Hidrohlorothiazidum Polpharma

Leaflet attached to the packaging: patient information

Hydrochlorothiazidum Polpharma, 12.5 mg, tablets

Hydrochlorothiazidum Polpharma, 25 mg, tablets

Hydrochlorothiazidum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Hydrochlorothiazidum Polpharma and what is it used for
• 2. Important information before taking Hydrochlorothiazidum Polpharma
• 3. How to take Hydrochlorothiazidum Polpharma
• 4. Possible side effects
• 5. How to store Hydrochlorothiazidum Polpharma
• 6. Package contents and other information

1. What is Hydrochlorothiazidum Polpharma and what is it used for

Hydrochlorothiazidum Polpharma is a moderately acting diuretic.
It increases the volume of urine and the excretion of sodium, potassium, magnesium, phosphates, and chlorides,
while reducing the excretion of calcium in the urine.
The medicine lowers blood pressure in patients with hypertension.
The diuretic effect starts 2 hours after administration, and the maximum effect occurs after 3 to 6 hours. The duration of the diuretic effect after a single dose of the medicine is 6 to 12 hours.

Hydrochlorothiazidum Polpharma is indicated:

• In edema:
• in congestive heart failure
• in liver cirrhosis
• in renal function disorders (e.g., in nephrotic syndrome, acute interstitial nephritis).
• In hypertension:Hydrochlorothiazidum Polpharma is used in combination with other diuretics that spare potassium or with other antihypertensive drugs.

2. Important information before taking Hydrochlorothiazidum Polpharma

When not to take Hydrochlorothiazidum Polpharma:

• if the patient is allergic to hydrochlorothiazide, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has anuria;
• if the patient has severe renal or hepatic impairment;
• if the patient has Addison's disease;
• if the patient has elevated serum calcium levels;
• if the patient is pregnant;
• if the patient is taking lithium salts.

Warnings and precautions

Before starting to take Hydrochlorothiazidum Polpharma, the patient should discuss it with their doctor.

• Hydrochlorothiazide may disrupt the water-electrolyte balance, so during prolonged use of this medicine, it is recommended to monitor the levels of electrolytes (sodium, potassium, magnesium, chlorides). A potassium-rich diet is also recommended to prevent a decrease in potassium levels in the blood (hypokalemia). Patients with liver cirrhosis are particularly at risk of hypokalemia. Hypokalemia in patients taking digitalis glycosides increases the toxicity of these drugs. The following symptoms indicate water-electrolyte balance disorders: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, convulsions, disorientation, muscle cramps, muscle weakness, hypotension, oliguria, tachycardia, nausea, and vomiting.
• Hydrochlorothiazide may accelerate the onset or exacerbate symptoms of gout in patients with renal function disorders. In this case, the medicine should be discontinued.
• Hydrochlorothiazide may reduce the effectiveness of oral antidiabetic drugs and insulin, and increase cholesterol levels.
• In patients with latent diabetes, treatment with hydrochlorothiazide may cause diabetes to manifest.
• Patients with liver function disorders should use the medicine with caution, as even slight electrolyte disturbances can cause hepatic coma.
• Hydrochlorothiazide may increase the level of uric acid in the blood and cause gout.
• Hydrochlorothiazide may exacerbate symptoms of systemic lupus erythematosus.
• If the patient has a history of malignant skin tumors or if an atypical skin change appears during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Hydrochlorothiazidum Polpharma, the patient should protect their skin from sunlight and UV radiation.
• If the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they can occur within a few hours to weeks after taking Hydrochlorothiazidum Polpharma. If left untreated, they can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.
• If the patient has experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Hydrochlorothiazidum Polpharma, they should seek medical help immediately.

Children

The use of the medicine is not recommended in infants and children.

Hydrochlorothiazidum Polpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
When hydrochlorothiazide is used in combination with corticosteroids, corticotropin, and amphotericin B, hypokalemia may be exacerbated.
In patients with diabetes, taking hydrochlorothiazide may increase the need for insulin and oral antidiabetic drugs.
In patients treated with digitalis glycosides, hydrochlorothiazide increases the toxicity of these drugs.
Hydrochlorothiazide increases the toxicity of lithium salts.
When hydrochlorothiazide is used in combination with non-steroidal anti-inflammatory drugs, the risk of renal failure may increase.
These drugs may also reduce the diuretic, natriuretic, and antihypertensive effects of hydrochlorothiazide.
When hydrochlorothiazide is used in combination with certain antihypertensive drugs, such as guanethidine, methyldopa, or ganglionic blockers, severe orthostatic hypotension may occur.
Cholestyramine and colestipol may bind hydrochlorothiazide and reduce its absorption from the gastrointestinal tract (hydrochlorothiazide should be taken 2 hours before these drugs).
Hydrochlorothiazide enhances the muscle-relaxing effect of tubocurarine.
In laboratory tests performed during treatment with hydrochlorothiazide, false-negative results may be obtained in tyramine and phentolamine assays, as well as in the histamine test for pheochromocytoma.
Hydrochlorothiazide should be discontinued before performing functional tests of the parathyroid glands, as the medicine affects calcium metabolism.

