Telmix Plus

Leaflet attached to the packaging: information for the user

Telmix Plus, 40 mg + 12.5 mg, tablets

Telmix Plus, 80 mg + 12.5 mg, tablets

Telmix Plus, 80 mg + 25 mg, tablets

Telmisartan + Hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Telmix Plus and what is it used for
• 2. Important information before taking Telmix Plus
• 3. How to take Telmix Plus
• 4. Possible side effects
• 5. How to store Telmix Plus
• 6. Contents of the packaging and other information

1. What is Telmix Plus and what is it used for

Telmix Plus is a combination medicine that contains two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both substances help control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to dilate and blood pressure to decrease.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It increases urine production, which leads to a decrease in blood pressure.

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 appear, 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 Plus 40 mg + 12.5 mg is used to treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan alone.

Telmix Plus 80 mg + 12.5 mg is used to treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan alone.

Telmix Plus 80 mg + 25 mg is used to treat high blood pressure (essential hypertension) in adults who are not adequately controlled by Telmix Plus 80 mg + 12.5 mg or in adults who have achieved blood pressure control with telmisartan and hydrochlorothiazide taken separately.

2. Important information before taking Telmix Plus

When not to take Telmix Plus:

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to hydrochlorothiazide or other sulfonamide derivatives;
• after the third month of pregnancy (it is also recommended to avoid taking Telmix Plus in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor finds that the patient has low potassium levels or high calcium levels in the blood that do not improve with treatment;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Before taking Telmix Plus, the patient should inform their doctor or pharmacist if any of the above conditions apply to them.

Warnings and precautions

The patient should inform their doctor if they have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated (excessive water loss from the body), has a sodium deficiency due to the use of diuretics, follows a low-sodium diet, has diarrhea or vomiting, or is undergoing hemodialysis;
• kidney disease or post-kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• increased aldosterone levels (water and sodium retention in the body, with electrolyte imbalance);
• systemic lupus erythematosus (also called lupus or SLE) - a disease in which the immune system attacks the body.

Before starting Telmix Plus, the patient should discuss the following with their doctor:

• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, or ramipril, especially if the patient has diabetic kidney disease;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also "When not to take Telmix Plus" and "Warnings and precautions".
• if the patient is taking digoxin,
• if the patient has a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During Telmix Plus treatment, the patient should protect their skin from sunlight and UV radiation.
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they can occur within a few hours to weeks after taking Telmix Plus. If left untreated, they can lead to permanent vision loss. The risk of these side effects may be higher in patients who have previously been allergic to penicillin or sulfonamides.
• if the patient has experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Telmix Plus, they should seek medical help immediately.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Telmix Plus is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").

Hydrochlorothiazide treatment may lead to electrolyte imbalance in the body. Typical symptoms of electrolyte disorders include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, fatigue, and irregular heartbeat (faster than 100 heartbeats per minute). If any of these symptoms occur, the patient should inform their doctor.

The patient should also inform their doctor about increased sensitivity to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) that appears more quickly than usual.

In case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmix Plus.

Telmix Plus may be less effective in lowering blood pressure in black patients.

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Telmix Plus, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmix Plus on their own.

Children and adolescents

Telmix Plus should not be used in children and adolescents under 18 years of age.

Telmix Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may recommend changing the dose of these medicines or taking 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 Plus:

• lithium preparations used to treat certain types of depression;
• medicines that lower potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), benzylpenicillin sodium (an antibiotic), salicylic acid, and its derivatives;
• medicines that increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines, such as heparin (an anticoagulant);
• medicines whose effects are influenced by changes in potassium levels in the blood, such as cardiac glycosides (e.g., digoxin), medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), and medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), as well as other medicines, such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine);
• antidiabetic medicines (insulin or oral medicines, such as metformin);
• cholestyramine and colestipol, used to lower blood lipid levels;
• medicines that increase blood pressure, such as noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium supplements and/or vitamin D;
• anticholinergic medicines (used to treat various disorders, such as painful intestinal contractions, bladder contractions, asthma, motion sickness, muscle cramps, Parkinson's disease, and as an adjunct during anesthesia), such as atropine and biperiden;
• amantadine (used to treat Parkinson's disease and to treat and prevent certain viral diseases);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (such as nonsteroidal anti-inflammatory drugs - NSAIDs), medicines used to treat cancer, gout, or arthritis;
• ACE inhibitors or aliskiren (see also "When not to take Telmix Plus" and "Warnings and precautions").

Telmix Plus may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may further decrease: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken by the patient during Telmix Plus treatment should be adjusted, and the patient should consult their doctor.

NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) may weaken the effect of Telmix Plus.

Telmix Plus with food, drink, and alcohol

Telmix Plus can be taken with or without food.

The patient should avoid drinking alcohol while taking Telmix Plus. Alcohol may enhance the blood pressure-lowering effect and increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor before taking this medicine.

Pregnancy

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Telmix Plus before planned pregnancy or as soon as pregnancy is detected, and will recommend another medicine instead of Telmix Plus. Telmix Plus should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Telmix Plus is not recommended during breastfeeding. The doctor may recommend alternative treatment if the patient wants to breastfeed.

Driving and using machines

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

Telmix Plus contains sugar (lactose) and mannitol, and sodium

If the patient has an intolerance to certain sugars, they should consult their doctor before taking Telmix Plus.

