Panoprist

Package Leaflet: Information for the Patient

Panoprist, 4 mg + 1.25 mg, Tablets

Perindopril Erbumine + Indapamide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you; do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What is Panoprist and what is it used for

Panoprist is a combination of two active substances, perindopril and indapamide. The medication is used
to treat high blood pressure (hypertension).
Perindopril belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors).
These medications dilate blood vessels, making it easier for the heart to pump blood throughout the body.
Indapamide is a diuretic medication. These medications increase the amount of urine produced by the kidneys.
However, indapamide differs from other diuretic medications, as it only slightly increases urine production.
Each active substance lowers blood pressure, and they are used together to achieve blood pressure control.

2. Important information before taking Panoprist

When Not to Take Panoprist

if the patient is allergicto perindopril, another ACE inhibitor, indapamide, or any other component of this medication (listed in section 6 and at the end of section 2);
if the patient has experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or severe skin rashwhile taking an ACE inhibitor or if the patient or their relative has ever experienced such symptoms in any circumstances (a condition known as angioedema);
if the patient has severe liver diseaseor hepatic encephalopathy(liver dysfunction);
if the patient has severe kidney diseasewith reduced blood flow to the kidneys (renal artery stenosis);
if the patient is undergoing dialysisor another type of blood filtration. Depending on the device used, Panoprist may not be suitable for the patient;
if the patient has diabetesor kidney dysfunctionand is taking a medication to lower blood pressure that contains aliskiren;
if the patient has high or low potassium levels in the blood;
if the patient has uncontrolled or untreated heart failure(edema, difficulty breathing);
if the patient is pregnant for more than 3 months(it is also recommended not to take Panoprist during early pregnancy - see the section on pregnancy);
if the patient is breastfeeding(see the section on breastfeeding);
if the patient has taken or is currently taking sacubitril with valsartan, a medication used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and Precautions

Beforestarting to take Panoprist, the patient should discuss the following with their doctor:
if the patient has narrowing of the main blood vesselleaving the heart (aortic stenosis);
if the patient has narrowing of the mitral valve;
if the patient has heart muscle disease(hypertrophic cardiomyopathy);
if the patient has renal artery stenosis(narrowing of the blood vessel supplying the kidney);
if the patient has heart failureor any other heart function disorders;
if the patient has kidney diseaseor is undergoing dialysis;
if the patient has abnormal, elevated levels of a hormone called aldosteronein the blood (primary hyperaldosteronism);
if the patient has liver function disorders;
if the patient has collagenosis, such as systemic lupus erythematosus or scleroderma;
if the patient has atherosclerosis;
if the patient has hyperparathyroidism(parathyroid gland dysfunction);
if the patient has gout;
if the patient has diabetes;
if the patient is on a low-salt dietor is taking salt substitutescontaining potassium;
if the patient is taking lithiumor potassium-sparing diuretics(spironolactone, triamterene) or potassium supplements, as concurrent use with Panoprist should be avoided (see "Panoprist and other medications");
if the patient experiences severe allergic reactionswith facial, oral, or throat swelling, which can cause difficulty swallowing or breathing (angioedema). This side effect can occur at any time during treatment. If the patient experiences such symptoms, they should discontinue treatment and immediatelyconsult their doctor;
if the patient is taking one of the following antihypertensive medications:

• angiotensin II receptor antagonist (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease,
• aliskiren. The doctor may regularly monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information in the "When Not to Take Panoprist" section. The patient is undergoing hemodialysisusing high-flux membranes; the patient is taking any of the following medications, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) may increase:
• racecadotril (a medication used to treat diarrhea);
• medications used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus, and other mTOR kinase inhibitors);
• wildagliptin (a medication used to treat diabetes). The patient is over 70 years old; if the patient is black, as they may be at higher risk of angioedema, and the medication may be less effective in lowering blood pressure than in patients of other races; the patient is pregnant or may become pregnant. Panoprist is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it can be very harmful to the fetus (see the section on pregnancy).

