ZOFEN plus 30 mg. / 12.5 mg. 28 tablets

WHAT ZOFEN PLUS AND WHAT IT IS USED
Zofen plus contains zofenopril calcium 30 mg and hydrochlorothiazide 12,5 mg as active ingredients:
Zofenopril calcium is a cardiovascular drug that belongs to the group of blood pressure lowering drugs called angiotensin converting enzyme (ACE);
Hydrochlorothiazide is a diuretic, which works by increasing urine output.
Zofen Plus is used to treat mild to moderately high blood pressure (hypertension), when not optimally controlled by only zofenopril.

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE ZOFEN PLUS
Do NOT take Zofen plus if:
you are three months pregnant (it is also better to avoid Zofen Plus in early pregnancy - see pregnancy section);
you are allergic (hypersensitive) to zofenopril, hydrochlorothiazide or any of the other ingredients of this medicine (see section 6 "What Zofen plus" and end of Section 2 "Important information about some of the ingredients of Zofen plus');
you are allergic (hypersensitive) to other substances derived from sulfonamides (such as hydrochlorothiazide, which is a drug, sulfonamide derivative);
It has previously had an allergic reaction to any other ACE inhibitor, eg. captopril or enalapril;
had severe swelling and itching of the face, nose and throat (angioneurotic edema) in previous treatment with an ACE inhibitor or if you suffer from hereditary / idiopathic angioneurotic edema (rapid swelling of the skin, tissues, digestive system and other organs);
have severe liver or kidney problems;
You have narrowing of the renal arteries.
Warnings and Precautions
Talk to your doctor before taking Zofen plus:
have liver or kidney problems;
have high blood pressure due to kidney problems or narrowing of the arteries supplying blood to the kidneys (renovascular hypertension);
you have recently had a kidney transplant;
you are undergoing dialysis;
you undergo LDL apheresis of (a procedure similar to hemodialysis, 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;
suffer from lupus erythematosus (a disease of the immune system, the defense system of your body);
have a tendency to low levels of potassium in the blood, especially if you suffer from the syndrome of prolonged QT interval (a kind of ECG abnormality) or if you are taking digitalis (to aid the pumping function of the heart);
have diabetes;
if you have angina or diseases affecting the brain, as low blood pressure can lead to heart attack or stroke.
Contained in Zofen plus hydrochlorothiazide can cause skin sensitivity to sunlight or artificial UV light. Stop taking Zofen plus and tell your doctor if a rash, itchy spots or sensitive skin during treatment (see section 4).

Doping test: Zofen plus can give a positive result in doping tests.

Your blood pressure can be reduced significantly with the use of Zofen plus, especially after the first dose (this is characteristic if you are taking diuretics, if you are dehydrated or if you are subjected to a diet, limiting salt intake or if you vomit or have diarrhea) . In such cases, contact your doctor immediately and lie on your back (see section 4).
If you have an operation, tell your anesthetist that you are taking Zofen plus before you are given anesthesia. This will help to control blood pressure and heart rate during the procedure.
You should tell your doctor if you think you are (or might become) pregnant. Zofen Plus is not recommended in early pregnancy and must not be taken if you are pregnant after the third month since the application at this stage could seriously harm your baby (see pregnancy section).

Children and adolescents
Do not give this medicine to children and adolescents under the age of 18, as it is unlikely to be safe.

Other medicines and Zofen plus
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. trimethoprim, potassium supplements, potassium-sparing diuretics such as spironolactone, triamterene, amiloride), potassium-containing salt substitutes;
other medicines that affect the levels of chemicals in the blood (adrenocorticotropic hormone, ACTH, used to stimulate the production of certain hormones in the body, injections of amphotericin B, carbenoxolone, stimulant laxatives);
lithium (used in the treatment of mood disorders);
anesthetics;
narcotics (such as morphine);
antipsychotic agents (used in the treatment of schizophrenia and related diseases);
tricyclic antidepressants, e. amitriptyline and clomipramine;
other drugs for lowering high blood pressure and vasodilators (including beta-blockers, alpha-blockers, diuretics such as hydrochlorothiazide, furosemide, torasemide);
nitroglycerin and other nitrates used for chest pain (angina pectoris);
antacids including cimetidine (used for heartburn or stomach ulcers);
ciclosporin (used after organ transplants) or other immunosuppressive drugs (drugs that suppress the body's defense system);
medicines for gout (eg., probenecid, sulfinpyrazone, allopurinol);
insulin or oral antidiabetic agents;
cytostatics (used in the treatment of cancer or a disease affecting the immune system);
corticosteroids (powerful anti-inflammatory drugs);
procainamide (used to treat abnormal heart rhythms);
nonsteroidal anti-inflammatory drugs (NSAIDs such as aspirin or ibuprofen);
sympathomimetic drugs (drugs affecting the nervous system, including drugs for the treatment of asthma and hay fever and pressor amines, eg. adrenalin);
calcium salts;
digitalis (used to assist the pumping function of the heart);
cholestyramine and colestipol resins (used to lower cholesterol);
drugs used to relax the muscles (eg. tubocurarine);
amantadine (an antiviral drug).
Zofen plus food, beverages and alcohol
Zofen plus can be taken with or without food, but always with a little water. To facilitate swallowing, may break the tablet in two and swallow both parts one after another.
Alcohol increases the hypotensive effect (lowering blood pressure) of Zofen plus. Consult further with your doctor about your alcohol intake while using this medicine.

Pregnancy and lactation
Pregnancy
If you are pregnant, you think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
Typically, the doctor will advise you to stop taking Zofen Plus before you become pregnant or as soon as you know you are pregnant and will recommend another medicine instead Zofen plus.
Zofen Plus is not recommended in early pregnancy and must not be taken if you are after the third month of pregnancy, since the application after the third month of pregnancy can seriously harm your baby.

Breastfeeding
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine. Zofen Plus is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
This medicine may cause dizziness or fatigue. If this happens, do not drive or operate machinery.

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

3. HOW TO TAKE ZOFEN PLUS
Always take Zofen plus just as you have been told by your doctor. If you're not sure, ask your doctor.
Zofen plus the recommended dose is one tablet daily.
Zofen plus can be taken with or without food. It is best to take the tablet with some water.

Use in children and adolescents
This drug is not recommended for use in children and adolescents under 18 years of age.
If you are over 65 and suffer from impaired renal function, plus Zofen may not be suitable for you (see also section 2 - "Warnings and Precautions").

If you take more dose plus Zofen
If you accidentally take too many tablets, immediately contact your doctor or nearest hospital (as take with you any remaining tablets box or this leaflet, if possible).
The most common signs and symptoms of overdose are low blood pressure with fainting (hypotension), very slow heartbeat (bradycardia), changes in chemicals in the blood (electrolytes), renal dysfunction, frequent urination with consequent dehydration, nausea and somnolence, muscle spasms, abnormal heart rhythm (especially if you are taking digitalis or medicines for heart rhythm problems).

If you forget to take Zofen plus
If you forget to take a dose, do it as soon as you remember. However, if you should soon take the next dose, skip the missed and take your next dose at the usual time. Do not take a double dose to make up for a missed tablet.

If you stop taking Zofen plus
Always consult your doctor before stopping treatment with Zofen plus.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zofen plus can cause side effects, although not everybody gets them.

