Zofenil 30

Package leaflet: Information for the patient

Zofenil 30
30 mg, film-coated tablets
( Zofenoprilum calcicum )
Please read carefully the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 package 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, known as angiotensin-converting enzyme (ACE) inhibitors.
Zofenil 30 is used to treat the following conditions:

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

2. Important information before using Zofenil 30

When not to use Zofenil 30:

• If the patient is allergic to calcium zofenopril or any of the other ingredients of this medicine (listed in section 6)
• if the patient has previously experienced an allergic reaction to any other ACE inhibitor, such as captopril or enalapril
• if the patient has previously had swelling and itching of the face, nose, and throat (angioedema) related to treatment with ACE inhibitors, or if the patient has 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 certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases
• in case of severe liver function disorders
• in case of renal artery stenosis
• after the third month of pregnancy (Zofenil 30 should also be avoided during early pregnancy – see section "Pregnancy and breastfeeding")
• in women of childbearing age who are not using an effective method of 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 30, discuss this with your doctor.
Inform your doctor:

• if the patient has hypertension and liver or kidney disease
• if hypertension is caused by kidney disease or narrowing of the artery supplying blood to the kidney (renovascular hypertension)
• if the patient has recently received a kidney transplant
• if the patient is undergoing dialysis
• if the patient is undergoing LDL apheresis (a procedure similar to dialysis that removes harmful cholesterol from the blood)
• if the patient has abnormal, excessively high levels of the hormone aldosterone in the blood (primary hyperaldosteronism) or reduced levels of the hormone aldosterone in the blood (hypoaldosteronism)
• if the patient has aortic valve stenosis or thickening of the heart walls (hypertrophic cardiomyopathy)
• if the patient has or has had psoriasis (a skin condition characterized by red, scaly patches)
• if the patient is undergoing allergen immunotherapy (injections to reduce allergy symptoms) for insect venom
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney disorders related to diabetes
  • aliskiren
• if the patient is taking any of the following medicines, the risk of developing angioedema (rapid swelling of the skin in areas such as the throat) may increase:
  • racecadotril, a medicine used to treat diarrhoea
  • medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus)
  • vildagliptin, a medicine used to treat diabetes

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Zofenil 30".
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 occurs, lie down on your back and contact your doctor immediately.
In the case of surgery, before receiving anaesthesia, inform the anaesthesiologist that you are taking Zofenil 30. This will allow appropriate monitoring of the patient's blood pressure and heart rate during the procedure.
Additionally, in patients with heart attack (acute myocardial infarction) and:

• low blood pressure (< 100 mmHg) or circulatory shock (due to heart disorders) – Zofenil 30 is not recommended
• aged over 75 years – Zofenil 30 should be used with particular caution.

Inform your doctor if you suspect (or are planning) pregnancy. Use of Zofenil 30 is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as the safety of use has not been established.
Zofenil 30 and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is 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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• lithium (used to treat mood disorders)
• anaesthetics
• opioids (e.g. morphine)
• antipsychotics (used to treat schizophrenia and similar disorders)
• tricyclic antidepressants, such as amitriptyline and clomipramine
• barbiturates (used to treat anxiety disorders, insomnia, and epileptic seizures)
• other medicines used to treat hypertension and blood vessel dilators (including beta-blockers, alpha-blockers, and diuretics such as hydrochlorothiazide, furosemide, torasemide)
• angiotensin II receptor antagonists (AIIRAs) or aliskiren – your doctor may recommend adjusting the dose and/or taking additional precautions (see also sections "When not to use Zofenil 30" and "Warnings and precautions")
• glyceryl trinitrate and other nitrates, used for chest pain (angina pectoris)
• acid-neutralizing medicines, including cimetidine (used to treat heartburn and peptic ulcer disease)
• cyclosporine (used after organ transplantation) and other immunosuppressive medicines (medicines that suppress the body's immune defenses)
• allopurinol (used to treat gout)
• insulin or oral antidiabetic medicines
• cytostatic medicines (used to treat cancer or diseases affecting the immune system)
• corticosteroids (potent anti-inflammatory medicines)
• procainamide (used for heart rhythm disorders)
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen
• sympathomimetic medicines (medicines acting on the nervous system, including those used to treat asthma and hay fever, and amines that increase blood pressure, e.g. adrenaline)
• racecadotril (used to treat diarrhoea), medicines used to prevent rejection of transplanted organs and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus), and vildagliptin (used to treat diabetes). The risk of angioedema may increase.

Zofenil 30 with food, drink, and alcohol
Zofenil 30 can be taken during or before a meal, preferably with a glass of water.
Alcohol intensifies the blood pressure-lowering (hypotensive) effect of Zofenil 30. For detailed information on alcohol consumption while taking this medicine, consult your doctor.
Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. The doctor will usually recommend discontinuing Zofenil 30 before planned pregnancy or immediately after pregnancy is confirmed, and will recommend taking another medicine instead of Zofenil 30.
Use of Zofenil 30 is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using this medicine. Use of Zofenil 30 is not recommended in breastfeeding mothers. The doctor may recommend using another medicine during breastfeeding, especially if breastfeeding a newborn or premature infant.
Driving and operating machinery
This medicine may cause dizziness and fatigue. If these symptoms occur, do not drive or operate machinery.
Zofenil 30 contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Zofenil 30

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor.

