ZOPRANOL <7.5 mg Фильм-coated таблетки

Содержание инструкции

1. ZOPRANOL 7.5mg, 15mg, 30mg, 60mg film-coated tablets
   1. WHAT YOU NEED TO KNOW BEFORE TAKING ZOPRANOL
   2. HOW TO TAKE ZOPRANOL
   3. HOW TO STORE ZOPRANOL

ZOPRANOL 7.5mg, 15mg, 30mg, 60mg film-coated tablets

(Zofenopril calcium)

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ZOPRANOL IS AND WHAT IT IS USED FOR
ZOPRANOL contains 7.5 mg, 15mg, 30 mg, 60 mg of zofenopril calcium which belongs to a group of medicines
that lower blood pressure, called angiotensin converting enzyme (ACE) inhibitors.
ZOPRANOL is used to treat the following conditions:

• high blood pressure (hypertension).
• heart attack (acute myocardial infarction) in people who may or may not show signs and symptoms of heart failure and who have not received treatment to dissolve blood clots (thrombolytic therapy).

2. WHAT YOU NEED TO KNOW BEFORE TAKING ZOPRANOL

Do not take ZOPRANOL if:

• you are allergic to Zofenopril calcium or to any of the other ingredients of this medicine (listed in Section 6);
• you have had previous allergic reactions to another ACE inhibitor, such as captopril or enalapril;
• you have had previous severe episodes of swelling and itching of the face, nose and throat (angioedema) associated with a previous therapy based on ACE inhibitors or if you suffer from hereditary/idiopathic angioedema (rapid swelling of the skin, tissues, digestive tract and other organs);
• you suffer from serious liver problems;
• you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• you suffer from narrowing of the arteries of the kidneys;
• you are beyond the third month of pregnancy (it is best to avoid taking ZOPRANOL even in the early stages of pregnancy - see Section: Pregnancy);
• you are a woman of childbearing potential, unless you are using effective contraceptive methods.
• you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor before taking ZOPRANOL.
Tell your doctor if:

• you have high blood pressureand problems with the liverand kidneys;
• you have high blood pressure due to a kidney problem or narrowing of the renal artery (nephrovascular hypertension);
• you have recently undergone a kidney transplant;
• you are in dialysis;
• you are undergoing LDL-apheresis(a procedure similar to kidney dialysis that frees your blood from harmful cholesterol);
• you have abnormally high levels of the hormone aldosterone in the blood(primary hyperaldosteronism);
• you have a narrowing of the heart valve(aortic stenosis) or a thickening of the heart walls(hypertrophic cardiomyopathy);
• you suffer from or have suffered from psoriasis(a skin disease characterized by scaly pink patches);
• you are receiving desensitization treatment('allergy shots') for insect stings.
• if you are taking any of the following medicines used to treat high blood pressure: or an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes; or aliskiren..
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased: or Racecadotril, a medicine used to treat diarrhea. or Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus). or o Vildagliptin, a medicine used to treat diabetes.

The doctor may check your kidney function, blood pressure and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is reported in the entry “Do not take Zopranol”.
With the assumption of ZOPRANOL, blood pressure may drop to levels that are too low, especially after taking the first dose (this condition is more likely to occur if you are also taking diuretics, if you are dehydrated, or if you are following a low-salt diet). If this happens, tell your doctor immediatelyand lie down on your back.
If you are to undergo surgery, tell the anesthesiologist that you are taking ZOPRANOL before receiving anesthesia. This will help the anesthesiologist control your blood pressure and heart rate during the procedure.
Also, if you suffer from heart attacks(acute myocardial infarction) and if:

• you have low blood pressure (<100mmHg) or are in circulatory shock (resulting from your heart problem) - ZOPRANOL is not the recommended medicine for you;
• you are over 75 years of age - ZOPRANOL should be used with particular caution.

You must tell your doctor if you think you are (or might be) pregnant. The use of ZOPRANOL is not recommended in the early stages of pregnancy and should not be taken if you are beyond the third month of pregnancy, as the medicine may cause serious harm to the baby if used at this stage (see Section: Pregnancy).

