Zanacodar combi

Package leaflet: Information for the user

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

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

Leaflet 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 a single 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 relax and widen, which lowers blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It increases urine output, which helps reduce blood pressure.

Untreated high blood pressure may damage blood vessels in vital organs and, in some cases, may lead to serious complications such as heart attack, heart failure or kidney failure, stroke, or loss of vision. Often, there are no noticeable symptoms of high blood pressure before such complications occur. Therefore, it is important to measure your blood pressure regularly 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 adequately controlled by telmisartan or hydrochlorothiazide taken alone.

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;
• during the third trimester 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, inform your doctor or pharmacist before taking Zanacodar Combi.

Warnings and precautions

Talk to your doctor before starting Zanacodar Combi if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have 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 disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure. These symptoms may occur from several hours to a week after taking Zanacodar Combi. If left untreated, they may lead to permanent vision impairment;
• if you have 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 cancers and lip cancers. While taking Zanacodar Combi, protect your skin from sunlight and UV radiation;
• if you have previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Zanacodar Combi, seek immediate medical help;
• if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Zanacodar Combi, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Zanacodar Combi on your own.

Talk to your doctor or pharmacist before starting Zanacodar Combi:

• If you are taking any of the following medicines for high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have 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 Zanacodar Combi”.

• if you are taking digoxin.

Women must inform their doctor if they suspect or are planning pregnancy. Zanacodar Combi is not recommended during 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.
Typical symptoms of fluid or electrolyte imbalance include dryness of 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 your doctor.
Also inform your doctor if you experience skin photosensitivity, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.
If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Zanacodar Combi.
Zanacodar Combi may be less effective in lowering blood pressure in black patients.

Children and adolescents
Zanacodar Combi is not recommended for use in children and adolescents under 18 years of age.

Zanacodar Combi and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may need to adjust the dose of these medicines or take other precautions. In some cases, one of the medicines may need to be discontinued. This is especially important when taking any of the following medicines together with Zanacodar Combi:

• Lithium preparations, used to treat certain types of depression;
• Medicines that may cause low potassium levels (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 to treat mouth ulcers), sodium salt of penicillin G (an antibiotic), salicylic acid and its derivatives;
• Medicines that may increase potassium levels, 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 to treat 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 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 for treating or preventing certain viral infections);
• 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 information under “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 high blood pressure 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 any other medicine taken during Zanacodar Combi treatment is needed, consult your doctor.
The effect of Zanacodar Combi may be reduced when taken together with 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 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
Women must inform their doctor if they suspect or are planning pregnancy. Usually, the doctor will advise stopping Zanacodar Combi before a planned pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine. Zanacodar Combi 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 beyond 3 months of gestation.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Zanacodar Combi is not recommended during breastfeeding. Your doctor may choose an alternative treatment during this period.

Driving and using machines
Some patients taking Zanacodar Combi may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Zanacodar Combi contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking Zanacodar Combi.

Zanacodar Combi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered “sodium-free”.

3. How to use Zanacodar Combi

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Try to take the tablet at the same time each day. Zanacodar Combi may be taken during or between meals.
Tablets should be swallowed 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 has impaired liver function, 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 increased heart rate may occur. Cases of slowed heart rate, 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 may lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, especially when used concomitantly with drugs such as digitalis glycosides and certain antiarrhythmic medications. Seek immediate medical advice from 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 on one day, the patient should 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 will experience 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 1,000 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 discontinued immediately and medical help sought without delay. If left untreated, these symptoms may result in death. Increased incidence of sepsis has been observed in individuals taking telmisartan as a single agent; however, sepsis 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, dry mouth, 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), activation or worsening 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 (dyspepsia), nausea (vomiting), inflammation of the stomach lining (gastritis), abnormal liver function (more frequent in patients of Japanese origin), skin redness (erythema), allergic reactions such as itching or rash, excessive sweating, urticaria, joint pain and limb pain, muscle cramps, influenza-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme or creatine kinase 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 trials 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 infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anaemia), high potassium levels, slow heart rate (bradycardia), kidney dysfunction, including acute renal failure, fatigue, cough.

Rare adverse reactions (may occur in up to 1 in 1,000 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 diabetic patients), inflammation of the stomach lining, rash (skin disorder), osteoarthritis, tendonitis, decreased haemoglobin levels (blood protein), drowsiness.

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

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

*This phenomenon may be coincidental or related to a mechanism not yet understood.
**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:

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 1,000 patients):
Reduced platelet count, leading to increased risk of bleeding or bruising (small purple-red skin lesions or in other tissues due to 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):
Salivary gland inflammation, skin and lip malignancies (non-melanoma skin cancers), reduced number (or even absence) of blood cells, including low numbers of red and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, dizziness, blurred or yellow vision, visual impairment or eye pain due to elevated pressure (possible signs of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid buildup between choroid and sclera—or acute angle-closure glaucoma), vasculitis (necrotising vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disorder mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of lips, eyes and mouth, skin peeling, fever (possible signs of erythema multiforme), fatigue, kidney inflammation or kidney function disorders, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, increased blood cholesterol levels, reduced blood volume, increased blood glucose levels, 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 of the 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this 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 after: "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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Zanacodar Combi contains
The active substances 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, monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), and yellow iron oxide (E 172).

What Zanacodar Combi looks like and contents of the pack
Zanacodar Combi 40 mg + 12.5 mg are round, two-layered, white-yellow tablets.
Zanacodar Combi is available in blister packs 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 about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.