Telmicar

Leaflet attached to the packaging: patient information

Telmycar, 80 mg + 12.5 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 specifically for you. 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 Telmycar and what is it used for
• 2. Important information before taking Telmycar
• 3. How to take Telmycar
• 4. Possible side effects
• 5. How to store Telmycar
• 6. Contents of the packaging and other information

1. What is Telmycar and what is it used for

Telmycar 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 narrow, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to widen and blood pressure to decrease.
• Hydrochlorothiazide, which belongs to a group of so-called thiazide diuretics, increases urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in various organs, which can sometimes lead to heart attack, heart failure, or kidney failure, 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.

Telmycar is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by taking telmisartan alone.

2. Important information before taking Telmycar

When not to take Telmycar

• 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 sulfonamide derivatives;
• after the third month of pregnancy (it is also recommended to avoid taking Telmycar in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as bile stagnation or bile duct narrowing (disorders of bile flow from the liver and 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 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 conditions apply to the patient, they should inform their doctor or pharmacist before taking Telmycar.

Warnings and precautions

Before starting to take Telmycar, the patient should discuss it with 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) or has a sodium deficiency due to the use of diuretics, a low-sodium diet, diarrhea, vomiting, or hemodialysis;
• 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 sodium retention in the body, with accompanying electrolyte imbalance);
• systemic lupus erythematosus (also called lupus or SLE) - a disease in which the immune system attacks the body itself;
• the active substance, hydrochlorothiazide, may cause an unusual reaction, resulting in impaired vision and eye pain - these may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure in the eyeball, which may occur within a few hours to a few weeks after taking Telmycar, and if left untreated, may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• 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 treatment with Telmycar, the patient should protect their skin from sunlight and UV radiation.

Before starting to take Telmycar, the patient should discuss it with their doctor if they are taking:

• any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders associated with diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Telmycar".
• Digoxin;
• If the patient has previously 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 Telmycar, they should seek medical attention immediately.

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

Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.

Typical symptoms of water and electrolyte disorders include dryness of the mucous membranes, weakness, lethargy, drowsiness, anxiety, muscle pain or cramps, nausea, vomiting, fatigue, and rapid heart rate (over 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, in the form of sunburn (such as redness, itching, swelling, blistering) that occurs more quickly than usual.

In the event of planned surgery or anesthesia, the patient should inform their doctor about taking Telmycar.

Telmycar may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Telmycar 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 discontinue one of the medicines. This is especially true for the following medicines taken with Telmycar:

• lithium preparations used to treat certain types of depression;
• medicines that can cause low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisolone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), benzylpenicillin sodium (an antibiotic), and salicylic acid and its derivatives;
• medicines that can 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), anti-arrhythmic medicines (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);
• medicines used to treat diabetes (insulin or oral medicines, such as metformin);
• cholestyramine and colestipol, medicines that lower blood fat levels;
• medicines that increase blood pressure, such as noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium and/or vitamin D supplements;
• medicines with anticholinergic effects (used to treat many disorders, such as spasms in the digestive tract, bladder spasms, asthma, motion sickness, muscle cramps, Parkinson's disease, and as an adjunct during 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 (e.g., non-steroidal anti-inflammatory medicines, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• ACE inhibitors or aliskiren (see also the sections "When not to take Telmycar" and "Warnings and precautions");
• digoxin.

Telmycar may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with blood pressure-lowering properties (e.g., baclofen, amifostine). Additionally, blood pressure lowering may be enhanced by: alcohol, barbiturates, opioids, or antidepressants. A symptom of hypotension is dizziness when standing up. The patient should consult their doctor if it is necessary to adjust the dose of another medicine while taking Telmycar.

The effect of Telmycar may be reduced when taken with non-steroidal anti-inflammatory medicines (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Telmycar with food, drink, or alcohol

Telmycar can be taken with or without food.

The patient should avoid alcohol until they have talked to their doctor. Alcohol may enhance the blood pressure-lowering effect and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.

Usually, the doctor will recommend stopping Telmycar before planned pregnancy or as soon as pregnancy is confirmed, and will recommend a different medicine instead of Telmycar. It is not recommended to take Telmycar during pregnancy, and it 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. It is not recommended to take Telmycar while breastfeeding - the doctor may recommend a different medicine if the patient wants to breastfeed.

Driving and using machines

Some patients taking Telmycar may experience dizziness or fatigue. In this case, they should not drive or operate machinery.

Telmycar contains sugar (lactose) and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Telmycar.

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

3. How to take Telmycar

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.

The recommended dose of Telmycar is one tablet per day. The patient should try to take the tablet at the same time every day. Telmycar can be taken with or without food.

The tablets should be swallowed with water or a non-alcoholic drink. It is essential to take Telmycar every day, unless the doctor recommends otherwise.

In the event of liver function disorders, the patient should not take a dose higher than 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day (Telmycar is not available in a dose of 40 mg + 12.5 mg; if such a dose is necessary, the patient should use a different medicine).

Taking a higher dose of Telmycar than recommended

If the patient accidentally takes too many tablets, they may experience symptoms such as low blood pressure and rapid heart rate. There have also been reports of slow heart rate, dizziness, vomiting, impaired kidney function, including kidney failure. Due to the presence of hydrochlorothiazide, there may also be a significant decrease in blood pressure and a decrease in potassium levels in the blood, which can lead to nausea, drowsiness, muscle cramps, and/or irregular heart rhythm, associated with the concurrent use of medicines such as digitalis glycosides and certain anti-arrhythmic medicines. The patient should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Telmycar

If the patient forgets to take a dose, they should take it as soon as they remember, on the same day. If the tablet is not taken on 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, Telmycar can cause side effects, although not everybody gets them.

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

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

• sepsis (also known as blood poisoning), 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 patients) or have an unknown frequency (cannot be estimated from available data), but are extremely severe; in such cases, the patient should stop taking the medicine and contact their doctor immediately. If these symptoms are not treated, they may be fatal. An increased frequency of sepsis has been observed in patients taking telmisartan in monotherapy, but it cannot be ruled out in the case of Telmycar.

Possible side effects of Telmycar:

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):

• decreased potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia),

vertigo (dizziness of labyrinthine origin), rapid heart rate (tachycardia), irregular heart rhythm, 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 (may occur in less than 1 in 1000 patients):

• bronchitis (inflammation of the bronchi), activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, abnormal liver function (more common in patients of Japanese origin), skin redness (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.

Telmisartan

In patients taking only telmisartan, 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, slow heart rate (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 number of certain white blood cells (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in patients with diabetes), gastritis, skin peeling (exfoliative dermatitis), 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 scarring of the lung tissue (interstitial lung disease)**

*This phenomenon may be coincidental or related to a mechanism that has not yet been understood.

**Cases of interstitial lung disease have been reported in association with telmisartan, but a causal relationship has not been established.

Hydrochlorothiazide

In patients taking only hydrochlorothiazide, 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):

• decreased platelet count, which increases the risk of bleeding or bruising (small, purple-red spots on the skin or in other tissues, caused by bleeding), high calcium levels in the blood, headache.

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

• increased 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 with unknown frequency (frequency cannot be estimated from available data):

• salivary gland inflammation, malignant skin tumors and lip cancer (non-melanoma skin cancer), decreased blood cell count, including low red 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, impaired vision and eye pain (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera, acute angle-closure glaucoma, or acute myopia), vasculitis (inflammation of blood vessels), pancreatitis, gastritis, jaundice (yellowing of the skin or eyes), a condition similar to systemic lupus erythematosus (a disease in which the immune system attacks the body), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of the lips, eyes, or mouth, 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/in urine in patients with diagnosed diabetes.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

PL-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 Telmycar

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 and blister after "EXP".

The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine.

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 Telmycar contains

The active substances of Telmycar are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are lactose monohydrate, magnesium stearate, meglumine, povidone K25, sodium hydroxide, mannitol, sodium stearylfumarate, and a coloring mixture PB-24880 Pink.

Composition of the coloring mixture PB-24880 Pink:lactose monohydrate, iron oxide red (E 172).

What Telmycar looks like and contents of the pack

The tablets are elongated, biconvex, two-layered, uncoated, with one layer white to off-white and one layer pink, with the inscription "L200" embossed. The white to off-white layer may contain pink spots. The length is 16.2 mm, and the width is 7.9 mm.

Telmycar is available in blisters containing 14, 28, 30, or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Swyssi AG

Lyoner Strasse 14

60528 Frankfurt am Main

Germany

Tel. +49 69 66554 162

Email: info@swyssi.com

This medicinal product is authorized in the EEA countries under the following names:

Austria

Telhycar

Czech Republic

Telhycar

Greece

Telhycar

Poland

Telmycar

Portugal

Telhycar

Romania

Telhycar

Slovakia

Telhycar

To obtain information on this medicine, the patient should contact their local representative of the marketing authorization holder.

Date of last revision of the leaflet:19.05.2022