Toptelmi Hct

Leaflet accompanying the packaging: patient information

Toptelmi HCT, 80 mg + 25 mg, effervescent tablets

Telmisartan + Hydrochlorothiazide

It is essential to 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 you can read it again if you need to. If you have any doubts, you should consult a doctor or pharmacist. This medicine has been prescribed to you specifically. 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Toptelmi HCT is a combination medicine that contains 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 antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to constrict and increases blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to dilate and reducing blood pressure.
• Hydrochlorothiazide belongs to a group of thiazide diuretics, which increase urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in various organs, which can sometimes lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Before such damage occurs, high blood pressure is usually asymptomatic. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range. Toptelmi HCTis used to treat high blood pressure (essential hypertension) in adults who are not adequately controlled by Toptelmi HCT 80 mg + 12.5 mg or in patients who have achieved blood pressure stabilization by taking telmisartan and hydrochlorothiazide separately.

2. Important information before taking Toptelmi HCT

When not to take Toptelmi HCT

if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6); if you are allergic to hydrochlorothiazide or other sulfonamides; if you are pregnant more than 3 months (in early pregnancy, it is also better not to take Toptelmi HCT - see the section on pregnancy); if you have severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or other severe liver disease; if you have severe kidney disease; if your doctor has found that you have low potassium levels or high calcium levels in your blood that do not respond to treatment; if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren. If any of the above situations apply to you, you should consult a doctor or pharmacist before taking Toptelmi HCT.

Warnings and precautions

Before taking Toptelmi HCT, you should discuss it with your doctor if you have or have had any of the following conditions or diseases: low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have an electrolyte imbalance due to taking diuretics, following a low-salt diet, diarrhea, vomiting, or hemodialysis; kidney disease or kidney transplant; renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys); liver disease; heart rhythm disorders; diabetes; gout; increased aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood); systemic lupus erythematosus (also known as "lupus" or "SLE") - a disease in which the body's immune system attacks its own tissues and organs; visual impairment, eye pain due to an abnormal reaction caused by hydrochlorothiazide, an active substance in this medicine. 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 Toptelmi HCT. If left untreated, they can lead to permanent vision impairment. The risk of developing such disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides. a history of malignant skin tumor or the occurrence of unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). While taking Toptelmi HCT, you should protect your skin from sunlight and UV radiation. if you have experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Toptelmi HCT, you should seek medical attention immediately.

Before taking Toptelmi HCT, you should discuss it with your doctor if:

you are taking any of the following medicines for high blood pressure:

• ACE inhibitor(e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease,
• aliskiren.

Your doctor may regularly monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also the information in the section "When not to take Toptelmi HCT". you are taking digoxin, a medicine used to treat heart conditions. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Toptelmi HCT, you should discuss it with your doctor. The doctor will decide on further treatment. You should not stop taking Toptelmi HCT on your own. If you are pregnant (or think you may be pregnant), you must inform your doctor. Toptelmi HCT is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use at this time may be very harmful to the fetus (see the section on pregnancy). Treatment with hydrochlorothiazide may cause electrolyte imbalance in the body. Typical symptoms of water and electrolyte imbalance are dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heart rate (over 100 beats per minute). If you experience any of these symptoms, you should inform your doctor. You should also tell your doctor if you experience increased skin sensitivity to sunlight with symptoms such as sunburn (e.g., redness, itching, swelling, blistering), which appear more quickly than usual. In case of surgery or anesthesia, you should inform your doctor that you are 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 children and adolescents under 18 years of age.

Toptelmi HCT and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This is especially true for the following medicines taken simultaneously with Toptelmi HCT: lithium(used to treat certain forms of depression); medicines that may cause low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives(e.g., castor oil), corticosteroids(e.g., prednisone), ACTH(hormone), amphotericin(antifungal medicine), carbenoxolone(used to treat mouth ulcers), benzylpenicillin sodium(antibiotic), and salicylic acidand its derivatives; medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine(a medicine that suppresses the immune system), and other medicines, such as sodium heparin(anticoagulant); heart medicines(e.g., digoxin) or medicines that control heart rhythm(e.g., quinidine, disopyramide, amiodarone, sotalol); medicines used to treat mental disorders(such as thioridazine, chlorpromazine, levomepromazine); certain antibiotics(e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergies(e.g., terfenadine); medicines used to treat diabetes(insulin or oral medicines, such as metformin); cholestyramine and colestipol(medicines that lower blood fat levels); medicines that increase blood pressure, such as noradrenaline; muscle relaxants, such as tubocurarine; anticholinergic medicines(used to treat many disorders, such as painful contractions of the digestive tract, bladder contractions, asthma, motion sickness, muscle cramps, Parkinson's disease, and as auxiliary medicines given during general anesthesia), such as atropine and bipiperidine; 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, medicinesused to treat gout or arthritis, and calcium and (or) vitamin D supplements; ACE inhibitoror aliskiren(see also the information in the sections "When not to take Toptelmi HCT" and "Warnings and precautions"); digoxin(a medicine used to treat heart conditions). Toptelmi HCT may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may lower blood pressure (i.e., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom may be dizziness when standing up. You should consult your doctor if you need to adjust the dose of another medicine you are taking while taking Toptelmi HCT. The effect of Toptelmi HCT may be weakened if you are taking a non-steroidal anti-inflammatory drug (e.g., acetylsalicylic acid or ibuprofen) at the same time.

Taking Toptelmi HCT with alcohol

You should 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.

Pregnancy and breastfeeding

Pregnancy It is essential to inform your doctor if you are pregnant (or think you may be pregnant). Your doctor will usually recommend stopping Toptelmi HCT before you become pregnant or as soon as possible after pregnancy is confirmed, and will offer an alternative medicine. Toptelmi HCT is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use at this time may seriously harm the fetus. Breastfeeding You should inform your doctor if you are breastfeeding or plan to start breastfeeding. Toptelmi HCT is not recommended during breastfeeding. For mothers who plan to breastfeed, especially newborns or premature babies, the doctor may choose a different suitable medicine.

Driving and using machines

Some patients taking Toptelmi HCT may experience dizziness or fatigue. In such cases, you should not drive vehicles or operate machines.

Toptelmi HCT contains lactose

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

Toptelmi HCT contains sodium

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

3. How to take Toptelmi HCT

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The recommended dose of Toptelmi HCT is one tablet per day. You should try to take the tablets at the same time every day. Toptelmi HCT can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic drink. It is essential to take the medicine every day, unless your doctor advises you to stop. In patients with liver dysfunction, the usual dose should not exceed 40 mg + 12.5 mg once daily.

Taking more than the recommended dose of Toptelmi HCT

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heart rate. Slow heart rate, dizziness, vomiting, kidney problems, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, you may also experience a significant decrease in blood pressure and low potassium levels in the blood, which can cause nausea, drowsiness, and muscle cramps and (or) irregular heart rhythm, associated with the concurrent use of such medicines as digitalis glycosides or certain antiarrhythmic medicines. You should contact your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Toptelmi HCT

If you forget to take a dose, you should take it as soon as you remember, and then return to your previous dosing schedule. If you miss a dose, you should take your usual dose the next day. You should nottake a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious and may require immediate medical attention.

If you experience any of the following symptoms, you should immediatelyconsult your doctor: sepsis (often referred to as "blood poisoning", a severe infection with a systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the skin (toxic epidermal necrolysis). These side effects are rare (may occur in less than 1 in 1000 patients) or have an unknown frequency (toxic epidermal necrolysis), but are extremely severe and require immediate medical attention. If left untreated, they can be fatal. More frequent cases of sepsis have been observed during the use of telmisartan alone, but it cannot be ruled out that it may occur during the use of Toptelmi HCT. Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). This side effect is very rare (may occur in less than 1 in 10,000 patients).

Possible side effects of Toptelmi HCT

Common side effects (may occur in less than 1 in 10 people): dizziness Uncommon side effects (may occur in less than 1 in 100 people): low potassium levels in the blood anxiety fainting feeling of tingling feeling of numbness and tingling sensation of spinning (vertigo of labyrinthine origin) rapid heart rate (tachycardia) heart rhythm disorders low blood pressure sudden drop in blood pressure when standing up shortness of breath diarrhea dry mouth bloating back pain muscle spasms muscle pain sexual dysfunction (erectile dysfunction) chest pain increased uric acid levels in the blood Rare side effects (may occur in less than 1 in 1000 people): pneumonia (bronchitis), exacerbation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues and organs, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, blurred vision, breathing difficulties, abdominal pain, constipation, indigestion, nausea (vomiting), gastritis, liver function disorders (more common in patients of Japanese origin), redness of the skin (flushing), allergic reactions, such as itching or rash, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like syndrome, pain, low sodium levels in the blood, increased creatinine, liver enzyme activity, or creatine kinase levels in the blood Side effects of one of the active substances may also be side effects of Toptelmi HCT, even if they were not observed during clinical trials of this medicine.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed: Uncommon side effects (may occur in less than 1 in 100 people): upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, anemia, high potassium levels, slow heart rate (bradycardia), kidney problems, including acute kidney failure, weakness, cough Rare side effects (may occur in less than 1 in 1000 people): low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in patients with diabetes), gastrointestinal upset, skin rash (dermatitis), tendon pain, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness Very rare side effects (may occur in less than 1 in 10,000 people): progressive scarring of the lungs (interstitial lung disease)** Side effects with an unknown frequency (frequency cannot be determined based on available data): intestinal angioedema - after using similar products, angioedema has been observed in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea. * It is possible that it was a coincidence or is related to an unknown mechanism. ** Cases of interstitial lung disease have been reported during the use of telmisartan, but a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed: Common side effects (may occur in less than 1 in 10 people): nausea low magnesium levels in the blood Rare side effects (may occur in less than 1 in 1000 people): low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising (small purple spots on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache Very rare side effects (may occur in less than 1 in 10,000 people): high blood pH (acid-base imbalance) due to low chloride levels in the blood Side effects with an unknown frequency (frequency cannot be determined based on available data): parotitis, decreased white blood cell count (including low red and white blood cell count), severe allergic reactions (e.g., hypersensitivity, anaphylactic reaction), decreased or lost appetite, restlessness, feeling of emptiness in the head, blurred vision or yellow vision, visual impairment, and eye pain (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma or acute angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, gastrointestinal upset, jaundice (yellowing of the skin or eyes), lupus-like syndrome (a condition similar to systemic lupus erythematosus, in which the body's immune system attacks its own tissues and organs), skin disorders, such as vasculitis of the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, around the eyes, or in the mouth, peeling of the skin, fever, weakness, kidney problems or kidney dysfunction, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, high glucose levels, difficulty controlling glucose levels in the blood and urine in patients with diagnosed diabetes, and high fat levels in the blood, non-melanoma skin cancer and lip cancer

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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, you can help provide more information on the safety of this medicine.

5. How to store Toptelmi HCT

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month stated. Do not store above 30°C. Store in the original blister pack to protect from moisture. Do not use this medicine if its appearance has changed in any way. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This 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 effervescent tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide. The other ingredients are: Tablet core: sodium hydroxide, meglumine, povidone K25, Ludipress (lactose monohydrate, 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 on lactose can be found at the end of section 2.

What Toptelmi HCT looks like and contents of the pack

Yellow, oval, biconvex effervescent tablets with the symbol 80 embossed on one side and 25 on the other (15.4 mm x 8.0 mm). Aluminum/Aluminum foil blisters in a carton pack containing 28, 30, 56, 60, 84, or 90 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer/Importer Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek S.A. ul. Domaniewska 50 C 02-672 Warsaw 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 more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:01/2025 Sandoz logo