The patient should also inform their doctor or pharmacist if they:
are to undergo general anesthesiaand/or surgery;
have recently had diarrheaor vomiting, or are dehydrated;
have noticed increased sensitivity of the skin to sunlight;
have a persistent, dry cough;
have abdominal pain with nausea or vomiting (or without them); these may be symptoms of a severe allergic reaction, known as angioedema of the intestine;
are to undergo dialysisor LDL apheresis(a procedure that removes cholesterol from the blood using a special device);
are to undergo desensitization treatmentto reduce allergy symptoms to bee or wasp stings;
are to undergo a test that requires the administration of a contrast agent containing iodine(a substance that makes organs such as the kidneys or stomach visible on X-rays);
experience 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 intraocular pressure — they can occur within a few hours to weeks after taking Panoprist and, if left untreated, can lead to permanent vision loss. The risk of developing such disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides. The patient should discontinue treatment and consult their doctor.

Children and Adolescents

The medication should not be used in children and adolescents.

Panoprist and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should avoidtaking this medication with:
lithium(used to treat depression),
potassium supplements(including salt substitutes),
potassium-sparing diuretics(such as eplerenone, spironolactone, triamterene, amiloride),
other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole [also known as trimethoprim with sulfamethoxazole], used to treat bacterial infections, cyclosporine [an immunosuppressive medication used to prevent transplant rejection], and heparin [a medication used to thin the blood and prevent clots]),
estramustine(used to treat cancer).
Before takingPanoprist, the patient should consult their doctor, especially if they are taking any of the following medications:
other medications used to treat high blood pressure;
if the patient is taking an angiotensin II receptor antagonist or aliskiren (the doctor may change the dose of the medication and/or recommend other precautions; see also the information in the "When Not to Take Panoprist" and "Warnings and Precautions" sections) or diuretics (medications that increase urine production in the kidneys);
medications used to treat heart rhythm disorders(e.g., procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difemanyl);
potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
sacubitril with valsartan(used to treat chronic heart failure). See the sections "When Not to Take Panoprist" and "Warnings and Precautions".
antihistamine medications used to treat allergic rhinitisor allergies, e.g., terfenadine, astemizole, mizolastine;
bepridil(a medication used to treat angina pectoris);
benzamides(medications used to treat psychotic disorders, e.g., sultopride);
butyrophenones(medications used to treat psychotic disorders, e.g., haloperidol);
anesthetics;
iodine-containing contrast agents;
cisapride(a medication used to treat gastrointestinal and digestive disorders);
erythromycinadministered intravenously (an antibiotic);
moxifloxacinor sparfloxacin(antibiotics);
methadone(a medication used to treat addiction);
allopurinol(a medication used to treat gout);
corticosteroidsused to treat various diseases, including severe asthma and rheumatoid arthritis;
immunosuppressive medicationsused to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
anticancer medications;
halofantrine(a medication used to treat malaria);
pentamidine(a medication used to treat pneumonia);
vincamine(a medication used to treat cognitive disorders in the elderly);
baclofen(a medication used to treat muscle stiffness in conditions such as multiple sclerosis);
antidiabetic medications, such as insulin, metformin, glimepiride, wildagliptin, and other gliptins;
calcium, including calcium supplements;
laxativeswith a stimulating effect (e.g., senna);
nonsteroidal anti-inflammatory medications (NSAIDs), medications used to treat pain(e.g., ibuprofen), or high doses of salicylates (e.g., acetylsalicylic acid);
amphotericin Badministered intravenously (a medication used to treat severe fungal infections);
medications used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics);
tetracosactide(a medication used to treat Crohn's disease);
gold preparations(sodium aurothiomalate) administered by injection (a medication used to treat rheumatic diseases);
vasodilators, including nitrates;
medications used to treat low blood pressure, shock, or asthma(e.g., ephedrine, norepinephrine, or epinephrine);
medications commonly used to treat diarrhea ( racecadotril) or to prevent transplant rejection ( sirolimus, everolimus, temsirolimus, and other mTOR kinase inhibitors). See the "Warnings and Precautions" section.
In case of doubt about the medications listed, the patient should consult their doctor.

