Polsart plus

Package leaflet: Information for the patient

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
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Polsart Plus is and what it is 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. Contents of the pack and other information

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

Polsart Plus is a combination medicine containing two active substances, telmisartan and hydrochlorothiazide, in a single 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, which increase urine production, leading 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 or kidney failure, stroke, or vision loss. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to regularly monitor blood pressure to ensure it remains within normal limits.
Polsart Plus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan or hydrochlorothiazide taken alone.

2. Important information before using Polsart Plus

When not to use 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;
• during the third trimester of pregnancy (Polsart Plus 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 gallbladder), or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor has diagnosed persistently low blood potassium levels or high blood calcium levels that do not improve with treatment;
• if the patient has diabetes or kidney dysfunction 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 Polsart Plus.
Warnings and precautions
Before starting treatment with Polsart Plus, discuss with your doctor or pharmacist if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), particularly if the patient is dehydrated (excessive fluid loss from the body) or has sodium deficiency 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 problems;
• diabetes;
• gout;
• elevated 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 itself);
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Polsart Plus, protect the skin from sunlight and UV radiation.
• if the patient experiences vision disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Polsart Plus. Without treatment, these symptoms may lead to complete vision loss. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at increased risk of developing these symptoms.
• 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 Polsart Plus, seek immediate medical help.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Polsart Plus,
discuss this with the doctor. The doctor will decide whether to continue treatment. Do not independently
decide to stop taking Polsart Plus.
Before starting Polsart Plus, discuss with the doctor:

• if the patient is taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney impairment related to diabetes;
  • aliskiren;
• if the patient is taking digoxin.

The treating physician 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 Polsart Plus".
Inform your doctor if you suspect (or are planning) pregnancy. Use of Polsart Plus is not recommended
during early pregnancy. Do not take Polsart Plus after the third month of pregnancy, as it may seriously harm 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 (faster than 100 beats
per minute). If any of these symptoms occur, inform your doctor.
Also inform your doctor if you experience increased skin sensitivity to sunlight,
manifesting as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.
If undergoing surgery or anaesthesia, inform the doctor that you are 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
Tell your 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,
it may be necessary to discontinue one of the medicines. This particularly applies to concomitant use of the following medicines with Polsart Plus:

• lithium products, used to treat certain types of depression;
• medicines that may reduce blood potassium levels (hypokalaemia), such as: other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisolone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium salt of penicillin G (antibiotic), salicylic acid and its derivatives;
• medicines that may increase blood potassium levels, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (immunosuppressant), and other medicinal products such as sodium heparin (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 to treat 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 in diabetes (insulin or oral medicines such as metformin);
• cholestyramine and colestipol, lipid-lowering medicines;
• medicines that raise blood pressure, such as noradrenaline;
• muscle relaxants such as tubocurarine;
• calcium supplements and/or vitamin D;
• 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 infections);
• other medicines used to treat hypertension, 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 information under the headings "When not to use 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 may potentially reduce blood pressure (e.g. baclofen,
amifostine). In addition, low blood pressure may be further reduced by: alcohol, barbiturates,
narcotics, or antidepressants. The patient may experience this as dizziness when standing up. Consult your doctor if dose adjustment of another medicine is needed while taking Polsart Plus.
The effect of Polsart Plus may be weakened by concomitant use of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).
Taking Polsart Plus with food and alcohol
Polsart Plus can be taken with or without food.
Avoid alcohol until you have spoken with your doctor. Alcohol may additionally lower blood
pressure and/or increase the risk of dizziness or fainting.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Usually, the doctor will advise stopping Polsart Plus before planned pregnancy or immediately
after pregnancy is confirmed and will recommend an alternative medicine. Use of Polsart Plus
is not recommended during pregnancy. Do not use Polsart Plus after the third month of pregnancy, as
it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Polsart Plus is not recommended
during breastfeeding. The doctor may choose an alternative treatment during breastfeeding.
Effect on fertility
Preclinical studies did not show any effect of telmisartan and hydrochlorothiazide
on fertility in men and women.
Driving and operating machinery
Some patients taking Polsart Plus may experience dizziness or fatigue. In such cases,
do not drive or operate machinery.
Polsart Plus contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Polsart Plus

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose of Polsart Plus is one tablet daily. Try to take the tablet at the same time each
day. Polsart Plus may be taken with or between meals. Swallow the tablets with water or a non-alcoholic
drink. It is important to take Polsart Plus every day unless otherwise instructed by your doctor.
If the patient has impaired liver function, the usual dose should not exceed 40 mg telmisartan and 12.5 mg
hydrochlorothiazide per day.
Taking more Polsart Plus than recommended
If too many tablets are taken by mistake, 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, and muscle cramps and/or
irregular heartbeat, especially when taking other medicines such as digitalis glycosides and certain
antiarrhythmic drugs. Seek immediate medical advice from your doctor or pharmacist, or go to the nearest
hospital emergency department.
If you miss a dose of Polsart Plus
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 not taken one 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 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* (commonly known as blood poisoning), a severe infection causing systemic inflammatory response, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of skin (toxic epidermal necrolysis).
The above adverse reactions are rare (occur in fewer than 1 in 1,000 patients) or occur with unknown frequency (in the case of toxic epidermal necrolysis), but are extremely serious. In such cases, the medicine must be discontinued immediately and medical advice sought without delay.
If left untreated, these symptoms may lead to death.
An increased incidence of sepsis has been observed in individuals taking telmisartan as monotherapy; however, it cannot be excluded in patients treated with Polsart Plus.

Possible adverse reactions of Polsart Plus:
Common (occur in fewer than 1 in 10 patients):
Dizziness.

Uncommon (occur in fewer than 1 in 100 patients):
Decreased potassium levels in blood, anxiety, fainting, tingling and numbness (paresthesia), vertigo, rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnea), diarrhea, dryness of mucous membranes in the mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.

Rare (occur in fewer than 1 in 1,000 patients):
Lung inflammation (bronchitis), onset or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea, inflammation of the gastric mucosa, liver function abnormalities (more frequent in patients of Japanese origin), skin redness (flushing), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, influenza-like symptoms, pain, decreased sodium levels, increased creatinine levels, increased liver enzyme activity or increased creatine phosphokinase in blood.

Adverse reactions reported for one of the components may also occur during treatment with Polsart Plus, even if they were not observed during clinical trials of the product.

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been observed:

Uncommon (occur in fewer 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), increased potassium levels, slow heart rate (bradycardia), kidney function impairment, including acute renal failure, fatigue, cough.

Rare (occur in fewer than 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), decreased blood glucose levels (in patients with diabetes), gastritis, rash (skin disorder), osteoarthritis, tendonitis, decreased hemoglobin levels (blood protein), somnolence.

Very rare (occur in fewer than 1 in 10,000 patients):
Progressive fibrosis of lung alveoli (interstitial lung disease)**.

Frequency not known (frequency cannot be determined from available data):
Intestinal angioedema – after administration of similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

*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 (occur in fewer than 1 in 10 patients):
Nausea, decreased magnesium levels in blood.

Rare (occur in fewer than 1 in 1,000 patients):
Decreased platelet count, leading to increased risk of bleeding or bruising (small purple-red skin lesions or in other tissues caused by bleeding), increased calcium levels in blood, headache.

Very rare (occur in fewer than 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to decreased chloride levels in blood.
Acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion).

Frequency not known (frequency cannot be determined from available data):
Sialadenitis, skin and lip malignancies (non-melanoma skin cancers), reduced number (or complete 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, feeling of emptiness in the head, blurred vision or yellow vision, visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disease resembling systemic lupus erythematosus in which the body is attacked by its own immune system), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney inflammation or impaired kidney function, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, increased blood cholesterol levels, decreased blood volume, increased glucose levels, difficulty controlling blood/urine glucose levels or blood lipid levels in patients with diagnosed diabetes.

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 Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting adverse reactions helps increase the knowledge about the safety of this medicine.

5. How to store Polsart Plus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister
or label on the bottle following EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Aluminium/Aluminium foil blisters and HD7PE container
No special storage conditions required.
PVC/PVDC/Aluminium foil blisters
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Polsart Plus Contains

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

What Polsart Plus Looks Like and Contents of the Pack
Polsart Plus tablets, 40 mg + 12.5 mg are white or almost white, biconvex, oval-shaped,
measuring 6.55 x 13.6 mm, marked with "TH" on one side.
Polsart Plus tablets, 80 mg + 12.5 mg are white or almost white, capsule-shaped,
measuring 9.0 x 17 mm, marked with "TH 12.5" on both sides.
Polsart Plus tablets, 80 mg + 25 mg are white or almost white, biconvex, oval-shaped,
measuring 9.0 x 17 mm, marked with "TH" on one side and "25" on the other side.
Pack sizes
Polsart Plus, 40 mg + 12.5 mg
Blister packs: 14, 28, 56, 84 and 98 tablets
Bottle: 30, 90 and 250 tablets
Polsart Plus, 80 mg + 12.5 mg and Polsart Plus, 80 mg + 25 mg
Blister packs: 14, 28 and 56 tablets
Bottle: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne 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
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański