Zanacodar combi

Patient Information Leaflet

Zanacodar Combi, 80 mg + 25 mg, tablets
Telmisartanum + Hydrochlorotiazydum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

1. What Zanacodar Combi is and what it is used for
2. What you need to know 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 Zanacodar Combi is and what it is used for

Zanacodar Combi is a combination medicine containing 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 output, leading to a reduction in blood pressure.

Untreated high blood pressure may damage blood vessels in organs and, in some cases, may lead to complications such as heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. For this reason, it is important to regularly monitor your blood pressure to ensure it remains within normal limits.
Zanacodar Combi is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with Zanacodar Combi 80 mg + 25 mg, or in patients previously stabilized on telmisartan or hydrochlorothiazide given separately.

2. Important information before using Zanacodar Combi

When not to use 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 (Zanacodar Combi should also be avoided in early pregnancy – see section “Pregnancy”);
• if the patient has severe liver disease, such as biliary obstruction or cholestasis (impaired bile flow from the liver and gallbladder), or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor has diagnosed persistently low potassium or high calcium levels in the blood despite 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, inform the doctor or
pharmacist before taking Zanacodar Combi.
Warnings and precautions
Before starting Zanacodar Combi, discuss with the doctor 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 fluid loss from the body) or has low sodium levels due to diuretics (water tablets), a low-salt diet, diarrhoea, vomiting, or haemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• elevated aldosterone levels (retention of water and sodium in the body, including electrolyte imbalance);
• systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the immune system attacks the body itself;
• the active ingredient, hydrochlorothiazide, may rarely cause reactions leading to vision impairment or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure. These may occur from several hours to a week after taking Zanacodar Combi. If untreated, they may lead to permanent vision impairment;
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancers and lip cancer. While taking Zanacodar Combi, protect the skin from sunlight and UV radiation;
• if the patient previously experienced breathing problems or lung issues (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Zanacodar Combi, seek immediate medical help.
• if the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Zanacodar Combi, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Zanacodar Combi on your own.

Before starting Zanacodar Combi, discuss with the doctor or
pharmacist:

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

The treating 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 Zanacodar Combi”.

• if the patient is taking digoxin.

The patient must inform the doctor about suspected (or planned) pregnancy. Use of
Zanacodar Combi is not recommended in early pregnancy and must not be taken after the third month
of pregnancy, as it may cause severe harm to 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 mucous membranes in the mouth,
weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting,
muscle fatigue, and abnormally rapid heartbeat (over 100 beats per minute). If any
of these symptoms occur, inform the doctor.
Also inform the doctor if skin becomes unusually sensitive to sunlight,
manifesting as sunburn (e.g. redness, itching, swelling, blistering), occurring more easily than usual.
If undergoing planned surgery or anaesthesia, inform the doctor
about taking Zanacodar Combi.
Zanacodar Combi may be less effective in lowering blood pressure in patients of Black race.
Children and adolescents
Zanacodar Combi is not recommended for use in children and adolescents under 18 years of age.
Zanacodar Combi and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. 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 Zanacodar Combi:

• Lithium preparations, used in the treatment of certain types of depression;
• Medicines associated with low potassium levels in the blood (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used in the treatment of oral ulcers), sodium salt of penicillin G (an antibiotic), salicylic acid and its derivatives;
• Medicines that may increase potassium levels in the blood, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicinal products, e.g. 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 for 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;
• Anticholinergic medicines (used in the treatment of 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 in cancer, gout or arthritis treatment;
• If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings “When not to use Zanacodar Combi” and “Warnings and precautions”);
• Digoxin.

Zanacodar Combi may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that may cause low blood pressure (e.g. baclofen, amifostine).
Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics or antidepressants. Symptoms include dizziness upon standing. If dose adjustment of another medicine taken during Zanacodar Combi treatment is needed, consult the doctor.
The effect of Zanacodar Combi may be weakened by concomitant use of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).
Taking Zanacodar Combi with food and alcohol
Zanacodar Combi can be taken with or without food.
Avoid alcohol until discussing with the doctor. Alcohol may further lower blood pressure and (or) increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
The patient must inform the doctor about suspected (or planned) pregnancy. Usually, the doctor will advise
discontinuing Zanacodar Combi before planned pregnancy or immediately after
confirming pregnancy and will recommend an alternative medicine instead of Zanacodar Combi. Use of
Zanacodar Combi during pregnancy is not recommended and must not be used after the third month of
pregnancy, as it may seriously harm the unborn child if used beyond 3 months of pregnancy.
Breastfeeding
Inform the doctor about breastfeeding or plans to breastfeed. Use of
Zanacodar Combi during breastfeeding is not recommended. The doctor may choose an alternative treatment during breastfeeding.
Driving and operating machinery
Some patients taking Zanacodar Combi may experience dizziness or
fatigue. In such cases, do not drive or operate machinery.
Zanacodar Combi contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking Zanacodar Combi.
Zanacodar Combi contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to use Zanacodar Combi