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

3. How to take Telmix Plus

Telmix Plus should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended dose of Telmix Plus for adults is one tablet per day. The patient should try to take the tablet at the same time every day. Telmix Plus can be taken with or without food. The tablet should be swallowed with water or a non-alcoholic drink. It is essential to take Telmix Plus every day, unless the doctor recommends otherwise.

If the patient has liver function disorders, the daily dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

Taking a higher dose of Telmix Plus than recommended

If the patient takes more tablets than recommended, they may experience low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, the patient may experience severe low blood pressure and low potassium levels in the blood, which can cause nausea, drowsiness, and muscle cramps, as well as heart rhythm disturbances associated with the concomitant use of medicines such as digitalis glycosides or certain antiarrhythmic medicines. The patient should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Telmix Plus

If the patient misses a dose, they should take it as soon as possible, and then return to their usual dosing schedule. However, if more than 12 hours have passed, they should skip the missed dose and take the usual dose the next day. The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

If the patient experiences any of the following symptoms, they should contact their doctor immediately:

• sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory response throughout the body),
• sudden swelling of the skin and mucous membranes (angioedema),
• blistering and peeling of the outer layers of the skin (toxic epidermal necrolysis). These side effects are rare (occurring in less than 1 in 1000 patients) or of unknown frequency (toxic epidermal necrolysis), but are extremely serious. If they occur, the patient should stop taking the medicine and contact their doctor immediately. If left untreated, these symptoms can be fatal.

*An increased incidence of sepsis has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Telmix Plus. This phenomenon may be coincidental or related to a mechanism that has not yet been understood.

Possible side effects of Telmix Plus

Common side effects (may occur in less than 1 in 10 patients):

• dizziness.

Uncommon side effects (may occur in less than 1 in 100 patients):

• low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation (vertigo), rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath, diarrhea, dry mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.

Rare side effects (may occur in less than 1 in 1000 patients):

• bronchitis (inflammation of the airways), activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body), sore throat, sinusitis, depression, insomnia, vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea/vomiting, gastritis, abnormal liver function (more common in patients of Japanese origin), redness of the skin (erythema), allergic reactions, such as itching or rash, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera or acute angle-closure glaucoma).

Side effects reported for individual components may also occur when taking Telmix Plus, even if they were not observed during clinical trials of the combination product containing telmisartan and hydrochlorothiazide.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:

Uncommon side effects (may occur in less than 1 in 100 patients):

• upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels in the blood, slow heartbeat (bradycardia), kidney function disorders, including acute kidney failure, weakness, cough.

Rare side effects (may occur in less than 1 in 1000 patients):

• low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in patients with diabetes), gastritis, skin rash (exanthema), joint degeneration, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness.

Very rare side effects (may occur in less than 1 in 10,000 patients):

• progressive pulmonary fibrosis (interstitial lung disease)**

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• intestinal angioedema - angioedema of the intestine has been reported with similar products, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

**Cases of progressive pulmonary fibrosis have been reported in association with telmisartan treatment. However, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:

Common side effects (may occur in less than 1 in 10 patients):

• nausea, low magnesium levels in the blood.

Rare side effects (may occur in less than 1 in 1000 patients):

• low platelet count, which increases the risk of bleeding or bruising, high calcium levels in the blood, headache.

Very rare side effects (may occur in less than 1 in 10,000 patients):

• increased blood pH (acid-base imbalance) due to low chloride levels in the blood.
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• salivary gland inflammation, decreased blood cell count (including low red and white blood cell count), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, restlessness, feeling of "emptiness" in the head, blurred vision or yellow vision, vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera or acute angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, jaundice (yellowing of the skin and eyes), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body), skin disorders, such as vasculitis of the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or kidney function disorders, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, difficulty controlling blood sugar levels/urine (in patients with diagnosed diabetes), increased triglyceride levels in the blood, malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 collected on the safety of the medicine.

5. How to store Telmix Plus

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" and on the blister after "EXP". The expiry date refers to the last day of the month stated.

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 packaging and other information

What Telmix Plus contains

• The active substances of the medicine are telmisartan and hydrochlorothiazide.

Each 40 mg + 12.5 mg tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

Each 80 mg + 12.5 mg tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

Each 80 mg + 25 mg tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

• The other ingredients are mannitol, sodium hydroxide, meglumine, povidone K30, magnesium stearate, sodium stearyl fumarate, lactose monohydrate, microcrystalline cellulose (PH101), yellow iron oxide (E172), red iron oxide (E172).

What Telmix Plus looks like and contents of the pack

Telmix Plus, 40 mg + 12.5 mg, tablets

White or almost white on one side, red, marbled with possible spots on the other side, biconvex, bilayer, oblong tablets with the letter T1 embossed on the red side and smooth on the other.

Telmix Plus, 80 mg + 12.5 mg

White or almost white on one side, red, marbled with possible spots on the other side, biconvex, bilayer, oblong tablets with the letter T2 embossed on the red side and smooth on the other.

Telmix Plus, 80 mg + 25 mg

White or almost white on one side, yellow, marbled with possible spots on the other side, biconvex, bilayer, oblong tablets with the letter T2 embossed on the yellow side and smooth on the other.

The medicine is packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.

The pack contains 7, 28, or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Manufacturer/Importer

Laboratori Fundació DAU

C/C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Date of last revision of the leaflet: 31.12.2024