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).

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- 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.

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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. If necessary, this dose can be increased or reduced. Whilst you are taking chlortalidone tablets, your doctor may want to carry out a number of tests from time to time. It is recommended that you take chlorthalidone tablets with food in the morning. Swallow the tablets whole with water.

Adults Therapy should be start with the lowest possible dose and be increased gradually depending on the individual therapeutic response, until an optimal effect is achieved.

The usual doses for adults are as follows:  High blood pressure: The starting dose is 25 mg a day. Your doctor may increase this to 50 mg a day if necessary.

 Heart failure: The starting dose is 25 mg a day. Your doctor may increase this up to 200 mg a day if necessary.

 Fluid retention associated with kidney or liver disease: Adults, initially 50 mg to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals. Dosages above this level, however, do not usually produce a greater response.

 Diabetes insipidus (a disease in which an individual produces large amounts of dilute urine and is constantly thirsty): The starting dose is 100 mg twice a day. Your doctor may reduce your dose to 50 mg a day.

Use in children and adolescents Your doctor will choose a suitable dose based on your child’s age and weight.

Elderly patients or those with kidney problems Your doctor may give you a lower dose because your body may not get rid of chlortalidone tablets as quickly as normal due to functional reduction in renal function of age and a greater incidence of impaired hepatic and cardiac function.

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If you are not sure how many tablets to take, ask your doctor or pharmacist. Do not stop taking your tablets suddenly. Ask your doctor first.

If you take more Zornichka than you should If you accidentally take too many tablets, you should tell your doctor immediately or contact your nearest accident and emergency department. Symptoms of overdose include nausea, vomiting, drowsiness, hypovolaemia (a condition in which the volume of plasma in the blood is reduced), hypotension (low blood pressure) and water-electrolyte imbalance, accompanied by heart rhythm disturbances and muscle spasms.

There is no specific antidote to chlortalidone. In case of overdose, it is necessary to evacuate the gastric contents by induced vomiting, gastric tube and lavage, after which strict control and correction of the water-electrolyte balance should be carried out by careful parenteral administration of glucose and glucose-saline solutions with the addition of potassium.

If you forget to take Zornichka If you miss a dose, take it at the next regular intake. Do not take a double dose to make up for a forgotten tablet, then go back to your regular dosing schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects with chlorthalidione are dose-dependent. For the most part, they are mild, transient, and resolve after dose reduction or discontinuation of therapy. The following undesirable effects have been observed and reported with the following frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).

Metabolism and nutrition disorders Very common: mainly at higher doses, hypokalaemia (low levels of potassium in the blood, which may cause muscle weakness or twitching, or changes in heart rhythm), hyperuricaemia (increase in uric acid), and increase in serum lipids. Common: hyponatraemia (low levels of sodium in the blood, which can cause fatigue and confusion, muscle twitching, seizures or coma), hypomagnesaemia (low magnesium content in the blood) and hyperglycaemia (high blood sugar). Uncommon: gout. Rare: hypercalcaemia (increased levels of calcium in the blood), glycosuria (excretion of sugar in the urine), worsening of diabetic metabolic state. Very rare: hypochloraemic alkalosis.

Skin and subcutaneous tissue disorders Common: urticaria and other forms of skin rash. Rare: photosensitisation (increased sensitivity to light).

Hepato-biliary disorders Rare: intrahepatic cholestasis or jaundice.

Cardiovascular system disorders Common: postural hypotension. Rare: cardiac arrhythmias.

Nervous system disorders

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Common: dizziness. Rare: paraesthesia (numbness, tingling in the skin of hands and feet), headache.

Gastrointestinal disorders Common: loss of appetite and mild stomach discomfort. Rare: mild nausea and vomiting, abdominal pain, constipation or diarrhoea. Very rare: pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back).

Blood and lymphatic system disorders Rare: thrombocytopenia (reduction in platelet count, which increases the risk of bleeding or bruising), leucopenia (decrease in the number of white blood cells, which increases the likelihood of infection), agranulocytosis (a sharp decrease in the number of certain white blood cells, which increases the likelihood of infection) and eosinophilia (increase in the amount of a certain type of white blood cells).

Reproductive system and breast disorders Common: impotence.

Respiratory, thoracic and mediastinal disorders Rare: idiosyncratic pulmonary oedema (respiratory disorders)

Immune system disorders Rare: allergic interstitial nephritis.

Eye disorders Not known: Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system of Bulgarian Drug Agency. By reporting side effects you can help provide more information on the safety of this medicine.

Contacts: Bulgarian Drug Agency 8 Damyan Gruev Str. 1303 Sofia. Tel.: +359 2 890 3417 Website: www.bda.bg

5. How to store Zornichka

This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zornichka contains

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- The active substance is chlortalidone. - The other excipients are :  Cellulose, microcrystalline  Lactose, monohydrate  Povidone (K-30)  Sodium Starch Glycolate (Type A)

Zornichka 12.5 mg contains also: Magnesium stearate. Zornichka 25 mg contains also: Magnesium Stearate, Yellow Iron Oxide (E172) and Red Iron Oxide (E172).

What Zornichka looks like and contents of the pack Zornichka 12,5 mg tablets are white, circular and convex tablets, without break line. Zornichka 25 mg tablets are pale pink to reddish, circular and convex tablets, without break line.

Each pack contains 30 tablets packed in blisters of PVC+PVdC-Alu, placed into cardboard boxes.

Marketing Authorisation Holder and Manufacturer Tchaikapharma High Quality Medicines Inc. 1 G. M. Dimitrov Blvd, Sofia 1172, Bulgaria Tel. : + 359 2 962 54 54 FAX: + 359 2 9603 703 e-mail: [email protected]

This leaflet was last revised in: June 2020

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