Package leaflet: information for the patient

Toptelmi HCT, 80 mg + 25 mg, coated tablets
Telmisartanum + Hydrochlorothiazidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any questions.
This medicine has been prescribed for a specific individual only. Do not give it to others.
The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed
in this leaflet, inform the doctor or pharmacist. See section 4.
Table of contents:

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

1. What Toptelmi HCT is and what it is used for

Toptelmi HCT is a combination medicine containing two active substances in one tablet:
telmisartan and hydrochlorothiazide. Both substances help control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. Angiotensin II is a substance produced by the body that causes narrowing of blood vessels, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, leading to widening of blood vessels and lowering of blood pressure.
Hydrochlorothiazide belongs to a group of diuretic medicines called thiazides, which increase urine output, resulting in a reduction of blood pressure.

Untreated high blood pressure may cause damage to blood vessels in various organs, sometimes leading to myocardial infarction, heart or kidney failure, stroke, or loss of vision. Before such damage occurs, high blood pressure is usually asymptomatic. Therefore, it is important to regularly monitor blood pressure to ensure it remains within the normal range.
Toptelmi HCT is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with Toptelmi HCT 80 mg + 12.5 mg, or in patients whose blood pressure has been stabilized using telmisartan and hydrochlorothiazide administered separately.

2. Important information before using Toptelmi HCT

When NOT to use Toptelmi HCT
if the patient is allergic to telmisartan or to any of the other ingredients of this medicine
(listed in section 6);
if the patient is allergic to hydrochlorothiazide or to other sulfonamides;
if the patient is more than 3 months pregnant (in early pregnancy it is also better not to
take Toptelmi HCT – see section on pregnancy);
if the patient has been diagnosed with severe liver dysfunction, such as biliary obstruction or
cholestasis (problems with bile flow from the liver and gallbladder)
or another severe liver disease;
if the patient has severe kidney disease or anuria (less than 100 mL urine per day);
if the doctor has diagnosed the patient with low potassium levels or high calcium levels in the blood
that are unresponsive to treatment;
if the patient has diabetes or kidney dysfunction and is taking a blood pressure-lowering medicine containing aliskiren.
If any of the above situations apply to the patient, consult a doctor or pharmacist before using Toptelmi HCT.

Warnings and precautions
Before using Toptelmi HCT, discuss with your doctor if the patient has or has had any of the following conditions or diseases:
low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has salt deficiency due to diuretic use, low-salt diet, diarrhea, vomiting, or hemofiltration;
kidney disease or kidney transplant;
renal artery stenosis (narrowing of blood vessels supplying one or both kidneys);
liver disease;
heart function disorders;
diabetes;
gout;
elevated aldosterone levels (water and salt retention in the body, accompanied by imbalances in various blood minerals);
systemic lupus erythematosus (also known as "lupus" or "SLE") – a disease in which the body's immune system attacks its own tissues and organs;
the active substance hydrochlorothiazide may cause rare reactions leading to vision loss and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between choroid and sclera) or increased intraocular pressure – they may occur from several hours to weeks after taking Toptelmi HCT. Untreated, they may lead to permanent vision impairment.
Higher risk of such disorders may occur in patients who previously had an allergy to penicillin or sulfonamides.
a history of skin malignancy or the occurrence during treatment of unexpected skin changes. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). During treatment with Toptelmi HCT, protect the skin from sunlight and UV radiation.

Before using Toptelmi HCT, discuss with your doctor if:
the patient is taking any of the following medicines used to treat high blood pressure:

ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes,
aliskiren.

The doctor may regularly monitor the patient's kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also information in the section "When not to use Toptelmi HCT".
the patient is taking digoxin.
if in the past the patient 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 Toptelmi HCT, seek immediate medical help.
If the patient develops abdominal pain, nausea, vomiting, or diarrhea after taking Toptelmi HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not independently decide to stop taking Toptelmi HCT.
If the patient suspects she is pregnant (or may become pregnant), it is essential to inform the doctor. Toptelmi HCT is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use during this time may be very harmful to the fetus (see section on pregnancy).
Hydrochlorothiazide treatment may cause electrolyte imbalance in the body.
Typical symptoms of water or electrolyte imbalance include: dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (over 100 beats per minute). If the patient experiences any of these symptoms, inform the doctor.
Also inform the doctor about increased skin sensitivity to sunlight with symptoms such as sunburn (e.g. redness, itching, swelling, blistering) appearing faster than usual.
In case of surgery or anesthesia, inform the doctor about taking Toptelmi HCT.
Toptelmi HCT may be less effective in reducing blood pressure in black patients.

Children and adolescents
Toptelmi HCT is not recommended for use in children and adolescents under 18 years of age.

