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Patient Information Leaflet Package leaflet: Information for the patient Zornichka 12,5 mg tablets Zornichka 25 mg tablets Chlortalidone Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Zornichka is and what it is used for 2. What you need to know before you take Zornichka 3. How to take Zornichka 4. Possible side effects 5. How to store Zornichka 6. Contents of the pack and other information 1. What Zornichka is and what it is used for Zornichka belongs to a group of medicines called thiazide diuretics (“water tablets”). Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the amount of water that you pass as urine. Zornichka is used to: treat high blood pressure (hypertension) – as monotherapy or in combination with other antihypertensive (lowering high blood pressure) medicines. as an additional therapy for the treatment of edema caused by mild to moderate heart failure (II- III functional class); hepatic cirrhosis with ascites; corticosteroid and estrogen therapy, and some forms of impaired renal function (nephrotic syndrome, acute glomerulonephritis and chronic renal failure - creatinine clearance > 30 ml/min). treat diabetes insipidus (a condition in which an individual produces large amounts of dilute urine and is constantly thirsty). 2. What you need to know before you take Zornichka Do not take Zornichka: - if you are allergic to active substance, any other sulfonamides or any of the other ingredients of this medicine (listed in section 6). - if you are not passing any urine at all. - if you have severe renal failure (creatinine clearance <30 ml/min). - if you have severe hepatic failure - if you have a hypokalaemia, difficult managed (low potassium in your blood) or a state of high potassium loss. - if you have hyponatraemia (low sodium levels in your blood). 2 - if you have hypercalcemia (high calcium levels in your blood). - if you have ever had gout or kidney stones compound of uric acid. - if you have high blood pressure during pregnancy. - if you have untreated Addison's disease. - if you are taking lithium. Warnings and precautions Talk to your doctor or pharmacist before taking Zornichka. Zornichka should be used with caution: Renal impairement: chlortalidone as other thiazide diuretics, should be used with caution in patients with moderate renal impairment (diuretics are not effective in patients with advanced renal failure - creatinine clearance <30 ml/min). Thiazide diuretic-associated azotemia may occur in patients with impaired renal function. Therefore periodic monitoring of creatinine and urea serum levels is recommended. If renal insufficiency progress in patients treated with chlorthalidone, treatment should be discontinued. Hepatic impairment: chlorthalidone and other thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Electrolyte imbalance (hypokalaemia, hyponatraemia, hypochloremic alkalosis and others): as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals. The risk of hypokalaemia is greatest in patients with vomiting, diarrhea, deterioration in renal function, liver cirrhosis, hyperaldosteronism (endocrine disease of the adrenal glands), or concomitant use of corticosteroids. If hypokalaemia is developed, it should be adjusted (by simultaneous administration of potassium salt) or by combining with a potassium-sparing diuretic). The patients receiving chlortalidone should be monitored for electrolyte imbalance symptoms. Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, confusion, muscle pain and cramps, gastrointestinal disturbances such as nausea or vomiting, hypotension (low blood pressure), oliguria (decreased urine output), tachycardia (palpitations), and, heart rhythm and ECG disturbances. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia (low magnessium levels in blood). Thiazides and chlorthalidone may decrease urinary calcium excretion and cause a transient increase in serum calcium. Thiazides should be discontinued before carrying out tests for parathyroid function. Hyperuricemia (high uric acid) and gout: the concentration of uric acid in the blood can be increased in patients treated with chlorthalidone and to show clinical signs of gout. Blood - sugar balance: treatment with thiazide diuretics may result in latent diabetes or an increase in insulin requirements in diabetics. Periodic blood glucose monitoring is required during treatment with chlorthalidone Effect on fats: Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Systemic lupus erythematosus: The possibility that thiazides may activate or exacerbate systemic lupus erythematosus has been reported. Eye disorders: If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your 3 eye and can happen within hours to a week of taking Zornichka. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. Children and adolescents The information is not availablle. Other medicines and Zornichka Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines with: other treatments for high blood pressure or heart problems such as: - ACE inhibitors (for example, lisinopril); - beta blockers (for example propranolol hydrochloride); - methyldopa; - vasodilators (bosentan); - calcium channel blockers (amlodipine); - guanethidine. corticosteroids such as prednisolone or betamethasone - used to treat allergic and inflammatory diseases and immune reactions; cytotoxic agents such as cyclophosphamide or methotrexate - used to treat cancer; asthma treatments such as salbutamol or formoterol; amphotericin - used to treat infections; carbenoxolone - used to treat ulcers; insulin and other treatments for diabetes such as chlorpropamide or glibenclamide; digoxin - for an irregular heartbeat; lithium - used to treat mental illness adrenocorticotropic hormone (ACTH) - used to treat a number of different conditions, including ulcerative colitis, Crohn's disease and rheumatoid arthritis; anticholinergics such as atropine sulphate or hyoscine butylbromide - for abdominal or stomach spasms or cramps; colestyramine - used to reduce cholesterol levels and prevent heart disease; amantadine - used to treat Parkinson’s disease or viral infections; allopurinol - used to treat gout; calcium salts or vitamin D - used for replacement therapy; non-steroidal anti-inflammatories (NSAIDs) such as aspirin or indometacin - used for pain relief or rheumatism; ciclosporin - used to treat rheumatic disease or skin complaints or after a transplant. Zornichka with food and drink and alcohol It is best to take chlortalidone in the morning with food. Swallow your tablets whole with a drink of water. Taking chlortalidone tablets may reduce the amount of salt in your body. If you are on a low salt diet check with your doctor first before taking chlortalidone tablets. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Thiazide diuretics cross the placental barrier and may cause toxic effects on the fetus and newborn. Therefore, chlorthalidone should not be used during pregnancy. Breast-feeding Do not take chlortalidone tablets if you are breast-feeding because chlortalidone passes into breast milk and could harm your baby. A decision should be made whether to discontinue nursing or to discontinue the drug. 4 Driving and using machines Some side effects (e.g. symptoms of low blood pressure, such as dizziness) may impair the patient's ability to concentrate and react and therefore may pose a risk in situations where these abilities are particularly important (e.g. driving and using machines). This may happen especially at the beginning of treatment or when changing treatment from one medicine to another. Patients should be advised if they experience these reactions that they should not drive, operate machinery or engage in activities where these effects may put themselves or others at risk. Zornichka contains lactose If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine. 3. How to take Zornichka Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to take your tablets at the right time. Your doctor will choose an appropriate starting dose for your condition and monitor its development.
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