TELMISARTAN 80 mg/25 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Telmisartan/Hydrochlorothiazide Krka, 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
3. What is Telmisartan/Hydrochlorothiazide Krka and what is it used for
4. Important information before taking Telmisartan/Hydrochlorothiazide Krka
   1. When not to take Telmisartan/Hydrochlorothiazide Krka
   2. Warnings and precautions
   3. Children and adolescents
   4. Telmisartan/Hydrochlorothiazide Krka and other medicines
   5. Taking Telmisartan/Hydrochlorothiazide Krka with food and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Telmisartan/Hydrochlorothiazide Krka contains lactose monohydrate, sorbitol, and sodium.
5. How to take Telmisartan/Hydrochlorothiazide Krka
   1. Taking a higher dose of Telmisartan/Hydrochlorothiazide Krka than recommended
   2. Missing a dose of Telmisartan/Hydrochlorothiazide Krka
6. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Possible side effects of Telmisartan/Hydrochlorothiazide Krka:
   3. Telmisartan
   4. Hydrochlorothiazide
7. How to store Telmisartan/Hydrochlorothiazide Krka
8. Contents of the packaging and other information
   1. What Telmisartan/Hydrochlorothiazide Krka contains
   2. What Telmisartan/Hydrochlorothiazide Krka looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet accompanying the packaging: patient information

Telmisartan/Hydrochlorothiazide Krka, 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, pharmacist, or nurse.
• 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 those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Telmisartan/Hydrochlorothiazide Krka and what is it used for

Telmisartan/Hydrochlorothiazide Krka 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 belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in organs, and in some cases, it can lead to complications such as 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 normal.
Telmisartan/Hydrochlorothiazide Krka is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by Telmisartan/Hydrochlorothiazide Krka 80 mg + 12.5 mg or in patients who have achieved good blood pressure control with telmisartan and hydrochlorothiazide taken separately.

2. Important information before taking Telmisartan/Hydrochlorothiazide Krka

When not to take Telmisartan/Hydrochlorothiazide Krka

• 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 sulfonamide derivatives;
• after the third month of pregnancy (you should also avoid taking Telmisartan/Hydrochlorothiazide Krka in early pregnancy - see "Pregnancy");
• if you have 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 you have severe kidney disease;
• if you have low potassium or high calcium levels in your blood 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 situations apply to you, you should inform your doctor or pharmacist before taking Telmisartan/Hydrochlorothiazide Krka.

Warnings and precautions

You should inform your doctor before starting to take Telmisartan/Hydrochlorothiazide Krka if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to the use of diuretics (water pills), a low-salt diet, diarrhea, vomiting, or hemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance);
• systemic lupus erythematosus; a disease in which the immune system attacks the body;
• if you have had a malignant skin tumor 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Telmisartan/Hydrochlorothiazide Krka, you should protect your skin from sunlight and UV radiation.
• if you experience 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 pressure in the eyeball, which can occur within a few hours to a few weeks after taking Telmisartan/Hydrochlorothiazide Krka. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this disease.
• if you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Telmisartan/Hydrochlorothiazide Krka, you should seek medical attention immediately.

Before starting to take Telmisartan/Hydrochlorothiazide Krka, you should inform your doctor if you are taking:

• digoxin;
• any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

You should inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Telmisartan/Hydrochlorothiazide Krka 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 fluid or electrolyte imbalance include dryness of the mucous membranes in the mouth, weakness, drowsiness, restlessness, muscle cramps, nausea (nausea), vomiting, fatigue, and excessively rapid heartbeat (more than 100 beats per minute). If you experience any of these symptoms, you should inform your doctor.
You should also inform your doctor if you experience increased sensitivity of the skin to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.
If you are scheduled for surgery or anesthesia, you should inform your doctor that you are taking Telmisartan/Hydrochlorothiazide Krka.
Telmisartan/Hydrochlorothiazide Krka may be less effective in lowering blood pressure in black patients.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Telmisartan/Hydrochlorothiazide Krka:".

Children and adolescents

The use of Telmisartan/Hydrochlorothiazide Krka in children and adolescents under 18 years of age is not recommended.

Telmisartan/Hydrochlorothiazide Krka and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor may decide to change the dose of these 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 simultaneous use of Telmisartan/Hydrochlorothiazide Krka with the following medicines:

• lithium preparations, used to treat certain types of depression,
• medicines that may lower potassium levels in the blood (hypokalemia), such as other diuretics (water pills), laxatives (e.g., castor oil),
• corticosteroids (e.g., prednisolone), 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 medicinal products, such as sodium heparin (an anticoagulant);
• medicines whose effects are influenced by changes in potassium levels in the blood, such as cardiac glycosides (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 in the treatment of 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 noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium and/or vitamin D supplements;
• medicines with anticholinergic effects (used to treat a range of disorders, such as spasms in the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia), such as atropine and bipiperiden;
• amantadine (a medicine used to treat Parkinson's disease, as well as to treat or prevent certain viral diseases);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g., non-steroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• if you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmisartan/Hydrochlorothiazide Krka:" and "Warnings and precautions");
• digoxin,

Telmisartan/Hydrochlorothiazide Krka may enhance the blood pressure-lowering effect of other medicines or medicines that may cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. You should consult your doctor to adjust the dose of other medicines taken during treatment with Telmisartan/Hydrochlorothiazide Krka.
The effect of Telmisartan/Hydrochlorothiazide Krka may be weakened when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Taking Telmisartan/Hydrochlorothiazide Krka with food and alcohol

Telmisartan/Hydrochlorothiazide Krka can be taken with or without food.
You should avoid alcohol until you have talked to your doctor. Alcohol may further lower your blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
You should inform your doctor if you suspect (or plan) pregnancy. Usually, your doctor will advise you to stop taking Telmisartan/Hydrochlorothiazide Krka before planned pregnancy or as soon as you know you are pregnant, and will prescribe a different medicine instead of Telmisartan/Hydrochlorothiazide Krka. It is not recommended to take Telmisartan/Hydrochlorothiazide Krka during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after 3 months of pregnancy.
Breastfeeding
You should tell your doctor if you are breastfeeding or planning to breastfeed. Telmisartan/Hydrochlorothiazide Krka is not recommended during breastfeeding. Your doctor may choose a different treatment during breastfeeding.

Driving and using machines

Some patients taking Telmisartan/Hydrochlorothiazide Krka may experience dizziness or fatigue. In this case, you should not drive vehicles or operate machines.

Telmisartan/Hydrochlorothiazide Krka contains lactose monohydrate, sorbitol, and sodium.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Telmisartan/Hydrochlorothiazide Krka.
Telmisartan/Hydrochlorothiazide Krka 80 mg/12.5 mg and Telmisartan/Hydrochlorothiazide Krka 80 mg/25 mg contain 294.08 mg of sorbitol in each tablet.
Sorbitol is a source of fructose. If you have been diagnosed with an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should contact your doctor before taking Telmisartan/Hydrochlorothiazide Krka.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Telmisartan/Hydrochlorothiazide Krka

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose of Telmisartan/Hydrochlorothiazide Krka is one tablet per day. You should try to take the tablet at the same time every day. Telmisartan/Hydrochlorothiazide Krka can be taken with or without food. The tablets should be swallowed with water or a non-alcoholic drink. It is important to take Telmisartan/Hydrochlorothiazide Krka every day, unless your doctor tells you to stop.
If you have liver problems, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking a higher dose of Telmisartan/Hydrochlorothiazide Krka than recommended

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. There have also been reports of slow heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure. Due to the content of hydrochlorothiazide, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps, and (or) irregular heartbeat associated with the simultaneous use of medicines such as digitalis glycosides or certain anti-arrhythmic medicines. You should contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

Missing a dose of Telmisartan/Hydrochlorothiazide Krka

If you forget to take a dose, you should take it as soon as you remember, on the same day. If the tablet is not taken on one day, you should take the usual dose the next day. You should nottake a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

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

If you experience any of the following symptoms, you should contact your doctor immediately:
sepsis* (often referred to as blood poisoning, being a severe infection with an inflammatory response of the whole body), sudden swelling of the skin and mucous membranes (angioedema); blistering and peeling of the skin (toxic epidermal necrolysis). The above side effects are rare (may occur in up to 1 in 1000 patients) or have an unknown frequency (cannot be estimated from the available data), but are extremely serious.
In this case, you should stop taking the medicine and contact your doctor immediately.
If the above symptoms are not treated, they can be fatal. In patients taking telmisartan, an increased incidence of sepsis has been observed, so it cannot be ruled out that it may occur during treatment with Telmisartan/Hydrochlorothiazide Krka.

Possible side effects of Telmisartan/Hydrochlorothiazide Krka:

Common side effects (may occur in up to 1 in 10 patients):
Dizziness
Uncommon side effects (may occur in up to 1 in 100 patients):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation (vertigo), rapid heartbeat, irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dryness of the mucous membranes in the 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 up to 1 in 1000 patients):
bronchitis, 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, difficulty sleeping (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, abnormal liver function (more common in patients of Japanese origin), skin redness (rash), allergic reactions, such as itching or hives, 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 reported for one of the active substances may also occur during treatment with Telmisartan/Hydrochlorothiazide Krka, even if they were not observed during clinical trials of the medicine.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:
Uncommon side effects (may occur in up to 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, kidney function disorders, including acute kidney failure, weakness, cough.
Rare side effects (may occur in up to 1 in 1000 patients):
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 patients with diabetes), gastritis, skin inflammation, joint degeneration, tendonitis, decreased hemoglobin levels, drowsiness.
Very rare side effects (may occur in up to 1 in 10,000 patients):
progressive pulmonary fibrosis (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 hydrochlorothiazide alone, the following additional side effects have been observed:
Common side effects (may occur in up to 1 in 10 patients):
Nausea (nausea), low magnesium levels in the blood.
Rare side effects (may occur in up to 1 in 1000 patients):
low platelet count, which increases the risk of bleeding or bruising (small purple-red spots on the skin or other tissue caused by bleeding), high calcium levels in the blood, headache.
Very rare side effects (may occur in up to 1 in 10,000 patients):
high 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 the available data):
salivary gland inflammation, malignant skin tumors and lip tumors (non-melanoma skin cancer), decreased 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, weakness, kidney function disorders or kidney problems, presence of sugar in the urine, fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, difficulty in maintaining proper blood sugar levels/urine in patients with diagnosed diabetes or fat in the blood.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 Telmisartan/Hydrochlorothiazide Krka

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 stated.
Do not store above 30°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Telmisartan/Hydrochlorothiazide Krka contains

• The active substances of the medicine are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: meglumine, sodium hydroxide, povidone K30, lactose monohydrate, sorbitol, magnesium stearate, mannitol, hydroxypropyl cellulose, silica colloidal anhydrous, sodium stearyl fumarate, yellow iron oxide (E 172). See section 2 "Telmisartan/Hydrochlorothiazide Krka contains lactose monohydrate, sorbitol, and sodium".

What Telmisartan/Hydrochlorothiazide Krka looks like and contents of the pack

White to yellowish-white on one side and marbled yellow on the other side, two-layered, biconvex, oval tablets, 18 mm x 9 mm in size.
Packaging:10, 14, 28, 30, 56, 60, 84, 90, and 98 tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Date of last revision of the leaflet:14.12.2023