Telmidon

Leaflet accompanying the packaging: patient information

Telmidon, 40 mg + 12.5 mg, tablets

Telmidon, 80 mg + 12.5 mg, tablets

Telmidon, 80 mg + 25 mg, tablets

Telmisartan + Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Telmidon and what is it used for

Telmidon is a combination medicine that contains two active substances: telmisartan and hydrochlorothiazide. 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 the amount of urine excreted, 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 failure, 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. Telmidon 40 mg + 12.5 mg or 80 mg + 12.5 mg is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan alone. Telmidon 80 mg + 25 mg is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by Telmidon 80 mg + 12.5 mg or who have achieved blood pressure control with telmisartan and hydrochlorothiazide in separate preparations.

2. Important information before taking Telmidon

When not to take Telmidon

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to hydrochlorothiazide or other sulfonamide derivatives;
• after the third month of pregnancy (also, you should avoid taking Telmidon in early pregnancy - see "Pregnancy");
• if you have severe liver disease, such as cholestasis or biliary obstruction (bile flow disorders);
• if you have severe kidney disease;
• if you have low potassium or high calcium levels in your blood (detected in blood tests) that do not improve with treatment;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmidon.

Warnings and precautions

Before taking this medicine, talk to your doctor if you have or have had any of the following disorders or diseases:

• low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss) or have a low salt level due to the use of diuretics, a low-salt diet, diarrhea, vomiting, or dialysis therapy;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• high aldosterone levels (water and salt retention in the body, along with electrolyte imbalance);
• systemic lupus erythematosus (also called lupus or SLE), a disease in which the immune system attacks the body;
• the active substance - hydrochlorothiazide may cause a rare reaction that worsens vision and causes 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 pressure in the eyeball, which may appear within a few hours to a few weeks after taking Telmidon and, if left untreated, may lead to permanent vision disturbances.

Before starting Telmidon, discuss the following with your doctor:

• if you are taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if you have diabetic kidney disease;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also "When not to take Telmidon".
• if you are taking digoxin.
• if you have 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 Telmidon treatment, protect your skin from sunlight and UV radiation.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Telmidon should not be taken during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy"). Hydrochlorothiazide treatment may lead to electrolyte imbalance in the body. Typical symptoms of water and electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain, nausea, vomiting, muscle fatigue, and irregular heartbeat (more than 100 beats per minute). If you experience any of these symptoms, tell your doctor. You should also tell your doctor if you experience increased sensitivity to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering), which may occur more quickly than usual. Tell your doctor if you are taking Telmidon and plan to have surgery or anesthesia.

Children and adolescents

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

Telmidon with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. Your doctor may need to change the dose of other 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 Telmidon:

• Lithium preparations used to treat certain types of depression.
• Medicines that cause low 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), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives.
• Medicines that may 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 sodium (an anticoagulant).
• Medicines whose effects are influenced by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol).
• Medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine) and other medicines, such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine). Medicines used to treat diabetes (insulin or oral medicines such as metformin).
• Cholestyramine and colestipol, medicines that lower blood lipid levels;
• Medicines that increase blood pressure, such as norepinephrine;
• Muscle relaxants, such as tubocurarine;
• Calcium or vitamin D supplements;
• Anticholinergic medicines (used to treat various disorders, such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or 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 Telmidon" and "Warnings and precautions").
• Digoxin.

Telmidon may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may lower blood pressure as an additional effect (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines you are taking while taking Telmidon. The effect of Telmidon may be reduced when taken with nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Telmidon with food, drink, and alcohol

Telmidon can be taken with or without food. You should avoid drinking alcohol without consulting your doctor first. Alcohol may cause excessive blood pressure drop and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will usually recommend stopping Telmidon before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Telmidon. Telmidon should not be taken during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Telmidon should not be taken during breastfeeding. Your doctor may use a different treatment if you want to breastfeed.

Driving and using machines

Some people may experience dizziness or fatigue when taking Telmidon. If you experience dizziness or fatigue, do not drive or operate machinery.

Telmidon contains lactose

Patients with known intolerance to some sugars should consult their doctor before taking this medicine.

3. How to take Telmidon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The recommended dose of Telmidon is one tablet per day. Try to take the tablet at the same time every day. Telmidon can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is essential to take Telmidon every day, unless your doctor tells you otherwise. If you have liver function disorders, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking a higher dose of Telmidon than recommended

In case of accidental overdose, symptoms such as low blood pressure and rapid heartbeat may occur. Slow heartbeat, dizziness, vomiting, decreased kidney function, including kidney failure, have also been reported. Due to the hydrochlorothiazide component, a significant drop in blood pressure and low potassium levels in the blood, nausea, drowsiness, muscle cramps, and/or irregular heartbeat related to the concurrent use of medicines such as digitalis glycosides or certain antiarrhythmic medicines may also occur. Contact your doctor, pharmacist, or go to the emergency department of the nearest hospital immediately.

