Tialorid

Leaflet attached to the packaging: patient information

Tialorid, 5 mg + 50 mg, tablets

Amiloride hydrochloride + Hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 their symptoms 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 Tialorid and what is it used for
• 2. Important information before taking Tialorid
• 3. How to take Tialorid
• 4. Possible side effects
• 5. How to store Tialorid
• 6. Contents of the packaging and other information

1. What is Tialorid and what is it used for

Tialorid is a medicine that contains two active substances: amiloride hydrochloride, which is a potassium-sparing diuretic, and hydrochlorothiazide, which is a moderately acting diuretic.

Tialorid is indicated for the treatment of:

• mild or moderate hypertension (as a single medication or with other blood pressure-lowering medications);
• congestive heart failure;
• liver cirrhosis with ascites and edema.

2. Important information before taking Tialorid

When not to take Tialorid:

• if the patient is allergic to amiloride hydrochloride, hydrochlorothiazide, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6). Other sulfonamides may include: thiazide diuretics, antibacterial sulfonamides (e.g., sulfamethoxazole), and acetazolamide, which is used to treat edema and glaucoma (increased eye pressure), heart disease, and epilepsy;
• if the patient has elevated blood levels of one or more of the following substances: potassium, calcium, urea, or creatinine;
• if the patient has Addison's disease;
• if the patient has diabetes (high blood glucose levels);
• if the patient has liver or kidney disease;
• if the patient is taking lithium (a medication used for depression);
• if the patient is taking other potassium-sparing medications (e.g., triamterene, spironolactone, eplerenone);
• if the patient is taking potassium supplements or following a potassium-rich diet (in patients with significantly reduced potassium levels in the blood, the use of Tialorid will be decided by the doctor);

if the patient is breastfeeding;

• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Tialorid, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking Tialorid:

• if the patient has elevated levels of naturally occurring substances in the body: uric acid, cholesterol, and triglycerides;
• if the patient has systemic lupus erythematosus;
• if the patient has gout;
• if the patient has recently experienced severe vomiting or diarrhea;
• if the patient is receiving intravenous fluids;
• if the patient is scheduled for a parathyroid function test (the patient should stop taking the medication before the test);
• if the patient has a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip cancer (non-melanoma skin cancer). During treatment with Tialorid, 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 may occur within a few hours to weeks after taking Tialorid. If left untreated, they may 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 Tialorid, they should seek medical attention immediately.

Children and adolescents

The medicine is not indicated for use in children and adolescents under 18 years of age.

Tialorid and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, especially:

• medications for diabetes: chlorpropamide, other oral antidiabetic medications, or insulin;
• other medications for high blood pressure, such as guanethidine, methyldopa, angiotensin II antagonists, ACE inhibitors (enalapril, captopril);
• pressor amines (e.g., adrenaline) used to treat severe allergic reactions;
• lithium (used for depression);
• barbiturates (used to treat insomnia or anxiety);
• narcotic pain medications (e.g., codeine, dextropropoxyphene, morphine, pentazocine, pethidine);
• non-steroidal anti-inflammatory medications (used to treat pain and fever, e.g., acetylsalicylic acid, ibuprofen);
• cholestyramine or colestipol (used to treat high cholesterol levels in the blood);
• corticosteroids (used to treat rheumatism, arthritis, allergic diseases, certain skin diseases, asthma, or blood disorders);
• adrenocorticotropic hormone ACTH (used in tests to assess adrenal function);
• tacrolimus (used after liver or kidney transplantation to prevent organ rejection);
• cyclosporine (used to treat rheumatoid arthritis or to prevent transplant rejection);
• trilostane (used to treat breast cancer or adrenal hyperplasia);
• muscle relaxants from the tubocurarine group (muscle relaxants used during surgical procedures).

Tialorid with food, drink, and alcohol

When taking Tialorid with alcohol, orthostatic hypotension (low blood pressure when changing position from sitting or lying down to standing) may be exacerbated.

The doctor may recommend avoiding certain foods that contain high amounts of potassium, such as milk, bananas, raisins, and dried plums.

