ZOFEN 28 tablets - 30 mg


Zofen 30 mg is used to treat high blood pressure (hypertension). Applies also
to treat a heart attack (acute myocardial infarction) in patients with and without signs and symptoms of heart failure and who have not received treatment that helps break down blood clots (thrombolytic therapy).


ZOFEN 28 tablets - 30 mg

 ZOFEN 28 tablets - 30 mg, Zofen contains 30 mg of zofenopril calcium, which belongs to the group of blood pressure lowering drugs called angiotensin converting enzyme (ACE)

What Zofen 30 mg and what it is used

Zofen contains 30 mg of zofenopril calcium, which belongs to the group of blood pressure lowering drugs called angiotensin converting enzyme (ACE).


Zofen 30 mg is used to treat high blood pressure (hypertension). Applies also

to treat a heart attack (acute myocardial infarction) in patients with and without signs and symptoms of heart failure and who have not received treatment that helps break down blood clots (thrombolytic therapy).


 Before you take 30 mg Zofen


Do not take Zofen 30 mg if:

  you are allergic (hypersensitive) to any of the ingredients (see section 6 'What Zofen mg-30');

  you have had an allergic reaction to any other ACE inhibitor such as captopril or enalapril;

  you have had intense swelling and itching of the face, nose and throat (angioedema) to previous treatment with an ACE inhibitor, or suffer from hereditary / idiopathic angioedema (rapid swelling of the skin, tissues, digestive tract and other organs);

  have severe liver problems;

  have narrowing of the renal arteries;

  you are pregnant or breast-feeding;

  you are a woman of childbearing potential unless using effective contraception.


Take special care with 30 mg Zofen


Please consult your doctor before taking 30 mg Zofen if:

  have high blood pressure, liver problems or kidney problems;

  have high blood pressure due to kidney problem or narrowing of the artery that supplies the kidney (renovascular hypertension);

  you have recently had a kidney transplant;

  If you are undergoing dialysis;

  you are receiving LDL-apheresis (a procedure similar to dialysis, blood purifier of harmful cholesterol);

  have increased their blood levels of the hormone aldosterone (primary aldosteronism);

  in a narrowing of the aortic valve (aortic stenosis) or thickening of the walls of the heart (hypertrophic cardiomyopathy);

  you suffer or have suffered from psoriasis (a skin disease characterized by scaly pink patches);

  if you are undergoing desensitisation treatment (injections in allergic diseases) to insect stings.


Your blood pressure can be reduced significantly with the use of 30 mg Zofen, especially after the first dose (this is if you are taking diuretics, or if you are dehydrated if you are subjected to a diet restricted in salt). In such cases, contact your doctor immediately and lie on your back.


If you have surgery, tell your anesthesiologist before being anesthetized that Zofen taking 30 mg. This will help him / her to help control blood pressure and heart rate during the procedure.


If you have had a heart attack (acute myocardial infarction) and:

  have low blood pressure (<100 mmHg) or are in circulatory shock (due to problems with the heart) - Zofen 30 mg is not recommended;

 you are aged over 75 years - 30 mg Zofen - should be given special attention.


Zofen 30 mg are not recommended in children and adolescents.


Taking other medicines


Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


In particular, tell your doctor if you are taking:

  drugs that increase the level of potassium in the blood (eg potassium-sparing diuretics or potassium supplements);

  Lithium (used to treat mood disorders);


  narcotics (such as morphine);

  antipsychotic drugs (used to treat schizophrenia and other diseases);

  other medicines to lower blood pressure (including diuretics, b-blockers, a-blockers);

  antacids, including cimetidine (used for heartburn or stomach ulcers);

  ciclosporin (used after organ trans-plantation) or other immunosuppressive drugs (drugs that inhibit the body's defense system);

  allopurinol (used for gout);

  insulin or oral antidiabetic drugs;

  cytostatics (used in the treatment of cancer or disease affecting the body's defense system);

  corticosteroids (powerful protivovazpali-tional funds);

  procainamide (used to treat irregular heartbeat);

  non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin or ibuprofen);

  sympathomimetic agents (agents affecting the nervous system, including treatments for asthma and hay fever).


Taking Zofen 30 mg with food and drink


Zofen 30 mg may be taken before or after meals, but the tablet can be taken with water. Alcohol enhances the hypotensive (blood pressure lowering) effect of 30 mg Zofen, ask your doctor for further advice when taking alcohol during treatment with 30 mg Zofen.


Pregnancy and lactation


Do not take Zofen 30 mg if you are pregnant, planning a pregnancy or breastfeeding. The drug may harm the fetus if you are pregnant or pass into the milk if you are breastfeeding. Ask your doctor for advice before taking any medicine.


Driving and operating machinery


This medicine may cause drowsiness or fatigue. In such cases it is advisable to drive or operate machinery.


Important information about some of the ingredients of the 30 mg Zofen


This medicinal product contains lactose - if you know that you have an intolerance to some sugars, contact your doctor before taking this medicine.


 How to take 30 mg Zofen


Always Zofen 30 mg exactly as your doctor tells you. If you're not sure, ask your doctor.


Zofen 30 mg may be taken before or after food. Best tablet to be taken with water.

It is recommended that this medication be taken by children and adolescents.


Treatment of high blood pressure (hypertension)


The normal starting dose is 15 mg Zofen daily. Your doctor will adjust your dose gradually (usually four weeks) to reach the right dose.


Prolonged antihypertensive effect is usually achieved with 30 mg once daily Zofen. The maximum dose is 60 mg daily, taken all at once or in two divided doses.


If you are dehydrated, with salt deficiency or taking diuretics (water tablets), it is necessary to start treatment with 7.5 mg Zofen.


Liver or kidney problems


If you suffer from mild to moderate hepatic impairment or mild to severe renal impairment, your doctor will start with a half dose of Zofen. If you are on hemodialysis, at the beginning of your treatment is needed one-quarter of the dose.


Heart attack (acute myocardial infarction)


Zofen treatment must be started within 24 hours after onset of symptoms.


The dose you receive will be as follows:


 7,5 mg twice daily during the first and second day of treatment;

 15 mg twice daily during the third and fourth day of treatment;

 After the fifth day, the dose may be increased to 30 t § BID;

 according to the values of blood pressure, your doctor will determine the maximum dose;

 If symptoms of heart failure persist, treatment may be continued for six weeks or more.


If you take more than 30 mg dose Zofen


If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency medical services (take with you, if possible, all other tablets pack or leaflet).


The most common symptoms and signs of an overdose are low blood pressure and fainting (hypotension), slow heart rate (bradycardia), changes in some blood parameters (electrolytes) and impaired renal function.


If you forget to take 30 mg Zofen


If you miss a dose of 30 mg Zofen accept the following as soon as possible after you have established. If it's been a long time (several hours) and the next dose is rather skip the missed dose and take the next dose at the normal time as prescribed. Do not take a double dose to make up for a missed dose.


If you stop taking 30 mg Zofen


Always consult your doctor before discontinuing use of Zofen 30 mg, whether you take for high blood pressure or after a heart attack.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


 Possible side effects


Like all medicines, Zofen 30 mg can cause side effects, although not everybody gets them.

Most of the side effects associated with the use of ACE inhibitors are reversible and disappear after cessation of therapy.


Common side effects (affecting less than 1 in 10 treated)


 fatigue (tiredness)

 nausea and / or vomiting





Uncommon side effects (affecting less than 1 in every 100 patients treated)



 muscle cramps

skin rash.


Rare side effects (affecting less than 1 in 1,000)

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


In addition to the adverse reactions reported with intake of 30 mg Zofen may occur following side effects typical of ACE inhibitors:


 dramatic reduction in blood pressure at the beginning of treatment or when increasing the dose by dizziness, blurred vision, fainting (syncope);

 fast or irregular heartbeat, palpitations and chest pain (heart attack or angina pectoris); reduced consciousness and sudden dizziness, sudden visual disturbances or weakness and / or loss of sense of touch in one half of the body (transient ischemic attack or stroke);

 peripheral edema (water retention in the legs), low blood pressure when standing, chest pain, muscle pain and / or cramps;

 decreased renal function, change in amount of urine separated during the day, the presence of protein in the urine (proteinuria), impotence;

 abdominal pain, diarrhea, constipation, dry mouth;

 allergic reactions like skin rash, hives (urticaria), itching, peeling, redness, soreness and blistering of the skin (toxic epidermal necrolysis), exacerbation of psoriasis (a skin disease characterized by the formation of pink scaly patches) hair loss (alopecia);

 increased sweating and flushing;

 mood swings, depression, sleep disturbances, abnormal skin sensation of burning, numbness, or tingling (paraesthesia), impaired balance, confusion, tinnitus, taste disturbances, blurred vision;

 difficulty breathing, narrowing of the airways in the lungs (bronchospasm), sinusitis, runny or stuffy nose (rhinitis), sore tongue (glossitis), bronchitis;

 yellowing of the skin (jaundice), inflammation of the pancreas or liver (hepatitis, pancreatitis), bowel obstruction (ileus);

Changes in blood tests, eg. change in the number of red blood cells, white blood cells or platelets, or reduction in the number of all blood cells (pancytopenia). Tell your doctor if you notice bruising for minor injuries or no reason you have a sore throat and fever;

  Increased blood levels of liver enzymes (transaminases) and bilirubin increased, blood urea and creatinine;

 anemia due to destruction of red blood cells (hemolytic anemia), which can occur if you have glucose-6-phosphate dehydrogenase deficiency.


If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.


 Storage Zofen 30 mg


Keep out of reach of children!

This medicinal product does not require any special storage conditions.


Do not use Zofen 30 mg after the expiry date ("EXP") shown on the carton and blister. Always store the tablets in the original container.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


Additional Information


What Zofen 30 mg


The active substance is zofenopril calcium: 30 mg.


The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 6000 (see Section 2 "Important information about some of the ingredients of the 30 mg Zofen ").

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