Telmix
Ask a doctor about a prescription for Telmix
How to use Telmix
Leaflet attached to the packaging: patient information
Telmix
40 mg, tablets
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.
- If you have any doubts, consult your 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 as yours.
- If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- 1. What is Telmix and what is it used for
- 2. Important information before taking Telmix
- 3. How to take Telmix
- 4. Possible side effects
- 5. How to store Telmix
- 6. Contents of the packaging and other information
1. What is Telmix and what is it used for
Telmix 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. Telmix blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmix is usedto treat essential hypertension (high blood pressure) in adults. 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 failure, 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.
Telmix is also usedto reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults 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 disorders.
2. Important information before taking Telmix
When not to take Telmix
- after the third month of pregnancy. (You should also avoid taking Telmix in early pregnancy - see the "Pregnancy" section).
Warnings and precautions
Before starting to take Telmix, you should discuss it with 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.
- High aldosterone levels (water and salt retention in the body, accompanied by mineral balance disorders in the blood).
- 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.
- 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 Telmix".
You should inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Telmix in early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby (see the "Pregnancy" section).
In the event of planned surgery or anesthesia, you should inform your doctor that you are taking Telmix.
Telmix may be less effective in lowering blood pressure in people of black race.
Children and adolescents
Telmix is not recommended for use in children and adolescents under 18 years of age.
Telmix and other medicines
You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, 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 simultaneous use of the following medicines with Telmix:
- Lithium products used to treat certain types of depression.
- Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics (some diuretics), non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
- Diuretics, especially when taken in high doses with Telmix, as they can lead to significant water loss from the body and a decrease in blood pressure (hypotension).
- Digoxin.
Your doctor may need to change the dose and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmix" and "Warnings and precautions").
The effect of Telmix may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmix 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 may 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 Telmix, consult your doctor.
Taking Telmix with food and drink
You can take Telmix with or without food.
Pregnancy, breastfeeding, and fertility
You should inform your doctor if you suspect (or plan) pregnancy. Usually, your doctor will advise you to stop taking Telmix before planned pregnancy or as soon as you find out you are pregnant and will prescribe another medicine instead of Telmix. You should not take Telmix in early pregnancy and must not take it after the third month of pregnancy, as it may seriously harm your baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Telmix 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 Telmix may feel dizzy or tired. In this case, do not drive or operate machinery.
Excipients
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, which means that the medicine is considered "sodium-free".
3. How to take Telmix
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Telmix is available in tablets of 2 strengths: 40 mg and 80 mg. The tablets can be divided into equal doses.
The recommended dose of Telmix is one tablet per day. Try to take the tablet at the same time every day.
Telmix can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is important to take Telmix every day, unless your doctor tells you to stop. If you feel that the effect of Telmix is too strong or too weak, talk to your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmix is one 40 mg tablet once daily, which provides 24-hour blood pressure control. Your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg once daily. Telmix can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmix.
To reduce the risk of cardiovascular events, the usual dose of Telmix is one 80 mg tablet once daily. Blood pressure should be frequently monitored at the beginning of treatment.
Taking a higher dose of Telmix than recommended
Missing a dose of Telmix
Stopping treatment with Telmix
4. Possible side effects
Like all medicines, Telmix can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention:
These side effects are rare (may affect up to 1 in 1000 patients), but are extremely serious; in such cases, you should stop taking the medicine and contact your doctor immediately. If these symptoms are not treated, they can be fatal.
Possible side effects of Telmix:
Common side effects (may affect up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may affect 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, kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1000 patients):
sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in patients with diabetes), restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also be fatal (angioedema), skin eruptions (skin disease), skin redness, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 patients):
Progressive scarring of the lung tissue (interstitial lung disease)**
* The event may be coincidental or related to an unknown mechanism.
** Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.
Reporting side effects
02-222 Warsaw
Phone: +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 Telmix
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of that month.
There are no special storage instructions for the medicine.
Store the blister in the outer packaging to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist 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 Telmix contains
The active substance is telmisartan.
Telmix, 40 mg, tablets
One tablet contains 40 mg of telmisartan
Telmix, 80 mg, tablets
One tablet contains 80 mg of telmisartan
The other ingredients are: sodium hydroxide, povidone type 30, mannitol (E421), cornstarch, calcium carmellose, sodium stearyl fumarate, and magnesium stearate.
What Telmix looks like and contents of the pack
Telmix 40 mg tablets are white or almost white, oval tablets with a score line on one side.
The tablet can be divided into equal doses.
Telmix 80 mg tablets are white or almost white, oval tablets with the letter "T" embossed and a score line on one side.
The tablet can be divided into equal doses.
Telmix is available in blisters of OPA/Aluminum/PVC/Aluminum or PVC/PVDC/Aluminum, placed in a cardboard box
The pack contains: 7, 14, 28, 30, 56, 60, 84, or 90 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Delorbis Pharmaceuticals Ltd.
17, Athinon Street, Ergates
2643 Lefkosia
Cyprus
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Poland:
Telmix
Date of last revision of the leaflet: 11.03.2024
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterBiofarm Sp. z o.o. Delorbis Pharmaceuticals Ltd.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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