Package leaflet: Information for the patient

Toptelmi, 40 mg, tablets
Toptelmi, 80 mg, tablets
Telmisartanum
Please read carefully all the information in this leaflet before using this 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 further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:

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

1. What Toptelmi is and what it is used for

Toptelmi belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced by the body that causes narrowing of blood vessels, thereby increasing blood pressure. Toptelmi inhibits the action of angiotensin II, resulting in dilation of blood vessels and reduction of blood pressure.
Toptelmi is used for the treatment of essential hypertension (high blood pressure) in adults. "Essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure may lead to damage of blood vessels in various organs, which may sometimes result in 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 measure blood pressure regularly to ensure it remains within the normal range.
Toptelmi is also used 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 who have previously had a stroke, or who are at risk of developing diabetes. Your doctor may inform you whether you belong to a high-risk group for such events.

2. Important information before using Toptelmi

When NOT to use Toptelmi
if the patient is allergic to telmisartan or to any of the ingredients of this medicine
(listed in section 6);
if the patient is pregnant for more than 3 months (it is also better not to take
Toptelmi during early pregnancy – see section on pregnancy);
if the patient has been diagnosed with severe liver function disorders, such as cholestasis or
biliary obstruction (problems with bile flow from the liver and gallbladder), or
other severe liver disease;
if the patient has diabetes or kidney function disorders and is receiving an antihypertensive medicine containing aliskiren.
If any of the above situations apply to the patient, consult a doctor or pharmacist before taking Toptelmi.
Warnings and precautions
Before starting Toptelmi, discuss with the doctor if the patient has or has 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,
elevated aldosterone levels (water and salt retention in the body, accompanied by
imbalances in various blood minerals),
low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of water from the body) or has salt deficiency due to, for example, taking diuretics (water pills), following a low-salt diet, diarrhea, or vomiting,
elevated blood potassium levels,
diabetes.
Before taking Toptelmi, discuss with the 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 monitor the patient's kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "When not to take Toptelmi." The patient is taking digoxin.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Toptelmi,
discuss this with the doctor. The doctor will decide on further treatment. Do not independently
decide to stop taking Toptelmi.
If the patient is pregnant (or may become pregnant), it is essential to inform the doctor.
Toptelmi is not recommended during 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).
In case of surgery or anesthesia, inform the doctor about taking Toptelmi.
Toptelmi may be less effective in lowering blood pressure in patients of black race.
Children and adolescents
Toptelmi is not recommended for use in children and adolescents under 18 years of age.
Toptelmi with other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
The doctor may decide to adjust the dose of these other medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This particularly applies to the following medicines taken concomitantly with Toptelmi:
medicines containing lithium (used to treat certain forms of depression);
medicines that may increase blood potassium levels, such as potassium-containing salt substitutes,
potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim;
diuretics, especially when taken in high doses together with Toptelmi, may cause excessive fluid loss from the body and lead to low blood pressure (hypotension);
if the patient is taking an ACE inhibitor or aliskiren (see also information in sections "When not to take Toptelmi" and "Warnings and precautions");
digoxin.
The effect of Toptelmi may be reduced when taken simultaneously 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 hypertension or medicines that may lower blood pressure (e.g. baclofen, amifostine).
Additionally, alcohol, barbiturates, or antidepressants may worsen hypotension.
The patient may experience this effect as dizziness upon standing. Consult the doctor if dosage adjustment of another medicine is needed during Toptelmi treatment.
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 stopping Toptelmi before pregnancy or as soon as possible after pregnancy is confirmed, and instead prescribe another medicine. Use of Toptelmi is not recommended during early pregnancy, and must not be taken after the 3rd month of pregnancy, as the medicine taken during this period may seriously harm the fetus.
Breastfeeding
Inform the doctor about breastfeeding or plans to start breastfeeding. Use of Toptelmi is not recommended during breastfeeding. For patients planning to breastfeed, especially a newborn or premature infant, the doctor may choose another suitable medicine.
Driving and operating machinery
In some patients taking Toptelmi, adverse effects such as fainting or dizziness (vertigo) may occur. If the patient experiences these adverse effects, driving vehicles or operating machinery should be avoided.
Toptelmi contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.
Toptelmi contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet.

