ZOFENOPRIL DOC GENERICI

Package leaflet: Information for the user

ZOFENOPRIL DOC Generici 30 mg film-coated tablets

Equivalent medicine
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 only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ZOFENOPRIL DOC Generici is and what it is used for
2. What you need to know before taking ZOFENOPRIL DOC Generici
3. How to take ZOFENOPRIL DOC Generici
4. Possible side effects
5. How to store ZOFENOPRIL DOC Generici
6. Contents of the pack and other information

1. What ZOFENOPRIL DOC Generici is and what it is used for

ZOFENOPRIL DOC Generici belongs to a class of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors). ZOFENOPRIL DOC Generici works by widening your blood vessels. This helps lower your blood pressure. It also makes it easier for your heart to pump blood around the body.

ZOFENOPRIL DOC Generici can be used to treat

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

2. What you should know before taking ZOFENOPRIL DOC Generici

Do not take ZOFENOPRIL DOC Generici

• if you are allergic (hypersensitive) 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, or throat (angioedema) associated with prior therapy with ACE inhibitors, or if you have ever had these symptoms without a known cause (idiopathic/heritable angioedema);
• if you are more than 3 months pregnant (it is best to avoid taking ZOFENOPRIL DOC Generici during early pregnancy – see also section Pregnancy and breastfeeding);
• if you have renal artery stenosis (narrowing of the arteries supplying the kidneys);
• 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZOFENOPRIL DOC Generici

• if you have diabetes;
• if you suffer from psoriasis;
• if you have liver problems;
• if you have been advised to restrict salt intake, if you are undergoing renal dialysis, or have had severe diarrhoea or nausea, because ZOFENOPRIL DOC Generici may cause a drop in blood pressure;
• if you have kidney problems, including narrowing of the blood vessels in the kidneys (renal artery stenosis), or have recently undergone a kidney transplant. Your doctor may consider it necessary to reduce the dose;
• if you have ever had "angioedema" or "angioneurotic edema" after taking other medicines. Signs include itching, red spots on hands, feet, and throat, swelling around the eyes and lips, and difficulty breathing;
• if you are undergoing treatment to reduce the effects of an allergy to insect stings, are on dialysis, or your blood is being treated with a machine that lowers cholesterol levels (LDL apheresis), as you may be at risk of an allergic reaction to ZOFENOPRIL DOC Generici;
• if you are taking potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes, because ZOFENOPRIL DOC Generici may lead to significant increases in blood potassium levels;
• if you have low blood pressure, as ZOFENOPRIL DOC Generici may cause a further drop in blood pressure;
• if you have thickening of the heart walls leading to obstruction of blood flow from the left ventricle of the heart (hypertrophic cardiomyopathy) or narrowing of a heart valve (aortic or mitral stenosis);
• if you have abnormally high levels of the hormone aldosterone in your blood (primary aldosteronism);
• if you are over 75 years of age; ZOFENOPRIL DOC Generici should be used with caution;
• if you are due to undergo anaesthesia (for surgery), inform your doctor. This will help the anaesthetist manage your blood pressure and heart rhythm during the procedure;
• you must inform your doctor if you think you may be 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 child if taken during this period (see section Pregnancy and breastfeeding);
• if you are taking any of the following medicines for high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren (see also Other medicines and ZOFENOPRIL DOC Generici below);
• 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);
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• Racecadotril, a medicine used to treat diarrhoea;
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take ZOFENOPRIL DOC Generici”.

• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). ZOFENOPRIL DOC Generici 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 child if taken during this period (see also section Pregnancy and breastfeeding in section 2).

Other medicines and ZOFENOPRIL DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, or the following:

• Potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, or amiloride), and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
• lithium (used for certain mental disorders), because ZOFENOPRIL DOC Generici may increase lithium levels in the blood;
• medicines for severe mental disorders (psychosis), anaesthetics, or narcotics, because taking these together with ZOFENOPRIL DOC Generici may cause low blood pressure;
• other medicines for low blood pressure, including diuretics, beta-blockers, and α-blockers; when taken with ZOFENOPRIL DOC Generici, they may cause low blood pressure;
• cimetidine may increase the risk of low blood pressure;
• allopurinol (used to treat gout and kidney stones), procainamide (used to treat irregular heartbeat), corticosteroids, and immunosuppressive medicines may increase the risk of low white blood cell counts;
• ciclosporin, because it increases the risk of kidney problems when taken with ZOFENOPRIL DOC Generici;
• non-steroidal anti-inflammatory drugs (NSAIDs) (for pain or inflammation), which may reduce the effectiveness of ZOFENOPRIL DOC Generici;
• medicines for diabetes, such as insulin, because ZOFENOPRIL DOC Generici 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), as these may reduce the effectiveness of ZOFENOPRIL DOC Generici. Your doctor will advise you if this applies;
• certain types of haemodialysis, as there is a risk of an allergic reaction. Your doctor will inform you if you are at risk;
• nitroglycerin and other nitrates;
• cytostatic agents;
• tricyclic antidepressants;
• gold injections for the treatment of arthritis, as 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 DOC Generici" and "Warnings and precautions").

ZOFENOPRIL DOC Generici with food, drinks, and alcohol
ZOFENOPRIL DOC Generici 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 ZOFENOPRIL DOC Generici (causing a drop in blood pressure); consult your doctor for further advice on alcohol consumption while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will usually advise you to stop taking ZOFENOPRIL DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. ZOFENOPRIL DOC Generici is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breastfeeding or planning to breastfeed. ZOFENOPRIL DOC Generici is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Occasionally, this medicine may cause dizziness, drowsiness, or fatigue. If this occurs, do not drive or operate machinery.

ZOFENOPRIL DOC Generici contains:

• lactose If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
• sodium This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ZOFENOPRIL DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole, or split in half, with a glass of water. You may take them before,
during, or after meals. The tablet may be divided into equal doses.
Recommended dose:
Adults with high blood pressure (hypertension)
Treatment usually starts at 15 mg daily. Your doctor may increase the dose until the appropriate dose for you is found. The usual effective dose is 30 mg daily. The maximum dose is 60 mg daily, to be taken as a single dose or in two separate doses.
Hypertensive adults with hypovolemia or salt depletion
Episodes of hypotension may occur with the first dose of ZOFENOPRIL DOC Generici. If you have any concerns, contact your doctor or pharmacist. If you are taking diuretics, you should stop taking them for two or three days before starting ZOFENOPRIL DOC Generici. The usual starting dose is 15 mg daily, but your doctor may start you on 7.5 mg daily if considered more suitable for you. Not all recommended dosages may be available with this product.
Adults with heart failure
Your doctor will prescribe the dose appropriate for you.
Adults with kidney problems
If you have kidney problems, your doctor will adjust the dose of ZOFENOPRIL DOC Generici according to how well your kidneys are functioning.
Elderly
The dose depends on how well your kidneys are working. Your doctor will tell you how much ZOFENOPRIL DOC Generici to take.
Use in children
The use of ZOFENOPRIL DOC Generici is not recommended in children.
If you take more ZOFENOPRIL DOC Generici than you should
Contact your doctor immediately or go to the nearest hospital emergency department. Take the pack and any remaining tablets with you. Signs and symptoms of overdose include: sudden drop in blood pressure, shock, stupor, abnormally slow heartbeat, electrolyte disturbances, and renal failure.
If you forget to take ZOFENOPRIL DOC Generici
If you forget a dose, do not worry. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking ZOFENOPRIL DOC Generici
If you stop treatment with ZOFENOPRIL DOC Generici suddenly, you may experience adverse effects. If you wish to stop taking this medicine, consult your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects associated with ACE inhibitors are reversible and disappear at the end of treatment.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• general weakness, muscle cramps
• skin rash

Rare (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 side effects reported for ZOFENOPRIL DOC Generici, the following side effects have generally been reported for ACE inhibitors:

• severe drop in blood pressure at the start of treatment or with dose increase, accompanied by 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 touch 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, diarrhoea, constipation, dry mouth;
• allergic reactions such as skin rash, urticaria, itching, skin peeling, redness, skin laxity and blister formation on the skin (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, runny or itchy 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 blood levels of urea and creatinine;
• anemia due to breakdown of red blood cells (hemolytic anemia), which may occur if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency.

Reporting of side effects
If you experience any side effects, 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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZOFENOPRIL DOC Generici

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 outer packaging and on the blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZOFENOPRIL DOC Generici contains

• The active substance is zofenopril calcium. Each tablet contains 30 mg of zofenopril calcium.
• The other components are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate, Opadry II White (composed of polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc).

Description of the appearance of ZOFENOPRIL DOC Generici and the contents of the pack
ZOFENOPRIL DOC Generici 30 mg tablets are white, round, film-coated tablets with a break line on one side. The tablet may be divided into equal doses.
ZOFENOPRIL DOC Generici is available in packs of 14, 28, 30 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via F. Turati, 40
20121 Milan
Italy

Manufacturer
Bluepharma Indústria Farmacêutica S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Zofenopril DOC Generici
Italy: ZOFENOPRIL DOC Generici