Telmisartan/hidrohlorothiazide Krka

Leaflet accompanying the packaging: patient information

Telmisartan/Hydrochlorothiazide Krka, 80 mg + 12.5 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.
• In case of any doubts, 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 of the time, before these complications occur, 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 whose blood pressure is not adequately controlled by telmisartan or hydrochlorothiazide alone.

2. Important information before taking Telmisartan/Hydrochlorothiazide Krka

When not to take Telmisartan/Hydrochlorothiazide Krka

• 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 Telmisartan/Hydrochlorothiazide Krka in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the patient has low potassium levels or high calcium levels in the blood that do not improve with treatment;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should inform their doctor or pharmacist before taking Telmisartan/Hydrochlorothiazide Krka.

Warnings and precautions

The patient should inform their doctor before starting to take Telmisartan/Hydrochlorothiazide Krka 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 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 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Telmisartan/Hydrochlorothiazide Krka, the skin should be protected from sunlight and UV radiation.
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased 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 the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this disease.
• if the patient has experienced respiratory 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 Telmisartan/Hydrochlorothiazide Krka, they should seek medical help immediately.

Before starting to take Telmisartan/Hydrochlorothiazide Krka, the patient should inform their doctor if they are taking:

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

The patient should inform their doctor if they 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 any of these symptoms occur, the patient should inform their doctor.
The patient should also inform their doctor if they experience increased sensitivity of the skin to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.
If the patient is scheduled for surgery or anesthesia, they should inform their doctor that they are taking Telmisartan/Hydrochlorothiazide Krka.
Telmisartan/Hydrochlorothiazide Krka may be less effective in lowering blood pressure in black patients.
The patient's doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the 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

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 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 and the following medicines:

• lithium preparations, used to treat certain types of depression,
• medicines that may cause low 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 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 colestipol, medicines that lower blood fat levels;
• medicines that increase blood pressure, such as norepinephrine;
• muscle relaxants, such as tubocurarine;
• calcium supplements and/or vitamin D supplements;
• medicines with anticholinergic effects (used to treat a range of disorders, such as spastic conditions in the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia), such as atropine and biphenhydramine;
• amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent certain viral diseases);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g., nonsteroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• if the patient is 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. The patient should consult their doctor to adjust the dose of other medicines taken while taking Telmisartan/Hydrochlorothiazide Krka.
The effect of Telmisartan/Hydrochlorothiazide Krka may be reduced when taken with nonsteroidal 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.
The patient should avoid alcohol until they have talked to their doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect (or plan) pregnancy. Usually, the doctor will advise the patient to stop taking Telmisartan/Hydrochlorothiazide Krka before planned pregnancy or as soon as pregnancy is confirmed and will prescribe another 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
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Telmisartan/Hydrochlorothiazide Krka is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding.

Driving and using machines

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

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

If the patient has been diagnosed with intolerance to some sugars, they should contact their 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 the patient has been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should contact their 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 prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Telmisartan/Hydrochlorothiazide Krka is one tablet per day. The patient 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 essential to take Telmisartan/Hydrochlorothiazide Krka every day, unless the doctor advises otherwise.
If the patient has 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 the patient accidentally takes too many tablets, they 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, very low blood pressure and low potassium levels in the blood may also occur, 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. The patient should contact their doctor or pharmacist immediately or go to the nearest hospital emergency department.

Missing a dose of Telmisartan/Hydrochlorothiazide Krka

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 nottake a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan/Hydrochlorothiazide Krka can cause side effects, although not everybody gets them.

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

If the patient experiences any of the following symptoms, they should contact their doctor immediately:
sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory response throughout the body), sudden swelling of the skin and mucous membranes (angioedema); blistering and peeling of the skin (toxic epidermal necrolysis). These side effects are rare (may occur in up to 1 in 1000 patients) or of unknown frequency (in the case of toxic epidermal necrolysis), but they are extremely serious.
In this case, the patient should stop taking the medicine and contact their doctor immediately.
If these 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, insomnia (difficulty sleeping), vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis (inflammation of the stomach lining), 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 only telmisartan, 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 problems, 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, tendon inflammation, 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. However, 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 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):
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 of unknown frequency (frequency cannot be estimated from 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, decreased vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera, acute angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, 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.
Reporting side effects
If the patient experiences any side effects, including any not listed in this 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:
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.
Reporting side effects helps to gather more information on the safety of the 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.
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. 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 Telmisartan/Hydrochlorothiazide Krka contains

• The active substances of the medicine are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: meglumine, sodium hydroxide, povidone K30, lactose monohydrate, sorbitol, magnesium stearate, mannitol, hydroxypropyl cellulose, silicon dioxide, sodium stearyl fumarate, red 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 almost white or pinkish-white on one side and marbled pink on the other side, two-layer, 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