Toptelmi Hct

Leaflet attached to the packaging: patient information

Toptelmi HCT, 40 mg + 12.5 mg, effervescent tablets

Toptelmi HCT, 80 mg + 12.5 mg, effervescent tablets

Telmisartan + Hydrochlorothiazide

You should 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 that you can read it again if you need to.
In case of 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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 packaging 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 of these 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 telmisartan alone.

2. Important information before taking Toptelmi HCT

When not to take Toptelmi HCT

if the patient is allergic to telmisartanor any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to hydrochlorothiazideor other sulfonamides;
if the patient is pregnant for more than 3 months(it is also recommended not to take Toptelmi HCT in early pregnancy - see the section on pregnancy);
if the patient has severe liver dysfunction, such as cholestasisor bile duct obstruction(problems with bile flow from the liver and gallbladder) or other severe liver disease;
if the patient has severe kidney disease;
if the doctor has found that the patient has low potassium levelsor high calcium levelsin the blood that cannot be treated;
if the patient has diabetesor kidney problemsand is taking a blood pressure-lowering medicine containing aliskiren.
If any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Toptelmi HCT.

Warnings and precautions

Before taking Toptelmi HCT, the patient should discuss with their doctor if they have or have had any of the following conditions or diseases:
low blood pressure(hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a salt deficiency due to taking diuretics, following a low-salt diet, diarrhea, vomiting, or hemodialysis;
kidney diseaseor kidney transplant;
renal artery stenosis(narrowing of the blood vessels supplying one or both kidneys);
liver disease;
heart rhythm disorders;
diabetes;
gout;
hyperaldosteronism(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 paindue 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 pressure inside the eye - 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 malignant skin tumordiagnosed in the past or an unexpected skin changeduring 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). During treatment with Toptelmi HCT, the patient should protect their skin from sunlight and UV radiation.
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 Toptelmi HCT, they should seek medical help immediately.

Before taking Toptelmi HCT, the patient should discuss with their doctor if:

the patient is taking any of the following medicines for high blood pressure:

• ACE inhibitor(e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease,
• aliskiren.

The doctor may regularly monitor the patient's kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the information in the section "When not to take Toptelmi HCT".
the patient is taking digoxin, a medicine used to treat heart conditions.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Toptelmi HCT, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Toptelmi HCT on their own.
If the patient suspects they are pregnant (or may become pregnant), they must inform their 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 disorders 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 the patient experiences any of these symptoms, they should inform their doctor.
The patient should also tell their doctor if they 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, the patient should inform their doctor about taking Toptelmi HCT.
Toptelmi HCT may be less effective in lowering 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The 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 applies in particular 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 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(e.g., enalapril, lisinopril, ramipril), 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);
some antibiotics(e.g., sparfloxacin, pentamidine) or some 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 spasms, asthma, motion sickness, muscle cramps, Parkinson's disease, and as auxiliary medicines given during 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, 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 (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom may be dizziness when standing up. The patient should consult their doctor if they need to adjust the dose of another medicine they are taking while taking Toptelmi HCT.
The effect of Toptelmi HCT may be reduced if the patient is taking a non-steroidal anti-inflammatory drug (e.g., acetylsalicylic acid or ibuprofen) at the same time.

Taking Toptelmi HCT with alcohol

The patient should not drink alcohol without first discussing it with their doctor. Alcohol may excessively lower blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
The patient must inform their doctor if they are pregnant (or may become pregnant).
Usually, the doctor recommends stopping Toptelmi HCT before the patient becomes pregnant or as soon as possible after pregnancy is confirmed, and instead offers 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
The patient should inform their doctor about breastfeeding or planning to breastfeed. Toptelmi HCT is not recommended during breastfeeding. For patients planning to breastfeed, especially a newborn or premature baby, the doctor may choose a different suitable medicine.

Driving and operating machinery

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

Toptelmi HCT contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dose of Toptelmi HCT is one tablet per day.
The patient 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 the doctor advises otherwise.
In patients with liver function disorders, the usual dose should not exceed 40 mg + 12.5 mg once a day.

Taking more than the recommended dose of Toptelmi HCT

If the patient accidentally takes too many tablets, they may experience symptoms such as low blood pressure and rapid heart rate. Slow heart rate, dizziness, vomiting, kidney disorders, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, there may also be 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, related to the concomitant use of such medicines as digitalis glycosides or certain antiarrhythmic medicines. The patient should immediately contact their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Toptelmi HCT

If the patient forgets to take their medicine, they should do so as soon as they remember, and then return to their previous dosing schedule. If the patient does not take their medicine for one day, they should take their usual dose the next day. The patient should nottake a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

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

If the patient experiences any of the following symptoms, they should immediatelyconsult their 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 outer layer 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 discontinuation of treatment and immediate medical attention. If left untreated, they can be fatal. More frequent sepsis has been observed with telmisartan alone, but it cannot be ruled out with 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
tingling sensation
numbness and tingling sensation
feeling of spinning (vertigo)
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 cramps
muscle pain
erectile dysfunction
chest pain
high uric acid levels in the blood
Rare side effects (may occur in less than 1 in 1000 people):
pneumonia (bronchitis), lupus erythematosus exacerbation or worsening (a disease in which the body's immune system attacks its own tissues and organs, causing joint pain, skin rashes, and fever)
throat pain
sinusitis
depression
insomnia
visual impairment
breathing difficulties
abdominal pain
constipation
indigestion
nausea (vomiting)
gastritis
liver function disorders (more frequent 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 illness
pain
low sodium levels in the blood
high creatinine levels, 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 (low red blood cell count), high potassium levels in the blood, slow heart rate (bradycardia), kidney function disorders, 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 disorders, skin disorders (e.g., urticaria), tendon pain, tendonitis, low hemoglobin levels (a protein in the blood), drowsiness
Very rare side effects (may occur in less than 1 in 10,000 people):
progressive interstitial lung disease (a condition in which the lungs become scarred)**
Side effects with an unknown frequency (frequency cannot be estimated from available data):
intestinal angioedema - after using similar products, intestinal angioedema has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* It is possible that this was a coincidental or unknown mechanism.
** Interstitial lung disease has been reported with 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
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 estimated from available data):
parotid gland inflammation, 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 angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, gastrointestinal disorders, liver function disorders, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition resembling systemic lupus erythematosus, in which the body's immune system attacks its own tissues and organs), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, around the eyes, or in the mouth, skin peeling, fever, kidney inflammation or kidney function disorders, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, high glucose levels, difficulty controlling blood sugar levels in the blood and urine in patients with diagnosed diabetes, and increased triglyceride levels in the blood, malignant skin tumor and lip cancer (non-melanoma skin cancer)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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.
Reporting side effects will help gather 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 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 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Toptelmi HCT contains

The active substances are telmisartan and hydrochlorothiazide.
40 mg + 12.5 mg tablets
Each effervescent tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
80 mg + 12.5 mg tablets
Each effervescent tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Other ingredients are:
40 mg + 12.5 mg tablets
Tablet core: sodium hydroxide, meglumine, povidone K25, Ludipress (lactose monohydrate, povidone K30, crospovidone [type A]), anhydrous lactose, magnesium stearate.
Coating: polyvinyl alcohol, polyethylene glycol, anhydrous colloidal silica, citric acid monohydrate, yellow iron oxide (E172), red iron oxide (E172).
80 mg + 12.5 mg tablets
Tablet core: sodium hydroxide, meglumine, povidone K25, Ludipress (lactose monohydrate, povidone K30, crospovidone [type A]), anhydrous lactose, magnesium stearate.
Coating: polyvinyl alcohol, polyethylene glycol, anhydrous colloidal silica, citric acid monohydrate.
Further information on lactose can be found at the end of section 2.

What Toptelmi HCT looks like and contents of the pack

40 mg + 12.5 mg tablets
Red, oval, biconvex effervescent tablets with a symbol embossed on one side and 12.5 on the other (12.4 mm x 6.2 mm).
80 mg + 12.5 mg tablets
White or almost white, oval, biconvex effervescent tablets with a symbol embossed on one side and 12.5 on the other (15.4 mm x 8.0 mm).
Aluminum/Aluminum foil blisters in a carton 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 on the 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
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