Zanacodar

Package leaflet: Information for the patient

Zanacodar, 40 mg, tablets
Zanacodar, 80 mg, tablets
Telmisartan
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 them, 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 is and what it is 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 Zanacodar is and what it is used for

Zanacodar belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to
increased blood pressure. Zanacodar blocks the action of angiotensin II, allowing blood vessels to
relax and blood pressure to decrease.
Zanacodar is used to treat essential hypertension (high blood pressure). The term "essential" means
that high blood pressure is not caused by another disease.
Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may
lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of
high blood pressure before such complications occur. Therefore, it is important to measure blood
pressure regularly to ensure it remains within normal limits.
Zanacodar is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in
adults at high risk, including those with reduced or blocked blood flow to the heart or lower limbs, those
who have previously had a stroke, or those with diabetes associated with high risk. Your doctor can
provide further information about your individual risk of such events.

2. Important information before using Zanacodar

When not to use 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 in the third month of pregnancy (it is better not to use Zanacodar also in early pregnancy – see section "Pregnancy").
• if the patient has severe liver function disorders, such as biliary obstruction or bile duct stenosis (problems with bile drainage from the liver and gallbladder), or any other severe liver disease.
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, the doctor or pharmacist should be informed before using Zanacodar.

Warnings and precautions

Tell the doctor if the patient currently has or has previously 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 disorders;
• Increased aldosterone levels (water and salt retention in the body, accompanied by imbalances in various blood mineral components);
• Low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of water from the body) or has salt deficiency due to diuretic (water pill) use, low-salt diet, diarrhea, or vomiting;
• Increased blood potassium levels;
• Diabetes.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Zanacodar, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not make independent decisions about stopping Zanacodar.

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

• if the patient is taking any of the following medicines used to treat high blood pressure:
  • ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially 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".

• if the patient is taking digoxin

Inform the doctor if the patient is pregnant (or suspects pregnancy). Use of Zanacodar is not recommended during early pregnancy, and its use after the third month of pregnancy is contraindicated, as it may seriously harm the unborn child (see section "Pregnancy").

If undergoing surgery or anesthesia, inform the doctor about taking Zanacodar.

Zanacodar may be less effective in lowering blood pressure in patients of Black race.

Children and adolescents

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

Zanacodar with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has 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 with the following medicines:

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

The effect of Zanacodar may be reduced when used concomitantly 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 hypertension or medicines that may cause reduced blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. Dizziness upon standing may occur. If dose adjustment of another medicine taken by the patient during Zanacodar treatment is needed, consult the doctor.

Taking Zanacodar with food and drink

Zanacodar can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform the doctor if pregnancy is suspected (or planned). Usually, the doctor will recommend discontinuing Zanacodar before a planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine to Zanacodar. Use of Zanacodar is not recommended during early pregnancy, and its use after the 3rd month of pregnancy is contraindicated, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor if breastfeeding or planning to breastfeed. Zanacodar is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding, especially when feeding newborns or premature infants.

Driving and operating machinery

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

Zanacodar contains sodium

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

3. How to use Zanacodar

This medicine should always be taken as prescribed by the doctor. If in doubt, consult a doctor or pharmacist.

To remove the tablet, follow these steps:

1. Separate one blister section containing the tablet by gently tearing along the perforation.
2. Carefully peel back the foil from the blister above the tablet.
3. Push the tablet out through the foil.

The recommended dose of Zanacodar is one tablet per day. Try to take the tablet at the same time each day. Zanacodar may be taken during or between meals. Tablets should be swallowed with water or another non-alcoholic drink.

It is important to take Zanacodar every day unless otherwise advised by your doctor. If you feel that the effect of Zanacodar is too strong or too weak, consult your doctor or pharmacist.

For the treatment of hypertension, the usual dose of Zanacodar in most patients is one 40 mg tablet taken once daily to control blood pressure over a 24-hour period. However, in some cases, the 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 demonstrated when hydrochlorothiazide is used together with Zanacodar.

To reduce the risk of cardiovascular events, the usual dose of Zanacodar is one 80 mg tablet taken once daily. When initiating preventive treatment with Zanacodar 80 mg, blood pressure should be monitored frequently.

In case of impaired liver function, the usual dose should not exceed 40 mg once daily.

Taking more Zanacodar than prescribed
If the patient accidentally takes too many tablets, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department.

Missed dose of Zanacodar
If a dose is missed, take it as soon as you remember, then continue taking the medicine according to the prescribed schedule. If the tablet is not taken during the entire 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:
Sepsis* (often referred to as "blood poisoning", a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema). These adverse reactions are rare (may occur in up to 1 in 1,000 patients), but are extremely serious. In such cases, treatment with the medicine must be stopped immediately and medical advice must be sought without delay. If these symptoms are not treated, they may result in death.

Possible adverse reactions of Zanacodar:
Common adverse reactions (may occur in 1 to 10 out of 100 patients):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced red blood cell count (anaemia), increased potassium levels, difficulty sleeping, feeling of sadness (depression), fainting, dizziness, slowed heart rate (bradycardia), low blood pressure (hypotension) in patients treated for arterial hypertension, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), impaired kidney function including acute kidney failure, chest pain, feeling of weakness, and elevated blood creatinine levels.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):
Sepsis* (often referred to as "blood poisoning", a severe infection causing systemic inflammatory response, which may lead to death), increased number of certain white blood cells (eosinophilia), reduced 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 glucose levels (in diabetic patients), anxiety, somnolence, visual disturbances, increased heart rate (tachycardia), dryness of the oral mucosa, stomach upset, taste disturbances, abnormal liver function (this adverse reaction occurs more frequently in patients in Japan), sudden swelling of the skin and mucous membranes (angioedema, which may also lead to death), eczema (a skin disorder), skin redness, urticaria, severe drug rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin concentration (a protein present in blood), increased uric acid levels, increased liver enzyme or creatine kinase activity in blood.

Very rare adverse reactions (may occur in 1 to 10 out of 100,000 patients):
Progressive fibrosis of pulmonary alveoli (interstitial lung disease)**

Frequency not known (cannot be estimated from available data):
Angioedema of the intestine – with similar products, intestinal swelling has occurred, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

*This phenomenon may be coincidental or related to a mechanism not yet identified.
**Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

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 of 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, e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zanacodar

Keep this 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 label "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
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 packaging and other information

What Zanacodar contains

• The active substance is telmisartan: one Zanacodar 40 mg tablet contains 40 mg of telmisartan; one Zanacodar 80 mg tablet contains 80 mg of telmisartan.
• 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, elongated-shaped tablets
Zanacodar 80 mg: white or slightly yellowish, elongated-shaped tablets
Zanacodar is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets.
Not all pack sizes or tablet strengths may be marketed.

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

Manufacturer
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów, Poland

Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the EEA countries 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