HYDROCHLOROTHIAZIDE SANDOZ 25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Hydrochlorothiazide Sandoz 25 mgtablets EFG

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 they have the same symptoms as you, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. See section 4.

Contents of the pack

1. What is Hydrochlorothiazide Sandoz and what is it used for
2. What you need to know before you take Hydrochlorothiazide Sandoz
3. How to take Hydrochlorothiazide Sandoz
4. Possible side effects
5. Storing Hydrochlorothiazide Sandoz
6. Contents of the pack and other information

1. What is Hydrochlorothiazide Sandoz and what is it used for

Hydrochlorothiazide belongs to a group of medicines called "diuretics". Diuretics increase the amount of urine produced by the kidneys and are sometimes called water pills.

Hydrochlorothiazide is indicated for the treatment of:

• high blood pressure (hypertension),
• excessive fluid retention in the tissues due to heart, kidney, or liver disease (cardiac, hepatic, or renal edema).

2. What you need to know before you take Hydrochlorothiazide Sandoz

Do not take Hydrochlorothiazide Sandoz

• if you are allergic to hydrochlorothiazide or other sulfonamide-derived medicines or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney function disorders and your kidneys produce very little or no urine (oliguria or anuria),
• if you have acute kidney inflammation (glomerulonephritis),
• if you have severe liver disease such as liver failure with loss of consciousness (hepatic coma or precoma),
• if you have low potassium levels in the blood (hypokalemia),
• if you have low sodium levels in the blood (hyponatremia),
• if you have a reduced amount of circulating blood (hypovolemia),
• if you have high calcium levels in the blood (hypercalcemia),
• if you have high uric acid levels in the blood that are causing symptoms (patients who have suffered from gout),
• if you suffer from gout.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if you have:

• very low blood pressure (hypotension),
• a disease called Addison's disease,
• systemic lupus erythematosus (SLE),
• insufficient blood flow to the brain (cerebrovascular insufficiency),
• coronary heart disease,
• diabetes, or subclinical diabetes (manifest or latent diabetes mellitus),
• kidney failure (serum creatinine 1.1 - 1.8 mg/100ml or moderately impaired creatinine clearance 30 – 60 ml/min)
• liver failure
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking hydrochlorothiazide.

• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking hydrochlorothiazide. If you have had an allergic reaction to penicillin or sulfonamide previously, you are at higher risk of having an allergic reaction to this medicine,
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking hydrochlorothiazide, seek medical attention immediately,

In cases of severe kidney failure (creatinine clearance below 30 ml/min and/or serum creatinine above 1.8/100 ml) hydrochlorothiazide is ineffective. It may even be harmful by further reducing kidney function.

In cases of chronic abuse of diuretic medications, pseudo-Bartter syndrome may develop along with fluid retention in the body's tissues (edema).

During long-term treatment with this medicine, your doctor will regularly check your blood electrolyte levels (especially sodium, potassium, and calcium). They will also check creatinine, urea, serum lipids (cholesterol and triglycerides), uric acid, and blood sugar levels.

During treatment with this medicine, you should drink sufficient amounts of liquid. Because potassium loss increases, you should follow a potassium-rich diet (e.g., bananas, vegetables, nuts). Potassium loss can also be reduced or prevented by simultaneous treatment with potassium-sparing diuretics.

Special observations

Treatment should be stoppedin case of:

• therapy-resistant electrolyte metabolism disorder
• abnormal drop in blood pressure that causes dizziness when changing posture, e.g., standing up (orthostatic hypotension)
• allergic reaction
• severe gastrointestinal problems
• central nervous system disorders
• pancreatitis
• changes in blood count (anemia, leucopenia, thrombocytopenia)
• acute cholecystitis
• vasculitis
• worsening of myopia
• serum creatinine above 1.8/100 ml or creatinine clearance below 30 ml/min.

Advanced age (65 years or older)

In the treatment of these patients, attention should be paid to possible restrictions of kidney function (see section 3. "How to take Hydrochlorothiazide Sandoz).

Children and adolescents (< 18 years)

There is no experience in this age group. Therefore, this medicine should not be used in children and adolescents.

Other medicines and Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant use not recommended:

Medicines associated with potassium loss and potassium deficiency in the blood (hypokalemia), e.g., kaliuretic diuretics (e.g., furosemide), glucocorticoids, ACTH, laxatives, carbenoxolone, amphotericin B, sodium penicillin G, salicylic acid, and derivatives:

The simultaneous administration of hydrochlorothiazide and medicines that increase potassium loss and are associated with potassium deficiency in the blood may lead to an increase in potassium loss. Monitoring of potassium levels is recommended. Therefore, such combinations are not recommended.

Lithium:

The simultaneous administration of hydrochlorothiazide and lithium increases the harmful effect of lithium on the heart and nerves. Therefore, the simultaneous administration of lithium and hydrochlorothiazide should only be allowed under strict medical supervision and is not recommended. If the combination is necessary, it is recommended to monitor lithium serum levels during simultaneous treatment.

Concomitant use requiring caution:

Other diuretics, blood pressure-lowering medicines, beta-blockers (a group of medicines for high blood pressure, heart problems, or high eye pressure), nitrates (medicines used for angina pectoris), barbiturates (anxiolytic and anesthetic medicines), phenothiazines (such as certain antipsychotic medicines), tricyclic antidepressants (medicines for depression, in particular), vasodilators (medicines that widen blood vessels, vasodilators), alcohol: The blood pressure-lowering effect of hydrochlorothiazide may be increased by simultaneous administration with these medicines or alcohol consumption.

ACE inhibitors (e.g., captopril, enalapril):

During treatment with hydrochlorothiazide and concomitant administration of ACE inhibitors (e.g., captopril, enalapril), there is a risk of extreme blood pressure drop at the start of treatment and worsening of kidney function. Therefore, treatment with hydrochlorothiazide should be interrupted 2 - 3 days before the start of therapy with an ACE inhibitor to reduce the possibility of a blood pressure drop at the start of therapy.

Salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., indomethacin) including selective COX-2 inhibitors:

These medicines may decrease the blood pressure-lowering and diuretic effect of hydrochlorothiazide. There have been isolated cases of worsening kidney function, especially in patients with pre-existing poor kidney function.

When salicylates are taken in high doses, the toxic effect of salicylates on the central nervous system may be reinforced. In patients with reduced circulating blood volume during treatment with hydrochlorothiazide, simultaneous administration with non-steroidal anti-inflammatory drugs may cause acute kidney failure.

Betablockers and diazoxide

The concomitant use of hydrochlorothiazide with beta-blockers or diazoxide may increase the risk of having high blood sugar (hyperglycemia).

Insulin or other oral medicines for the treatment of diabetes mellitus / diabetes (antidiabetics), medicines for the treatment of gout (e.g., probenecid, sulfinpyrazone), norepinephrine, adrenaline:

The effect of insulin or oral antidiabetic medicines, medicines for the treatment of gout (e.g., probenecid, sulfinpyrazone), norepinephrine, and adrenaline may be decreased during simultaneous treatment with hydrochlorothiazide. A dose adjustment may be necessary.

Metformin:

Metformin should be used with caution due to the risk of lactic acid accumulation in the blood induced by possible kidney failure associated with the use of hydrochlorothiazide.

Digitalis glycosides:

The effect and side effects of cardiac glycosides may be increased.

Cytostatics (e.g., cyclophosphamide, fluorouracil, methotrexate)

During simultaneous treatment with cytostatics, an increase in bone marrow toxicity (especially a reduction in white blood cells, granulocytopenia) can be expected.

Skeletal muscle relaxants of the curare type:

The effect of curare-type muscle relaxants, which may be administered during certain operations, may be increased or prolonged by hydrochlorothiazide. Therefore, inform the anesthesiologist of treatment with hydrochlorothiazide before undergoing surgery.

Colestyramine, colestipol

Simultaneous use of colestyramine or colestipol reduces the absorption of hydrochlorothiazide.

Methyldopa:

During simultaneous use of methyldopa, there have been cases of red blood cell breakdown (hemolysis)

Medicines affected by changes in potassium levels in the blood:

Periodic monitoring of serum potassium levels and ECG is recommended when hydrochlorothiazide is administered with the following medicines:

• Class Ia antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide)
• Class III antiarrhythmics (e.g., amiodarone, sotalol, dofetilide, ibutilide)
• certain antipsychotics (e.g., thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
• other medicines, e.g., bepridil, cisapride, difemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine IV.

Allopurinol

The simultaneous administration of thiazides may increase the incidence of allergic reactions to allopurinol.

Amantadine:

Hydrochlorothiazide may increase the risk of side effects caused by amantadine.

Calcium salts:

Hydrochlorothiazide may increase serum calcium levels. If calcium supplements are prescribed, serum calcium levels should be monitored and the calcium dose adjusted accordingly.

Vitamin D supplements

The simultaneous administration of hydrochlorothiazide with vitamin D supplements may increase serum calcium levels due to decreased calcium excretion.

Cyclosporin:

The simultaneous administration of hydrochlorothiazide with cyclosporin may increase the risk of high uric acid levels (hyperuricemia) and gout complications.

Carbamazepine:

The simultaneous administration of hydrochlorothiazide with carbamazepine may decrease sodium levels in the blood. Therefore, sodium levels in the blood should be monitored.

Quinine:

The clearance of quinine may be reduced when administered with hydrochlorothiazide.

Tetracyclines:

The simultaneous use of hydrochlorothiazide and tetracyclines may cause an increase in serum urea.

Taking Hydrochlorothiazide Sandoz with foodand alcohol

Do not drink alcohol while being treated with this medicine, especially if you are also taking barbiturates (e.g., phenobarbital) and opioids, as it may intensify orthostatic hypotension (a sudden drop in blood pressure that causes dizziness due to changes in posture, such as standing up)

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:

There is limited data on the use of this medicine during the first trimester of pregnancy to estimate the potential harm. No adverse effects have been found in animal studies. Hydrochlorothiazide crosses the placenta. Hydrochlorothiazide may be harmful in the second and third trimester. You should only take this medicine during pregnancy if your doctor advises you to.

Breast-feeding:

Hydrochlorothiazide passes into breast milk. Do not take this medicine while breast-feeding unless your doctor advises you to.

Fertility:

There is no data on the possible effects of hydrochlorothiazide on fertility.

Driving and using machines

Hydrochlorothiazide has a minor to moderate influence on the ability to drive or use machines.

Even when taken as directed, this medicine may affect your reactions. Therefore, your ability to drive or use machines or work in locations without solid support may be affected.

This is especially true at the start of treatment, when the dose is increased, the medication is changed, or when it is taken in combination with alcohol.

Hydrochlorothiazide Sandoz contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to Take Hydrochlorothiazide Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is available in 25 mg tablets.

The dose should be established individually, especially after treatment has proven to be effective.

The recommended dose is:

Adults

High blood pressure (hypertension):

The initial recommended dose is 12.5 mg or 25 mg of hydrochlorothiazide (half a tablet to one tablet per day).

The recommended dose for long-term treatment is usually 12.5 mg of hydrochlorothiazide per day (half a tablet per day).

Cardiac, hepatic, and renal edema:

The initial recommended dose is 25 mg or 50 mg per day.

The recommended dose for long-term treatments is usually 25 mg to 100 mg per day.

Patient with hepatic or renal insufficiency:

In patients with hepatic or renal insufficiency, the dose should be adjusted according to the degree of insufficiency.

Patient with severe cardiac decompensation:

In patients with fluid retention due to severe cardiac muscle weakness (severe cardiac decompensation), the absorption of hydrochlorothiazide may be significantly reduced.

Advanced age:

In the treatment of elderly patients (65 years or older), attention should be paid to possible restrictions of renal function.

Use in children and adolescents (<18 years)

There is no experience in children and adolescents. Therefore, hydrochlorothiazide should not be administered to children or adolescents.

Method of administration

Oral route.

Take the tablets at breakfast time. Swallow the tablet whole with a sufficient amount of liquid, do not chew it.

The 25 mg tablet can be divided into equal doses.

Duration of treatment

The duration of treatment is not limited and will depend on the severity of your illness. After long-term treatments, hydrochlorothiazide should be discontinued gradually.

Please inform your doctor or pharmacist if you notice that the effect of this medication is too strong or too weak.

If you takemore Hydrochlorothiazide Sandoz than you should

If you take more hydrochlorothiazide than you should, contact your doctor immediately, he or she will decide what measures to take depending on your symptoms. In case of poisoning and/or severe symptoms, immediate medical treatment is required.

The symptoms of acute or chronic overdose will depend on the amount of fluid and electrolytes that have been lost.

When the loss of fluid and sodium is significant, an overdose can result in thirst, weakness, and dizziness, vomiting, muscle pain, and muscle spasms (e.g., cramps) and headache. Also, rapid heartbeat, decreased blood pressure (hypotension), and a drop in blood pressure that causes dizziness when standing up (orthostatic hypotension).

Dehydration and reduced blood volume can lead to thickening of the blood. Additionally, convulsions, fainting sensation (obnubilation), lethargy, confusion, brief periods of unconsciousness that disappear spontaneously, and renal failure may occur.

The loss of potassium can result in fatigue, weakness, muscle weakness, sensory disorders in the limbs (paresthesia), partial paralysis (paresis), and apathy. Furthermore, constipation, flatulence, and bloating may occur, as well as heart rhythm disorders.

Severe potassium loss can result in partial intestinal paralysis (subileus) or intestinal obstruction (paralytic ileus), altered consciousness, or even coma.

Changes in the ECG and increased sensitivity to digitalis preparations (sensitivity to glycosides) may occur.

It is common to have an increased excretion of magnesium in the urine (hyperMagnesuria) and, sometimes, a deficiency of magnesium in the blood may occur.

As a consequence of electrolyte and fluid losses, metabolic alkalosis may develop or a pre-existing metabolic alkalosis may worsen.

This medication can also cause the following side effects:

Very common side effects (may affect more than 1 in 10 people)

• Disorders of electrolyte and fluid balance, especially decreased levels of potassium, sodium, magnesium, and chloride, and increased levels of calcium in the blood (hypokalemia, hyponatremia, hypochloremia, and hypercalcemia).
• Increased blood sugar levels (hyperglycemia) and the presence of sugar in the urine (glucosuria) observed in patients with healthy metabolism, patients in pre-diabetic states (latent diabetes mellitus), or in diabetic patients and patients with potassium deficiency.
• Increased levels of uric acid in the blood (hyperuricemia), which can lead to gout attacks in patients with a predisposition.
• Increased levels of lipids in the blood (cholesterol, triglycerides).
• Increased presence of sugar in the urine (glucosuria).

Common side effects (may affect up to 1 in 10 people)

• Increased heart rate (palpitations).
• Lack of appetite, gastrointestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal pain, and cramps).
• Temporary increase in substances excreted in the urine (creatinine, urea).

Uncommon side effects (may affect up to 1 in 100 people)

• Decrease in the number of white blood cells (leukopenia).
• Visual disturbances (e.g., blurred vision, yellow vision, lack of tears, worsening of myopia).
• Decreased blood pressure when changing position, e.g., when standing up (orthostatic hypotension), especially in patients with depleted intravascular volume, e.g., patients with severe heart failure or undergoing high-dose diuretic treatment (increased when taken with alcohol, anesthetics, or sedatives).
• Vasculitis (inflammation of blood vessels).
• Shortness of breath (respiratory distress), acute interstitial pneumonia.
• Elevated levels of certain liver enzymes (amylase) in the blood (hyperamylasemia), pancreatitis, jaundice (cholestasis).
• Allergic skin reactions (e.g., itching, redness of the skin, skin rash, or photosensitivity).
• Acute renal inflammation (interstitial nephritis).
• Impotence.
• Drug fever (fever caused by an allergic reaction to the medication).

Rare side effects (may affect up to 1 in 1,000 people)

• Sleep disorders, depression.
• Headache, dizziness, tingling or numbness in arms or legs (paresthesia).
• Changes in heart rhythm (arrhythmias).
• Constipation.

Very rare side effects (may affect up to 1 in 10,000 people)

• Bone marrow depression, significant reduction in the number of certain white blood cells with a tendency towards infections and severe general symptoms (agranulocytosis).
• Anemia due to disorders in blood formation in the bone marrow (aplastic anemia).
• Destruction of red blood cells (hemolytic anemia) or autoimmune hemolytic anemia due to the formation of antibodies against hydrochlorothiazide during concomitant administration with methyldopa, resulting from increased breakdown of red blood cells.
• Hypochloremic acidosis.
• Pulmonary edema (excess fluid in the lungs).

Side effects of unknown frequency (cannot be estimated from the available data)

• In patients with diabetes (manifest diabetes mellitus), the metabolic situation may worsen. In patients with pre-diabetic states (latent diabetes), diabetes may become apparent.
• In cases of pre-existing gallstones (cholelithiasis), acute inflammation of the gallbladder (cholecystitis) may occur.
• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hydrochlorothiazide Sandoz

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Store this medication in its original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Hydrochlorothiazide Sandoz

The active ingredient is hydrochlorothiazide.

Each tablet contains 25 mg of hydrochlorothiazide.

The other ingredients are: lactose monohydrate, cornstarch, talc (E553b), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Appearance of the product and package contents

The 25 mg tablets are white, round, flat with a diameter of 7.8 to 8.2 mm and a thickness of 2.7 to 3.4 mm and are marked on one side.

The tablets are packaged in aluminum/transparent colored or colorless blisters or non-transparent PVC blisters.

Package size: 20, 30, or 90 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Zaklady Farmaceutyczne Polpharma S.A.

Ul Pelplinska 19

Starogard Gdanski

Pomorskie 83-200

Poland

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands Hydrochloorthiazide Sandoz 25 mg gluten-free, tablets

Spain Hidroclorotiazida Sandoz 25 mg EFG tablets

Date of the last revision of this leaflet:April 2022

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/