Missing a dose of Telmidon

Missing a dose is not a cause for concern. Take the missed dose as soon as possible, and then continue treatment as usual. If you miss a dose one day, take the usual dose the next day. Do not take a double dose to make up for the missed dose. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Consult your doctor immediately if you experience any of the following symptoms: sepsis (also known as "blood poisoning") is a severe infection with a systemic inflammatory response; sudden swelling of the skin and mucous membranes (angioedema), blistering, and peeling of the outer layer of the skin (toxic epidermal necrolysis). These side effects are rare (may occur in less than 1 in 1000 people) or of unknown frequency (toxic epidermal necrolysis), but are very serious, and patients should stop taking the medicine and contact their doctor immediately. If left untreated, these side effects can be fatal. The increased frequency of sepsis has only been observed for telmisartan, but it cannot be ruled out for Telmidon.

Possible side effects of Telmidon

Common side effects (occurring in less than 1 in 10 people):
Dizziness.
Uncommon side effects (occurring in less than 1 in 100 people):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), vertigo (dizziness of inner ear origin), rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath, dry mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, high uric acid levels in the blood.
Rare side effects (occurring in less than 1 in 1000 people):
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.
Side effects of unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, decreased blood cell count (or even their absence), including low red blood cell count and low 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, worsening vision and eye pain (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), blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach inflammation, jaundice (yellowing of the skin or eyes), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body), skin disorders, such as blood vessel inflammation in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, eyes, skin, and peeling of the outer layer of the skin (toxic epidermal necrolysis), weakness, kidney inflammation or kidney function disorders, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, high glucose or fat levels in the blood, difficulty controlling blood glucose levels in the blood/urine in patients with diabetes, malignant skin tumors and lip cancer (non-melanoma skin cancer).

Telmisartan

In patients taking only telmisartan, the following additional side effects have been observed:
Uncommon side effects (occurring in less than 1 in 100 people):
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 (occurring in less than 1 in 1000 people):
Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), low blood glucose levels (in diabetic patients), stomach inflammation, skin peeling (exfoliative dermatitis), joint degeneration, tendon inflammation, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (occurring in less than 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**
*This phenomenon may be coincidental or related to a mechanism that has not yet been understood.
**During telmisartan treatment, cases of progressive scarring of lung tissue have been reported. However, it has not been determined whether telmisartan was the cause.

Hydrochlorothiazide

In patients taking only hydrochlorothiazide, the following additional side effects have been observed:
Common side effects (occurring in less than 1 in 10 people):
Nausea, low magnesium levels in the blood.
Rare side effects (occurring in less than 1 in 1000 people):
Low platelet count, which increases the risk of bleeding and bruising (small red spots on the skin or other tissues caused by bleeding from small blood vessels), high calcium levels in the blood, headache.
Very rare side effects (occurring in less than 1 in 10,000 people):
Increased blood pH (acid-base imbalance) due to low chloride levels in the blood.
Side effects of unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, decreased blood cell count (or even their absence), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, restlessness, feeling of "emptiness" in the head, blurred vision or yellow vision, worsening vision and eye pain (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), blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach inflammation, jaundice (yellowing of the skin or eyes), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body), skin disorders, such as blood vessel inflammation in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, eyes, skin, and peeling of the outer layer of the skin (toxic epidermal necrolysis), weakness, kidney inflammation or kidney function disorders, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, high glucose or fat levels in the blood, difficulty controlling blood glucose levels in the blood/urine in patients with diabetes, malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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, you can help provide more information on the safety of this medicine.

5. How to store Telmidon

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month. There are no special storage precautions for this medicine. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Telmidon contains

The active substances of Telmidon are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide. The other ingredients are: microcrystalline cellulose, lactose monohydrate, mannitol, sodium hydroxide, meglumine, povidone (K30), magnesium stearate, sodium stearyl fumarate, red iron oxide (E 172) [in 40 mg/12.5 mg and 80 mg/12.5 mg tablets] and yellow iron oxide (E172) [in 80 mg/25 mg tablets].

What Telmidon looks like and contents of the pack

40 mg/12.5 mg tablets: white or almost white on one side and red, possibly speckled, on the other side, biconvex, bilayer, oblong, uncoated tablets, approximately 13 mm long and 6.2 mm wide, with the inscription "T1" on the red side and smooth on the other side. 80 mg/12.5 mg tablets: white or almost white on one side and red, possibly speckled, on the other side, biconvex, bilayer, oblong, uncoated tablets, approximately 16.2 mm long and 7.9 mm wide, with the inscription "T2" on the red side and smooth on the other side. 80 mg/25 mg tablets: white or almost white on one side and yellow, possibly speckled, on the other side, biconvex, bilayer, oblong, uncoated tablets, approximately 16.2 mm long and 7.9 mm wide, with the inscription "T2" on the yellow side and smooth on the other side. Telmidon is available in aluminum/aluminum blisters containing 14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw

Manufacturer/importer

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands; Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: December 2021