Zanacodar

Package Leaflet: Information for the Patient

Zanacodar, 40 mg, Tablets

Zanacodar, 80 mg, Tablets

Telmisartan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Zanacodar and what is it used for

Zanacodar belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body, which causes blood vessels to narrow, leading to an increase in blood pressure. Zanacodar blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Zanacodar is usedto treat essential hypertension (high blood pressure). The term "essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which in some cases can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most often, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is important to regularly measure blood pressure to check if it is within the normal range.
Zanacodar is also usedto reduce the risk of cardiovascular events (such as heart attack or stroke) in adults at risk, who have restricted or blocked blood flow to the heart or legs, or who have had a stroke or have diabetes that poses a significant risk. Information on the degree of risk of such events can be obtained from the attending physician.

2. Important information before taking Zanacodar

When not to take Zanacodar

(listed in section 6).

If any of the above situations apply to you, inform your doctor or pharmacist before taking Zanacodar.

Warnings and precautions

Tell your doctor if you have or have had any of the following conditions or diseases:

• Kidney disease or kidney transplant;
• Renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• Liver disease;
• Heart problems;
• Increased aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood);
• Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have a low salt level due to the use of diuretics, a low-salt diet, diarrhea, or vomiting;
• Increased potassium levels in the blood;
• Diabetes.

Before starting to take Zanacodar, discuss it with your doctor or pharmacist:

• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren.

Your doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Zanacodar".

Inform your doctor about pregnancy (or suspected pregnancy). It is not recommended to take Zanacodar in early pregnancy, and taking it after 3 months of pregnancy is contraindicated, as it may seriously harm the fetus (see section "Pregnancy").
In case of planned surgery or anesthesia, inform your doctor about taking Zanacodar.
Zanacodar may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Zanacodar and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Your doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This applies especially to the simultaneous use of the following medicines with Zanacodar.

• Lithium preparations used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Zanacodar, as they may lead to significant water loss from the body and a decrease in blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Zanacodar" and "Warnings and precautions").
• Digoxin

The effect of Zanacodar may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Zanacodar 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 reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, adjust the dose of another medicine you are taking while taking Zanacodar, consult your doctor.

Taking Zanacodar with food and drink

Zanacodar can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor about suspected (or planned) pregnancy. Usually, your doctor will advise you to stop taking Zanacodar before planned pregnancy or as soon as pregnancy is confirmed and will prescribe another medicine instead of Zanacodar. It is not recommended to take Zanacodar in early pregnancy, and taking it after 3 months of pregnancy is contraindicated, as it may seriously harm the fetus.
Breastfeeding
Tell your doctor about breastfeeding or intending to breastfeed. Zanacodar is not recommended during breastfeeding. Your doctor may choose another treatment during breastfeeding, especially in the period of breastfeeding newborns and premature babies.

Driving and using machines

Some patients may experience dizziness or fatigue while taking Zanacodar. If you experience dizziness or fatigue, do not drive or operate machinery.

Zanacodar contains sodium

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

3. How to take Zanacodar

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
To remove a tablet, follow these steps:

• 1. Separate one part of the blister with the tablet by gently tearing along the perforation.
• 2. Carefully peel off the foil from the blister above the tablet.
• 3. Push the tablet out.

The recommended dose of Zanacodar is one tablet per day. Try to take the tablet at the same time every day. Zanacodar can be taken with or without food. Swallow the tablets with water or another non-alcoholic drink. It is important to take Zanacodar every day, unless your doctor advises you to stop.
If you feel that the effect of Zanacodar is too strong or too weak, consult your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Zanacodar is one 40 mg tablet taken once daily to control blood pressure over a 24-hour period. However, your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg.
Alternatively, Zanacodar may be used in combination with diuretics, such as hydrochlorothiazide. Additional blood pressure-lowering effects have been shown when hydrochlorothiazide is used with Zanacodar.
To reduce the risk of cardiovascular events, the usual dose of Zanacodar is one 80 mg tablet taken once daily. When starting preventive treatment with Zanacodar 80 mg, blood pressure should be frequently monitored.
In case of liver function impairment, the usual dose should not exceed 40 mg once daily.

Taking a higher dose of Zanacodar than recommended

If you accidentally take too many tablets, contact your doctor or pharmacist or the nearest hospital emergency department immediately.

Missing a dose of Zanacodar

If you miss a dose, take it as soon as you remember, and then continue taking the medicine as scheduled. If you do not take the tablet within the entire 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 taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zanacodar can cause side effects, although not everybody gets them.

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

Septicaemia* (often referred to as "blood poisoning", a severe infection with an inflammatory reaction of the whole body), sudden swelling of the skin and mucous membranes (angioedema). The above side effects are rare (may occur in up to 1 in 1000 patients), but are extremely serious, and in such cases, you should stop taking the medicine and contact your doctor immediately. If the above symptoms are not treated, they may be fatal.

Possible side effects of Zanacodar:

Common side effects (may occur in 1 to 10 in 100 patients):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may occur in 1 to 10 in 1000 patients):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), anaemia (low red blood cell count), high potassium levels, difficulty sleeping, feeling sad (depression), fainting, dizziness, slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain (myalgia), impaired kidney function, including acute kidney failure, chest pain, feeling weak, and high creatinine levels in the blood.
Rare side effects (may occur in 1 to 10 in 10,000 patients):
Septicaemia* (often referred to as "blood poisoning", a severe infection with an inflammatory reaction of the whole body, which can cause death), increased levels of certain white blood cells (eosinophilia), decreased platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), anxiety, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, stomach upset, taste disturbances, abnormal liver function (this side effect occurs more frequently in Japanese patients), sudden swelling of the skin and mucous membranes (angioedema, which can also cause death), eczema (skin disease), redness of the skin, hives, severe rash, joint pain (arthralgia), limb pain, tendon pain, flu-like symptoms, decreased haemoglobin levels (a protein found in blood), high uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in 1 to 10 in 100,000 patients):
Progressive scarring of the lungs (interstitial lung disease)**
*This phenomenon may be random or related to a mechanism that has not yet been understood.
**Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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, e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zanacodar

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the expiry date (EXP) or (EXP). The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zanacodar contains

• The active substance of Zanacodar is telmisartan: one 40 mg tablet of Zanacodar contains 40 mg of telmisartan; one 80 mg tablet of Zanacodar contains 80 mg of telmisartan
• The other ingredients are: povidone (K 25) (E1201), meglumine, sodium hydroxide (E524), mannitol (E 421), crospovidone (E1202), and magnesium stearate (E470b).

What Zanacodar looks like and contents of the pack

Zanacodar is available as tablets.
Zanacodar, 40 mg: white or slightly yellowish tablets of elongated shape
Zanacodar, 80 mg: white or slightly yellowish tablets of elongated shape
Zanacodar is available in blisters containing 14, 28, 30, 56, 84, 90, or 98 tablets.
Not all pack sizes or tablet strengths may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal:
Zanacodar 20, 40 e 80 mg comprimidos
Denmark:
Zanacodar 20 mg / 40 mg/ 80 mg tabletter
Luxembourg:
Zanacodar 20 mg / 40 mg/ 80 mg comprimé
Poland:
Zanacodar, 40 mg /80 mg, tablets

Date of last revision of the leaflet: June 2021