Toptelmi

Package Leaflet: Information for the Patient

Toptelmi, 40 mg, tablets

Toptelmi, 80 mg, tablets

Telmisartan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Toptelmi and what is it used for

Toptelmi belongs to a class of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to narrow and increases blood pressure. Toptelmi blocks the action of angiotensin II, causing blood vessels to widen and blood pressure to decrease.
Toptelmi is usedto treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by another disease.
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 is alsoused to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adult patients who are at risk due to reduced or blocked blood flow to the heart or legs, or have had a stroke or are at risk of developing diabetes. The doctor may inform the patient if they belong to a high-risk group for such events.

2. Important information before taking Toptelmi

When NOT to take Toptelmi

if the patient is allergicto telmisartan or any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant for more than 3 months(it is also recommended not to take Toptelmi in early pregnancy - see the section on pregnancy);
if the patient has severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or other severe liver disease;
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.

Warnings and precautions

The patient should discuss with their doctor if they have or have had any of the following conditions or diseases:
kidney disease or kidney transplant,
renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys),
liver disease,
heart function disorders,
increased aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood),
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, having diarrhea, or vomiting,
increased potassium levels in the blood,
diabetes.

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

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

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease,
• aliskiren, or if they are taking digoxin.

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".
If the patient is pregnant(or may become pregnant), they must inform their doctor. Toptelmi 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).
In case of surgeryor anesthesia, the patient should inform their doctor about taking Toptelmi.
Toptelmi may be less effective in lowering blood pressure in patients of black race.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Toptelmi, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Toptelmi on their own.

Children and adolescents

Toptelmi is not recommended for use in childrenand adolescents under 18 years of age.

Toptelmi 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 other medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This applies especially to the following medicines taken with Toptelmi:
medicines containing lithium (used to treat certain types of depression);
medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
diuretics, especially when taken in high doses with Toptelmi, may cause excessive water loss from the body and lead to low blood pressure (hypotension);
ACE inhibitors or aliskiren (see also the information in the sections "When NOT to take Toptelmi" and "Warnings and precautions");
digoxin.
The effect of Toptelmi may be weakened when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Toptelmi 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, alcohol, barbiturates, or antidepressants may exacerbate hypotension.
The patient may experience this effect as dizziness when standing up. They should consult their doctor if they need to adjust the dose of another medicine while taking Toptelmi.

Taking Toptelmi with food and drink

Toptelmi can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
The patient must inform their doctor if they are pregnant (or may become pregnant). The doctor usually recommends stopping Toptelmi before the patient becomes pregnant or as soon as possible after pregnancy is confirmed, and instead offers an alternative medicine. Toptelmi 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 is not recommended during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose an alternative medicine.

Driving and using machines

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

Toptelmi contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Toptelmi contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet.

3. How to take Toptelmi

Toptelmi should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Toptelmi is one tablet per day.
The patient should try to take the tablets at the same time every day.
Toptelmi 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 recommends otherwise.
If the patient feels that the effect of Toptelmi is too strong or too weak, they should inform their doctor or pharmacist.
Tablets with a break line can be divided into two halves.
In the treatment of high blood pressure, the usual dose of Toptelmi is one 40 mg tablet per day, which provides 24-hour blood pressure control. However, sometimes the doctor may recommend a lower (20 mg) or higher (80 mg) dose of the medicine.
Toptelmi can also be taken in combination with diuretics (such as hydrochlorothiazide, which additionally lowers blood pressure).
To reduce the frequency of cardiovascular events, the usual dose is one 80 mg tablet per day. At the beginning of treatment with a dose of 80 mg, blood pressure should be frequently monitored.

Use in children

Toptelmi is not recommended for use in childrenand adolescents under 18 years of age.

Use in patients with liver function disorders

In patients with liver function disorders, the usual dose should not exceed 40 mg per day.

Use in patients with kidney function disorders

In patients with kidney function disorders, dose adjustment is not necessary.
Patient with severe kidney function disorders or undergoing hemodialysis may be recommended a lower initial dose of 20 mg by their doctor.

