Zofenopril Mylan Generics: detailed information

Package Leaflet: Information for the Patient

Zofenopril Mylan Generics 30 mg Film-coated Tablets

zofenopril calcium
Generic medicine
Read this entire 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 other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Zofenopril Mylan Generics is and what it is used for
What you need to know before taking Zofenopril Mylan Generics
How to take Zofenopril Mylan Generics
Possible side effects
How to store Zofenopril Mylan Generics
Contents of the pack and other information

1. What Zofenopril Mylan Generics is and what it is used for

Zofenopril Mylan Generics contains zofenopril, which belongs to a group of medicines
known as ACE inhibitors (angiotensin-converting enzyme inhibitors). Zofenopril
works by widening your blood vessels. This helps lower your blood pressure,
making it easier for your heart to pump blood around the body.
Zofenopril Mylan Generics can be used

To treat high blood pressure – also known as hypertension.
After a heart attack (acute myocardial infarction) in people with or without signs and symptoms of heart failure and who are not undergoing treatment to dissolve blood clots (thrombolytic therapy).

2. What you need to know before taking Zofenopril Mylan Generics

Do not take Zofenopril Mylan Generics:

if you are allergic to zofenopril or to any of the other ingredients of this medicine (listed in section 6)
if you have previously had an allergic reaction to other ACE inhibitors, such as captopril or enalapril
if you have previously experienced severe swelling of the face, tongue, and throat (angioedema) associated with prior treatment with ACE inhibitors, or if you have ever had these symptoms for no known reason (hereditary/idiopathic angioedema)
if you are more than 3 months pregnant (it is best to avoid taking Zofenopril Mylan Generics in early pregnancy – see section Pregnancy and breastfeeding)
if you are a woman of childbearing age, unless you are using an effective method of contraception
if you suffer from narrowing of the blood vessels (arteries) to both kidneys (or to the only kidney if you have just one)
if you suffer from severe liver impairment
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
if 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, for example in the throat)

Warnings and precautions
Talk to your doctor or pharmacist before taking Zofenopril Mylan Generics if:

you have diabetes
you suffer from psoriasis
you have liver problems
you have been advised to limit salt intake, or have had severe diarrhoea or nausea, because zofenopril may cause excessive lowering of blood pressure
you have low levels of fluids and salts in your body due to diuretic treatment
you have kidney problems, including narrowing of the blood vessels (arteries) to a kidney (renal artery stenosis), or have recently undergone a kidney transplant. Your doctor may consider it necessary to reduce the dose.
you are receiving treatment to reduce the effects of an allergy to insect stings, undergoing dialysis, or receiving treatment to remove cholesterol from your blood via a machine (LDL cholesterol apheresis), as there is a risk of developing an allergic reaction to zofenopril
you are taking potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium, because zofenopril may lead to significant increases in blood potassium levels
you suffer from low blood pressure, as zofenopril may cause a further drop in blood pressure
you suffer from heart failure (weakening of the heart muscle), have thickening of the heart walls causing obstruction of blood flow from the left side of the heart (hypertrophic cardiomyopathy), or narrowing of a heart valve (aortic or mitral stenosis)
you have reduced blood flow to the heart (angina) or brain, or have had a stroke or mini-stroke (also known as transient ischaemic attack, TIA)
you suffer from a collagen vascular disease, for example scleroderma or systemic lupus erythematosus (or lupus, an autoimmune condition causing joint pain, skin rash, and fever)
you have abnormally high levels of aldosterone in the blood (primary hyperaldosteronism)
you are over 75 years of age; zofenopril should be used with caution
you are of Black origin. You may be at higher risk of angioedema, or this medicine may be less effective compared to non-Black patients.
you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is increased:
racecadotril, a medicine used to treat diarrhoea
medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus)
vildagliptin, a medicine used to treat diabetes.
you are taking any of the following medicines used to treat high blood pressure:
an “angiotensin II receptor antagonist” (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
aliskiren

Your doctor may monitor 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 Zofenopril Mylan Generics”.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Zofenopril is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy and breastfeeding).

During treatment

Inform your doctor, dentist, or hospital staff that you are taking this medicine if you are due to receive anaesthesia (for a surgical procedure). This will help the anaesthetist monitor your blood pressure and heart rate during the operation.
Inform your doctor if, while taking this medicine, you develop a dry cough, as alternative treatment may be needed.

