Zofenil 30

Leaflet attached to the packaging: patient information

Zofenil 30

30 mg, film-coated tablets
(Zofenopril calcium)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Zofenil 30 is and what it is used for
• 2. Important information before taking Zofenil 30
• 3. How to take Zofenil 30
• 4. Possible side effects
• 5. How to store Zofenil 30
• 6. Contents of the pack and other information

1. What Zofenil 30 is and what it is used for

Zofenil 30 contains 30 mg of zofenopril calcium, which belongs to a group of medicines that lower blood pressure, called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Zofenil 30 is used to treat the following conditions:

• High blood pressure (hypertension)
• Heart attack (acute myocardial infarction) in patients with symptoms of heart failure or without them, who have not received thrombolytic treatment.

2. Important information before taking Zofenil 30

When not to take Zofenil 30:

• If the patient is allergic to zofenopril calcium or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had an allergic reaction to any other ACE inhibitor medicine, such as captopril or enalapril
• if the patient has had swelling and itching in the face, nose, and throat (angioedema) related to ACE inhibitor treatment, or if they have hereditary or idiopathic angioedema (sudden swelling of the skin, tissues, gastrointestinal tract, and other organs)
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema increases

angioedema (rapid swelling of tissues under the skin, such as the throat)

• in case of severe liver dysfunction
• in case of renal artery stenosis
• after the third month of pregnancy (it is also recommended to avoid taking Zofenil 30 in early pregnancy - see "Pregnancy and breastfeeding")
• in women of childbearing age, if they do not use effective contraception
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Zofenil 30, the patient should discuss it with their doctor.
The patient should inform their doctor:

• if they have high blood pressureand liver or kidney disease
• if their high blood pressure is caused by kidney disease or narrowing of the artery that supplies blood to the kidney (renal artery stenosis)
• if they have recently had a kidney transplant
• if they are undergoing dialysis
• if they are undergoing LDL apheresis(a procedure similar to dialysis that cleans the blood of harmful cholesterol)
• if they have abnormal, high levels of aldosterone hormone in the blood(primary hyperaldosteronism) or low levels of aldosterone hormonein the blood (hypoaldosteronism)
• if they have valvular heart disease(narrowing of the heart valve) or thickening of the heart muscle(hypertrophic cardiomyopathy)
• if they have or have had psoriasis(a skin disease characterized by red, scaly patches)
• if they are undergoing desensitization treatmentfor insect stings (injections that alleviate allergy symptoms)
• if they are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes
• aliskiren
• if they are taking any of the following medicines, which may increase the risk of angioedema (rapid swelling of the skin, such as the throat):
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent organ rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus)
• wildagliptin, a medicine used to treat diabetes

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the "When not to take Zofenil 30" section.
Zofenil 30 may cause excessive, sudden lowering of blood pressure, especially after the first dose (this risk increases when taking diuretics, in case of dehydration, or when following a low-salt diet). If this happens, the patient should lie down and immediatelycontact their doctor.
In case of surgery, before receiving anesthesia, the anesthesiologistshould be informed about taking Zofenil 30. This will allow for proper control of blood pressure and heart rate during the procedure.
Additionally, in patients with heart attack(acute myocardial infarction) and:

• low blood pressure (<100 mmhg) or shock (due to heart problems) - zofenil 30 is not recommended< li>
• over 75 years old - Zofenil 30 should be used with caution.

The patient should inform their doctor if they suspect or plan to become pregnant. Zofenil 30 is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Children and adolescents

Zofenil 30 should not be given to children and adolescents under 18 years of age, as the safety of the medicine has not been established.

Zofenil 30 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor if they are taking:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; heparin, a medicine used to thin the blood and prevent clots)
• lithium (used to treat mood disorders)
• anesthetics
• opioids (e.g., morphine)
• antipsychotic medicines (used to treat schizophrenia and similar diseases)
• tricyclic antidepressants, e.g., amitriptyline and clomipramine
• barbiturates (used to treat anxiety, insomnia, and seizures)
• other medicines used to treat high blood pressure and vasodilators (including beta-blockers, alpha-blockers, and diuretics, such as hydrochlorothiazide, furosemide, torasemide)
• angiotensin II receptor antagonists (AIIRA) or aliskiren - the doctor may recommend a dose change and/or take other precautions (see also "When not to take Zofenil 30" and "Warnings and precautions")
• glyceryl trinitrate and other nitrates, used to treat chest pain (angina pectoris)
• antacids, including cimetidine (used to treat heartburn and stomach ulcers)
• cyclosporine (used after organ transplantation) and other immunosuppressive medicines (medicines that weaken the body's defense mechanisms)
• allopurinol (used to treat gout)
• insulin or oral antidiabetic medicines
• cytostatic medicines (used to treat cancer or diseases that affect the immune system)
• corticosteroids (strong anti-inflammatory medicines)
• procainamide (used to treat heart rhythm disorders)
• non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin or ibuprofen
• sympathomimetic medicines (medicines that act on the nervous system, including those used to treat asthma and hay fever, as well as amines that increase blood pressure, e.g., adrenaline)
• racecadotril (used to treat diarrhea), medicines used to prevent organ rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus), and wildagliptin (used to treat diabetes). The risk of angioedema may increase.

Zofenil 30 with food, drink, and alcohol

Zofenil 30 can be taken with or without food, preferably with a glass of water.
Alcohol increases the blood pressure-lowering effect of Zofenil 30. For more information on consuming alcohol while taking Zofenil 30, the patient should consult their doctor.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The doctor will usually recommend stopping Zofenil 30 before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Zofenil 30.
Zofenil 30 should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
If the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking this medicine. Zofenil 30 is not recommended for breastfeeding mothers. The doctor may recommend a different medicine during breastfeeding, especially when breastfeeding a newborn or premature baby.

