TELMABAX 80 mg Tablets

Contents of the leaflet

1. What is Telmabax and what is it used for
2. Important information before taking Telmabax
   1. When not to take Telmabax
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Telmabax
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Telmabax contains sorbitol
   8. Telmabax contains sodium
3. How to take Telmabax
   1. Taking a higher dose of Telmabax than recommended
   2. Missing a dose of Telmabax
4. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Possible side effects:
   3. Reporting side effects
5. How to store Telmabax
6. Contents of the pack and other information
   1. What Telmabax contains
   2. What Telmabax looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

1. What is Telmabax and what is it used for

Telmabax 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 an increase in blood pressure. Telmabax blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmabax 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, blood pressure should be regularly monitored.
Telmabax is also usedto reduce the frequency of cardiovascular events (such as heart attack or stroke) in patients at risk, i.e., 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 are at risk of these events.

2. Important information before taking Telmabax

When not to take Telmabax

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• after the third month of pregnancy (you should also avoid taking Telmabax in early pregnancy - see section "Pregnancy");

If any of the above situations apply to you, you should inform your doctor or pharmacist before starting to take Telmabax.

Warnings and precautions

You should inform your doctor if you 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 problems;
• increased aldosterone levels (water and salt retention in the body, accompanied by disturbances in the balance of various minerals);
• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have a low salt level due to the use of diuretics, a low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes.

Before starting to take Telmabax, you should discuss this with your doctor or pharmacist:

• angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the heading "When not to take Telmabax" and "Warnings and precautions".

You should inform your doctor if you suspect or plan to become pregnant. It is not recommended to take Telmabax in early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby (see section "Pregnancy").
In the event of planned surgery or anesthesia, you should inform your doctor that you are taking Telmabax.
Telmabax may be less effective in lowering blood pressure in black patients.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Telmabax, you should discuss this with your doctor. Your doctor will decide on further treatment. You should not stop taking Telmabax on your own.

Children and adolescents

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

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor may decide to change the dose of these medicines or take 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 Telmabax:

• medicines containing lithium, used to treat certain types of depression;
• medicines that can 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, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics, especially when taken in high doses with Telmabax, as they can lead to significant water loss and low blood pressure (hypotension);
• digoxin.

The effect of Telmabax may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmabax may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure can be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If you need to adjust the dose of another medicine you are taking while taking Telmabax, you should consult your doctor.

Pregnancy and breastfeeding

Pregnancy
You should inform your doctor if you suspect or plan to become pregnant. Usually, your doctor will advise you to stop taking Telmabax before planned pregnancy or as soon as you become pregnant and will prescribe another medicine instead of Telmabax. It is not recommended to take Telmabax in early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby.
Breastfeeding
You should tell your doctor if you are breastfeeding or plan to breastfeed. Telmabax is not recommended during breastfeeding. Your doctor may choose another treatment during breastfeeding, especially in the period of breastfeeding newborns and premature babies.

Driving and using machines

Some patients taking Telmabax may experience dizziness or fatigue. If you experience dizziness or fatigue, you should not drive or operate machinery.

Telmabax contains sorbitol

If you have intolerance to some sugars, you should consult your doctor before taking the medicine.

Telmabax contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".
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3. How to take Telmabax

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Usually, the recommended dose of Telmabax is one tablet per day. You should take one tablet daily at the same time.
Telmabax can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is important to take Telmabax every day, unless your doctor tells you to stop. If you feel that the effect of Telmabax is too strong or too weak, you should consult your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmabax is 40 mg once daily for most patients, which provides blood pressure control for more than 24 hours. Your doctor may prescribe a lower dose of 20 mg once daily or a higher dose of 80 mg once daily. Telmabax can also be given in combination with a diuretic, 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 80 mg once daily. At the beginning of treatment, you should frequently monitor your blood pressure.
In patients with liver problems, the usual dose should not exceed 40 mg once daily.

Taking a higher dose of Telmabax than recommended

If you accidentally take too many tablets, you should immediately contact your doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Telmabax

You should not worry if you forget to take a dose. You should take it as soon as you remember, and then continue taking the medicine as scheduled. If you do not take a tablet during the day, you should take your usual dose the next day. You should nottake a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

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

If you experience any of the following symptoms, you should immediately contact your doctor:
sepsis (blood poisoning, a severe infection with an inflammatory reaction throughout the body), angioedema (sudden swelling of the skin and mucous membranes). These side effects are rare (they occur in 1 to 10 out of 10,000 patients), but they are extremely serious, and you should stop taking the medicine and contact your doctor immediately. If these symptoms are not treated, they can be fatal.

Possible side effects:

Common side effects (occurring in 1 to 10 out of 100 patients):
low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events
Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):
urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), anemia, high potassium levels, insomnia, depression, fainting, peripheral vertigo (dizziness), bradycardia (slow heart rate), 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 impairment, including acute renal failure, chest pain, feeling of weakness, and increased creatinine levels in the blood
Rare side effects (occurring in 1 to 10 out of 10,000 patients):
sepsis (blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), eosinophilia (increased white blood cell count), thrombocytopenia (low platelet count), anaphylactic reaction (severe allergic reaction), allergic reactions (e.g., rash, itching, breathing problems, wheezing, facial swelling, or low blood pressure), hypoglycemia (low blood sugar) in patients with diabetes, restlessness, drowsiness, vision disturbances, tachycardia (fast heart rate), dry mouth, gastritis, taste disturbances, liver function disorders (the likelihood of these side effects is higher in Japanese patients), angioedema (sudden swelling of the skin and mucous membranes, which can also be fatal), erythema (skin redness), urticaria, severe rash, arthralgia (joint pain), limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels, increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood
Very rare side effects (occurring in less than 1 out of 10,000 patients):
progressive interstitial lung disease (pulmonary fibrosis) **
* this side effect may have occurred independently or may be related to the use of the medicine, but the mechanism of this relationship is unknown
** cases of progressive interstitial lung disease have been observed during treatment with telmisartan. However, it is not known whether they were caused by the medicine.
Frequency not known (frequency cannot be estimated from the available data): intestinal angioedema - after the use of similar products, angioedema in the intestine has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmabax

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 pack. The expiry date refers to the last day of that month.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Telmabax contains

The active substance of Telmabax is telmisartan. Each tablet contains 40 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 white to light yellow, elongated tablets with the inscription "T12" on one side and smooth on the other side.
Telmabax, 80 mg, are white to light yellow, elongated tablets with the inscription "T13" on one side and smooth on the other side.
Telmabax is available in packs containing 14 or 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o., ul. Idzikowskiego 16, 00-710 Warsaw

Manufacturer

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, Netherlands
Terapia S.A., Str. Fabricii Nr 124, Cluj Napoca 400 632, Romania
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Date of last revision of the leaflet:January 2025