Hydrochlorothiazidum Polpharma with food, drinks, and alcohol

Hydrochlorothiazidum Polpharma can be taken with or without food.
During treatment with the medicine, the patient should not consume alcohol, especially if they are also taking barbiturates (e.g., phenobarbital) and opioids, as orthostatic hypotension may be exacerbated.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine should not be taken during pregnancy.
Women should tell their doctor if they are or think they may be pregnant. The doctor will recommend an alternative medicine instead of Hydrochlorothiazidum Polpharma. Hydrochlorothiazide crosses the placental barrier, and its use after the third month of pregnancy may cause fetal and neonatal damage.
Breastfeeding
Hydrochlorothiazide passes into breast milk in small amounts. The use of thiazides in high doses has a diuretic effect and may inhibit milk production. The use of hydrochlorothiazide during breastfeeding is not recommended, and the lowest effective dose should be used.

Use in elderly patients (over 65 years old)

In patients with congestive heart failure and liver disease, during heat waves, hyponatremia may occur. Elderly patients, women, individuals with low body mass, those on a low-sodium diet, and those taking small amounts of fluids orally are particularly at risk of these disorders. In these conditions, the doctor will recommend restricting fluid intake to 500 ml per day and discontinuing the diuretic.

Driving and operating machinery

The medicine may cause side effects from the central nervous system (such as dizziness and vision disturbances), so there is a risk associated with driving and operating machinery.

Hydrochlorothiazidum Polpharma contains lactose

Hydrochlorothiazidum Polpharma, 12.5 mg, tablets: Each tablet contains 65.2 mg of lactose monohydrate.
Hydrochlorothiazidum Polpharma, 25 mg, tablets: Each tablet contains 130.4 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Hydrochlorothiazidum Polpharma

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose

Infants and children

The use of the medicine is not recommended in infants and children.

Adults

• In edemaInitially 25 mg to 75 mg per day, taken once or in 2 divided doses. After improvement, the doctor will recommend gradually reducing the dose to a maintenance dose, which is taken every other day. The recommended maximum daily dose is 100 mg.
• In hypertension12.5 mg to 25 mg per day, taken once or in 2 divided doses (in monotherapy or with another antihypertensive drug). The daily dose should not exceed 50 mg.

Dosing in elderly patients (over 65 years old)

The dose of the medicine in these patients should be adjusted according to their renal function and response to the medicine.

Taking a higher dose of Hydrochlorothiazidum Polpharma than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or go to the nearest hospital.
The most common symptoms of overdose may be:

• loss of water and electrolytes, decreased potassium, sodium, and alkalosis (alkalinity), elevated blood urea nitrogen, especially in patients with renal failure;
• rapid heartbeat, hypotension;
• shock, weakness, fatigue;
• confusion, dizziness, loss of consciousness;
• muscle cramps, paresthesia (tingling, burning, and numbness in the limbs);
• polyuria, oliguria, or anuria;
• nausea, vomiting, thirst.

Procedure in case of overdose

There is no specific antidote for hydrochlorothiazide poisoning.
In case of poisoning, the patient should induce vomiting, or gastric lavage should be performed with the addition of activated charcoal. Symptomatic treatment should be applied. If necessary, oxygen or assisted breathing should be used.
A patient with hypotension or shock should be placed in a suitable position (legs elevated relative to the torso), given fluids and electrolytes, especially potassium and sodium. The patient should remain under close supervision until the water-electrolyte balance disorders have resolved.

Missing a dose of Hydrochlorothiazidum Polpharma

In case of missing a dose, the patient should take it as soon as possible. If it is already time for the next dose, the patient should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Hydrochlorothiazidum Polpharma

The patient should not stop treatment or change the dosage without consulting their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Long-term use of the medicine may lead to the development of electrolyte disorders, such as:
decreased potassium, sodium, and magnesium levels in the blood, as well as metabolic alkalosis.
Hydrochlorothiazidum Polpharma may cause the following side effects:

• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion) (very rare - occurs in less than 1 in 10,000 patients);
• loss of appetite, gastric irritation, nausea, vomiting, cramps, diarrhea, or constipation;
• jaundice, pancreatitis, and salivary gland inflammation;
• dizziness and headaches, paresthesia (tingling, burning, and numbness in the limbs);
• photosensitivity, rash, urticaria, exfoliative dermatitis, fever, purpura, vasculitis, allergic pneumonitis, and pulmonary edema;
• renal function disorders and interstitial nephritis;
• decreased white blood cell count, platelet count, and anemia;
• heart function disorders due to potassium deficiency, manifested by ECG changes and arrhythmias. These disorders can be life-threatening in patients taking digitalis glycosides.
• orthostatic hypotension (related to changes in body position);
• hyperglycemia (elevated blood glucose), glycosuria (glucose in the urine), hyperuricemia (elevated uric acid in the blood), electrolyte balance disorders;
• muscle cramps;
• weakness, restlessness;
• impotence;
• vision disturbances (xanthopsia), blurred vision (transient);
• malignant skin tumors and lip tumors (non-melanoma skin cancer) (frequency unknown - frequency cannot be determined from available data);
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma) (frequency unknown).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hydrochlorothiazidum Polpharma

Store in the original packaging to protect from light and moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydrochlorothiazidum Polpharma contains

• The active substance of the medicine is hydrochlorothiazide. Each tablet contains 12.5 mg or 25 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, modified cornstarch, talc, colloidal anhydrous silica, magnesium stearate.

What Hydrochlorothiazidum Polpharma looks like and what the package contains

The 12.5 mg tablets are white, round, and biconvex.
The 25 mg tablets are white, round, and flat, with a dividing line. The tablet can be divided into equal doses.
The package contains 30 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of the last update of the leaflet: