Package Insert: Information for the Patient

Hidroclorotiazida Sandoz 25 mgTablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others

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

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Hidroclorotiazida belongs to a group of medicines called “diuretics”. Diuretics increase the amount of urine produced by the kidneys and are sometimes referred to as water pills.

Hidroclorotiazida is indicated for the treatment of:

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

Do not take Hidroclorotiazida Sandoz

• if you are allergic to hydrochlorothiazide or other sulfonamide-derived medications or to any of the other components of this medication (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 diseases such as hepatic failure with loss of consciousness (hepatic coma or precoma),
• if you have low levels of potassium in your blood (hypokalemia),
• if you have low levels of sodium in your blood (hyponatremia),
• if you have a reduced amount of circulating blood (hypovolemia),
• if you have elevated levels of calcium in your blood (hypercalcemia),
• if you have elevated levels of uric acid in your blood that are causing symptoms (patients who have had gout),
• if you have gout.

Warnings and precautions

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

• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may 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 a higher risk of having an allergic reaction to this medication,
• 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 renal insufficiency (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 renal function.

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

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

During treatment with this medication, you should drink enough fluids. Due to increased potassium loss, you should follow a diet rich in potassium (e.g., bananas, vegetables, nuts). Potassium loss can also be reduced or prevented by simultaneous treatment with potassium-sparing diuretics.

Special observations

Treatment should bestoppedin case of:

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

Advanced age (65 years or more)

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

Children and adolescents (<18

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

Other medications and Hidroclorotiazida Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Concomitant use not recommended:

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

The simultaneous administration of hydrochlorothiazide and medications that increase potassium loss and are associated with potassium deficiency in the blood may lead to increased 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 permitted 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 medications, beta-blockers (group of medications for high blood pressure, heart problems, or elevated eye pressure), nitrates (medications used for angina pectoris), barbiturates (anxiolytic and anesthetic medications), phenothiazines (e.g., certain antipsychotic medications), tricyclic antidepressants (medications for depression), vasodilators (medications that dilate blood vessels), alcohol: The hypotensive effect of hydrochlorothiazide may increase by simultaneous administration with these medications or alcohol consumption.

Inhibitors of the ECA (e.g., captopril, enalapril):

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

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

These medications may reduce the effect of reducing blood pressure and the diuretic effect of hydrochlorothiazide. There have been isolated cases of worsening renal function, especially in patients with pre-existing poor renal function.

When taking salicylates 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 NSAIDs may cause acute renal failure.

Beta-blockers and diazoxide

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

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

The effect of insulin or oral antidiabetic medications, medications for treating gout (e.g., probenecid, sulfinpyrazone), noradrenaline, and adrenaline may be reduced during simultaneous treatment with hydrochlorothiazide. It may be necessary to adjust the dose.

Metformin:

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

Digitoxins:

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

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

During simultaneous treatment with cytostatics, there may be an increase in the toxicity of the bone marrow (especially a reduction in white blood cells (granulocytopenia)).

Curare-type muscle relaxants:

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

Colestiramine, colestipol

The simultaneous use of colestiramine or colestipol reduces the absorption of hydrochlorothiazide.

Metildopa:

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

Medications affected by potassium alterations in the blood:

It is recommended to monitor potassium serum levels and ECG periodically when hydrochlorothiazide is administered with the following medications:

• Class Ia antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide)
• Class III antiarrhythmics (e.g., amiodarone, sotalol, dofetilide, ibutilide)
• some antipsychotics (e.g., thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
• other medications, e.g., bepridil, cisapride, difemanil, erythromycin IV, halofantrin, mizolastine, pentamidine, esparfloxacine, terfenadine, vincamine IV.

Alopurinol

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

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.

Ciclosporin:

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

Carbamazepine:

The simultaneous administration of hydrochlorothiazide with carbamazepine may reduce serum sodium levels. Therefore, serum sodium levels 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 Hidroclorotiazida Sandoz with food and alcohol

Do not take alcohol while taking this medication, 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 position, e.g., standing up)

Pregnancy,lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

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

Lactation:

Hydrochlorothiazide passes into breast milk. Do not take this medication while breastfeeding unless your doctor advises it.

Fertility:

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

Driving and operating machines

Hydrochlorothiazide has a minor or moderate effect on your ability to drive or operate machines.

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

This occurs mainly at the beginning of treatment, when the dose is increased, when the medication is changed, or when it is taken in combination with alcohol.

Hidroclorotiazida Sandoz contains lactose.

This medication contains lactose. If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medication.

Follow exactly the administration instructions of this medication 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 the treatment has proven to be effective.

The recommended dose is:

Adults

Hypertension:

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

The recommended dose for long-term treatment is usually 12.5 mg of hydrochlorothiazide per day (half 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 treatment is usually 25 mg to 100 mg per day.

Patients with liver or kidney insufficiency:

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

Patients with severe cardiac decompensation:

In patients with significant fluid retention due to severe cardiac 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 on renal function.

Use in children and adolescents (<18

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

Administration form

Oral route.

Take the tablets with breakfast. Swallow the tablet whole with sufficient liquid, do not chew it.

The 25 mg tablet can be divided into equal doses.

Treatment duration

The duration of treatment is not limited and will depend on the severity of your disease. 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 Hidroclorotiazida Sandoz than you should

If you take more hydrochlorothiazide than you should, contact your doctor immediately, and they 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 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 orthostatic hypotension that causes dizziness when standing up.

Dehydration and reduced blood volumes can lead to blood thickening. Additionally, seizures, feeling of fainting (obnubilation), lethargy, confusion, brief periods of unconsciousness that disappear spontaneously caused by reduced blood flow to the brain (circulatory collapse) and renal insufficiency may appear.

The loss of potassium can result in fatigue, muscle weakness, tingling, itching, or prickling in arms and legs (paresthesia), partial paralysis (paresis), apathy, flatulence, and feeling of swelling, constipation, and cardiac rhythm disturbances. A severe loss of potassium can lead to intestinal blockage (paralytic ileus), decreased level of consciousness, or even coma (hypokalemic coma).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Hidroclorotiazida Sandoz

If you forgot to take a dose, take it as soon as you remember. Do not take a double dose to compensate for the missed dose, but continue treatment with the prescribed dose.

If you interrupt treatment with Hidroclorotiazida Sandoz

Do not interrupt treatment with hydrochlorothiazide or change the dose without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking this medicine and immediately inform your doctor, or go to the nearest hospital emergency department.

• Decreased platelet count in the blood (thrombocytopenia, sometimes with purpura) that causes bleeding or bruising more easily than normal.
• Anaphylactic reaction, e.g., sudden signs of allergy such as hives, itching, or urticaria on the skin.
• Swelling of the face, lips, tongue, or other parts of the body.
• Lack of air, wheezing, or difficulty breathing.
• Severe skin reactions (toxic epidermal necrolysis, cutaneous lupus erythematosus, reactions similar to lupus erythematosus, reactivation of lupus erythematosus).
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), this is a very rare adverse reaction (can affect up to 1 in 10,000 people).

The following side effects may occur due to disturbances in electrolyte and fluid balance

If you take hydrochlorothiazide for a long time, disturbances in hydroelectrolyte metabolism occur frequently. In particular, reduced levels of sodium and potassium (hypokalemia and hyponatremia), reduced levels of magnesium and chloride (hypomagnesemia, hypochloremia), and elevated levels of calcium in the blood (hypercalcemia).

At high doses, fluid and sodium loss may occur. These can cause the following symptoms: dry mouth and thirst, feeling of weakness and dizziness, muscle pain and muscle cramps (e.g., calf cramps), headaches, nervousness, palpitations, decreased blood pressure (hypotension), and orthostatic hypotension that causes dizziness when changing position, e.g., when standing up.

In cases of excessive urine excretion, dehydration and decreased circulating blood volume (hypovolemia) may occur, resulting in blood becoming thicker (hemoconcentration). In rare cases, seizures, feeling of fainting (obnubilation), confusion, brief periods of unconsciousness that resolve spontaneously, and circulatory collapse may occur.

Thrombosis and embolism have also been reported, especially in elderly patients or those with venous diseases.

The consequences of potassium loss may include fatigue, drowsiness, muscle weakness, sensory disturbances in the extremities (paresthesia), partial paralysis (paresis), and apathy. Additionally, constipation, flatulence, and a feeling of bloating (meteorism), and cardiac arrhythmias may occur.

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

Changes in the ECG and increased sensitivity to digital preparations (sensitivity to glucosides) may occur.

Commonly, an increase in urinary magnesium excretion (hypermagnesuria) occurs, and sometimes it may cause magnesium deficiency in the blood.

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

This medicine may also cause the following side effects:

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

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

Frequent side effects (may affect 1 in 10 people)

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

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

• Decreased white blood cell count (leukopenia).
• Visual disturbances (e.g., blurred vision, seeing objects yellow, lack of tears, worsening of myopia).
• Reduced 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 those treated with high doses of diuretics (increases when taken with alcohol, anesthetics, or sedatives).
• Inflammation of blood vessels (vasculitis).
• Lack of air (respiratory distress), acute interstitial pneumonia.
• Elevated levels of certain liver enzymes (amylase) in the blood (hyperamylasemia), pancreatitis, yellow discoloration (jaundice, intrahepatic cholestasis).
• Skin allergic reactions (e.g., itching, skin redness, skin eruptions, or hives caused by hypersensitivity to sunlight (photoallergic exanthema), localized petechiae hemorrhages on the skin and mucous membranes (purpura), severe itching rashes (urticaria).
• Acute interstitial nephritis (inflammation of the kidneys).
• Impotence.
• Medication fever (fever caused by an allergic reaction to the medication).

Rare side effects (may affect up to 1 in 10,000 people):

• Sleep disturbances, depression.
• Headaches, dizziness, itching, or tingling in the arms or legs (paresthesia).
• Changes in heart rhythm (arrhythmias).
• Constipation.

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

• Medullary bone depression, significant reduction in the number of certain white blood cells in the blood with a tendency towards infections and severe general symptoms (agranulocytosis).
• Anemia due to disturbances in blood cell formation in the bone marrow (aplastic anemia).
• Reduction of red blood cells (hemolytic anemia) or autoimmune hemolytic anemia due to the formation of antibodies against hydrochlorothiazide during concomitant administration with metildopa, resulting in increased destruction of red blood cells.
• Metabolic acidosis.
• Pulmonary edema (excess fluid in the lungs).

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

• In patients with diabetes (manifest diabetes), the metabolic situation may worsen. In patients with pre-diabetes (latent diabetes), diabetes may manifest.
• In cases of pre-existing gallstones (cholelithiasis), acute inflammation of the gallbladder (cholecystitis) may occur.
• Skin cancer 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 of side effects

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

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

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

Conserve this medication in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hydrochlorothiazide Sandoz

The active ingredient is hydrochlorothiazide

Each tablet contains 25 mg of hydrochlorothiazide.

The other components are: lactose monohydrate, cornstarch, talc (E553b), anhydrous colloidal silica (E 551) and magnesium stearate (E470b).

Appearance of the product and content of the container

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 marked on one side.

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

Container size: 20, 30 or 90 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Zaklady Farmaceutyczne Polpharma S.A.

Ul Pelplinska 19

Starogard Gdanski

Pomorskie 83-200

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

NetherlandsHydrochloorthiazide Sandoz 25 mg glutenvrij, tablets

SpainHydrochlorothiazide Sandoz 25 mg tablets EFG

Date of the last review of this leaflet:April 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/