Toptelmi HCT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines taken concomitantly with Toptelmi HCT:
lithium-containing medicines (used to treat certain forms of depression);
medicines that may cause low potassium levels (hypokalemia), such as other diuretics, laxatives (e.g. castor oil), glucocorticosteroids (e.g. prednisone), ACTH (hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium benzylpenicillin (antibiotic), and salicylic acid and its derivatives;
iodinated contrast agents used in imaging procedures;
medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, angiotensin-converting enzyme (ACE) inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines such as sodium heparin (anticoagulant);
medicines affected by changes in blood potassium levels, such as medicines used for heart diseases (e.g. digoxin) or medicines controlling heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for psychiatric disorders (such as thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines used to treat allergies (e.g. terfenadine);
medicines used in diabetes treatment (insulin or oral medicines such as metformin);
cholestyramine and colestipol (medicines that reduce blood lipid levels);
medicines that increase blood pressure, such as noradrenaline;
muscle relaxants, such as tubocurarine;
calcium supplements and (or) vitamin D;
anticholinergic medicines (used to treat various disorders such as painful gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts in general anesthesia), such as atropine and biperiden;
amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases);
other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs, NSAIDs), anticancer medicines, medicines used to treat gout or inflammation;
ACE inhibitor or aliskiren (see also information in sections "When not to use Toptelmi HCT" and "Warnings and precautions");
digoxin.
Toptelmi HCT may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that may reduce blood pressure (e.g. baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. A symptom may be dizziness upon standing. Consult your doctor if dose adjustment of another medicine taken concomitantly with Toptelmi HCT is necessary.
The effect of Toptelmi HCT may be weakened if the patient is simultaneously taking a non-steroidal anti-inflammatory medicine (e.g. acetylsalicylic acid or ibuprofen).

Taking Toptelmi HCT with food and alcohol
Toptelmi HCT can be taken with food or independently of meals. Do not drink alcohol without first discussing it with your doctor. Alcohol may excessively lower blood pressure and (or) increase the risk of dizziness or fainting sensations.

Pregnancy and breastfeeding
Pregnancy
It is essential to inform the doctor if the patient is pregnant (or may become pregnant).
Usually, the doctor will recommend discontinuing Toptelmi HCT before conception or as soon as possible after pregnancy is confirmed, and will suggest an alternative medicine.
Use of Toptelmi HCT is not recommended during pregnancy, and it must not be taken after the 3rd month of pregnancy, as its use during this period may seriously harm the fetus.

Breastfeeding
Inform the doctor about breastfeeding or plans to start breastfeeding. Use of Toptelmi HCT is not recommended during breastfeeding. For patients planning to breastfeed, the doctor may choose another suitable medicine.

Driving and operating machinery
Some patients taking Toptelmi HCT may experience dizziness, fainting, or a sensation that everything is spinning. If such adverse effects occur, do not drive or operate machinery.

Toptelmi HCT contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

Toptelmi HCT contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Toptelmi HCT

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one tablet daily.
Try to take the tablets at the same time each day.
Toptelmi HCT may be taken with or without food.
Tablets should be swallowed whole with water or another non-alcoholic drink.
It is important to take the medicine every day, unless otherwise advised by your doctor.
In patients with impaired liver function, the usual dose should not exceed 40 mg of telmisartan once daily.

Taking more Toptelmi HCT than prescribed
If a patient accidentally takes too many tablets, symptoms such as low blood pressure and rapid heartbeat may occur. Slowed heart rate, dizziness, vomiting, and kidney dysfunction, including renal failure, have also been reported. Due to the presence of hydrochlorothiazide, a significant drop in blood pressure and low blood potassium levels may also occur, which could lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with cardiac glycosides or certain antiarrhythmic drugs. Seek immediate medical attention by contacting your doctor or going to the nearest hospital emergency department.

Missing a dose of Toptelmi HCT
If a patient forgets to take a dose, they should take it as soon as they remember, then continue with their regular dosing schedule. If a dose is missed on one day, the patient should take the usual dose the next day. Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention.
If any of the symptoms listed below occur, seek medical advice immediately:
Sepsis* (often called "blood poisoning", a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema, including fatal cases), blistering and shedding of the outer layer of skin (toxic epidermal necrolysis). These adverse reactions are rare (may occur in fewer than 1 in 1,000 patients) or very rare (toxic epidermal necrolysis; may occur in fewer than 1 in 10,000 patients), but are extremely serious. If they occur, treatment must be discontinued immediately and medical help must be sought. If left untreated, these symptoms may result in death. A higher incidence of sepsis has been observed with telmisartan alone, but it cannot be ruled out during treatment with Toptelmi HCT.
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). This adverse reaction is very rare (may occur in fewer than 1 in 10,000 patients).

