POLSART 80 mg/25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Polsart Plus, 40 mg + 12.5 mg, tablets
3. Polsart Plus, 80 mg + 12.5 mg, tablets
4. Polsart Plus, 80 mg + 25 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
5. What is Polsart Plus and what is it used for
6. Important information before taking Polsart Plus
   1. When not to take Polsart Plus
   2. Warnings and precautions
   3. Children and adolescents
   4. Polsart Plus and other medicines
   5. Taking Polsart Plus with food and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Polsart Plus contains sodium
7. How to take Polsart Plus
   1. Taking a higher dose of Polsart Plus than recommended
   2. Missing a dose of Polsart Plus
8. Possible side effects
   1. Some side effects can be serious and require immediate medical attention:
   2. Possible side effects of Polsart Plus:
   3. Telmisartan
   4. Hydrochlorothiazide
   5. Reporting side effects
9. How to store Polsart Plus
10. Package contents and other information
    1. What Polsart Plus contains
    2. What Polsart Plus looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer

Leaflet attached to the packaging: patient information

Polsart Plus, 40 mg + 12.5 mg, tablets

Polsart Plus, 80 mg + 12.5 mg, tablets

Polsart Plus, 80 mg + 25 mg, tablets

Telmisartan + Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Polsart Plus and what is it used for
• 2. Important information before taking Polsart Plus
• 3. How to take Polsart Plus
• 4. Possible side effects
• 5. How to store Polsart Plus
• 6. Package contents and other information

1. What is Polsart Plus and what is it used for

Polsart Plus is a combination medicine that contains 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 constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to dilate and blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in organs, and in some cases, can lead to complications such as heart attack, heart failure, or kidney failure, 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.

Polsart Plus is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan or hydrochlorothiazide alone.

2. Important information before taking Polsart Plus

When not to take Polsart Plus

• 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 other sulfonamide derivatives;
• after the third month of pregnancy (it is also recommended to avoid taking Polsart Plus during early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (bile flow disorders);
• if the patient has severe kidney disease;
• if the doctor has found low potassium or high calcium levels in the blood that do not improve with 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 to the patient, they should inform their doctor or pharmacist before taking Polsart Plus.

Warnings and precautions

Before starting to take Polsart Plus, the patient should discuss with their doctor or pharmacist if they have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated or has low sodium levels due to the use of diuretics, a low-salt diet, diarrhea, vomiting, or hemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• increased aldosterone levels (water and sodium retention in the body, along with electrolyte imbalance);
• systemic lupus erythematosus (also known as "lupus" or "SLE", a disease in which the immune system attacks the body);
• if the patient has a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Polsart Plus, the patient should protect their skin from sunlight and UV radiation.
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure, which can occur within a few hours to weeks after taking Polsart Plus. Without treatment, the symptoms can lead to complete vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.
• if the patient has experienced respiratory or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Polsart Plus, they should seek medical help immediately.

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Polsart Plus, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Polsart Plus on their own.

Before starting to take Polsart Plus, the patient should discuss with their doctor:

• if they are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease;
• aliskiren;
• if they are taking digoxin.

The 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 Polsart Plus".

The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Polsart Plus during pregnancy. Do not take Polsart Plus after the third month of pregnancy, as it may seriously harm the baby (see "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 cramps, nausea (nausea), vomiting, fatigue, and irregular heartbeat (faster than 100 beats per minute). If any of these symptoms occur, the patient should inform their doctor.

The patient should also inform their doctor if they experience increased sensitivity of the skin to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.

In case of planned surgery or anesthesia, the patient should inform their doctor about taking Polsart Plus.

Polsart Plus may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of Polsart Plus in children and adolescents under 18 years of age is not recommended.

Polsart Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken together with Polsart Plus:

• lithium products, used to treat certain types of depression;
• medicines that can lower potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisolone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines, such as sodium heparin (an anticoagulant);
• medicines whose effects are influenced by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental 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 to treat diabetes (insulin or oral medicines such as metformin);
• cholestyramine and colestipol, medicines that lower blood fat levels;
• medicines that increase blood pressure, such as noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium and/or vitamin D supplements;
• medicines with anticholinergic effects (used to treat various disorders, such as spasms in the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia), such as atropine and biperiden;
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases);
• 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 the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Polsart Plus" and "Warnings and precautions");
• digoxin.

Polsart Plus may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The patient may notice this as dizziness when standing up. The patient should consult their doctor if it is necessary to adjust the dose of another medicine while taking Polsart Plus.

The effect of Polsart Plus may be weakened when taken together with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Taking Polsart Plus with food and alcohol

Polsart Plus can be taken with or without food.

The patient should avoid alcohol until they have talked to their doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Normally, the doctor will advise the patient to stop taking Polsart Plus before planned pregnancy or as soon as they know they are pregnant, and will prescribe a different medicine instead of Polsart Plus. It is not recommended to take Polsart Plus during pregnancy. Do not take Polsart Plus after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Polsart Plus is not recommended during breastfeeding. The doctor may choose a different treatment during breastfeeding.

Fertility

In preclinical studies, no effect of telmisartan and hydrochlorothiazide on fertility in women and men has been observed.

Driving and using machines

Some patients taking Polsart Plus may experience dizziness or fatigue. In this case, they should not drive or operate machines.

Polsart Plus contains sodium

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

3. How to take Polsart Plus

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended dose of Polsart Plus is one tablet per day. The patient should try to take the tablet at the same time every day. Polsart Plus can be taken with or without food. The tablets should be swallowed with water or a non-alcoholic drink. It is essential to take Polsart Plus every day, unless the doctor advises otherwise.

If the patient has liver problems, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking a higher dose of Polsart Plus than recommended

If the patient accidentally takes too many tablets, they may experience symptoms such as low blood pressure and rapid heartbeat. There have also been reports of slow heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure. Due to the hydrochlorothiazide content, very low blood pressure and low potassium levels in the blood may also occur, which can lead to nausea, drowsiness, and muscle cramps, and/or irregular heartbeat associated with the concomitant use of medicines such as digitalis glycosides and certain anti-arrhythmic medicines. The patient should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Polsart Plus

If the patient forgets to take a dose, they should take it as soon as they remember, on the same day. If the tablet is not taken on one day, the patient should take the usual dose the next day. The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

If the patient experiences any of the following symptoms, they should contact their doctor immediately:

Septicemia* (also known as blood poisoning, a severe infection with an inflammatory response throughout the body), sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the skin (toxic epidermal necrolysis). These side effects are rare (occurring in less than 1 in 1,000 patients) or have an unknown frequency (cannot be estimated from available data), but are extremely serious, and the patient should stop taking the medicine and contact their doctor immediately.

If these symptoms are not treated, they can be fatal.

An increased incidence of septicemia has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Polsart Plus therapy.

Possible side effects of Polsart Plus:

Common (occurring in less than 1 in 10 patients):

Dizziness.

Uncommon (occurring in less than 1 in 100 patients):

Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), dry mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.

Rare (occurring in less than 1 in 1,000 patients):

Pneumonia (inflammation of the lungs), exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea, gastritis, abnormal liver function (more common in patients of Japanese origin), redness of the skin (erythema), allergic reactions, such as itching or rash, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.

Side effects reported for one of the active substances may also occur during treatment with Polsart Plus, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:

Uncommon (occurring in less than 1 in 100 patients):

Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels, slow heartbeat (bradycardia), kidney problems, including acute kidney failure, weakness, cough.

Rare (occurring in less than 1 in 1,000 patients):

Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, skin rash), low blood sugar levels (in patients with diabetes), gastritis, skin rash (dermatitis), joint degeneration, tendonitis, low hemoglobin levels (a protein in the blood), drowsiness.

Very rare (occurring in less than 1 in 10,000 patients):

Progressive scarring of the lungs (interstitial lung disease)**.

Frequency not known (cannot be estimated from available data):

Intestinal angioedema - intestinal edema with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with similar products.

*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 association with telmisartan, but a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:

Common (occurring in less than 1 in 10 patients):

Nausea, low magnesium levels in the blood.

Rare (occurring in less than 1 in 1,000 patients):

Low platelet count, which can increase the risk of bleeding or bruising (small, purple-red spots on the skin or in other tissues, caused by bleeding), high calcium levels in the blood, headache.

Very rare (occurring in less than 1 in 10,000 patients):

Increased pH (disturbed acid-base balance) due to low chloride levels in the blood.

Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data):

Salivary gland inflammation, malignant skin tumors and lip cancer (non-melanoma skin cancer), low white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), loss of appetite, restlessness, feeling of emptiness in the head, blurred vision or yellow vision, weakness of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, abnormal liver function (more common in patients of Japanese origin), redness of the skin (erythema), allergic reactions, such as itching or rash, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Polsart Plus

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, or label on the bottle after EXP. The expiry date refers to the last day of the month stated.

The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.

Aluminum/Aluminum blisters and HDPE container

No special precautions for storage are necessary.

PVC/PVDC/Aluminum blisters

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Polsart Plus contains

• The active substances of the medicine are telmisartan and hydrochlorothiazide. Each Polsart Plus 40 mg + 12.5 mg tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each Polsart Plus 80 mg + 12.5 mg tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each Polsart Plus 80 mg + 25 mg tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium carboxymethylcellulose (type A), microcrystalline cellulose, mannitol (E421).

What Polsart Plus looks like and contents of the pack

Polsart Plus 40 mg + 12.5 mg tablets are white or almost white, biconvex, oval, 6.55 x 13.6 mm in size, marked with "TH" on one side.

Polsart Plus 80 mg + 12.5 mg tablets are white or almost white, capsule-shaped, 9.0 x 17 mm in size, marked with "TH 12.5" on both sides.

Polsart Plus 80 mg + 25 mg tablets are white or almost white, biconvex, oval, 9.0 x 17 mm in size, marked with "TH" on one side and "25" on the other side.

Package sizes

Polsart Plus 40 mg + 12.5 mg

Blisters: 14, 28, 56, 84, and 98 tablets

Container: 30, 90, and 250 tablets

Polsart Plus 80 mg + 12.5 mg and Polsart Plus 80 mg + 25 mg

Blisters: 14, 28, and 56 tablets

Container: 30, 90, and 250 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Actavis Ltd.

BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Date of last revision of the leaflet:March 2025