Zofenil 7,5

Leaflet attached to the packaging: patient information

Zofenil 7.5

7.5 mg, film-coated tablets
(Zofenopril calcium)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Zofenil 7.5 and what is it used for
• 2. Important information before taking Zofenil 7.5
• 3. How to take Zofenil 7.5
• 4. Possible side effects
• 5. How to store Zofenil 7.5
• 6. Contents of the packaging and other information

1. What is Zofenil 7.5 and what is it used for

Zofenil 7.5 contains 7.5 mg of zofenopril calcium, which belongs to a group of blood pressure-lowering medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Zofenil 7.5 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 7.5

When not to take Zofenil 7.5:

• 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 angioedema (swelling and itching of the face, lips, tongue, and/or throat) in the past, associated with 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/valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema increases
• in case of severe liver function disorders
• in case of narrowing of the renal arteries
• after the third month of pregnancy (it is also recommended to avoid taking Zofenil 7.5 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 function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Zofenil 7.5, discuss it with your doctor.
Tell your doctor:

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

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When not to take Zofenil 7.5".
Zofenil 7.5 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, lie down and immediatelycontact your doctor.
In case of surgery, before receiving anesthesia, inform the anesthesiologistthat you are taking Zofenil 7.5. 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 in cardiogenic shock (due to heart disorders) - zofenil 7.5 is not recommended< li>
• over 75 years old - Zofenil 7.5 should be used with caution.

Tell your doctor if you suspect or plan to become pregnant. Zofenil 7.5 is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").

Children and adolescents

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

Zofenil 7.5 and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you 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 transplant rejection, and 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, such as 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, and torasemide)
• angiotensin II receptor antagonists (AIIRA) or aliskiren - your doctor may recommend a dose change or other precautions (see also the sections "When not to take Zofenil 7.5" 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 affect 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 transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus), and wildagliptin (used to treat diabetes). The risk of angioedema may increase.

  Zofenil 7.5 with food, drink, and alcohol

  Zofenil 7.5 can be taken with or without food, preferably with a glass of water.
  Alcohol enhances the blood pressure-lowering effect of Zofenil 7.5. For more information on consuming alcohol while taking this medicine, consult your doctor.

  Pregnancy and breastfeeding

  Pregnancy
  If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine. Your doctor will usually recommend stopping Zofenil 7.5 before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Zofenil 7.5.
  Zofenil 7.5 is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby.
  Breastfeeding
  If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine. Zofenil 7.5 is not recommended for breastfeeding mothers. Your doctor may recommend a different medicine while breastfeeding, especially if you are breastfeeding a newborn or premature baby.

  Driving and using machines

  The medicine may cause dizziness and fatigue. If you experience these symptoms, do not drive or operate machinery.

  Zofenil 7.5 contains lactose

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

  3. How to take Zofenil 7.5

  Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
  Zofenil 7.5 can be taken with or without food, preferably with a glass of water.
  Treatment of high blood pressure(hypertension)
  The usual initial dose of Zofenil 7.5 is 15 mg, once daily. Your doctor will gradually adjust the dose (usually at 4-week intervals) to determine the optimal dose for you. The long-term antihypertensive effect is usually achieved with a dose of 30 mg of Zofenil 7.5, 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 to moderate liver function disorders or moderate to severe kidney function disorders, your doctor will start treatment with half the usual recommended dose (15 mg). If you are undergoing dialysis, treatment will start with one-quarter of the usual recommended dose (7.5 mg).
  Treatment of heart attack(acute myocardial infarction)
  Your doctor will start Zofenil 7.5 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, your doctor will increase the dose to 30 mg twice daily.
  • Your 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 7.5 than recommended

  If you have accidentally taken too many tablets, contact your doctor or go to the emergency department of the nearest hospital (taking any remaining tablets, packaging, or leaflet - if possible).
  The most common symptoms of overdose are excessively low blood pressure with fainting (hypotension), very slow heart rate (bradycardia), blood biochemical changes (electrolyte disturbances), and kidney function disorders.

  Missing a dose of Zofenil 7.5

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

  Stopping treatment with Zofenil 7.5

  Before stopping the medicine, consult your doctor, whether you are taking Zofenil 7.5 for high blood pressure or after a heart attack.
  If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Zofenil 7.5 can cause side effects, although not everybody gets them.
  Side effects associated with 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 1,000 patients):

  • sudden swelling and itching, especially of the face, mouth, and throat, which may be accompanied by difficulty breathing.
  • fainting (short-term 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 7.5, 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 function disorders, 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, such as 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, tingling, or numbness), balance disorders, disorientation, ringing in the ears (tinnitus), taste disturbances, blurred vision.
  • Breathing difficulties, bronchospasm, sinusitis, runny or stuffy nose (rhinitis), inflammation of the tongue, bronchitis.
  • Jaundice (yellowing of the skin), liver or pancreas inflammation.
  • Changes in blood test results, such as red blood cell count, white blood cell count, or platelet count, or a decrease in all types of blood cells (pancytopenia). If you experience bruising, sore throat, or fever without a known cause, contact your 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 G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency).

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

  5. How to store Zofenil 7.5

  Keep out of the 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.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Zofenil 7.5 contains

  The active substance of the medicine is zofenopril calcium 7.5 mg.
  The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica. Coating: hypromellose, titanium dioxide (E171), macrogol 400, and macrogol 6000 (see section 2 "Zofenil 7.5 contains lactose").

  What Zofenil 7.5 looks like and contents of the pack

  Zofenil 7.5 is a white, round, flat, film-coated tablet, available in packs of 7, 14, and 28 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

  For more information, 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