Telmisartan Orion

Leaflet attached to the packaging: patient information

Telmisartan Orion, 40 mg, tablets

Telmisartan Orion, 80 mg, tablets

Telmisartan

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

• Keep this leaflet, so you can read it again if you need to.
• 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Telmisartan Orion and what is it used for

Telmisartan Orion 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, leading to increased blood pressure. Telmisartan Orion blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Orion is usedto treat essential hypertension (high blood pressure) in adults. The term essential means that high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most often, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Telmisartan Orion is also usedto reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults at risk, who have been diagnosed with reduced blood flow to the heart or legs, who have had a stroke, or who have been diagnosed with diabetes. The doctor will inform the patient if they are at risk of these disorders.

2. Important information before taking Telmisartan Orion

When not to take Telmisartan Orion

• if the patient is allergic to telmisartan or any other ingredient of this medicine (listed in section 6);
• after the third month of pregnancy (it is also recommended to avoid taking Telmisartan Orion in early pregnancy - see section "Pregnancy");
• if the patient has severe liver problems, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

The doctor or pharmacist should be informed before taking Telmisartan Orion if any of the above conditions apply to the patient.

Warnings and precautions

The doctor should be informed 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 problems;
• increased aldosterone levels (water and sodium retention in the body, accompanied by electrolyte imbalance);
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has low sodium levels due to the use of diuretics, a low-sodium diet, diarrhea, or vomiting;
• increased potassium levels in the blood;
• diabetes.

Before starting to take Telmisartan Orion, the following should be discussed with the doctor:

• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, or ramipril, especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Telmisartan Orion".
• if the patient is taking digoxin.

The doctor should be informed about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Telmisartan Orion in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see section "Pregnancy").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan Orion, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmisartan Orion on their own.
In the case of planned surgery or anesthesia, the doctor should be informed about the use of Telmisartan Orion.
Telmisartan Orion may be less effective in lowering blood pressure in people of black race.

Children and adolescents

Telmisartan Orion is not recommended for use in children and adolescents under 18 years of age.

Telmisartan Orion and other medicines

The doctor or pharmacist should be told 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 recommend a dose change or other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmisartan Orion:

• lithium preparations used to treat certain types of depression;
• medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, certain diuretics, ACE inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics, especially in high doses, as this may lead to significant water loss from the body and low blood pressure (hypotension);
• ACE inhibitors or aliskiren (see also sections "When not to take Telmisartan Orion" and "Warnings and precautions");
• digoxin.

The effect of Telmisartan Orion may be reduced if taken with nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Orion may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with blood pressure-lowering properties (e.g., baclofen, amifostine). Additionally, low blood pressure may be enhanced by alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken by the patient while taking Telmisartan Orion should be adjusted, and the patient should consult their doctor.

Pregnancy and breastfeeding

Pregnancy
The doctor should be informed about pregnancy, suspected pregnancy, or planned pregnancy. Usually, the doctor will recommend stopping the use of Telmisartan Orion before planned pregnancy or immediately after pregnancy is confirmed and will recommend another medicine instead of Telmisartan Orion. It is not recommended to take Telmisartan Orion in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after 3 months of pregnancy.
Breastfeeding
The doctor should be told about breastfeeding or the intention to breastfeed. It is not recommended to take Telmisartan Orion during breastfeeding. The doctor may recommend taking another medicine if the patient wants to breastfeed, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Telmisartan Orion may experience dizziness or fatigue.
In such cases, patients should not drive vehicles or operate machines.

Excipients

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 Telmisartan Orion

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The recommended dose of Telmisartan Orion is one tablet per day. Patients should try to take the tablet at the same time every day.
Telmisartan Orion can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Telmisartan Orion every day, unless the doctor recommends otherwise. If the patient feels that the effect of Telmisartan Orion is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartan Orion is 40 mg once daily for most patients, which provides 24-hour blood pressure control. In some patients, the doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Orion can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Orion.
To reduce the frequency of cardiovascular events, the usual dose of Telmisartan Orion is 80 mg once daily. At the beginning of treatment, blood pressure should be frequently monitored.
In patients with liver function disorders, the usual dose should not exceed 40 mg once daily.

Taking a higher dose of Telmisartan Orion than recommended

In case of accidental ingestion of too many tablets, the doctor or the emergency department of the nearest hospital should be contacted immediately.

Missing a dose of Telmisartan Orion

If a dose is missed, it should be taken as soon as remembered, and then the patient should continue taking the medicine as scheduled. If the tablet is not taken within a day, the usual dose should be taken the next day. A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

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

In case of any of the following symptoms, the doctor should be contacted immediately:
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction of the entire body), sudden swelling of the skin and mucous membranes (angioedema) – these are very serious side effects that occur rarely (may occur in up to 1 in 1,000 patients); in such cases, the medicine should be stopped, and the doctor should be contacted immediately, as if left untreated, these symptoms may be fatal.

Possible side effects of Telmisartan Orion:

Common side effects (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.
Uncommon side effects (may occur in up to 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, insomnia, depression, fainting, peripheral vertigo (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, orthostatic hypotension (dizziness when standing up), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, renal disorders, including acute renal failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may occur in up to 1 in 1,000 patients):
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction of the entire body, which may be fatal), increased eosinophil count, low platelet count, severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dryness of the mucous membranes of the mouth, gastritis, taste disturbances, liver function disorders (occurring more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, which may be fatal), erythema (skin disease), skin redness, urticaria, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Progressive scarring of lung tissue (interstitial lung disease)**
Unknown ( frequency cannot be estimated from the available data):
Angioedema of the intestine: after the use of similar products, angioedema occurred in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
*May occur randomly or due to an unknown mechanism.
**During the use of telmisartan, cases of progressive scarring of lung tissue have been reported. However, a causal relationship has not been established.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Telmisartan Orion

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Telmisartan Orion contains

• The active substance of the medicine is telmisartan. Each Telmisartan Orion 40 mg tablet contains 40 mg of telmisartan. Each Telmisartan Orion 80 mg tablet contains 80 mg of telmisartan.
• The other ingredients are sodium hydroxide, povidone, meglumine, mannitol (E421), magnesium stearate, and crospovidone.

What Telmisartan Orion looks like and contents of the pack

Telmisartan Orion 40 mg tablets
White, oblong tablets, approximately 12.0 mm x 5.9 mm in size, with the letters LC embossed on one side.
Telmisartan Orion 80 mg tablets
White, oblong tablets, approximately 16.0 mm x 8.0 mm in size, with the letters LC embossed on one side.
Telmisartan Orion is available in blister packs containing 14, 28, 56, 84, and 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, 7, Pol. Ind. Miralcampo,
Azuqueca de Henares, Guadalajara, 19200,
Spain
To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:20.01.2025