3. How to use Toptelmi

Toptelmi should always be taken exactly as directed by the physician. In case of doubt, consult a doctor or pharmacist.
The recommended dose of Toptelmi is one tablet per day.
Try to take the tablets at the same time every day.
Toptelmi may be taken independently of meals.
The tablets should be swallowed with water or another non-alcoholic drink.
It is important to take the medicine every day, unless otherwise advised by the physician.
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 division line can be split into halves.
In the treatment of arterial hypertension, the usual dose of Toptelmi for most patients is one 40 mg tablet once daily, providing blood pressure control for 24 hours. However, the physician may sometimes prescribe a lower (20 mg) or higher (80 mg) dose.
Toptelmi may also be used 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 taken once daily. During initial treatment with the 80 mg dose, blood pressure should be monitored frequently.
In patients with impaired liver function, the usual dose should not exceed 40 mg per day.
Taking more Toptelmi than prescribed
If the patient accidentally takes too many tablets, they should contact a doctor, pharmacist, or the emergency department of the nearest hospital immediately.
Missing a dose of Toptelmi
If the patient forgets to take the medicine, they should take it as soon as they remember, then return to their regular dosing schedule. If the patient misses a dose for one day, they should take the usual dose the next day. Do not take a double dose to make up for the missed dose.
If there are any further doubts regarding the use of this medicine, consult a 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 require immediate medical attention.
If any of the symptoms listed below occur, consult a doctor immediately:
sepsis* (often called "blood poisoning", a severe infection with systemic inflammatory response),
sudden swelling of the skin and mucous membranes (angioedema).
The above adverse reactions are rare (may occur in 1 in 1,000 patients), but extremely serious. In such cases, treatment must be discontinued and immediate contact with a doctor is required. If the above symptoms are not treated, they may result in death.
Possible adverse reactions
Common adverse reactions (may occur in fewer than 1 in 10 people)
low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon adverse reactions (may occur in fewer than 1 in 100 people)
urinary tract infections,
upper respiratory tract infections (e.g. sore throat, sinusitis, common cold),
low red blood cell count (anaemia),
high potassium levels,
difficulty sleeping (insomnia),
feeling of sadness (depression),
fainting,
dizziness,
slow heart rate (bradycardia),
low blood pressure (hypotension) in patients treated for hypertension,
dizziness upon standing (orthostatic hypotension),
shortness of breath,
cough,
abdominal pain,
diarrhoea,
indigestion,
bloating,
vomiting,
itching,
excessive sweating,
drug rash,
back pain,
muscle cramps,
muscle pain,
renal dysfunction, including acute renal failure,
chest pain,
feeling of fatigue,
increased blood creatinine levels.
Rare adverse reactions (may occur in fewer than 1 in 1,000 people)
sepsis* (often called "blood poisoning", a severe infection with systemic inflammatory response, potentially fatal),
increased number of certain white blood cells (eosinophilia),
low platelet count (thrombocytopenia),
severe allergic reaction (anaphylactic reaction),
allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure),
low blood sugar levels (in patients with diabetes),
feeling of restlessness,
drowsiness,
blurred vision,
increased heart rate (tachycardia),
dry mouth,
discomfort in the abdominal cavity,
taste disturbances,
liver function disorders (more frequent in patients of Japanese origin),
sudden swelling of the skin and mucous membranes which may lead to death (angioedema, including fatal cases),
eruptions (skin disorders),
redness of the skin,
urticaria,
severe drug rash,
joint pain,
limb pain,
tendon pain,
influenza-like illness,
decreased haemoglobin concentration (blood protein),
increased uric acid levels, increased liver enzyme or creatine kinase activity in blood,
low sodium levels.
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people)
progressive fibrosis of pulmonary alveoli (interstitial lung disease)**.
* May be due to a coincidental case or related to a previously unknown mechanism.
** Cases of interstitial lung disease have been reported during treatment with telmisartan. However, a causal relationship has not been established.
Frequency not known (frequency cannot be estimated from available data):
intestinal angioedema – following administration of similar products, swelling in the intestine has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
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 at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Toptelmi

Keep this medicine out of the 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 stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, anhydrous lactose, magnesium stearate.

What Toptelmi looks like and contents of the pack
40 mg tablets are white, elongated, smooth, with a score line on one side and the engraved mark "40" on the other side.
The tablets are 11.5–11.8 mm in length and 6.4–6.8 mm in width.
80 mg tablets are white, elongated, smooth, with a score line on one side and the engraved mark "80" on the other side.
The tablets are 14.7–15.0 mm in length and 8.2–8.6 mm in width.
Aluminium/Aluminium blisters contain 14, 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Tel. +48 22 209 70 00

Manufacturers/Importers
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 Warszawa, Poland
S.C. Sandoz, S.R.L.
Str. Livezeni nr 7A, 540472
Targu Mures, Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland

Austria Telmisartan Sandoz 40 mg – Tabletten
Telmisartan Sandoz 80 mg – Tabletten
Belgium Telmisartan Sandoz 40 mg tabletten
Telmisartan Sandoz 80 mg tabletten
Cyprus Telmisartan Sandoz
Czech Republic Telmisartan Sandoz 80 mg
Estonia Telmisartan Sandoz 40 mg
Telmisartan Sandoz 80 mg
Finland Telmisartan Sandoz 40 mg tabletti
Telmisartan Sandoz 80 mg tabletti
France Telmisartan Sandoz 40 mg, comprimé
Telmisartan Sandoz 80 mg, comprimé
Greece Telmisartan/Sandoz, 40 mg, δισκία
Telmisartan/Sandoz, 80 mg, δισκία
Spain Telmisartan Sandoz 40 mg comprimidos EFG
Telmisartan Sandoz 80 mg comprimidos EFG
Netherlands Telmisartan Sandoz 40 mg, tabletten
Telmisartan Sandoz 80 mg, tabletten
Lithuania Telmisartan Sandoz 40 mg tabletės
Telmisartan Sandoz 80 mg tabletės
Poland Toptelmi
Portugal Telmisartan Sandoz
Slovakia Telmisartan Sandoz 40 mg tablety
Telmisartan Sandoz 80 mg tablety
Sweden Telmisartan Sandoz 40 mg tabletter
Telmisartan Sandoz 80 mg tabletter
United Kingdom Telmisartan 40 mg tablets
Telmisartan 80 mg tablets