Taking a higher dose of Toptelmi than recommended

If the patient has taken too many tablets, they should immediately contact their doctor, pharmacist, or the emergency department of the nearest hospital.

Missing a dose of Toptelmi

If the patient forgets to take the medicine, they should do so as soon as they remember, and then return to their previous dosing schedule. If the patient misses a dose one day, they should take their usual dose the next day. They should nottake a double dose to make up for the missed dose.

Stopping Toptelmi treatment

If the patient intends to stop taking the medicine, they should always consult their doctor first. Continued treatment may be necessary even if the patient feels well.
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 can cause side effects, although not everybody gets them.

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

In case of any of the following symptoms, the patient should immediately consult their doctor:
sepsis* (often referred to as "blood poisoning", a severe infection with an inflammatory reaction throughout the body), sudden swelling of the skin and mucous membranes (angioedema).
These side effects are rare (may occur in 1 in 1000 patients), but are extremely severe, and in such cases, treatment should be discontinued and medical attention sought immediately. If left untreated, these symptoms can be fatal.

Possible side effects

Common side effects(may occur in less than 1 in 10 people)
low blood pressure (hypotension), occurring in patients treated to reduce the frequency of cardiovascular events
Uncommon side effects(may occur in less than 1 in 100 people)
urinary tract infections
upper respiratory tract infections (e.g., sore throat, sinusitis, common cold)
anemia (low red blood cell count)
high potassium levels
difficulty sleeping (insomnia)
feeling sad (depression)
fainting
dizziness
slow heart rate (bradycardia)
low blood pressure (hypotension) in patients treated for high blood pressure
dizziness when standing up (orthostatic hypotension)
shortness of breath
cough
abdominal pain
diarrhea
discomfort in the abdomen
bloating
vomiting
itching
increased sweating
drug rash
back pain
muscle cramps
muscle pain
kidney function disorders, including acute kidney failure
chest pain
feeling tired
increased creatinine levels in the blood
Rare side effects(may occur in less than 1 in 1000 people)
sepsis* (often referred to as "blood poisoning", a severe infection with an inflammatory reaction throughout the body, which can be fatal)
increased white blood cell count (eosinophilia)
low platelet count (thrombocytopenia)
severe allergic reaction (anaphylaxis)
allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure)
low blood sugar levels (in patients with diabetes)
feeling anxious
drowsiness
impaired vision
rapid heart rate (tachycardia)
dry mouth
upset stomach
liver function disorders (more common in patients of Japanese origin)
sudden swelling of the skin and mucous membranes, which can be fatal (angioedema)
skin rash (lichenoid eruption)
redness of the skin
hives
severe drug rash
joint pain
limb pain
tendon pain
flu-like illness
decreased hemoglobin levels (a protein in the blood)
increased uric acid levels, increased liver enzyme activity, or creatine kinase levels in the blood
Very rare side effects(may occur in less than 1 in 10,000 people)
progressive scarring of the lungs (interstitial lung disease)**
* It is possible that this was due to a coincidence or is related to an unknown mechanism.
** There have been reports of interstitial lung disease during treatment with telmisartan. However, a causal relationship has not been established.
Side effects with unknown frequency(frequency cannot be estimated from the available data):
intestinal angioedema - after using similar products, intestinal edema occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 to gather more information on the safety of the medicine.

5. How to store Toptelmi

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.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 contains

The active substance is telmisartan. Each tablet contains 40 or 80 mg of telmisartan.
The other ingredients are: sodium hydroxide, meglumine, povidone K25, lactose monohydrate, povidone, crospovidone, lactose anhydrous, magnesium stearate.

What Toptelmi looks like and contents of the pack

The 40 mg tablets are white, oblong, smooth, with a break line on one side and the symbol "40" embossed on the other side.
The tablets are 11.5-11.8 mm long and 6.4-6.8 mm wide.
The 80 mg tablets are white, oblong, smooth, with a break line on one side and the symbol "80" embossed on the other side.
The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide.
The blister packs contain 14, 28, or 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
S.C. Sandoz, S.R.L.
Str. Livezeni nr 7A, 540472,
Targu Mures, Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków

For more information about 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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