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose of Zanacodar Combi is one tablet daily. Try to take the tablet at the same
time each day. Zanacodar Combi may be taken with or between meals. Swallow the tablets with
water or a non-alcoholic drink.
It is important to take Zanacodar Combi every day, unless otherwise advised by your doctor.
If the patient's liver is not functioning properly, the usual dose should not exceed 40 mg telmisartan
and 12.5 mg hydrochlorothiazide per day.
Taking more Zanacodar Combi than prescribed
If too many tablets are taken by mistake, symptoms such as low blood pressure and rapid heartbeat
may occur. Cases of slow 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 can lead to nausea,
drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with
medicines such as cardiac glycosides or certain antiarrhythmic drugs. Seek immediate medical
attention by contacting your doctor or pharmacist, or go to the nearest hospital emergency department.
Missing a dose of Zanacodar Combi
If a patient forgets to take a dose, they should take it as soon as they remember, on the same day.
If a tablet is not taken 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).
The above adverse reactions are rare (may occur in up to 1 in 1000 patients) or of unknown frequency (in the case of toxic epidermal necrolysis), but are extremely serious. In such cases, treatment with the medicine must be stopped immediately and medical advice sought without delay. If left untreated, these symptoms may result in death. An increased incidence of sepsis has been observed in people taking telmisartan as a single agent; however, it cannot be excluded during therapy with Zanacodar Combi.

Possible adverse reactions of Zanacodar Combi:
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 (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing (orthostatic hypotension), shortness of breath (dyspnoea), diarrhoea, dryness of the oral mucosa, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.

Rare adverse reactions (may occur in up to 1 in 1000 patients):
Lung inflammation (bronchitis), activation or exacerbation of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rash and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), inflammation of the stomach mucosa, liver function abnormalities (more frequent in patients of Japanese origin), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, influenza-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme or creatine phosphokinase activity in blood.

Adverse reactions reported for one of the components may also occur during therapy with Zanacodar Combi, even if they were not observed during clinical studies of the product.

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, low number of red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney function disorders, including acute renal failure, fatigue, cough.

Rare adverse reactions (may occur in up to 1 in 1000 patients):
Low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in patients with diabetes), inflammation of the gastric mucosa, rash (skin disorder), osteoarthritis, tendonitis, decreased haemoglobin levels (blood protein), somnolence.

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

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

*This phenomenon may be coincidental or related to a mechanism not yet understood.
**Cases of interstitial lung disease temporally associated with telmisartan intake 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:

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

Rare adverse reactions (may occur in up to 1 in 1000 patients):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red skin lesions or in other tissues caused by haemorrhage), high blood calcium levels, headache.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to low chloride levels in blood, acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Inflammation of salivary glands, skin and lip malignancies (non-melanoma skin cancers), decreased number (or complete absence) of blood cells, including low levels of red and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, feeling of dizziness, blurred vision or yellow vision, visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye — excessive fluid accumulation between choroid and sclera — or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, inflammation of the gastric mucosa, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), 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 inflammation or kidney function disorders, presence of glucose in urine (glucosuria), fever, disturbances in electrolyte balance, increased blood cholesterol levels, decreased blood volume, increased glucose concentration, difficulty controlling blood/urine glucose levels in patients with diagnosed diabetes, or increased blood lipid levels.

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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 the medicine.

5. How to store Zanacodar Combi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature. Store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zanacodar Combi contains
The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of
telmisartan and 25 mg of hydrochlorothiazide.
Other ingredients are: mannitol, povidone K 25, crospovidone, magnesium stearate, meglumine,
sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium
carboxymethyl starch (type A), and iron oxide, yellow (E 172).

What Zanacodar Combi looks like and contents of the pack
Zanacodar Combi, 80 mg + 25 mg, are round, two-layered, white-yellow tablets.
Zanacodar Combi is available in blisters containing 28 tablets or 56 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.