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 before taking this medicine.

Pregnancy

The medicine may be used during pregnancy only if absolutely necessary.

Breastfeeding

Hydrochlorothiazide passes into breast milk.

The medicine should not be used during breastfeeding.

Driving and using machines

Tialorid may cause side effects that affect the central nervous system, such as:

weakness, fatigue, dizziness. If these types of side effects occur, there is a risk associated with driving and operating machines.

Tialorid contains lactose

Each tablet contains 100 mg of lactose monohydrate.

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Tialorid

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.

The doctor will determine the dose individually for each patient, depending on the severity of the disease and the patient's response to treatment.

Oral administration.

Use in adults

For hypertension

Initially, 1 tablet of Tialorid or another medication containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide per day. If necessary, the dose can be increased to 1 tablet of Tialorid per day.

For congestive heart failure

Initially, 1 tablet of Tialorid or another medication containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide per day. If necessary, the dose can be gradually increased to 2 tablets of Tialorid per day. The dose should not exceed 2 tablets of Tialorid per day.

For liver cirrhosis

Treatment starts with small doses, which are gradually increased until the desired diuretic effect is achieved. The dose should not exceed 2 tablets of Tialorid per day.

After the edema has subsided, the dose of Tialorid should be reduced. The maintenance dose may be lower than the initial dose. If necessary, Tialorid or another medication containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide can be used.

Use in children and adolescents

The medicine is not indicated for use in children and adolescents under 18 years of age.

Use in elderly patients (over 65 years)

In these patients, the dose of the medicine should be determined based on kidney function and clinical response to treatment.

Overdose of Tialorid

In case of overdose, the patient should inform their doctor or go to the emergency department of the nearest hospital as soon as possible. The patient should bring any remaining tablets or packaging of the taken medicine, so the doctor knows what medicine was taken.

Missed dose of Tialorid

If the patient forgets to take a dose, they should skip it and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur during treatment with Tialorid:

Very rare (occurring in less than 1 in 10,000 patients):

• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (frequency cannot be estimated from the available data):

• loss of appetite, nausea, vomiting, diarrhea, constipation, stomach pain, bleeding, feeling of fullness in the abdominal cavity, thirst, dryness of the oral mucosa, hiccups, pancreatitis, taste disturbances;
• cough;
• dizziness, headache, weakness, fatigue, chest pain, and back pain, malaise;
• paresthesia (sensory disturbances, e.g., tingling, burning), numbness, restlessness, insomnia or drowsiness, feeling of fatigue, nervousness, memory disorders, depression;
• changes in blood test results, anemia, arrhythmias, tachycardia (rapid heart rate), excessive lowering of blood pressure, fainting, coronary heart disease. These disorders may be life-threatening in patients taking digitalis glycosides.
• impotence;
• urination disorders, nocturia, urinary incontinence, kidney function disorders;
• itching, rash, photosensitivity;
• flushing, excessive sweating;
• limb pain, muscle cramps, joint pain;
• shortness of breath;
• vision disturbances;
• fever, nasal congestion;
• hyperkalemia (high potassium levels in the blood), electrolyte disturbances, hyperglycemia (high glucose levels in the blood), dehydration, gout;
• anaphylactic reaction (sudden allergic reaction with shortness of breath, rash, wheezing, and low blood pressure);
• malignant skin tumors and lip cancer (non-melanoma skin cancer);
• 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).

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +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 Tialorid

The medicine should be stored out of sight and reach of children.

Store in the original packaging.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date stated on the packaging is the last day of the given month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means 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. Contents of the packaging and other information

What Tialorid contains

• The active substances of the medicine are amiloride hydrochloride and hydrochlorothiazide. Each tablet contains 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.
• The other ingredients of the medicine are: lactose monohydrate, potato starch, povidone, talc, magnesium stearate.

What Tialorid looks like and what the packaging contains

Tialorid is a yellowish-green, round, flat tablet on both sides.

One packaging of the medicine contains 50 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet: