ZOFEN 7.5 mg. 60 tablets

What Zofen 7,5 mg / 30 mg and what it is used
Zofen 7,5 mg / 30 mg contains zofenopril calcium, which belongs to the group of blood pressure lowering drugs, m. Called. Angiotensin-converting enzyme (ACE).

Zofen 7,5 mg / 30 mg is used to treat the following conditions:
high blood pressure (hypertension);
heart attack (acute myocardial infarction) in patients with or without signs and symptoms of heart failure and who have not received treatment that helps break down blood clots (thrombolytic therapy).

2. What you need to know before taking Zofen 7,5 mg / 30 mg
Do not take Zofen 7,5 mg / 30 mg if:
you are allergic (hypersensitive) to any of the ingredients (see. Section 6 "What Zofen 7,5 mg / 30 mg);
you have had an allergic reaction to any other ACE inhibitors such as captopril or enalapril;
had severe swelling and itching of the face, nose and throat (angioneurotic edema) in previous treatment with an ACE inhibitor or suffer from hereditary / idiopathic angioneurotic edema (rapid swelling of the skin, tissues, digestive tract and other organs);
suffer from severe liver problems;
have narrowing of the renal arteries;
pregnant after the third month (also good to avoid Zofen 7,5 mg / 30 mg in early pregnancy - see. section "Pregnancy and lactation");
you are a woman of childbearing potential, unless using effective contraception;
if you have diabetes or renal impairment and are treated with medication to lower blood pressure, containing aliskiren.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Zofen 7,5 mg / 30 mg, if:
have high blood pressure and problems with the liver or kidneys;
have high blood pressure due to kidney problem or narrowing of the artery supplying blood to the kidney (renovascular hypertension);
you have recently had a kidney transplant;
you are undergoing dialysis;
you undergo LDL-apheresis (a procedure similar to kidney dialysis, blood purifier of harmful cholesterol);
You have in their blood increased 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);
suffer or have suffered from psoriasis (a skin disease characterized by scaly pink patches);
if you undergo desensitisation treatment (injections in allergic diseases) to insect stings;
if you are taking any of these medicines used to treat high blood pressure:
angiotensin II-receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes;
aliskiren.
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg. Potassium) in your blood.

See also the information titled "Do not take Zofen 7,5 mg / 30 mg"
Your blood pressure can be reduced significantly with the use of Zofen 7,5 mg / 30 mg, especially after the first dose (this is typical if you take diuretics, if you are dehydrated or if you are subjected to a diet, limiting salt intake). In such cases, contact your doctor immediately and lie back.

If you have an operation, tell your anesthetist before being anesthetized acceptance Zofen 7,5 mg / 30 mg. This will help him / her to control blood pressure and heart rate during the procedure.

If you have suffered a heart attack (acute myocardial infarction) and:
have low blood pressure (<100 mmHg) or are in circulatory shock (due to heart problems) - Zofen 7,5 mg / 30 mg are not recommended;
you are aged over 75 years - Zofen 7,5 mg / 30 mg should be used with special care.
You should tell your doctor if you think you are (or might become) pregnant. Zofen 7,5 mg 30 mg are not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage (see. Section "Pregnancy").

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because it is probably not safe.

Other medicines and Zofen 7,5 mg / 30 mg
Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you take:
drugs that increase the level of potassium in the blood (eg potassium-sparing diuretics such as spironolactone, triamterene, amiloride or potassium supplements);
lithium (used for the treatment of behavioral disorders);
anesthetics;
narcotics (such as morphine);
antipsychotic agents (used in the treatment of schizophrenia and related diseases);
tricyclic antidepressants, such as amitriptyline and clomipramine;
other medicines to lower blood pressure and vasodilators (including, β-blockers, α-blockers and diuretics such as hydrochlorothiazide, furosemide and torasemide;
you may need your doctor may change your dose and / or take other precautions: if you are taking angiotensin II-receptor blockers (ARB) or aliskiren (see also information entitled "Do not take Zofen 7,5 mg / 30 mg" and " Warnings and precautions ");
nitroglycerin and other nitrates used to treat chest pain (angina);
antacids including cimetidine (used for heartburn or stomach ulcers);
ciclosporin (used after organ transplants) or other immunosuppressive agents (drugs that suppress the body's defense system);
allopurinol (used in the treatment of gout);
insulin or oral antidiabetic agents;
cytostatics (used in the treatment of cancer or a disease affecting the body's defense system);
corticosteroids (powerful anti-inflammatory drugs);
procainamide (used to control irregular heartbeat);
NSAIDs (HCPBC such as aspirin or ibuprofen);
sympathomimetic drugs (drugs affecting the nervous system, including medicines to treat asthma and hay fever and pressor amines, eg. adrenaline).
Zofen 7,5 mg / 30 mg with food, drinks and alcohol
Zofen 7,5 mg / 30 mg may be taken with food or on an empty stomach, but the tablet to be taken with water. Alcohol increases the hypotensive (blood pressure lowering) effect of Zofen 7,5 mg / 30 mg; ask your doctor for further advice when taking alcohol during treatment with Zofen 7,5 mg / 30 mg.