Other medicines and Zofenopril Mylan Generics
Inform your doctor or pharmacist 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; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting). Racecadotril (a medicine used to treat diarrhoea), medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus), and vildagliptin (a medicine used to treat diabetes). The risk of angioedema may be increased.
medicines used to increase fluid elimination through urine (diuretics) such as spironolactone, triamterene, or amiloride are not recommended because they may increase blood potassium levels. Other types of diuretics may also cause excessive lowering of blood pressure.
lithium (for certain types of mental illness), because zofenopril may increase lithium levels in the blood
medicines for severe mental illness (psychosis), barbiturates (usually used for epilepsy), anaesthetics, or narcotics (e.g. strong painkillers), because taking these together with zofenopril may cause a drop in blood pressure
other medicines for high blood pressure, including calcium channel blockers, beta-blockers, and α-blockers; when taken with zofenopril, they may cause excessive lowering of blood pressure
cimetidine may increase the risk of low blood pressure
allopurinol (used to treat gout and kidney stones), procainamide (used to treat heart rhythm problems), corticosteroids, and immunosuppressive medicines may increase the risk of low white blood cell counts
ciclosporin (used to suppress the immune system), because there is a risk of kidney problems when taken with zofenopril
non-steroidal anti-inflammatory drugs (NSAIDs) (for pain or inflammation) may reduce the effectiveness of zofenopril
oral medicines for diabetes or insulin, because zofenopril may cause a decrease in blood sugar levels when taken with these medicines
antacids (used to treat heartburn and stomach ulcers), because they reduce the effectiveness of zofenopril
medicines affecting the nervous system (known as sympathomimetics) may reduce the effectiveness of zofenopril. Your doctor will advise you if this applies to you.
glyceryl trinitrate and other nitrates (used to relieve chest pain (angina) or improve blood flow)
cytostatic agents (used in cancer treatment)
tricyclic antidepressants (usually used for depression)
gold salt injections for the treatment of arthritis, because they may lower blood pressure.

Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the sections “Do not take Zofenopril Mylan Generics” and “Warnings and precautions”).

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking zofenopril before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Zofenopril Mylan Generics. Zofenopril is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Zofenopril is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
When driving or operating machinery, bear in mind that drowsiness, dizziness, or fatigue may occasionally occur.

3. How to take Zofenopril Mylan Generics

Dosage
Always take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablets should be swallowed whole, or split in half, with a glass of water. They may be taken
before, during, or after meals.
Your doctor or pharmacist will tell you how often and for how long you should take this medicine.

Adults with high blood pressure (hypertension)
The recommended starting dose is 15 mg once daily (half a tablet).
Your doctor may increase the dose until the appropriate dose for you is found. The usual effective dose is
30 mg once daily. The maximum dose is 60 mg once daily.

Adults with high blood pressure associated with hypovolemia or salt depletion
With the first dose of zofenopril, an excessive drop in blood pressure may occur. If this applies to you, consult your doctor or pharmacist. If you are taking diuretics, you will need to stop taking them for two or three days before starting zofenopril. The recommended starting dose is 15 mg once daily, but your doctor may start you on 7.5 mg once daily if this is considered more suitable for you. With this product, not all recommended doses may be available.

Adults with high blood pressure and liver problems
If you have mild to moderate liver problems, your doctor will adjust the dose of zofenopril based on your liver function response.

Adults with high blood pressure and kidney problems
If you have kidney problems, your doctor will adjust the zofenopril dosage based on your kidney function response.

Elderly
The dose depends on your kidney function. Your doctor will prescribe the appropriate dose of Zofenopril Mylan Generics for you.

Adults after a heart attack
It is recommended to start taking this medicine within 24 hours after a heart attack and to continue treatment for at least 6 weeks.
The recommended starting dose is 7.5 mg twice daily (every 12 hours). On the third day, the dose may be increased to 15 mg twice daily (every 12 hours). From the fifth day, the dose may be increased to 30 mg twice daily (every 12 hours). With this product, not all recommended doses may be available.

Use in children and adolescents
Zofenopril Mylan Generics is not recommended for use in children.

If you take more Zofenopril Mylan Generics than you should
Contact your doctor immediately or go to the nearest hospital emergency department. Bring the pack and any remaining tablets with you. Signs and symptoms of overdose include: sudden drop in blood pressure, shock, stupor, abnormally slow heart rate, electrolyte disturbances, and kidney failure.

