ZANACODAR 80 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Zanacodar, 40 mg, tablets
3. Zanacodar, 80 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Zanacodar and what is it used for
5. Important information before taking Zanacodar
   1. When not to take Zanacodar
   2. Warnings and precautions
   3. Children and adolescents
   4. Zanacodar and other medicines
   5. Taking Zanacodar with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Zanacodar contains sodium
6. How to take Zanacodar
   1. Taking a higher dose of Zanacodar than recommended
   2. Missing a dose of Zanacodar
7. POSSIBLE SIDE EFFECTS
   1. Some side effects can be serious and require immediate medical attention:
   2. Possible side effects of Zanacodar:
   3. Reporting side effects
8. How to store Zanacodar
9. Contents of the pack and other information
   1. What Zanacodar contains
   2. What Zanacodar looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the EEA under the following names:
   7. Date of last revision of the leaflet: June 2021

Leaflet accompanying the packaging: patient information

Zanacodar, 40 mg, tablets

Zanacodar, 80 mg, tablets

Telmisartan

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• 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 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 that 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 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 essential 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

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine

(listed in section 6).

• if the patient is over 3 months pregnant (it is also not recommended to take Zanacodar in early pregnancy - see "Pregnancy").
• if the patient has severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease.
• 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 inform their 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 balance disorders in the blood);
• Low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a salt deficiency due to the use of diuretics, a low-salt diet, diarrhea, or vomiting;
• High potassium levels in the blood;
• Diabetes.

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

• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes
• aliskiren.

Your 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" and "Warnings and precautions".

• if the patient is taking digoxin

Tell your doctor if you are pregnant (or suspect you are pregnant). 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 baby (see "Pregnancy").
In the event of planned surgery or anesthesia, inform your doctor that you are 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 the 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 can increase potassium levels in the blood, such as potassium-salt 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 agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Zanacodar, as they can lead to significant water loss and low blood pressure (hypotension).
• If the patient is 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 can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure can be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, adjust the dose of another medicine taken with Zanacodar, consult your doctor.

Taking Zanacodar with food and drink

Zanacodar can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect (or plan) pregnancy. Usually, your doctor will advise you to stop taking Zanacodar before planned pregnancy or immediately after confirming pregnancy and recommend 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 baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan 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 dizziness or fatigue occurs, do not drive or operate machinery.

Zanacodar contains sodium

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

3. How to take Zanacodar

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
To remove a tablet, perform the following 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 essential to take Zanacodar every day, unless your doctor tells you otherwise.
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 for most patients 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 can 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 monitored frequently.
In patients with liver dysfunction, the usual dose should not exceed 40 mg once daily.

Taking a higher dose of Zanacodar than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Zanacodar

If a dose is missed, take it as soon as you remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a 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 doubts about taking this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

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

Septicemia* (often called "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 they are extremely serious, and in such cases, the medicine should be discontinued, and immediate medical attention should be sought. If the above symptoms are not treated, they can 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), anemia (low red blood cell count), high potassium levels, insomnia, 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, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain (myalgia), impaired kidney function, including acute kidney failure, chest pain, weakness, and elevated creatinine levels in the blood.
Rare side effects (may occur in 1 to 10 in 10,000 patients):
Septicemia* (often called "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, facial swelling, 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), severe swelling of the skin and mucous membranes (angioedema, which can also cause death), eczema (skin disease), skin redness, hives, severe rash, joint pain (arthralgia), limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein found in blood), elevated 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 lung tissue (interstitial lung disease)**
*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 temporal association with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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: [email protected]
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" 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 in tablet form.
Zanacodar, 40 mg: white or slightly yellowish tablets with a elongated shape
Zanacodar, 80 mg: white or slightly yellowish tablets with a 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 marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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