Zofenil 30 may be taken during or before a meal, preferably with a glass of water.
The tablet may be divided into two equal doses.

Treatment of high blood pressure (hypertension)
The usual starting dose of Zofenil 30 is 15 mg once daily. Your doctor will gradually adjust the dose (usually at four-week intervals) to determine the optimal dose for you. Long-term antihypertensive effect is usually achieved with a daily dose of 30 mg of Zofenil 30, taken once daily. The maximum dose is 60 mg per day, administered as a single dose or in two divided doses.

In cases of dehydration, salt depletion, or concomitant use of diuretics, treatment may need to be initiated with a dose of 7.5 mg of Zofenil 7.5.

Liver or kidney disorders
In patients with mild or moderate liver dysfunction or moderate to severe kidney dysfunction, your doctor will initiate treatment with half the usual recommended dose (15 mg). If the patient is undergoing dialysis, treatment will be started with one-quarter of the usual recommended dose (7.5 mg).

Treatment of heart attack (acute myocardial infarction)
Your doctor will initiate treatment with Zofenil 30 within the first 24 hours after the onset of symptoms. The medicine is administered twice daily, in the morning and evening, as follows:

• 7.5 mg twice daily – on days 1 and 2 of treatment,
• 15 mg twice daily – on days 3 and 4 of treatment,
• from day 5 onwards, your doctor will increase the dose to 30 mg twice daily.

Your doctor may adjust the dose or maximum dose depending on the achieved blood pressure values.
Treatment is continued for the next six weeks or longer if symptoms of heart failure persist.

Taking more Zofenil 30 than prescribed
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department (bring any remaining tablets, the packaging, or the leaflet with you, if possible).

The most common symptoms of subjective and objective overdose include excessively low blood pressure associated with fainting (hypotension), very slow heart rate (bradycardia), biochemical blood changes (electrolyte disturbances), and impaired kidney function.

If you miss a dose of Zofenil 30
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 it is almost time for your next scheduled dose, wait and take the next recommended dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Zofenil 30
You must consult your doctor before discontinuing Zofenil 30, whether it is being taken for hypertension or after a heart attack.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Zofenil 30 can cause adverse effects, although not everyone experiences them.
Adverse effects associated with ACE inhibitors are mostly transient and
subside after discontinuation of treatment.

Common adverse effects (may occur in fewer than 1 in 10 patients):

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

Uncommon adverse effects (may occur in fewer than 1 in 100 patients):

• general weakness
• muscle cramps
• skin rash

Rare adverse effects (may occur in fewer than 1 in 1000 patients):

• sudden swelling and itching, especially around the face, mouth, and throat, which may be accompanied by breathing difficulties
• fainting (short-term loss of consciousness)
• rapid heartbeat, which may be fast or irregular (palpitations)
• low blood pressure
• urticaria (small rash)
• itching
• increased blood potassium levels

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

• Significant drop in blood pressure at the beginning of treatment or after dose increase, accompanied by dizziness and vision disturbances.
• Accelerated or irregular heart activity and chest pain (heart attack or angina pectoris).
• Disturbances of consciousness, sudden dizziness, sudden vision disturbances, or feeling of weakness and/or loss of touch sensation on one side of the body (transient ischaemic attack or stroke).
• Peripheral oedema (fluid accumulation in limbs), chest pain, muscle pain and/or cramps.
• Kidney function disorders, changes in daily urine volume, presence of protein in urine (proteinuria), impotence.
• Abdominal pain, diarrhoea, constipation, dryness of oral mucosa.
• Allergic reactions, e.g. rash, skin peeling, redness, loosening of skin layers and formation of blisters on the skin (toxic epidermal necrolysis), exacerbation of psoriasis (a skin disease characterized by pink, scaly patches), hair loss (alopecia).
• Excessive sweating and sudden flushing (especially of the face).
• Mood changes, depression, sleep disorders, unusual skin sensations such as burning, pricking or tingling (paraesthesia), balance disorders, disorientation, ringing in the ears (tinnitus), taste disturbances, blurred vision.
• Breathing difficulties, narrowing of airways in the lungs (bronchospasm), sinusitis, nasal discharge or nasal congestion (rhinitis), glossitis, bronchitis.
• Yellowing of the skin (jaundice), inflammation of the liver or pancreas, intestinal obstruction.
• Changes in blood test results, e.g. in the number of red blood cells, white blood cells or platelets, or decreased number of all types of blood cells (pancytopenia). If bruising easily, sore throat, or fever of unknown cause occur, consult a doctor.
• Increased liver enzyme activity (aminotransferases) and increased blood bilirubin levels, increased blood urea and creatinine levels
• Anaemia due to destruction of red blood cells (haemolytic anaemia), which may occur in patients with G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in
this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Zofenil 30

Keep the medicine out of the sight and reach of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation
'EXP'. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zofenil 30 contains
The active substance is calcium salt of zofenopril 30 mg.
Other ingredients are: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose,
magnesium stearate, colloidal anhydrous silica. Coating: hypromellose, titanium dioxide (E171), polyethylene glycol
400 and polyethylene glycol 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 containing 28 and 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (22) 566 21 00
Fax: (22) 566 21 01