Telmix

Package Leaflet: Information for the Patient

Telmix

40 mg, tablets

80 mg, tablets

Telmisartan

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

• Keep this leaflet, you may need to read it again.
• 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. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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 pack 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 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.
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.
The doctor will inform the patient if they are at risk of these disorders.

2. Important information before taking Telmix

When not to take Telmix

• after the third month of pregnancy. (It is also recommended to avoid taking Telmix in early pregnancy - see the "Pregnancy" section).
• 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 to the patient, they should inform their doctor or pharmacist before taking Telmix.

Warnings and precautions

Before starting Telmix, the patient should discuss with their doctor if they 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 the patient is dehydrated (excessive water loss from the body) or has a low salt level due to the use of diuretics, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.
• If the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• aliskiren.
• If the patient is taking digoxin.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Telmix".
The patient should inform their doctor about suspected or planned pregnancy. It is not recommended to take Telmix in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see the "Pregnancy" section).
In the case of planned surgery or anesthesia, the patient should inform their doctor about 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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. The 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 Telmix:

• Lithium products 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 Telmix, as they can lead to significant water loss and low blood pressure (hypotension).
• Digoxin.

The doctor may need to change the dose and/or take other precautions if the patient is taking an ACE inhibitor or aliskiren (see also the information under the headings "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 can be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken with Telmix should be adjusted, and the patient should consult their doctor.

Taking Telmix with food and drink

The patient can take Telmix with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about suspected or planned pregnancy. Usually, the doctor will advise stopping Telmix before planned pregnancy or as soon as pregnancy is confirmed and will recommend another medicine instead of Telmix. It is not recommended to take Telmix 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 patient should tell their doctor about breastfeeding or intending to breastfeed. Telmix is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the case of newborns and premature infants.

Driving and using machines

Some patients taking Telmix may experience dizziness or fatigue. In such cases, they should not drive or operate machines.
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

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their 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. The patient should try to take the tablet at the same time every day.
Telmix can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Telmix every day, unless the doctor advises otherwise. If the patient feels that the effect of Telmix is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmix is one 40 mg tablet per day for most patients, which provides 24-hour blood pressure control. The doctor may recommend a lower dose of 20 mg per day or a higher dose of 80 mg per day. 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 frequency of cardiovascular events, the usual dose of Telmix is one 80 mg tablet per day. At the beginning of treatment, blood pressure should be frequently monitored.
In the case of liver dysfunction, the usual dose should not exceed 40 mg per day.

Taking a higher dose of Telmix than recommended

If too many tablets are taken by mistake, the patient should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Telmix

If a dose is missed, the patient should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day. The patient should not take a double doseto make up for the missed dose.

Stopping Telmix treatment

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

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:

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body), sudden swelling of the skin and mucous membranes (angioedema).
These side effects are rare (may occur in up to 1 in 1000 patients), but they are extremely serious; in such cases, the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can be fatal.

Possible side effects of Telmix:

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 dysfunction, 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 1000 patients):
sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), increased eosinophil count, low platelet count (thrombocytopenia), 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), dry mouth, gastritis, liver dysfunction (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 rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (protein in the blood), 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 pulmonary fibrosis (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

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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, more information can be gathered on the safety of the medicine.

5. How to store Telmix

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 after "EXP:". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store the blister in the outer packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Telmix contains

The active substance of the medicine 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 stearylfumarate, 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 available on the market.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 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