If you forget to take Zofenopril Mylan Generics
If you miss a dose, do not worry. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Zofenopril Mylan Generics
If you stop treatment with Zofenopril Mylan Generics, you may experience adverse effects. If you wish to stop taking this medicine, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, contact your doctor immediately
or go to the Emergency Department of the nearest hospital. It is important to inform
healthcare professionals that you are taking this medicine:
Rare (may affect up to 1 in 1,000 people)

Severe allergic reaction causing swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties

Very rare (may affect up to 1 in 10,000 people)

Swelling of the intestine, which may cause stomach pain that can become severe

Not known (frequency cannot be estimated from available data)

Severe skin reaction, which may cause blisters on the skin, mouth, eyes and genitals, or a more severe form leading to extensive skin damage (separation of the top layer of skin from the lower layer) and flu-like symptoms (fever, muscle pain, joint pain and changes in blood cells, which may be detected by blood tests)
Severe reduction in blood cells, which may lead to weakness, bruising or bleeding, or make you more susceptible to infections. This may be detected by blood tests.
Fever associated with a severely compromised general state of health, or fever with signs of local infection such as sore throat/mouth ulcers or difficulty urinating (agranulocytosis)
Irregular heartbeat or chest pain, particularly at rest, which may be a sign of reduced blood flow to the heart (angina pectoris)
Heart attack. You may feel sweaty, short of breath, or have severe chest pain and pain radiating to the jaw and arms. This may occur if blood pressure is very low.
Inflammation of the pancreas causing severe abdominal and back pain
Absence of bowel movements, which may cause bloating, stomach pain, feeling unwell/nausea and vomiting, and no passing of gas or stools
Yellowing of the skin or whites of the eyes, which may be caused by blockage of the bile duct or inflammation of the liver. You may also have dark urine, pale stools or fever.
Stroke, which may be caused by bleeding in the brain. You may experience speech disturbances, sudden weakness or numbness on one side of the face or body, vision problems or a sudden, severe headache.

Other side effects reported with this medicine:
Common (may affect up to 1 in 10 people)

Unusual tiredness
Feeling unwell
Dizziness
Headache
Cough. This medicine may cause a persistent dry cough (without mucus production). If this occurs, consult your doctor, as you may need an alternative medicine.

Uncommon (may affect up to 1 in 100 people)

Rash
Weakness, muscle cramps

The following side effects have been reported with other ACE inhibitors and therefore may also occur while taking this medicine.
Rare (may affect up to 1 in 1,000 people)

Muscle pain
Shortness of breath, bronchitis
Swollen and inflamed sinuses causing pain, high temperature and tenderness
Runny nose and itching
Swollen and painful tongue
Abdominal pain
Diarrhoea
Constipation
Dry mouth
Depression
Mood changes
Sleep disturbances
Impotence
Confusion
Ringing in the ears
Increased sweating
Flushing
Difficulty urinating
Vision disturbances
Fainting (syncope)
Strong heartbeat, which may be rapid or irregular (palpitations)
Hypotension
Hives
Itching
Increased levels of potassium in the blood.

Very rare (may affect up to 1 in 10,000 people)

Chest pain
Swelling of the hands, ankles or feet
Low blood sugar levels

Not known (frequency cannot be estimated from available data)

Reduction in red blood cells, which may make the skin pale or yellow and cause weakness or shortness of breath. This occurs more frequently in people with another medical condition (known as glucose-6-phosphate dehydrogenase deficiency).
Severe kidney problems. You may experience lower back pain, reduced or absent urine output, or cloudy urine with blood traces.
Tingling sensations like pins and needles
Balance problems
Taste disturbances
A skin reaction similar to psoriasis or a rash with raised red spots similar to measles
Hair loss
Changes in blood cell counts and liver function tests, which may be detected by blood tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Zofenopril Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, carton, label or bottle after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Zofenopril Mylan Generics supplied in bottles must not be used more than 30 days after first opening the bottle.
Do not use this medicine if you notice that the tablets have discoloured.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zofenopril Mylan Generics contains
The active substance is zofenopril calcium. Each tablet contains 30 mg of zofenopril calcium.
The other components are microcrystalline cellulose, pregelatinized starch (corn), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400 and polysorbate 80.

Description of the appearance of Zofenopril Mylan Generics and package contents
The film-coated tablets of Zofenopril Mylan Generics 30 mg are white, film-coated, capsule-shaped tablets marked with “ZP line score 1” on one side and “M” on the other side.
The tablet can be divided into two equal doses.
Zofenopril Mylan Generics is available in plastic bottles containing 500 tablets (hospital pack) or in blisters containing 7, 12, 14, 28, 30, 56, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
France ZOFENOPRIL VIATRIS 30 mg, comprimé pelliculé sécable
Italy Zofenopril Mylan Generics
Netherlands Zofenoprilcalcium Viatris 30 mg, filmomhulde tabletten
Portugal Zofenopril Mylan