Package leaflet: Information for the patient

Tialorid, 5 mg + 50 mg, tablets
Amiloridi hydrochloridum + Hydrochlorothiazidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Tialorid is and what it is used for
Important information before taking Tialorid
How to take Tialorid
Possible side effects
How to store Tialorid
Contents of the pack and other information

1. What Tialorid is and what it is used for

Tialorid is a medicine containing two active substances: amiloride hydrochloride, which is a potassium-sparing diuretic, and hydrochlorothiazide, which is a diuretic with moderate diuretic action.
Tialorid is indicated in the treatment of:

mild or moderate arterial hypertension (as monotherapy or in combination with other antihypertensive medicines);
cardiac insufficiency;
liver cirrhosis with ascites and oedema.

2. Important information before using Tialorid

When not to use 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 in the treatment of oedema and glaucoma (increased eye pressure), heart conditions 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 medicine used in depression);
if the patient is taking other potassium-sparing medicines (e.g. triamterene, spironolactone, eplerenone);
if the patient is taking potassium supplements or following a potassium-rich diet (in patients with significant reduction in blood potassium levels, the decision to use Tialorid will be made by the doctor);
if the patient is breastfeeding;
in children and adolescents under 18 years of age.

Warnings and precautions
Before starting Tialorid, discuss this with your doctor or pharmacist.
Exercise particular caution when using 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 diarrhoea;
if the patient is receiving intravenous fluids;
if the patient is scheduled for parathyroid function testing (treatment with Tialorid should be discontinued before the test);
if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Tialorid, protect the skin from sunlight and UV radiation;
if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Tialorid. If untreated, they may lead to permanent vision loss. If the patient previously had an allergic reaction to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.
if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Tialorid, seek immediate medical help.

Children and adolescents
This medicine is not indicated for use in children and adolescents under 18 years of age.
Tialorid with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially if using:

medicines used in diabetes: chlorpropamide, other oral antidiabetic medicines or insulin;
other medicines used to treat high blood pressure, such as guanethidine, methyldopa, angiotensin II antagonists, ACE inhibitors (enalapril, captopril);
pressor amines (e.g. adrenaline) used in the treatment of severe allergic reactions;
lithium (used in depression);
barbiturates (used to treat insomnia or anxiety);
narcotic painkillers (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 elevated blood cholesterol levels);
corticosteroids (used to treat rheumatism, arthritis, allergic conditions, certain skin diseases, asthma or blood disorders);
adrenocorticotropic hormone (ACTH) (used in tests assessing proper adrenal gland function);
tacrolimus (used after liver or kidney transplantation to prevent organ rejection);
cyclosporine (used in the treatment of rheumatoid arthritis or to prevent transplant rejection after organ transplantation);
trilostane (used in the treatment of breast cancer or adrenal hyperfunction);
muscle relaxants of the tubocurarine group (muscle-relaxing medicines used during surgical procedures).

Tialorid with food, drink and alcohol
When taking Tialorid, alcohol may worsen orthostatic hypotension (a drop in blood pressure when changing position from sitting or lying down to standing).
Your doctor may recommend avoiding certain foods high in potassium, such as milk, bananas, raisins and dried plums.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Tialorid may be used during pregnancy only if clearly necessary.
Breastfeeding
Hydrochlorothiazide passes into breast milk.
Tialorid should not be used during breastfeeding.
Driving and operating machinery
Tialorid may cause adverse effects on the central nervous system such as: weakness, fatigue, dizziness. If such adverse effects occur, there is a risk associated with driving and operating machinery.
Tialorid contains lactose
Each tablet contains 100 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Tialorid

This medicine should always be used exactly as your doctor has instructed. If in doubt, 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 treatment.
Oral administration.
Use in adults
In arterial hypertension
Initially, 1 tablet of Tialorid mite or another medicine containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide per day. If necessary, the dose may be increased
to 1 tablet of Tialorid per day.
In congestive heart failure
Initially, 1 tablet of Tialorid mite or another medicine containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide per day. If necessary, the dose may be gradually
increased up to 2 tablets of Tialorid per day. The dose should not exceed 2 tablets of Tialorid
per day.
In liver cirrhosis
Treatment should be initiated with low 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 disappearance of oedema, the dose of Tialorid should be reduced. The maintenance dose may be
lower than the initial dose. If necessary, Tialorid mite or another medicine containing 2.5 mg of amiloride hydrochloride and 25 mg of hydrochlorothiazide may be used.
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Use in elderly patients (over 65 years of age)
In these patients, the dose should be determined according to renal function and clinical response to
treatment.
Taking more Tialorid than you should
If you take more medicine than you should, inform your doctor or go to the nearest hospital emergency department as soon as possible. Take the remaining tablets or the medicine packaging with you so that the doctor knows which medicine has been taken.
If you forget to take Tialorid
If you forget to take a dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects may occur during treatment with this medicine:

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

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

Frequency unknown (frequency cannot be determined from available data):

loss of appetite, nausea, vomiting, diarrhoea, 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, back pain, malaise;
paraesthesia (sensory sensations such as tingling, burning), numbness, motor restlessness, insomnia or somnolence, feeling of tiredness, nervousness, memory disturbances, depression;
blood count abnormalities, anaemia, cardiac arrhythmias, tachycardia (rapid heartbeat), excessive decrease in blood pressure, fainting, ischaemic heart disease. These disorders may be life-threatening in patients taking digitalis glycosides.
impotence;
urinary disorders, nocturia, urinary incontinence, renal function disorders;
itching, rash, photosensitivity;
facial flushing, excessive sweating;
limb pain, muscle cramps, joint pain;
dyspnoea (shortness of breath);
visual disturbances;
fever, nasal congestion;
hyperkalaemia (high potassium levels in the blood), electrolyte imbalances, hyperglycaemia (high blood glucose levels), dehydration, gout;
anaphylactic reaction (sudden allergic reaction with shortness of breath, rash, wheezing, and low blood pressure);
skin and lip malignancies (non-melanoma skin cancers);
impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive accumulation of fluid between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Tialorid

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 refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tialorid contains

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

What Tialorid looks like and contents of the pack
Tialorid is a round tablet, yellowish with a cyan tint, biconvex.
One pack contains 50 tablets.
Marketing authorisation holder and manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01