Zanacodar combi

Patient Information Leaflet

Zanacodar Combi, 80 mg + 12.5 mg, tablets
Telmisartanum + Hydrochlorotiazydum
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, please ask your doctor or pharmacist.
• 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Zanacodar Combi is and what it is 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 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. It increases urine output, which leads 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 failure 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 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 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 sulphonamide-derived medicines;
• 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 persistent low potassium levels 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, the patient must inform their 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 loss of body water) 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 substance hydrochlorothiazide may cause rare visual 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 may occur from a few hours to a week after taking Zanacodar Combi. If left 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 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 Zanacodar Combi, the skin should be protected from sunlight and UV radiation;
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Zanacodar Combi, immediate medical attention is required.
• if the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Zanacodar Combi, discuss this with the doctor. The doctor will decide whether to continue treatment. Do not stop taking Zanacodar Combi without medical advice.

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 of suspected (or planned) pregnancy. Use of Zanacodar Combi is not recommended in early pregnancy and must not be used 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.
The patient should also inform the doctor of skin hypersensitivity to sunlight, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.
If a surgical procedure or anaesthesia is planned, inform the doctor about taking Zanacodar Combi.
Zanacodar Combi may be less effective in lowering blood pressure in patients of Black ethnicity.
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 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 Zanacodar Combi with the following medicines:

• Lithium preparations, used in the treatment of certain types of depression;

• Medicines that reduce 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 to treat 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 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 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 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 for 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 reduced when taken concomitantly 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 food or independently of meals.
Alcohol should be avoided until discussed with the doctor. Alcohol may additionally lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
The patient must inform the doctor of suspected (or planned) pregnancy. The doctor will usually advise stopping Zanacodar Combi before planning pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine instead of Zanacodar Combi. Use of 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 after the third month.
Breast-feeding
Inform the doctor if breastfeeding or planning to breastfeed. Use of Zanacodar Combi is not recommended during breastfeeding. 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, driving or operating machinery should be avoided.
Zanacodar Combi contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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 directed by the physician. If in doubt, consult a 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 during or between meals. Swallow the tablet 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 dose should usually not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking more Zanacodar Combi than prescribed

If too many tablets are accidentally taken, 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 may lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with drugs such as digitalis glycosides and certain antiarrhythmic medicines. 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 missed on one day, take the usual dose the next day. Do not take a double dose to make up for the 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* (often called "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 stopped immediately and medical advice sought. If left untreated, these symptoms may result in death. Increased incidence of sepsis has been observed in patients taking telmisartan as monotherapy; however, it cannot be excluded during treatment 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, 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), 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 gastric mucosa, liver function abnormalities (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 activity of liver enzymes or creatine phosphokinase in blood.

Adverse reactions reported for one of the components may also occur during treatment with Zanacodar Combi, even if they were not observed in 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 number of red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney function impairment, 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 patients with diabetes), inflammation of gastric mucosa, rash (skin disorder), joint degeneration, tendonitis, decreased haemoglobin levels (blood protein), somnolence.

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

Frequency unknown (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 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, increasing the risk of bleeding or bruising (small purple-red skin or tissue lesions 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 blood chloride levels, 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), decreased 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 vision or yellow vision, visual impairment or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular membrane surrounding the eye — excessive fluid accumulation between choroid and sclera — or acute angle-closure glaucoma), vasculitis (necrotising vasculitis), pancreatitis, inflammation of gastric mucosa, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disorder 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 with 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, high 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 Reactions of Medicinal Products at 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 marketing authorisation 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 the 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 the storage temperature of the medicine. 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 pack and other information

What Zanacodar Combi contains
The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 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 starch
(type A) and iron oxide, red (E 172).
What Zanacodar Combi looks like and contents of the pack
Zanacodar Combi, 80 mg + 12.5 mg are round, two-layered, white-pink 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 medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.