Telmabax

PL/H/0698/002-003/IB/021

Package leaflet: Information for the user

Telmabax 40 mg tablets
Telmabax 80 mg tablets
Telmisartanum
Read the entire leaflet carefully before starting to take this medicine, as 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 you personally. Do not share it with others. It may harm them, even if their symptoms are similar to yours.
• If any of the side effects worsens or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Telmabax is and what it is used for

Telmabax 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, leading to increased blood pressure. Telmabax works by blocking the effects of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.

Telmabax is used to treat essential hypertension (high blood pressure) 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, may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, blood pressure should be checked regularly.

Telmabax is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in patients at risk, such as 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 whether you belong to such a risk group.

2. Information before using Telmabax

When not to use Telmabax

• 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 (Telmabax should also be avoided during early pregnancy - see section "Pregnancy");
• if the patient has severe liver function disorders, such as cholestasis or biliary obstruction (problems with 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.

If any of the above situations apply, the patient should inform their doctor or pharmacist before starting Telmabax.

Warnings and precautions

Tell 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-related disorders;
• increased aldosterone levels (retention of water and salt in the body, associated with disturbances in the balance of various minerals);
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has salt deficiency due to diuretic therapy (diuretics), low-salt diet, diarrhoea, or vomiting;
• increased potassium levels in the blood;
• diabetes.

Before starting Telmabax, discuss with the doctor or pharmacist:

• if the patient is taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes;
  • aliskiren. The doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Telmabax".
• if the patient is taking digoxin.

Inform the doctor about suspected or planned pregnancy. Telmabax 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 undergoing surgery or anaesthesia, inform the doctor about taking Telmabax.

Telmabax may be less effective in lowering blood pressure in black patients.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Telmabax, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Telmabax without consulting the doctor.

Children and adolescents

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

Other medicines and Telmabax

Tell the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

The doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies when Telmabax is taken together with any of the following medicines:

• lithium-containing medicines used to treat certain types of depression;
• medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), 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 tablets), especially when taken in high doses together with Telmabax, as they may lead to significant fluid loss and low blood pressure (hypotension);
• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Telmabax" and "Warnings and precautions");
• digoxin.

The effect of Telmabax may be reduced when taken together with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or glucocorticoids.

Telmabax may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that may cause low blood pressure (e.g. baclofen, amifostine). Additionally, alcohol, barbiturates, narcotics, or antidepressants may further lower blood pressure. Symptoms include dizziness upon standing. If dose adjustment of another medicine taken during Telmabax therapy is needed, consult the doctor.

Pregnancy and breastfeeding

Pregnancy

Inform the doctor about suspected or planned pregnancy. Usually, the doctor will recommend stopping Telmabax before a planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Telmabax 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.

Breastfeeding

Inform the doctor if breastfeeding or planning to breastfeed. Telmabax is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding, especially when feeding newborns or premature infants.

Driving and using machines

In some patients taking Telmabax, adverse effects such as fainting or dizziness (vertigo) may occur. If such adverse effects occur, the patient should not drive or operate machinery.

Telmabax contains sorbitol

If the patient has an intolerance to certain sugars, consult the doctor before taking this medicine.

Telmabax contains sodium

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

3. How to use Telmabax

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose of Telmabax is one tablet daily. The tablet should be taken at the same time each day.
Telmabax may be taken with or without food. Tablets should be swallowed with water or another non-alcoholic drink. It is important to take Telmabax every day, unless your doctor advises otherwise. If you feel that the effect of Telmabax is too strong or too weak, consult your doctor or pharmacist.

For the treatment of hypertension, the usual dose of Telmabax is one 40 mg tablet once daily for most patients, which ensures blood pressure control for over 24 hours. Your doctor may recommend a lower dose of one 20 mg tablet daily or a higher dose of 80 mg daily. Telmabax may also be administered in combination with a diuretic (water tablet), such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmabax.

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

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

Taking more Telmabax than prescribed
If too many tablets are taken by mistake, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

If you miss a dose of Telmabax
Do not worry if you forget to take a dose. Take it as soon as you remember, then continue taking the medicine as prescribed. If a tablet is not taken during the entire day, take the usual dose the next day. Do not take a double dose to make up for a 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 will experience them.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (often referred to as blood poisoning, a severe infection causing a systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema).
These adverse reactions are rare (occur in 1 to 10 out of 10,000 patients), but extremely serious. In such cases, discontinue the medicine immediately and contact your doctor without delay. If left untreated, these symptoms may result in death.

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

Uncommon adverse reactions (may occur in 1 out of 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced number of red blood cells (anaemia), high potassium levels, 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, skin itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, kidney dysfunction, including acute kidney failure, chest pain, feeling of weakness, and increased blood creatinine levels

Rare adverse reactions (may occur in 1 out of 1,000 people):
Sepsis* (often referred to as blood poisoning, a severe infection causing a 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, fast heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (these adverse reactions are more likely to occur in Japanese patients), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema resulting in death), skin eruption (skin disease), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (blood protein), increased uric acid levels, increased activity of liver enzymes or creatine phosphokinase in blood, low sodium levels

Very rare adverse reactions (occur in less than 1 out of 10,000 patients):
Progressive fibrosis of lung tissue (interstitial lung disease) **

* This reaction may have occurred independently or may be related to the use of the medicine; however, the mechanism of this association is unknown.
** Cases of progressive fibrosis of lung tissue have been observed during treatment with telmisartan. However, it is not known whether these cases were caused by the medicine.

Frequency not known (frequency cannot be estimated from available data):
Intestinal angioedema – angioedema of the intestine has been reported with similar medicinal products, presenting 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
PL/H/0698/002-003/IB/021
PL-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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Telmabax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and immediate
packaging. The expiry date refers to the last day of the specified month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the pack and other information

What Telmabax contains
The active substance is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.
The other ingredients are: povidone K30, meglumine, sodium hydroxide, sorbitol, magnesium stearate.

What Telmabax looks like and contents of the pack
Telmabax 40 mg are whitish to light yellow, elongated tablets, embossed with the code 'T12' on one side and smooth on the other.
Telmabax 80 mg are whitish to light yellow, elongated tablets, embossed with the code 'T13' on one side and smooth on the other.
Telmabax is available in packs containing 14 or 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw, Poland

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
The Netherlands
Terapia S.A.
Fabricii Street No. 124
Cluj Napoca 400 640
Romania
PL/H/0698/002-003/IB/021