Tialorid mite

Leaflet attached to the packaging: patient information

Tialorid mite, 2.5 mg + 25 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 your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tialorid mite and what is it used for
• 2. Important information before taking Tialorid mite
• 3. How to take Tialorid mite
• 4. Possible side effects
• 5. How to store Tialorid mite
• 6. Contents of the packaging and other information

1. What is Tialorid mite and what is it used for

Tialorid mite 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 mite is indicated for the treatment of:

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

2. Important information before taking Tialorid mite

When not to take Tialorid mite:

if you are breastfeeding;

• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to take Tialorid mite, discuss it with your doctor or pharmacist.

Particular caution should be exercised when taking Tialorid mite:

Children and adolescents

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

Tialorid mite and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take, especially:

• medicines for diabetes: chlorpropamide, other oral anti-diabetic drugs, or insulin;
• other medicines 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 to treat depression);
• barbiturates (used to treat insomnia or anxiety);
• narcotic analgesics (e.g., codeine, dextropropoxyphene, morphine, pentazocine, pethidine);
• non-steroidal anti-inflammatory drugs (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 of the tubocurarine group (muscle relaxants used during surgical procedures).

Tialorid mite with food, drink, and alcohol

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

Your doctor may advise you to avoid consuming certain foods high in potassium, such as milk, bananas, raisins, and dried plums.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Pregnancy

The medicine may be used during pregnancy if necessary.

Breastfeeding

Hydrochlorothiazide passes into breast milk.

The medicine should not be used during breastfeeding.

Driving and using machines

Tialorid mite may cause side effects that affect the central nervous system, such as weakness, fatigue, dizziness.

If you experience these types of side effects, there is a risk associated with driving and operating machinery.

Tialorid mite contains lactose

Each tablet contains between 200 mg and 209 mg of lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Tialorid mite

Always take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the dose individually for each patient, depending on the severity of the disease and the response to the medicine.

Oral administration.

Use in adults

In hypertension

Initially, 1 tablet per day. If necessary, the dose can be increased to 2 tablets per day, given once or in two divided doses.

In heart failure

Initially, 1 tablet of Tialorid mite per day. If necessary, the dose can be gradually increased. Do not exceed the dose of 4 tablets per day.

In liver cirrhosis

Treatment starts with small doses, which are gradually increased until the desired diuretic effect is achieved. Do not exceed the dose of 4 tablets per day.

After the edema has subsided, the dose of the medicine should be reduced. The maintenance dose may be lower than the initial dose.

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 renal function and clinical response to treatment.

Overdose of Tialorid mite

If you have taken more than the recommended dose of the medicine, inform your doctor or go to the emergency department of the nearest hospital as soon as possible.

Take the remaining tablets or the packaging of the taken medicine with you, so the doctor knows what medicine was taken.

Missed dose of Tialorid mite

If you forget to take a dose, skip it and take the next dose at the usual time.

Do not take a double dose to make up for the missed dose.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur when taking the medicine:

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 disorders;
• 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 count, anemia, arrhythmias, tachycardia (rapid heart rate), excessive lowering of blood pressure, fainting, coronary heart disease. These disorders can be life-threatening in patients taking cardiac 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 disorders;
• fever, nasal congestion;
• hyperkalemia (high potassium levels in the blood), electrolyte disturbances, hyperglycemia (high blood sugar levels), 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 you experience any side effects, including those not listed in this leaflet, tell your 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

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, you can help provide more information on the safety of this medicine.

5. How to store Tialorid mite

Keep the medicine 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 stated 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.

Ask your 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 mite contains

• The active substances of the medicine are amiloride hydrochloride and hydrochlorothiazide.
• Each tablet contains 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide.
• The other ingredients of the medicine are lactose monohydrate, povidone K 30, and povidone cross-linked CL, magnesium stearate.

What Tialorid mite looks like and what the packaging contains

Tialorid mite is a yellowish-green, round, biconvex tablet.

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: