Telmisartan/hydrochlorothiazide krka

Package leaflet: Information for the patient

Telmisartan/Hydrochlorothiazide Krka, 40 mg + 12.5 mg, tablets
telmisartanum + hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Telmisartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know 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 pack and other information

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

Telmisartan/Hydrochlorothiazide Krka is a combination medicine containing two active substances,
telmisartan and hydrochlorothiazide, in a single tablet. Both substances help control high
blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. 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 reduction in blood pressure.

Untreated high blood pressure can damage blood vessels in organs and, in some cases, may lead to complications such as heart attack, heart failure or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to measure your blood pressure regularly to ensure it is within the normal range.
Telmisartan/Hydrochlorothiazide Krka is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan or hydrochlorothiazide alone.

2. Important information before using Telmisartan/Hydrochlorothiazide Krka

When not to use 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 (Telmisartan/Hydrochlorothiazide Krka should also be avoided during early pregnancy - see section "Pregnancy");
• if the patient has severe liver disease, such as biliary obstruction or bile duct obstruction (impaired bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease or anuria (less than 100 ml urine per day);
• if the patient has low potassium or high calcium levels in the blood that do not improve with treatment;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, inform your doctor or pharmacist
before taking Telmisartan/Hydrochlorothiazide Krka.
Warnings and precautions
Tell your doctor before starting treatment with
Telmisartan/Hydrochlorothiazide Krka if the patient has or has had any of
the following conditions or diseases:

• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has salt depletion due to diuretics (water tablets), a low-salt diet, diarrhoea, vomiting, or haemofiltration;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• elevated aldosterone levels (water and salt retention in the body along with electrolyte imbalance);
• systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the immune system attacks the body itself;
• the active substance hydrochlorothiazide may cause rare reactions leading to vision disturbances and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Telmisartan/Hydrochlorothiazide Krka. If untreated, these may lead to permanent vision impairment.
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Telmisartan/Hydrochlorothiazide Krka, protect the skin from sunlight and UV radiation.

Before starting Telmisartan/Hydrochlorothiazide Krka, discuss with
your doctor:

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

Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to use Telmisartan/Hydrochlorothiazide Krka”.

• if the patient is taking digoxin.
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Telmisartan/Hydrochlorothiazide Krka, seek immediate medical help.

If the patient experiences abdominal pain,
nausea, vomiting, or diarrhoea after taking Telmisartan/Hydrochlorothiazide Krka, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Telmisartan/Hydrochlorothiazide Krka on your own.

Inform your doctor if you suspect (or are planning) pregnancy. Telmisartan/Hydrochlorothiazide Krka is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.
Typical symptoms of fluid or electrolyte imbalance include dryness of the oral mucosa, weakness, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, fatigue, and abnormally rapid heartbeat (more than 100 beats per minute). If any of these symptoms occur, inform your doctor.
Also inform your doctor if you experience skin hypersensitivity to sunlight, such as sunburn (e.g. redness, itching, swelling, blistering) occurring sooner than usual.
If surgery or anaesthesia is planned, inform the doctor that you are taking Telmisartan/Hydrochlorothiazide Krka.
Telmisartan/Hydrochlorothiazide Krka may be less effective in lowering blood pressure in black patients.
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
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. The doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to concomitant use of the following medicines with Telmisartan/Hydrochlorothiazide Krka:

• lithium preparations, used in the treatment of certain types of depression;
• medicines that may lower potassium levels in the blood (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisolone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives;
• iodine-containing contrast agents used in imaging procedures;
• medicines that may increase potassium levels in the blood, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicinal products such as sodium heparin (an anticoagulant);
• medicines affected by changes in blood potassium levels, such as cardiac medicines (e.g. digoxin) or medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used in the treatment of psychiatric 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 in diabetes (insulin or oral medicines such as metformin);
• cholestyramine and colestipol, medicines that lower blood lipid levels;
• medicines that raise blood pressure, such as noradrenaline;
• muscle relaxants such as tubocurarine;
• calcium supplements and (or) vitamin D supplements;
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts in anaesthesia), such as atropine and biperiden;
• amantadine (a medicine used in Parkinson's disease and also in the treatment or prevention of certain viral diseases);
• other medicines used to treat hypertension, corticosteroids, painkillers (e.g. non-steroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings “When not to use 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 low blood pressure (e.g. baclofen, amifostine). In addition,
low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. Symptoms include dizziness upon standing. Consult your doctor to determine the appropriate dosage of other medicines taken during treatment with Telmisartan/Hydrochlorothiazide Krka.
The effect of Telmisartan/Hydrochlorothiazide Krka may be reduced when taken concomitantly with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).
Taking Telmisartan/Hydrochlorothiazide Krka with food and alcohol
Telmisartan/Hydrochlorothiazide Krka can be taken with food or independently of meals.
Avoid alcohol until you have spoken with your doctor. Alcohol may further lower blood pressure and (or) increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, the doctor will recommend discontinuing Telmisartan/Hydrochlorothiazide Krka before a planned pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine. Telmisartan/Hydrochlorothiazide Krka is not recommended during pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Telmisartan/Hydrochlorothiazide Krka is not recommended during breastfeeding. Your doctor may choose an alternative treatment during breastfeeding.
Driving and operating machinery
Some patients taking Telmisartan/Hydrochlorothiazide Krka may experience dizziness, fainting, or a sensation of spinning. If such adverse effects occur, do not drive or operate machinery.
Telmisartan/Hydrochlorothiazide Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Telmisartan/Hydrochlorothiazide Krka