Pregnancy and lactation
Pregnancy
If you are pregnant, if you think you may be pregnant or planning to become pregnant, ask your doctor for advice before taking this medicine. Generally, your doctor will advise you to stop taking Zofen 7,5 mg / 30 mg of before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Zofen 7,5 mg / 30 mg.
Zofen 7,5 mg 30 mg are not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may seriously harm your baby if used after the third month of pregnancy.

Breastfeeding
If you are breastfeeding or about to start breast-feeding, ask your doctor for advice before taking this medicine. Zofen 7,5 mg / 30 mg are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

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

Zofen 7,5 mg / 30 mg contains lactose
This product contains lactose - if you know that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This drug is not recommended for use in children and adolescents.

3. How to take Zofen 7,5 mg / 30 mg
Always take Zofen 7,5 mg / 30 mg exactly as your doctor tells you. If you're not sure, ask your doctor.
Zofen 7,5 mg 30 mg may be taken with food or on an empty stomach. Best tablet should be taken with water.

Treatment of high blood pressure (hypertension)
The normal starting dose is Zofen 15 mg once daily. Your doctor will gradually adjust the dose (usually a period of four weeks) to reach the right dose for you. Prolonged antihypertensive effect is usually achieved with the 30 mg once daily Zofen. The maximum dose is 60 mg per day, taken all at once or in two divided doses.
If you are dehydrated, with salt deficiency or are 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 moderate to severe renal impairment, your doctor will start treatment with half the therapeutic dose Zofen (15 mg). If you are on hemodialysis, at the beginning of your treatment is needed one quarter of the usual therapeutic dose (7,5 mg).

Heart attack (acute myocardial infarction)
Treatment with Zofen should begin within 24 hours after onset of symptoms.
Zofen will receive twice daily, morning and evening, in the following dosage:
7,5 mg twice a day 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 can be increased to 30 mg twice daily;
according to blood pressure, your doctor will determine the maximum dose;
treatment can last six weeks or longer if symptoms of heart failure persist.
If you take more dose Zofen 7,5 mg / 30 mg
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest emergency medical care (take with you, if possible, any remaining tablets, package or leaflet).
The most common symptoms and signs of overdose are low blood pressure with fainting (hypotension), slow heart rate (bradycardia), changes in some blood parameters (electrolytes) and impaired renal function.

If you forget to take Zofen 7,5 mg / 30 mg
If you miss a dose, take one as soon as possible after you have established. If it's been a long time (eg several hours) and the next dose soon, skip the missed dose and take the next scheduled dose at the usual time as prescribed. Do not take a double dose to make up for forgotten tablet.

If you stop taking Zofen 7,5 mg / 30 mg
Always consult your doctor before discontinuing use of Zofen 7,5 mg / 30 mg, whether taking it for high blood pressure or after a heart attack.

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

4. Possible side effects
Like all medicines, Zofen 7,5 mg / 30 mg can cause side effects, although not everybody gets them.
Most of the adverse reactions associated with the use of ACE inhibitors are reversible and disappear after cessation of therapy.

Common side effects (affecting less than 1 in every 10 treated):
fatigue (tiredness);
nausea and / or vomiting;
dizziness;
headache;
cough.
Uncommon side effects (affecting less than 1 in every 100 treated):
general weakness;
muscle cramps;
skin rash.
Rare side effects (affecting less than 1 in every 1,000)
rapid swelling and itching, especially on the face, mouth and throat, with possible difficulty in breathing.
Besides the adverse reactions reported when taking Zofen 7,5 mg / 30 mg, may occur following side effects typical of ACE inhibitors:
severe reduction in blood pressure at the beginning of treatment or when the dose is increased by dizziness, impaired vision, fainting (syncope);
fast or irregular heartbeat, palpitations and chest pain (heart attack or angina pectoris);
reduced consciousness, sudden dizziness, sudden disturbance of vision or weakness and / or loss of the sense of touch in one half of the body (transient ischemic attack or stroke);
peripheral edema (water retention in the extremities), a decrease when standing, chest pain, muscle pain and / or cramps;
decreased renal function, change in amount of urine, presence of proteins in the urine (proteinuria), impotence;
abdominal pain, diarrhea, constipation, dry mouth;