Possible adverse reactions of Toptelmi HCT
Common adverse reactions (may occur in fewer than 1 in 10 people):
dizziness

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
low blood potassium levels
anxiety
fainting
tingling sensation
numbness and prickling sensation
vertigo (dizziness of labyrinthine origin)
increased heart rate (tachycardia)
heart rhythm disturbances
low blood pressure
sudden drop in blood pressure upon standing
shortness of breath
diarrhea
dry mouth
abdominal distension
back pain
muscle cramps
muscle pain
erectile dysfunction (inability to achieve or maintain erection)
chest pain
increased blood uric acid levels

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
inflammation of the airways leading to the lungs (bronchitis)
sore throat
sinusitis
increased uric acid levels
low sodium levels
feeling of sadness (depression)
difficulty falling asleep (insomnia)
sleep disturbances
blurred vision
difficulty breathing
abdominal pain
constipation
dyspepsia
nausea (vomiting)
inflammation of the gastric mucosa
liver function abnormalities (occur more frequently in patients of Japanese origin)
skin redness (erythema)
allergic reactions, such as itching or rash
excessive sweating
urticaria
joint pain and limb pain
muscle cramps
activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body's own tissues and organs, causing joint pain, skin rashes, and fever)
influenza-like illness
pain
low blood sodium levels
increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in blood

Adverse reactions of one of the active substances may also be adverse reactions of Toptelmi HCT, even if they were not observed during clinical trials of this medicine.

Telmisartan
In patients taking telmisartan alone, the following additional adverse reactions have been observed:

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, reduced red blood cell count (anemia), high blood potassium levels, slow heart rate (bradycardia), cough, kidney function disturbances, including acute kidney failure, fatigue.

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
reduced platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood sugar levels (in patients with diabetes), somnolence, gastric discomfort, rash (skin disorder), drug eruption, toxic skin rash, tendon pain (symptoms mimicking tendonitis), reduced hemoglobin levels (blood protein).

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
progressive fibrosis of lung alveoli (interstitial lung disease)**

Frequency unknown (frequency cannot be estimated from available data):
intestinal angioedema – after administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported.

* May have been due to a single case or related to a previously unknown mechanism.
** Cases of interstitial lung disease have been reported during telmisartan use, but a causal relationship has not been established.

Hydrochlorothiazide
In patients taking hydrochlorothiazide alone, the following additional adverse reactions have been observed:

Very common adverse reactions (may occur in more than 1 in 10 patients):
elevated blood lipid levels.

Common adverse reactions (may occur in fewer than 1 in 10 people):
nausea, low blood magnesium levels, reduced appetite.

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
acute kidney failure.

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
low platelet count (thrombocytopenia), increasing the risk of bleeding or bruising/petechiae (small purple-red spots on the skin or other tissues due to bleeding), high blood calcium levels, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reactions, uncontrolled blood glucose levels in patients with diagnosed diabetes, presence of sugars in urine (glucosuria).

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
abnormal breakdown of red blood cells (hemolytic anemia), inability of bone marrow to function properly, reduced white blood cell count (leukopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis), acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion), pancreatitis, lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system), vasculitis (necrotizing vasculitis).

Frequency unknown (frequency cannot be estimated from available data):
sialadenitis, skin and lip malignancies (non-melanoma skin cancers), reduced blood cell count (aplastic anemia), visual impairment and eye pain (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye—excessive accumulation of fluid between choroid and sclera—or acute angle-closure glaucoma), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on lips, around eyes or in the mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney function disturbances.

In isolated cases, low sodium levels occurred, accompanied by neurological or brain-related symptoms (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Toptelmi HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C. Store in the original blister to protect from moisture.
Do not use this medicine if its appearance has changed in any way.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Toptelmi HCT contains
The active substances are telmisartan and hydrochlorothiazide.
Each coated tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: sodium hydroxide, meglumine, povidone K25, Ludipress (monohydrate lactose,
povidone K30, crospovidone [type A]), anhydrous lactose, magnesium stearate.
Coating: polyvinyl alcohol, polyethylene glycol, colloidal anhydrous silica, citric acid monohydrate,
yellow iron oxide (E172).
Further information regarding lactose can be found at the end of section 2.

What Toptelmi HCT looks like and contents of the pack
Yellow, oval, biconvex coated tablets, embossed with the number 80 on one side and 25 on the other
(15.4 mm x 8.0 mm).
Aluminium/Aluminium foil blisters in cardboard packaging contain 28, 30, 56, 60, 84 or 90 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers/Importers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz, S.R.L.
Str. Livezeni nr 7A, 540472
Targu Mures, Romania
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For further information about this medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
tel. 22 209 70 00

Toptelmi hct