TELMIDON 40 mg /12.5 Mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Telmidon, 40 mg + 12.5 mg, tablets
3. Telmidon, 80 mg + 12.5 mg, tablets
4. Telmidon, 80 mg + 25 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Telmidon and what is it used for
6. Important information before taking Telmidon
   1. When not to take Telmidon
   2. Warnings and precautions
   3. Children and adolescents
   4. Telmidon and other medicines
   5. Telmidon with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Telmidon contains lactose
7. How to take Telmidon
   1. Taking more than the recommended dose of Telmidon
   2. Missing a dose of Telmidon
8. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Possible side effects of Telmidon
   3. Telmisartan
   4. Hydrochlorothiazide
   5. Reporting side effects
9. How to store Telmidon
10. Contents of the packaging and other information
    1. What Telmidon contains
    2. What Telmidon looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer/importer
    6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: December 2021

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

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.
• You should consult a doctor or pharmacist if you have any doubts.
• 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.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should 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 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 Telmidon in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (bile flow disorders from the gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the patient has low potassium levels or high calcium levels in the blood (detected in blood tests) that do not improve with treatment;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to the patient, they should inform their doctor or pharmacist before taking Telmidon.

Warnings and precautions

Before taking this medicine, the patient should discuss with their doctor if they have or have had any of the following disorders or diseases:

• low blood pressure (hypotension), which is more likely to occur 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, vomiting, or dialysis therapy;
• kidney disease or a history of kidney transplantation;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• increased 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;
• 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 intraocular pressure, 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, the patient should discuss with their doctor:

• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Telmidon".
• 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 Telmidon treatment, the patient should protect their skin from sunlight and UV radiation.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Telmidon during pregnancy, and it 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 water and electrolyte imbalance include dryness of the mucous membranes, weakness, lethargy, drowsiness, anxiety, muscle pain, nausea, vomiting, muscle fatigue, and irregular heartbeat (more than 100 beats per minute). If any of these symptoms occur, the patient should inform their doctor. The patient should also inform their doctor about increased skin sensitivity to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering), which may occur more quickly than usual. The patient should inform their doctor about taking Telmidon if surgery or anesthesia is planned. Telmidon may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmidon is not recommended for children and adolescents under 18 years of age.

Telmidon 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 recommend changing the dose of other medicines or taking other precautions. In some cases, it may be necessary to discontinue one of the medicines. This applies especially to the medicines listed below, taken at the same time as 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), 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 sodium heparin (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 colestypol, medicines that lower blood fat levels;
• Medicines that increase blood pressure, such as noradrenaline;
• 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 bipiperidine.
• 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. The patient should consult their doctor if they need to adjust the dose of other medicines they are taking while taking Telmidon. The effect of Telmidon may be reduced when taken with NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen).

Telmidon with food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy
The patient should tell their doctor if they are pregnant or think they may be pregnant. The 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. It is not recommended to take Telmidon during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after the third month of pregnancy.
Breastfeeding
The patient should tell their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Telmidon during breastfeeding. The doctor may use a different treatment if the patient wants to breastfeed.

Driving and using machines

Some people may experience dizziness or fatigue when taking Telmidon. If dizziness or fatigue occur, the patient should 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 prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of Telmidon is one tablet per day. The patient should try to take the tablet at the same time every day. Telmidon can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic drink. It is essential to take Telmidon every day, unless the doctor recommends otherwise. If the patient has liver function disorders, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking more than the recommended dose of Telmidon

In case of accidental ingestion of too many tablets, symptoms such as low blood pressure and rapid heartbeat may occur. There have also been reports of slow heartbeat, dizziness, vomiting, impaired kidney function, including kidney failure. Due to the hydrochlorothiazide component, there may also be a significant drop in blood pressure and low potassium levels in the blood, nausea, drowsiness, muscle cramps, and/or irregular heartbeat related to the concomitant use of medicines such as digitalis glycosides or certain antiarrhythmic medicines. The patient should immediately contact their doctor, pharmacist, or go to the emergency department of the nearest hospital.

Missing a dose of Telmidon

Missing a dose is not a cause for concern. The patient should take the missed dose as soon as possible and then continue treatment as usual. If a dose is missed one day, the patient should 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 this medicine, they should consult their 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:

The patient should consult their doctor immediately if they experience any of the following symptoms: sepsis (often referred to as "blood poisoning") is a severe infection with an inflammatory reaction throughout the body; 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 have an unknown frequency (toxic epidermal necrolysis), but they are very serious, and the patient should stop taking the medicine and contact their doctor immediately. If these side effects are not treated, they may 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), spinning sensation (vertigo), 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, increased uric acid levels in the blood.
Rare side effects (occurring in less than 1 in 1000 people):
Bronchitis (inflammation of the bronchi), activation or exacerbation of systemic lupus erythematosus (a disease in which the body is attacked by its own immune system, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, liver function disorders (in Japanese patients, there is a higher likelihood of such side effects), redness of the skin (flushing), 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 with an unknown frequency (frequency cannot be estimated from available data):

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, 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 reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), gastritis, skin exfoliation (exfoliative dermatitis), joint degeneration, tendonitis, 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 pH (acid-base imbalance) due to low chloride levels in the blood.

Side effects with an 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 and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, anxiety, 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), vasculitis (inflammation of blood vessels), pancreatitis, gastritis, jaundice (yellowing of the skin or eyes), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders, such as vasculitis, 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 (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased glucose or fat levels in the blood, difficulty controlling blood sugar levels/in the urine in patients with diagnosed diabetes, malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult their doctor or pharmacist. The patient can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 collected on the safety of the medicine.

5. How to store Telmidon

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 or blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine. Store in the original packaging to protect from 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 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, iron oxide red (E 172) [in 40 mg/12.5 mg and 80 mg/12.5 mg tablets] and iron oxide yellow (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, oval, 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, oval, 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, oval, 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