ZANACODAR 40 mg /12.5 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   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
2. What is Zanacodar Combi and what is it used for
3. Important information before taking Zanacodar Combi
   1. When not to take Zanacodar Combi
   2. Warnings and precautions
   3. Children and adolescents
   4. Zanacodar Combi and other medicines
   5. Taking Zanacodar Combi with food and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Zanacodar Combi contains lactose
   9. Zanacodar Combi contains sodium
4. How to take Zanacodar Combi
   1. Taking a higher dose of Zanacodar Combi than recommended
   2. Missing a dose of Zanacodar Combi
5. Possible side effects
   1. Some side effects can be serious and require immediate medical attention:
   2. Possible side effects of Zanacodar Combi:
   3. Telmisartan
   4. Hydrochlorothiazide
   5. Reporting side effects
6. How to store Zanacodar Combi
7. Contents of the pack and other information
   1. What Zanacodar Combi contains
   2. What Zanacodar Combi looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: December 2024
   7. Other sources of information

Leaflet attached to the packaging: information for the user

Zanacodar Combi, 40 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 Zanacodar Combi and what is it used for
• 2. Important information before taking Zanacodar Combi
• 3. How to take Zanacodar Combi
• 4. Possible side effects
• 5. How to store Zanacodar Combi
• 6. Contents of the pack and other information

1. What is Zanacodar Combi and what is it used for

Zanacodar Combi 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 constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, resulting in the dilation of blood vessels and a decrease in blood pressure.
• 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, can lead to complications such as heart attack, heart failure, or kidney failure, stroke, or vision loss. Most of the time, before the above complications appear, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Zanacodar Combi is usedto treat high blood pressure (essential hypertension) in adultswho are not adequately controlled by telmisartan or hydrochlorothiazide alone.

2. Important information before taking Zanacodar Combi

When not to take Zanacodar Combi

• 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 Zanacodar Combi 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 doctor has found low potassium or high calcium levels in the blood that do not respond to 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 tell their doctor or pharmacist before taking Zanacodar Combi.

Warnings and precautions

Before starting to take Zanacodar Combi, 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 low sodium level 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 disease;
• diabetes;
• gout;
• increased aldosterone levels (water and sodium retention in the body, including electrolyte imbalance);
• systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the immune system attacks the body;
• the active substance, hydrochlorothiazide, may cause rare reactions that lead to impaired vision 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 inside the eye - they may occur within a few hours to a week after taking Zanacodar Combi. If left untreated, they can lead to permanent vision impairment;

Before starting to take Zanacodar Combi, the patient should discuss it with their doctor or pharmacist:

• 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 diabetic kidney disease;
• aliskiren.

The 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 Zanacodar Combi".

• if the patient is taking digoxin.

The patient must tell their doctor if they are pregnant or planning to become pregnant. It is not recommended to take Zanacodar Combi 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, lethargy, drowsiness, restlessness, muscle cramps, nausea, vomiting, fatigue, and irregular heartbeat (above 100 beats per minute). If any of these symptoms occur, the patient should inform their doctor.
The patient should also tell their doctor if they experience increased sensitivity of the skin to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering), which appears more quickly than usual.
If the patient is scheduled for surgery or anesthesia, they should tell their doctor that they are taking Zanacodar Combi.
Zanacodar Combi may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Zanacodar Combi 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 following medicines taken with Zanacodar Combi:

• Lithium preparations used to treat certain types of depression;
• Medicines that can cause low potassium levels in the blood (hypokalemia), such as other diuretics (water pills), laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid, and its derivatives;
• Medicines that 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) 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 noradrenaline;
• Muscle relaxants, such as tubocurarine;
• Calcium and/or vitamin D supplements;
• Medicines with anticholinergic effects (used to treat various 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 biperiden;
• 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 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 Zanacodar Combi" and "Warnings and precautions");
• Digoxin.

Zanacodar Combi may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure 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. If the patient needs to adjust the dose of another medicine they are taking while taking Zanacodar Combi, they should consult their doctor.
The effect of Zanacodar Combi may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Taking Zanacodar Combi with food and alcohol

Zanacodar Combi 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 must tell their doctor if they are pregnant or planning to become pregnant. The doctor will usually advise the patient to stop taking Zanacodar Combi before a planned pregnancy or as soon as they know they are pregnant, and will prescribe a different medicine instead of Zanacodar Combi. It is not recommended to take Zanacodar Combi during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
Breastfeeding
The patient should tell their doctor if they are breastfeeding or planning to breastfeed. It is not recommended to take Zanacodar Combi while breastfeeding. The doctor may choose a different treatment during breastfeeding.

Driving and using machines

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

Zanacodar Combi contains lactose

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

Zanacodar Combi contains sodium

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

3. How to take Zanacodar Combi

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 is one tablet per day. The patient should try to take the tablet at the same time every day. Zanacodar Combi can be taken with or without food.
The tablets should be swallowed with water or a non-alcoholic drink. It is essential to take Zanacodar Combi every day, unless the doctor advises otherwise.
If the patient has liver problems, the dose should not usually be higher than 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking a higher dose of Zanacodar Combi 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 presence of hydrochlorothiazide, very low blood pressure and low potassium levels in the blood may also occur, leading to nausea, drowsiness, and muscle cramps, and/or irregular heartbeat associated with the concurrent use of medicines such as digitalis glycosides and 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 Zanacodar Combi

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. Do nottake 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, Zanacodar Combi can cause side effects, although not everybody gets them.

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

If the patient experiences any of the following symptoms, they should contact their doctor immediately:
Septicemia* (often called "blood poisoning", a severe infection with an inflammatory response throughout the body), sudden swelling of the skin and mucous membranes (angioedema). These side effects are rare (may affect up to 1 in 1000 patients) or have an unknown frequency (cannot be estimated from the available data), but are extremely severe, and the patient should stop taking the medicine and contact their doctor immediately. If left untreated, they can be fatal. The increased frequency of septicemia has been observed in patients taking telmisartan as a single medicine, but it cannot be ruled out in the case of Zanacodar Combi therapy.

Possible side effects of Zanacodar Combi:

Common side effects (may affect up to 1 in 10 patients):
Dizziness
Uncommon side effects (may affect up to 1 in 100 patients):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction, chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1000 patients):
Respiratory tract infections (e.g., bronchitis), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), sore throat, sinusitis, depression, 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 Zanacodar Combi, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking only telmisartan, the following additional side effects have been observed:
Uncommon side effects (may affect 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 (bradycardia), kidney function disorders, including acute kidney failure, weakness, cough.
Rare side effects (may affect up to 1 in 1000 patients):
Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, skin rash), low blood sugar levels (in patients with diabetes), gastritis, skin rash (exanthema), joint degeneration, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (may affect up to 1 in 10,000 patients):
Progressive pulmonary fibrosis (interstitial lung disease)**
Frequency not known (cannot be estimated from the available data):
Intestinal angioedema - angioedema of the intestine has been reported with similar products, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
*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 affect up to 1 in 10 patients):
Nausea, low magnesium levels in the blood.
Rare side effects (may affect 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 in other tissues, caused by bleeding), high calcium levels in the blood, headache.
Very rare side effects (may affect up to 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) 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 (cannot be estimated from the 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, restlessness, dizziness, blurred vision or yellow vision, weakness, kidney function disorders or kidney problems, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, or difficulty controlling blood sugar levels 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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland, 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, more information can be gathered on the safety of the medicine.

5. How to store Zanacodar Combi

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 after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine. Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zanacodar Combi contains

The active substances of the medicine are telmisartan and hydrochlorothiazide.
Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are mannitol, povidone K 25, crospovidone, magnesium stearate, meglumine, sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethyl cellulose (type A), and iron oxide yellow (E 172).

What Zanacodar Combi looks like and contents of the pack

Zanacodar Combi, 40 mg + 12.5 mg, are white-yellow, biconvex, two-layer tablets.
Zanacodar Combi is available in blisters containing 28 or 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

Laboratorios Liconsa, S.A.
Avda. Miralcampo, n° 7 Poligono Industrial Miralcampo
19200, Azuqueca de Henares,
Guadalajara
Spain

Date of last revision of the leaflet: December 2024

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.