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

Other medicines and ZOPRANOL
Tell your doctor if you are taking, have recently taken or might take any other medicines
In particular, tell your doctor if you are taking:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots);
• lithium (used to treat mood disorders);
• anesthetics;
• narcotic drugs (such as morphine);
• antipsychotic drugs (used for the treatment of schizophrenia and similar diseases);
• antidepressants or tricyclics, e.g. amitriptyline and clomipramine;
• other medicines for high blood pressure and vasodilators (including beta-blockers, alpha-blockers and diuretics such as hydrochlorothiazide, furosemide, torasemide); The doctor may need to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported in the entry “Do not take Zopranol” and “Warnings and precautions”);
• nitroglycerin and other nitrates used for chest pain (angina);
• antacids including cimetidine (used to treat heartburn and stomach ulcers);
• cyclosporine (used after organ transplantation) and other immunosuppressant drugs (drugs that suppress the body's defenses);
• allopurinol (used to treat gout);
• insulin and other oral antidiabetic drugs;
• cytostatic agents (used to treat cancer or diseases affecting the immune system);
• corticosteroids (potent anti-inflammatory drugs);
• procainamide (used to control irregular heartbeat);
• non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin or ibuprofen);
• sympathomimetic drugs (drugs that act on the nervous system, including some
• drugs used to treat asthma or hay fever and pressor amines such as adrenaline).
• Racecadotril (a medicine used to treat diarrhea), medicines usually used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) and vildagliptin (a medicine used to treat diabetes). The risk of angioedema may be increased. Sacubitril/valsartan, medicines used to treat a type of long-term (chronic) heart failure in adults. See paragraph “Do not take Zopranol”

ZOPRANOL with food, drinks and alcohol
ZOPRANOL can be taken with or without food, but it is preferable to take the tablet with water. Alcohol increases the hypotensive effect of ZOPRANOL (lowering blood pressure); consult your doctor for further information about alcohol consumption while taking this medicine.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Usually the doctor will advise you to stop taking ZOPRANOL before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine in place of ZOPRANOL. ZOPRANOL is not recommended in the early stages of pregnancy and should not be taken after the third month of pregnancy, as the medicine may cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
If you are breastfeeding or are about to start breastfeeding, ask your doctor for advice before taking this medicine. ZOPRANOL is not recommended during breastfeeding and your doctor may choose another medicine suitable for you if you wish to continue breastfeeding and especially if you are breastfeeding a premature baby.

Driving and using machines
This medicine can cause dizziness or fatigue. If this happens, do not drive or use machines until the symptoms have disappeared.

ZOPRANOL contains lactose
This product contains lactose. If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE ZOPRANOL

Always take ZOPRANOL exactly as your doctor has instructed. If you have any doubts, consult your doctor.
ZOPRANOL can be taken with or without food. It is preferable to take the tablet with water.

ZOPRANOL 15mg, 30mg, 60mg
The tablet can be divided into two equal doses

Treatment of high blood pressure(hypertension)
The usual starting dose of ZOPRANOL is 15mg once a day. Your doctor will gradually adjust the dose
(usually at intervals of four weeks) to find the best dose for you. Long-term antihypertensive effects are normally
obtained with a dose of 30mg of ZOPRANOL taken once a day. The maximum dose is 60 mg per day, which can be
taken as a single dose or in two separate doses.
If you are dehydrated, have a salt deficiency or are taking diuretics, you may need to start treatment
with 7.5 mg of ZOPRANOL.

Liver or kidney problems
If you have mild to moderate liver impairment or moderate to severe kidney impairment, your
doctor will start treatment with half the normal therapeutic dose of ZOPRANOL (15 mg). If you are on dialysis, it is
necessary to start treatment with a quarter of the normal therapeutic dose (7.5 mg).

Heart attack(acute myocardial infarction)
Treatment with ZOPRANOL should be started within the first 24 hours of the onset of symptoms.
Take the ZOPRANOL tablets twice a day, in the morning and evening as follows:

• 7.5mg twice a day, on the first and second day of treatment;
• 15mg twice a day, on the third and fourth day of treatment;
• from the fifth day onwards, the dose should be increased to 30mg twice a day;
• your doctor may adjust the dose or the maximum dose you receive, based on blood pressure measurements;
• treatment will then continue for six weeks or more if symptoms of heart failure persist.

If you take more ZOPRANOL than you should
If you accidentally take more tablets than you should, contact your doctor immediately or the nearest
emergency room (bring the remaining tablets, the box or this leaflet with you if possible). The most common
symptoms and signs of an overdose are low blood pressure with fainting (hypotension), a very slow heart rate
(bradycardia), changes in blood tests (electrolytes) and kidney dysfunction.

If you forget to take ZOPRANOL
If you forget to take a dose, take the normal dose the next day. However, if the delay is very
long (e.g. many hours) so that the time to take the next dose is very close, skip the forgotten dose and take the next
dose directly at the scheduled time. Do not take a double dose to make up for the missed tablet.