Panoprist with Food and Drink

The patient should exercise special caution if they are on a low-salt diet. Before taking the medication, they should consult their doctor.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
The patient must inform their doctor if they are pregnant or may become pregnant.
Usually, the doctor recommends stopping Panoprist before the patient becomes pregnant or as soon as possible after pregnancy is confirmed, and offers an alternative medication instead. Taking Panoprist is not recommended during early pregnancy and is contraindicated after the third month of pregnancy. Taking the medication during this period can be very harmful to the fetus.
Breastfeeding
Panoprist should not be taken during breastfeeding.
If the patient is breastfeeding or plans to start breastfeeding, they should immediately inform their doctor.

Driving and Operating Machines

The medication does not affect concentration, but it can cause dizziness or weakness due to decreased blood pressure, especially at the beginning of treatment or when increasing the dose. In such cases, the ability to drive vehicles and operate machines may be impaired.

Panoprist Contains Lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medication.

3. How to Take Panoprist

Panoprist should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be taken in the morning, before a meal, with a glass of water.

Adults

The recommended dose is one tablet per day.

Elderly Patients

The doctor will determine the appropriate dose.

Patients with Kidney Function Disorders

The doctor may decide to change the dosing regimen.

Use in Children and Adolescents

The medication should not be used in children and adolescents (see "Warnings and Precautions").

Overdose of Panoprist

If the patient takes too many tablets, they should go to the nearest hospital or immediately consult their doctor. The most likely consequence of overdosing is low blood pressure. In case of significant blood pressure decrease (symptoms are dizziness or fainting), it may be helpful to lie down with elevated legs.

Missed Dose of Panoprist

It is essential to take the medication every day, as regular treatment is more effective. However, if the patient forgets to take one or more doses, they should take it as soon as they remember, and then return to their normal dosing schedule. The patient should not take a double dose of the medication to make up for the missed dose.

Stopping Panoprist Treatment

If the patient intends to stop taking the medication, they should always consult their doctor. Continued treatment may be necessary even if the patient feels well.
In case of any further doubts about taking the medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Panoprist can cause side effects, although not everyone will experience them.

If the Patient Experiences Any of the Following Side Effects, They Should

STOP Taking the Tablets and Immediately Consult Their Doctor.