In clinical studies with Zofen plus reported the following adverse reactions:
Common side effects (affects less than 1 person in every 10):
dizziness;
headache;
cough.
Uncommon side effects (affects less than 1 person in 100):
infection;
bronchitis;
sore throat;
increased cholesterol and / or other blood lipids, high blood sugar, potassium, uric acid, creatinine and liver enzymes;
lower potassium levels in the blood;
insomnia;
drowsiness, seizures, muscle tightness (hypertonia);
angina, heart attack, atrial fibrillation, palpitations;
flushing, low blood pressure, high blood pressure;
nausea, indigestion, gastritis, inflammation of the gums, dry mouth, stomach pain;
rapidly emerging swelling, especially of the lips, cheeks, eyelids, tongue, palate, vocal cords (larynx), with possible sudden difficulty breathing (angioedema). If you have any of these symptoms, it means that you have a serious allergy to Zofen plus. You may need urgent medical attention or hospital admission;
skin disease characterized by scaly pink patches (psoriasis), acne, dry skin, pruritus, urticaria;
back pains;
increased excretion of urine (polyuria);
general weakness (asthenia), flu-like symptoms, peripheral edema (usually ankles);
impotence.
The following adverse reactions have been reported in clinical studies with Zofen plus, but are reported to zofenopril calcium and / or other ACE inhibitors, so that may occur and the use of Zofen plus:
fatigue; very low blood pressure at the start of treatment or dose increase of dizziness, impaired vision, seizures; low blood pressure when standing;
chest pain, muscle pain and / or cramps;
impaired consciousness, sudden dizziness, suddenly impaired vision or weakness and / or loss of the sense of touch on one side of the body (transient ischemic attack or stroke);
impaired renal function, a change in the amount of urine during the day, presence of protein in the blood (proteinuria);
vomiting, diarrhea, constipation;
allergic skin reaction with flaking, redness, sagging skin and blisters (toxic epidermal necrolysis), worsening of psoriasis, hair loss (alopecia);
increased sweating;
mood swings, depression, sleep disorders;
altered sensation of skin burning, numbness or tingling (paraesthesia);
disequilibrium, confusion, ringing in the ears (tinnitus), abnormal taste, blurred vision;
difficulty breathing, narrowing of the airways in the lung (bronchospasm), sinusitis, runny or stuffy nose (rhinitis), inflammation of the tongue (glossitis)
yellowing of the skin (jaundice), inflammation of the liver or pancreas (hepatitis, pancreatitis), bowel obstruction (ileus);
blood dyscrasias, eg. in the number of red blood cells, white blood cells or platelets or decreased number of all blood cells (pancytopenia): Contact your doctor if easy bruising or if a sore throat or fever for no reason;
elevated levels of bilirubin in the blood, increased blood urea;
anemia due to destruction of red blood cells (hemolytic anemia), which may occur if suffering from a deficiency of G6PD (glucose-6-phosphate dehydrogenase).
The following adverse reactions have been reported in clinical studies with Zofen plus, but reported for hydrochlorothiazide, so it can also occur with use of Zofen plus:
impaired production of new blood cells in the bone marrow (bone marrow failure);
fever, allergic reaction to the whole body (anaphylactic reaction);
altered levels of body fluids (dehydration) and chemical substances in the blood (electrolytes), gout, diabetes, metabolic alkalosis;
apathy, nervousness, anxiety;
convulsions, depressed level of consciousness, coma, paralysis;
yellowing of vision (xanthopsia), worsening of myopia, decreased tear production;
vertigo (dizziness);
heart rhythm disturbances (arrhythmias), changes in the electrocardiogram;
blood clots in the veins (thrombosis) and embolism, circulatory collapse (shock);
respiratory disorders, inflammation of the lungs (pneumonia), formation of fibrous tissue in the lungs (interstitial lung disease), fluid accumulation in the lungs (pulmonary edema);
thirst, loss of appetite (anorexia), lack of intestinal peristalsis (paralytic ileus), excessive gas in the stomach, inflammation of the glands that produce saliva (sialadenitis), increased blood amylase (an enzyme pancreatic hyperamylasaemia), inflammation of the gall bladder (cholecystitis);
purple spots on the skin (purpura), increased skin sensitivity to sunlight, rash (especially of the face) and / or red areas that may leave marks (cutaneous lupus erythematosus), inflammation of the blood vessels with subsequent tissue necrosis (necrotizing vasculitis );
acute renal insufficiency (reduced urine excretion and accumulation of fluids and waste products in the body), inflammation of the connective tissue in the kidneys (interstitial nephritis), sugar in urine.

5. HOW TO STORE ZOFEN PLUS
Keep out of reach of children!
Do not store above 30 ° C!