Telmisartan orion

Package leaflet: Information for the patient

Telmisartan Orion, 40 mg, tablets
Telmisartan Orion, 80 mg, tablets
Telmisartanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Telmisartan Orion belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, resulting in increased blood pressure. Telmisartan Orion blocks the effects of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.
Telmisartan Orion is used to treat essential (high) arterial hypertension in adults. The term "essential" means that the high blood pressure is not caused by another disease.
Untreated high blood pressure may damage blood vessels in various organs and, in some cases, lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to measure your blood pressure regularly to ensure it remains within normal limits.
Telmisartan Orion is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adult patients at risk, including those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes. Your doctor will inform you if you belong to this high-risk group.

2. Important information before using Telmisartan Orion

When not to use Telmisartan Orion

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (use of Telmisartan Orion should also be avoided in early pregnancy - see section "Pregnancy");
• if the patient has severe liver problems such as cholestasis or biliary obstruction (impaired 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.

You should inform your doctor or pharmacist before taking Telmisartan Orion if any of the above conditions apply to you.

Warnings and precautions

Please inform your doctor if you have or have had any of the following conditions or diseases:

• kidney disease or status post kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart problems;
• increased levels of aldosterone (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 loss of body water) or has sodium deficiency due to diuretic (water pill) use, low-sodium diet, diarrhoea, or vomiting;
• increased potassium levels in the blood;
• diabetes.

Before starting treatment with Telmisartan Orion, discuss with your doctor if:

• you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, particularly if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use Telmisartan Orion".
• you are taking digoxin.

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Use of Telmisartan Orion is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").

If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Telmisartan Orion, discuss this with your doctor. Your doctor will decide whether treatment should continue. Do not stop taking Telmisartan Orion on your own.

If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Telmisartan Orion.

Telmisartan Orion may be less effective in lowering blood pressure in patients of black racial origin.

Children and adolescents

Use of Telmisartan Orion is not recommended for the treatment of children and adolescents under 18 years of age.

Telmisartan Orion and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may need to adjust the dose or take other precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies to concomitant use with Telmisartan Orion of the following medicines:

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

The effect of Telmisartan Orion may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids. Telmisartan Orion may enhance the blood pressure-lowering effect of other antihypertensive medicines or medicines with blood pressure-lowering properties (e.g. baclofen, amifostine). In addition, low blood pressure may be intensified by alcohol, barbiturates, opioids, or antidepressants. Symptoms include dizziness upon standing. If dosage adjustment of another medicine taken during treatment with Telmisartan Orion is needed, consult your doctor.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will usually advise stopping Telmisartan Orion before a planned pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine. Use of Telmisartan Orion is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of gestation.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Telmisartan Orion is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery

Some patients taking Telmisartan Orion may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Excipients

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Telmisartan Orion

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
The recommended dose of Telmisartan Orion is one tablet daily. Try to take the tablet at the same time each day.
Telmisartan Orion may be taken with or without food. Swallow the tablets with water or another non-alcoholic drink. It is important to take Telmisartan Orion every day, unless your doctor advises otherwise. If you feel that the effect of Telmisartan Orion is too strong or too weak, consult your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Orion is one 40 mg tablet once daily for most patients, providing 24-hour blood pressure control. Your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg for some patients. Telmisartan Orion may also be used in combination with a diuretic (water tablet), such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Orion.

To reduce the risk of cardiovascular events, the usual dose of Telmisartan Orion is one 80 mg tablet once daily. Blood pressure should be monitored frequently, especially at the beginning of treatment.

In patients with impaired liver function, the usual dose should not exceed 40 mg once daily.

Taking more Telmisartan Orion than prescribed
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take Telmisartan Orion
If you miss a dose, take it as soon as you remember, then continue with your regular dosing schedule. If you do not remember until the next day, take your usual dose on the following day. Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious and may require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (commonly known as blood poisoning, a severe infection causing systemic inflammatory response) and sudden swelling of the skin and mucous membranes (angioedema) – these are very serious adverse reactions which are rare (may occur in up to 1 in 1,000 patients). In such cases, treatment with this medicine must be stopped immediately and medical advice sought urgently, as if left untreated, these symptoms may result in death.

Possible adverse reactions of Telmisartan Orion:
Common adverse reactions (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty sleeping, low mood (depression), fainting, sensation of spinning (peripheral vertigo), 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, abdominal discomfort, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, kidney function disorders, including acute kidney failure, chest pain, feeling of weakness, and increased blood creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Sepsis* (commonly known as blood poisoning, a severe infection causing systemic inflammatory response, which may lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (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, visual disturbances, rapid heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (occurring more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, including fatal cases), skin eruption (skin disease), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased uric acid levels, increased activity of liver enzymes or creatine kinase in blood.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive lung tissue fibrosis (interstitial lung disease)**

Not known (frequency cannot be estimated from available data):
Intestinal angioedema: following use of similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

*May occur incidentally or due to a currently unknown mechanism.
**Cases of progressive lung tissue fibrosis have been reported during telmisartan treatment. However, a causal relationship has not been established.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
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 Telmisartan Orion

Keep this medicine 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 specified month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Orion contains

• The active substance 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, elongated 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, elongated 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 Authorisation 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
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]