If you stop taking ZOPRANOL
Always consult your doctor before stopping treatment with ZOPRANOL, whether you are taking it for
high blood pressure or following a heart attack.
If you have any doubts about the use of ZOPRANOL, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, ZOPRANOL can cause side effects, although not everyone will experience them.
Most of the side effects associated with ACE inhibitors are reversible and disappear when treatment is stopped.

Common side effects(May affect up to 1 in 10 people):

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

Uncommon side effects(May affect up to 1 in 100 people):

• general weakness
• muscle cramps
• skin rash

Rare side effects(May affect up to 1 in 1,000 people):

• rapid swelling and itching, especially of the face, mouth and throat with possible difficulty breathing.

In addition to the side effects reported for ZOPRANOL, the following effects have generally been reported for
ACE inhibitors:

• severe lowering of blood pressure at the beginning of treatment or with an increase in dose with 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 sensation on one side of the body (transient ischemic attack or stroke);
• peripheral edema (swollen limbs due to fluid accumulation), low blood pressure in the upright position, chest pain, muscle pain and/or cramps;
• reduced kidney function, changes in the amount of urine produced daily, presence of protein in the urine (proteinuria), impotence;
• abdominal pain, diarrhea, constipation, dry mouth;
• allergic reactions such as skin rash, urticaria, itching, skin peeling, redness, skin relaxation and blistering of the skin (toxic epidermal necrolysis), worsening of psoriasis (a skin disease characterized by pink, scaly areas), hair loss (alopecia);
• increased sweating and hot flushes;
• mood changes, depression, sleep disturbances, altered skin sensations such as burning, tingling or numbness (paresthesia), balance disorders, confusion, ringing in the ears (tinnitus), taste disturbances, blurred vision;
• difficulty breathing, narrowing of the airways of the lungs (bronchospasm), sinusitis, nasal congestion (rhinitis), inflammation of the tongue (glossitis), bronchitis;
• jaundice (jaundice), inflammation of the liver or pancreas (hepatitis, pancreatitis), obstruction of the small intestine (ileus);
• changes in blood tests such as the count of red blood cells, white blood cells or platelets or a decrease in all blood cells (pancytopenia). Contact your doctor if you notice developing bruises easily or if you develop an unexplained sore throat orfever;
• increased levels of liver enzymes (transaminases) and bilirubin in the blood, increased levels of urea and creatinine in the blood;
• anemia due to the breakdown of red blood cells (hemolytic anemia) which can occur if you suffer from G6PD (glucose-6-phosphate dehydrogenase) deficiency.
• hypoglycemia

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor
or pharmacist.
You can also report side effects directly through the national reporting system
at https://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 ZOPRANOL

Keep this medicine out of the sight and reach of children
This medicine does not require any particular storage conditions.
Do not take this medicine after the expiry date which is stated on the package and on the blister after “Exp.”
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you no longer
use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHERINFORMATION
What ZOPRANOL contains
The active ingredientis zofenopril calcium 7.5mg, 15mg, 30mg, 60mg.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium
stearate, anhydrous colloidal silica, hypromellose, titanium dioxide (E 171), macrogol 400, and macrogol 6000 (see
section 2 “ ZOPRANOL contains lactose”).

Description of the appearance of ZOPRANOL and contents of the pack
ZOPRANOL 7.5 is available as white, round, film-coated tablets with convex faces in
packs of 12, 14, 15, 28, 30, 48, 50, 56, 90 or 100 and in packs of 50 and 56 in divisible blister packs for single doses.
ZOPRANOL 15 is available as white, oblong, film-coated tablets in packs of 12,
14, 15, 28, 30, 50, 56, 90 or 100 and in packs of 50 and 56 in divisible blister packs for single doses.
ZOPRANOL 30 is available as white, oblong, film-coated tablets in packs of 7,
14, 15, 28, 30, 50, 56, 90 or 100 and in packs of 50 and 56 in divisible blister packs for single doses.
ZOPRANOL 60 is available as white, oblong, film-coated tablets in packs of 14,
15, 28, 30, 50, 56, 90 or 100 and in packs of 50 and 56 in divisible blister packs for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Laboratori Guidotti S.p.A. - Via Livornese 897, PISA – La Vettola

Sales Concessionaire:A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 - Florence

Manufacturer

• A. MENARINI Manufacturing Logistics and Services Srl Campo di Pile - L'Aquila - Italy.

MENARINI Von Heyden GmbH
Leipziger Strasse 7-13

• 01097 – Dresden (Germany).

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