This medicine should always be used as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
The recommended dose of Telmisartan/Hydrochlorothiazide Krka is one tablet daily. Try
to take the tablet at the same time each day. Telmisartan/Hydrochlorothiazide Krka
can be taken with or without food. Swallow the tablets whole with water or another non-alcoholic drink. It is important to take Telmisartan/Hydrochlorothiazide Krka
every day, unless otherwise advised by your doctor.
If the patient has impaired liver function, the usual dose should not exceed 40 mg of
telmisartan per day.
Taking more Telmisartan/Hydrochlorothiazide Krka than prescribed
If too many tablets are taken by mistake, symptoms such as low blood pressure and rapid heartbeat may occur. Cases of slowed heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which could lead to nausea, drowsiness and muscle cramps, and (or) irregular heartbeat, particularly when used concomitantly with medicines such as cardiac glycosides or certain antiarrhythmic drugs. Seek immediate medical advice from your doctor or pharmacist, or go to the nearest hospital emergency department.
If you miss a dose of Telmisartan/Hydrochlorothiazide Krka
If a patient forgets to take a dose, it should be taken as soon as remembered on the same day. If a dose is missed on one day, take the usual dose the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (commonly known as blood poisoning, a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema, including fatal cases), blistering and peeling of the outer layer of skin (toxic epidermal necrolysis).
The above adverse reactions are rare (may occur in up to 1 in 1,000 patients) or very rare (in the case of toxic epidermal necrolysis, may occur in up to 1 in 10,000 patients), but are extremely serious.
In such cases, treatment with this medicine must be stopped immediately and medical advice sought without delay.
If left untreated, these symptoms may result in death. Increased incidence of sepsis has been observed in patients treated with telmisartan; therefore, occurrence of sepsis during treatment with Telmisartan/Hydrochlorothiazide Krka cannot be excluded.

Possible adverse reactions of Telmisartan/Hydrochlorothiazide Krka:
Common adverse reactions (may occur in up to 1 in 10 patients):
Dizziness

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Decreased blood potassium levels, anxiety, fainting, tingling and numbness (paraesthesia), sensation of spinning (vertigo), rapid heartbeat, heart rhythm disturbances, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dryness of oral mucous membranes, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Lung inflammation (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea (vomiting), inflammation of the stomach lining, abnormal liver function (more frequent in patients of Japanese origin), skin redness (flushing), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain (leg pain), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes and fever), influenza-like symptoms, pain, increased creatinine levels, increased liver enzyme activity or creatine kinase in blood.

Adverse reactions reported for one of the components may also occur during treatment with Telmisartan/Hydrochlorothiazide Krka, even if they were not observed during clinical trials of the medicine.

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been observed:

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, cystitis, low red blood cell count (anaemia), high potassium levels, slow heart rate (bradycardia), cough, kidney dysfunction, including acute renal failure, fatigue.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased levels of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood glucose levels (in patients with diabetes), drowsiness, gastritis, rash (skin disorder), drug eruption, toxic skin rash, tendon pain (symptoms mimicking tendonitis), decreased haemoglobin levels (blood protein).

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive lung tissue fibrosis (interstitial lung disease)**

Frequency not known (frequency cannot be estimated from available data):
Intestinal angioedema: following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has been reported.

*This phenomenon may be coincidental or related to a mechanism not yet identified.
**Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions have been observed:

Very common adverse reactions (may occur in more than 1 in 10 patients):
Elevated blood lipid levels.

Common adverse reactions (may occur in up to 1 in 10 patients):
Nausea (nausea), low blood magnesium levels, decreased appetite.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Acute renal failure.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), leading to increased risk of bleeding or bruising (small purple-red spots on the skin or other tissues caused by bleeding), high blood calcium levels, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reactions, uncontrolled blood glucose levels in patients with diagnosed diabetes, presence of sugars in urine (glucosuria).

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Abnormal breakdown of red blood cells (haemolytic anaemia), bone marrow failure to function properly, decreased white blood cell count (leukopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis), acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion), pancreatitis, lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), vasculitis (necrotizing vasculitis).

Frequency not known (frequency cannot be estimated from available data):
Sialadenitis (inflammation of salivary glands), skin and lip malignancies (non-melanoma skin cancers), decreased blood cell counts (aplastic anaemia), vision impairment and eye pain (possibly symptoms of fluid accumulation in the uvea—the membrane surrounding the eye—or excessive fluid buildup between choroid and sclera, or acute angle-closure glaucoma), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of lips, eyes and mouth, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney function disturbances.

In isolated cases, low sodium levels have occurred, accompanied by symptoms affecting the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Telmisartan/Hydrochlorothiazide Krka

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack, following the abbreviation EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of the medicine.
Store in the original packaging to protect from light and moisture. The tablet of Telmisartan/Hydrochlorothiazide Krka should be removed from the sealed blister immediately before ingestion.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Telmisartan/Hydrochlorothiazide Krka contains

• The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• Other ingredients: povidone K30, sodium hydroxide, mannitol, microcrystalline cellulose, meglumine, sodium croscarmellose, sodium stearyl fumarate, colloidal anhydrous silica, iron oxide red (E 172). See section 2, "Telmisartan/Hydrochlorothiazide Krka contains sodium".

What Telmisartan/Hydrochlorothiazide Krka looks like and contents of the pack
Light pink, speckled, oval, biconvex tablets, marked with "L1" on one side,
tablet dimensions: approximately 14 mm in length.
Pack sizes: Blister packs containing 10, 14, 28, 30, 56, 60, 84, 90 and 98 tablets, packed in cardboard boxes.
Marketing Authorisation 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
This medicinal product is authorised in the Member States of the European Economic Area under the following names: