Telmix

Package leaflet: Information for the patient

Telmix
40 mg, tablets
80 mg, tablets
Telmisartanum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

1. What Telmix is and what it is used for
2. What you need to know 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 Telmix is and what it is used for

Telmix 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. Telmix blocks the action of angiotensin II, causing blood vessels to relax and
blood pressure to decrease.
Telmix is used to 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 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 these complications occur. Therefore, it is important to measure blood
pressure regularly to ensure it remains within normal limits.
Telmix is also used to reduce the frequency of cardiovascular events (such as heart attack or
stroke) in adults at risk, i.e. those who have reduced blood flow to the heart or legs, who have had a
stroke, or who have diabetes.
Your doctor will inform you whether you belong to this risk group.

2. Important information before using Telmix

When not to use Telmix

• 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. (Telmix should also be avoided during early pregnancy – see section "Pregnancy").
• if the patient has severe liver problems, such as cholestatic disorders 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 taking Telmix.
Warnings and precautions
Before starting treatment with Telmix, discuss with your doctor if you have
or have previously 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-related disorders.
• Elevated aldosterone levels (retention of water and salt in the body, accompanied by disturbances in the balance of various blood 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 (water tablets), low-salt diet, diarrhoea or vomiting.
• Increased blood potassium levels.
• Diabetes.
• 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.
• If the patient is taking digoxin.

Your doctor may monitor kidney function, blood pressure and blood electrolyte levels (e.g.
potassium) at regular intervals.
Also see information under the heading “When not to use Telmix”.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Telmix is not recommended during early pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnacy”).
If undergoing surgery or anaesthesia, 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
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This particularly applies to concomitant use of Telmix with the following medicines:

• Lithium-containing products used in the treatment of certain types of depression.
• Medicines that may increase blood potassium levels, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain diuretics), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs such as acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (water tablets), especially when used in high doses together with Telmix, as they may lead to significant fluid loss and low blood pressure (hypotension).
• Digoxin.

Your doctor may need to adjust the dose and/or take additional precautions if you are taking an ACE inhibitor or aliskiren (see also information under the headings “When not to use Telmix” and “Warnings and precautions”).
The effect of Telmix may be reduced when taken together with NSAIDs (non-steroidal anti-inflammatory drugs such as acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmix may enhance the blood pressure-lowering effect of other antihypertensive medicines or medicines that may cause low blood pressure (e.g. baclofen, amifostine). In addition, alcohol, barbiturates, narcotics or antidepressants may further lower blood pressure. Symptoms include dizziness upon standing. If dose adjustment of any other medicine taken during Telmix treatment is needed, consult your doctor.
Taking Telmix with food and drink
You may take Telmix with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, your doctor will advise stopping Telmix before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of Telmix. Telmix 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 after the 3rd month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Telmix is not recommended during breastfeeding. Your doctor may choose an alternative treatment during breastfeeding, especially when breastfeeding newborns or premature infants.
Driving and using machines
Some patients taking Telmix 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 recommended dose unit, i.e. it is considered "sodium-free".

3. How to use Telmix

This medicine should always be taken as directed by the physician. In case of doubts, consult a
doctor or pharmacist.
Telmix is available in tablets of 2 strengths: 40 mg and 80 mg. Tablets may be divided into equal
doses.
The recommended dose of Telmix is one tablet daily. Try to take the tablet at the same time each day.
Telmix may be taken during or between meals. Swallow the tablet with water or another non-alcoholic
drink. It is important to take Telmix every day unless otherwise advised by the physician. If you feel
that the effect of Telmix is too strong or too weak, consult your doctor or pharmacist.
In the treatment of arterial hypertension, the usual dose of Telmix is one 40 mg tablet once daily
for most patients, providing 24-hour blood pressure control. The physician may recommend a lower
dose of half a 40 mg tablet per day or a higher dose of one 80 mg tablet per day. Telmix may also be
used in combination with a diuretic (water tablet), 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 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 Telmix than prescribed
If too many tablets are taken by mistake, contact a doctor or pharmacist immediately or go to the
nearest hospital emergency department.
Missing a dose of Telmix
If a dose is missed, take it as soon as remembered, then continue taking the medicine as before.
If the 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.
Stopping Telmix
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 called blood poisoning, a severe infection causing a systemic inflammatory response) and sudden swelling of the skin and mucous membranes (angioedema).
The above adverse reactions are rare (may occur in up to 1 in 1,000 patients), but extremely serious. In such cases, treatment with the medicine must be stopped immediately and medical advice sought without delay. If left untreated, these symptoms may result in death.

Possible adverse reactions of Telmix:
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 concentration in plasma, difficulty falling asleep, 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, renal 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* (often called 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, difficulty breathing, 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 (occur more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes which may also lead to death (angioedema, including fatal cases), skin eruptions (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 concentration, increased liver enzyme or creatine phosphokinase activity in blood.

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

* The event may be coincidental or related to a currently unknown mechanism.
** Cases of interstitial lung disease have been reported in temporal association with the use of telmisartan. 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 of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine 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: "Expiry date (EXP):". The expiry date refers to the last day of the specified month.
There are no special requirements regarding storage temperature.
Store the blister in the outer packaging to protect it from light and moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Telmix contains
The active substance in Telmix is telmisartan.
Telmix 40 mg tablets
One tablet contains 40 mg of telmisartan.
Telmix 80 mg tablets
One tablet contains 80 mg of telmisartan.
Other ingredients are: sodium hydroxide, povidone type 30, mannitol (E421), corn starch,
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-shaped tablets with a division line on one side.
The tablet can be divided into equal doses.
Telmix 80 mg tablets are white or almost white, oval-shaped tablets with an embossed letter 'T' and a division line on one side.
The tablet can be divided into equal doses.
Telmix is available in blisters made of OPA/Aluminium/PVC/Aluminium or PVC/PVDC/Aluminium, packed in a cardboard box.
Pack sizes contain: 7, 14, 28, 30, 56, 60, 84 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland

Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Delorbis Pharmaceuticals Ltd.
17, Athinon Street, Ergates
2643 Lefkosia
Cyprus

This medicinal product is authorized in the European Economic Area member states under the following names:
Poland: Telmix