Driving and using machines

The medicine may cause dizziness and fatigue. If these symptoms occur, the patient should not drive or operate machines.

Zofenil 30 contains lactose

The medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Zofenil 30

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor.
Zofenil 30 can be taken with or without food, preferably with a glass of water.
The tablet can be divided into two equal doses.
Treatment of high blood pressure(hypertension)
The usual initial dose of Zofenil 30 is 15 mg, once daily. The doctor will gradually adjust the dose (usually at four-week intervals) to determine the optimal dose for the patient. The long-term antihypertensive effect is usually achieved with a dose of 30 mg of Zofenil 30, once daily. The maximum dose is 60 mg per day, given in a single dose or two divided doses.
In case of dehydration, low salt levels, or diuretic use, it may be necessary to start treatment with a dose of 7.5 mg of Zofenil 7.5.
Liver or kidney disease
In case of mild and moderate liver dysfunction or moderate and severe kidney dysfunction, the doctor will start treatment with half the usual recommended dose (15 mg). If the patient is undergoing dialysis, treatment will start with one-quarter of the usual recommended dose (7.5 mg).
Treatment of heart attack(acute myocardial infarction)
The doctor will start Zofenil 30 within the first 24 hours of symptom onset.
The medicine is given 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, the doctor will increase the dose to 30 mg twice daily.
• The doctor may adjust the dose or maximum dose based on the achieved blood pressure values.
• Treatment is continued for the next six weeks or longer, if symptoms of heart failure persist.

Taking a higher dose of Zofenil 30 than recommended

In case of accidental ingestion of too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital (taking any remaining tablets, packaging, or leaflet - if possible).
The most common subjective and objective symptoms of overdose are excessively low blood pressure combined with fainting (hypotension), very slow heart rate (bradycardia), biochemical changes in the blood (electrolyte disturbances), and kidney problems.

Missing a dose of Zofenil 30

If a dose is missed, the patient should take the next dose as soon as they remember.
However, if the delay is long (e.g., several hours) and the next dose is soon due, the patient should wait and take the next scheduled dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Zofenil 30

Before stopping the medicine, the patient should consult their doctor, whether they are taking Zofenil 30 for high blood pressure or after a heart attack.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zofenil 30 can cause side effects, although not everybody gets them.
Side effects related to ACE inhibitors are usually temporary and disappear after treatment is stopped.
Common side effects(may occur in less than 1 in 10 patients):

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

Uncommon side effects(may occur in less than 1 in 100 patients):

• general weakness
• muscle cramps
• skin rash.

Rare side effects(may occur in less than 1 in 1000 patients):

• sudden swelling and itching, especially in the face, mouth, and throat, which may be accompanied by difficulty breathing.
• fainting (brief loss of consciousness)
• rapid or irregular heartbeat (palpitations)
• low blood pressure
• hives (small skin rash)
• itching
• high potassium levels in the blood

In addition to the side effects of Zofenil 30, the following side effects are typical of ACE inhibitors:

• Significant lowering of blood pressure at the start of treatment or after dose increase, with accompanying dizziness, vision disturbances.
• Increased or irregular heart rate and chest pain (heart attack or angina pectoris).
• Changes in consciousness, sudden dizziness, sudden vision disturbances, or feelings of weakness and/or loss of touch on one side of the body (transient ischemic attack or stroke).
• Peripheral edema (fluid accumulation in the limbs), chest pain, pain and/or muscle cramps.
• Kidney problems, changes in daily urine output, presence of proteins in the urine (proteinuria), impotence.
• Abdominal pain, diarrhea, constipation, dryness of the mucous membranes in the mouth.
• Allergic reactions, e.g., skin rash, peeling skin, redness, loosening of skin layers, and blistering (toxic epidermal necrolysis), exacerbation of psoriasis (a skin disease characterized by red, scaly patches), hair loss (alopecia).
• Excessive sweating and sudden flushing (especially of the face).
• Mood changes, depression, sleep disturbances, unusual skin sensations, e.g., burning, prickling, or tingling (paresthesia), balance problems, disorientation, ringing in the ears (tinnitus), taste disturbances, blurred vision.
• Breathing difficulties, bronchospasm, sinusitis, runny or blocked nose (rhinitis), tongue inflammation, bronchitis.
• Jaundice (yellowing of the skin), liver or pancreas inflammation.
• Changes in blood test results, e.g., red blood cell count, white blood cell count, or platelet count, or a decrease in all types of blood cells (pancytopenia). If the patient experiences bruising, sore throat, or fever without a known cause, they should contact their doctor.
• Increased liver enzyme activity (aminotransferase) and bilirubin levels in the blood, increased urea and creatinine levels in the blood
• Anemia due to red blood cell breakdown (hemolytic anemia), which may occur in people with a deficiency of G6PD (glucose-6-phosphate dehydrogenase).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Zofenil 30

Store in a place out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging and blister after the 'EXP' abbreviation. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zofenil 30 contains

The active substance of the medicine is zofenopril calcium 30 mg.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica. Coating: hypromellose, titanium dioxide (E171), macrogol 400, and macrogol 6000 (see section 2. 'Zofenil 30 contains lactose').)

What Zofenil 30 looks like and contents of the pack

Zofenil 30 is a white, oval, film-coated tablet, available in packs of 28 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
Manufacturer

• A. Menarini Manufacturing Logistics and Services S.r.l. Campo di Pile 67100 L'Aquila

Italy
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13

• 01097 – Dresden Germany

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01
Date of last revision of the leaflet:12/2024