These are symptoms of a severe allergic reactionand must be treated immediately, usually in a hospital setting.
swelling of the face, eyes, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema), see "Warnings and Precautions" in section 2. (uncommon - may occur in less than 1 in 100 people taking the medication);
chest tightness, wheezing, and shortness of breath (bronchospasm) (uncommon - may occur in less than 1 in 100 people taking the medication);
severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 people taking the medication)
severe skin reactions, including erythema multiforme (a skin rash often starting with red, itchy patches on the face, arms, or legs) or severe skin rash, urticaria, skin redness, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 people taking the medication).
The patient should immediately consult their doctorif they experience any of the following side effects:
(may occur in less than 1 in 1,000 people taking the medication):
kidney function disorders with significantly reduced or absent urine production, which may be accompanied by fever, nausea, fatigue, side pain, swelling of the legs, ankles, feet, face, and hands, or blood in the urine (acute kidney failure).
dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).
Very rare(may occur in less than 1 in 10,000 people taking the medication):
rapid or irregular heartbeat
chest pain
heart attack
weakness or difficulty moving the arms or legs, or difficulty speaking, which may be symptoms of a stroke
pancreatitis, which can cause severe abdominal and back pain with very poor general condition
yellowing of the skin or eyes (jaundice), which may be a symptom of liver inflammation
Frequency not known(frequency cannot be estimated from the available data):
life-threatening irregular heartbeat
brain disease caused by liver disease (hepatic encephalopathy)
sudden vision loss
eye pain or vision loss 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 angle-closure glaucoma)
Other side effects:
Common(may occur in less than 1 in 10 people taking the medication)
constipation
nausea
vomiting
discomfort in the upper abdomen after eating (dyspepsia)
abdominal pain
diarrhea
taste disorders
dry cough
breathing difficulties
vision disorders
ringing or buzzing in the ears
muscle cramps
feeling of weakness (asthenia)
headache
dizziness
tingling, itching, or numbness without apparent cause (paresthesia)
dizziness
skin reactions (rash, including papular, pruritus)
changes in laboratory test results: low potassium levels in the blood
Uncommon(may occur in less than 1 in 100 people taking the medication)
purple spots on the skin (purpura)
blistering
itchy skin rash (urticaria)
mood or sleep disorders
depression
kidney function disorders
impotence (inability to achieve or maintain an erection)
excessive sweating
increased eosinophil count (a type of white blood cell)
changes in laboratory test results: high potassium levels in the blood, which may be temporary and resolve after treatment discontinuation, low sodium levels in the blood, which may cause dehydration and low blood pressure
drowsiness
fainting
awareness of heartbeats (palpitations)
rapid heartbeat (tachycardia)
low blood sugar levels (hypoglycemia) in patients with diabetes
vasculitis
dry mouth
increased sensitivity of the skin to sunlight (photosensitivity reactions)
joint pain
muscle pain
chest pain
malaise
peripheral edema
fever
increased urea levels in the blood
increased creatinine levels in the blood
falls
Rare(may occur in less than 1 in 1,000 people taking the medication)
fatigue
exacerbation of psoriasis
changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood, low chloride levels in the blood, low magnesium levels in the blood
reduced or absent urine production
sudden redness of the face and neck
Very rare(may occur in less than 1 in 10,000 people taking the medication)
decreased platelet count
decreased white blood cell count, which increases the risk of infections
decreased red blood cell count, which can cause pale skin and weakness or shortness of breath (aplastic anemia, hemolytic anemia)
decreased hemoglobin levels
eosinophilic pneumonia (a rare type of pneumonia)
nasal congestion or runny nose
confusion
high calcium levels in the blood
abnormal liver function
Frequency not known(frequency cannot be estimated from the available data)
life-threatening irregular heartbeat
abnormal heart function detectable on an electrocardiogram (ECG)
changes in laboratory test results: high uric acid levels, high blood sugar levels
blurred vision
blue discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon)
if the patient has systemic lupus erythematosus (a type of collagenosis), the symptoms of the disease may worsen.
There may be blood disorders, kidney, liver, or pancreas disorders, as well as changes in laboratory test results. The doctor may recommend blood tests to monitor the patient's health.
Reporting side effects
If side effects occur, including those not listed in the package leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
Phone: +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.
Reporting side effects helps collect more information on the safety of the medication.

5. How to Store Panoprist

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after EXP.
The expiration date refers to the last day of the month stated.
Aluminum/Aluminum blisters
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Panoprist Contains

The active substances are perindopril erbumine and indapamide. Each tablet contains 4.00 mg of perindopril erbumine (equivalent to 3.338 mg of perindopril) and 1.25 mg of indapamide.
The other ingredients are hydroxypropylbetadex, lactose monohydrate, povidone K25, microcrystalline cellulose, silicon dioxide, colloidal anhydrous silica, and magnesium stearate.

What Panoprist Looks Like and Contents of the Package

Panoprist tablets are white, oval, biconvex, with the symbol "PI" embossed on one side.
The tablets are packaged in Aluminum/Aluminum blisters and placed in a cardboard box.
The packages contain 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Salutas Pharma GmbH
Dieselstrasse 5
70839 Gerlingen, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals, d.d.
Trimlini 2D
9220 Lendava
Slovenia

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Belgium:
Perindopril/Indapamide Sandoz 4 mg/1,25 mg tablets
Finland:
Perindopril/Indapamid Sandoz 4 mg / 1,25 mg tablets
France:
PERINDOPRIL/INDAPAMIDE SANDOZ 4 mg/1,25 mg, comprimé
Netherlands:
Perindopril tert-butylamine/Indapamide Sandoz 4/1,25 mg, tablets
Poland:
PANOPRIST
Portugal:
Perindopril + Indapamida Sandoz
Romania:
PANINDORIL 4 mg/1,25 mg comprimate
Slovenia:
Voxin Combo 4 mg/1.25 mg tablets
Slovakia:
PERINDASAN 4 mg/1,25 mg tablets
Spain:
Perindopril Indapamida Sandoz 4 mg/1.25 mg comprimidos EFG
Date of Approval of the Package Leaflet:03/2022
(logo of the marketing authorization holder)