone in the blood (hypoaldosteronism)
you have narrowing of the heart valve (aortic stenosis) or thickening of the heart 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 – e.g., 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, e.g., in the throat) may be increased: o racecadotril, a medicine used to treat diarrhea o medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) o vildagliptin, a medicine used to treat diabetes

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section “Do not take ZANTIPRES”.
When taking ZANTIPRES, 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 scheduled for surgery, inform the anesthetist that you are taking ZANTIPRES before receiving anesthesia. This will help the anesthetist manage your blood pressure and heart rate during the procedure.
Additionally, if you suffer from heart attacks (acute myocardial infarction) and:

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

You must inform your doctor if you think you are (or might be) pregnant. The use of ZANTIPRES is not recommended in 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 ZANTIPRES
Inform your doctor if you are taking, have recently taken, or might take any other medicine:

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 immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting)
lithium (used to treat mood disorders)
anesthetics
narcotic medicines (such as morphine)
antipsychotics (used to treat schizophrenia and similar conditions)
antidepressants or tricyclics, e.g., amitriptyline 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 ZANTIPRES” 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 immunosuppressive medicines (medicines that suppress the body’s 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 medicines)
procainamide (used to control irregular heartbeat)
non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin or ibuprofen)
sympathomimetic medicines (medicines acting on the nervous system, including some used to treat asthma or hay fever, and pressor amines such as adrenaline)
racecadotril (a medicine used to treat diarrhea), medicines 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.

ZANTIPRES with food, drinks, and alcohol
ZANTIPRES can be taken with or without food, but it is preferable to take the tablet with water. Alcohol increases the blood pressure-lowering effect of ZANTIPRES (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, planning to become pregnant, or think you may be pregnant, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking ZANTIPRES before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. ZANTIPRES is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to the 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. ZANTIPRES is not recommended during breastfeeding, and your doctor may choose another suitable medicine for you, especially 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.
ZANTIPRES 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 ZANTIPRES

Always take ZANTIPRES exactly as directed by your doctor. If you have any doubts, consult your doctor. ZANTIPRES can be taken with or without food. It is preferable to swallow the tablet with water.
ZANTIPRES 15mg, 30mg, 60mg
The tablet may be divided into two equal doses.
Treatment of high blood pressure (hypertension)
The usual starting dose of ZANTIPRES is 15 mg once daily. Your doctor will gradually adjust the dose (usually at four-week intervals) to find the best dose for you. Long-term antihypertensive effects are generally achieved with a daily dose of 30 mg of ZANTIPRES taken once daily. The maximum dose is 60 mg per day, which may be taken as a single dose or divided into two separate doses.
If you are dehydrated, have a salt deficiency, or are taking diuretics, it may be necessary to start treatment with 7.5 mg of ZANTIPRES.
Liver or kidney problems
If you have mild to moderate liver impairment or moderate to severe kidney impairment, your doctor will start treatment with half the usual therapeutic dose of ZANTIPRES (15 mg). If you are on dialysis, treatment must be started with a quarter of the usual therapeutic dose (7.5 mg).
Heart attack (acute myocardial infarction)
Treatment with ZANTIPRES should begin within the first 24 hours after onset of symptoms. Take ZANTIPRES 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 onwards, the dose should be increased to 30 mg twice daily;
your doctor may adjust your dose or maximum dose based on blood pressure measurements;
treatment will then continue for six weeks or longer if symptoms of heart failure persist.

If you take more ZANTIPRES than you should
If you accidentally take more tablets than you should, contact your doctor or the nearest emergency department immediately (bring the remaining tablets, the pack, 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 ZANTIPRES
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 the 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 ZANTIPRES
Always consult your doctor before stopping treatment with ZANTIPRES, whether you are taking it for high blood pressure or following a heart attack.
If you have any questions about the use of ZANTIPRES, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

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

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

fatigue
nausea and/or vomiting
dizziness
headache
cough

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

general weakness
muscle cramps
skin rash

Rare adverse 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 adverse effects reported for ZANTIPRES, the following effects have generally been reported with ACE inhibitors:

severe drop in blood pressure at the beginning of treatment or when increasing the dose, with dizziness, blurred vision, 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 (swelling of 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 the urine (proteinuria), impotence;
abdominal pain, diarrhea, constipation, dry mouth;
allergic reactions such as skin rash, hives, itching, skin peeling, redness, skin loosening and formation of blisters (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 disorders, altered skin sensations such as burning, pricking, or tingling (paresthesia), balance disorders, confusion, ringing in the ears (tinnitus), taste disturbances, blurred vision;
breathing difficulties, narrowing of the lung airways (bronchospasm), sinusitis, stuffy nose (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 levels of urea and creatinine in the blood;
anemia due to the breakdown of red blood cells (hemolytic anemia), which may occur if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency;
hypoglycemia.

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

5. HOW TO STORE ZANTIPRES

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 pack after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What ZANTIPRES 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 “ZANTIPRES contains lactose”).

Description of the appearance of ZANTIPRES and packaging contents
ZANTIPRES 7.5 is available as white, round, film-coated tablets with convex faces, in packs of 12, 14, 15, 28, 30, 48, 50, 56, 90 or 100 tablets, and in packs of 50 and 56 tablets in unit-dose divisible blisters.
ZANTIPRES 15 is available as white, oblong, film-coated tablets, in packs of 12, 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in packs of 50 and 56 tablets in unit-dose divisible blisters.
ZANTIPRES 30 is available as white, oblong, film-coated tablets, in packs of 7, 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in packs of 50 and 56 tablets in unit-dose divisible blisters.
ZANTIPRES 60 is available as white, oblong, film-coated tablets, in packs of 14, 15, 28, 30, 50, 56, 90 or 100 tablets, and in packs of 50 and 56 tablets in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
F.I.R.M.A. S.p.A. – Via di Scandicci, 37 – Florence, Italy.

Manufacturers
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.