Panoprist: detailed information

Package leaflet: Information for the patient

Panoprist, 4 mg + 1,25 mg, tablets
Perindoprilum erbuminum + Indapamidum
Please read the entire leaflet before taking the medicine, as it contains important information
for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Panoprist is and what it is used for
Important information before taking Panoprist
How to take Panoprist
Possible side effects
How to store Panoprist
Contents of the pack and other information

1. What Panoprist is and what it is used for

Panoprist is a combination of two active substances – perindopril and indapamide. The medicine is used
for the treatment of high blood pressure (hypertension).
Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.
These medicines dilate blood vessels, making it easier for the heart to pump blood throughout the body.
Indapamide is a diuretic medicine. Diuretics increase the amount of urine produced by the kidneys.
However, indapamide differs from other diuretics in that it only slightly increases urine production.
Each of the active substances helps lower blood pressure, and they are used together to achieve better blood pressure control.

2. Important information before taking Panoprist

When not to take Panoprist
if the patient has a hypersensitivity to perindopril, to another ACE inhibitor, to indapamide or other
sulphonamides, or to any of the other ingredients of this medicine (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 rash during previous treatment with an ACE inhibitor, or if such symptoms
have occurred in the patient or a relative at any time under any circumstances (this condition is called
angioedema);
if the patient has severe liver disease or hepatic encephalopathy (brain function disorders);
if the patient has severe kidney disease with reduced blood supply to the kidneys (renal artery stenosis);
if the patient is undergoing dialysis or another type of blood filtration. Depending on the device used,
Panoprist may not be suitable for the patient;
if the patient has diabetes or kidney function disorders and is taking a medicine to lower blood pressure
containing aliskiren;
if the patient has low or high potassium levels in the blood;
if the patient has untreated, uncontrolled heart failure (e.g. oedema, breathing difficulties);
if the patient is more than 3 months pregnant (in early pregnancy, it is also better not to take Panoprist – 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 medicine used to treat certain types
of chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues beneath
the skin, such as in the throat).

Warnings and precautions
Before starting treatment with Panoprist, discuss with your doctor if:
the patient has narrowing of the main blood vessel leaving the heart (aortic stenosis);
the patient has mitral valve stenosis;
the patient has heart muscle disease (hypertrophic cardiomyopathy);
the patient has narrowing of the artery supplying blood to the kidney (renal artery stenosis);
the patient has heart failure or any other heart function disorders;
the patient has kidney diseases or is undergoing dialysis;
the patient has abnormal, elevated levels of a hormone called aldosterone in the blood (primary
hyperaldosteronism);
the patient has liver function disorders;
the patient has collagenosis, such as systemic lupus erythematosus or scleroderma;
the patient has arterial atherosclerosis;
the patient has hyperparathyroidism (parathyroid gland disorders);
the patient has gout;
the patient has diabetes;
the patient is on a low-salt diet or uses salt substitutes containing potassium;
the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene) or potassium
supplements, as these should not be used together with Panoprist (see "Panoprist with other medicines");
the patient develops a severe allergic reaction with swelling of the face, mouth, tongue or throat, which may
cause difficulty in swallowing or breathing (angioedema). This reaction may occur at any time during treatment.
If such symptoms occur, treatment must be stopped and the patient should immediately contact a doctor.
the patient is taking one of the following antihypertensive medicines:

an angiotensin II receptor antagonist (medicines also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disease due to diabetes,
aliskiren. The doctor may regularly monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also information in the section "When not to take Panoprist".
the patient is undergoing haemodialysis with high-flux membranes;
the patient is taking any of the following medicines, as the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) may increase:
racecadotril (a medicine used to treat diarrhoea);
medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus and other mTOR kinase inhibitors);
vildagliptin (a medicine used to treat diabetes).
the patient is over 70 years old;
if the patient is of black race, as they may have a higher risk of angioedema and the medicine may be less effective in lowering blood pressure compared to patients of other races;
the patient is pregnant or may become pregnant. Panoprist is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may be highly harmful to the unborn child (see the section on pregnancy).

The patient should also inform their doctor or pharmacist about taking this medicine:
if the patient is to undergo general anaesthesia and/or surgery;
if the patient has recently had diarrhoea or vomiting, or is dehydrated;
if the patient has noticed increased skin sensitivity to sunlight;
if the patient has a persistent, dry cough;
if the patient has abdominal pain with nausea or vomiting (or without them); these may be symptoms of a severe allergic reaction, known as intestinal angioedema;
if the patient is to undergo dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a special device);
if the patient is scheduled for desensitisation treatment to reduce allergy symptoms to bee or wasp venom;
if the patient is scheduled for a diagnostic test requiring an iodine-containing contrast agent (a substance that makes organs such as kidneys or stomach visible in X-ray examinations);
if the patient develops visual impairment or pain in one or both eyes while taking this medicine. These may be symptoms of fluid accumulation in the vascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – they may occur from several hours to weeks after taking Panoprist, and if untreated, may lead to permanent vision loss. The risk of such disorders may be higher in patients who previously had hypersensitivity to penicillin or sulphonamides. The medicine should be discontinued and medical advice sought immediately.

Children and adolescents
This medicine must not be used in children and adolescents.

Panoprist with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Avoid taking this medicine with:
lithium (used to treat depression),
potassium supplements (including salt substitutes),
potassium-sparing diuretics (such as eplerenone, spironolactone, triamterene, amiloride),
other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole
[also known as trimethoprim with sulfamethoxazole], used for bacterial infections, cyclosporine [an immunosuppressive medicine used to prevent organ transplant rejection], and heparin [a medicine used to thin the blood to prevent clots]),
estramustine (used in cancer treatment).

Before taking Panoprist, consult your doctor, especially if the patient is taking any of the following medicines:
other medicines used to treat hypertension;
If the patient is taking an angiotensin II receptor antagonist or aliskiren (the doctor may adjust the dose and/or recommend additional precautions; see also information in sections "When not to take Panoprist" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys);
medicines used to treat heart rhythm disorders (e.g. procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difeminal);
potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
sacubitril with valsartan (used in the treatment of chronic heart failure). See sections "When not to take Panoprist" and "Warnings and precautions".
antihistamines used to treat hay fever or allergies, e.g. terfenadine, astemizole, mizolastine;
bepridil (a medicine used to treat angina pectoris);
benzamides (medicines used to treat psychotic disorders, e.g. sulpiride);
butyrophenones (medicines used to treat psychotic disorders, e.g. haloperidol);
anaesthetics;
iodine-containing contrast agents;
cisapride (a medicine used to treat gastrointestinal disorders);
intravenous erythromycin (an antibiotic);
moxifloxacin or sparfloxacin (antibiotics);
methadone (a medicine used to treat addiction);
allopurinol (a medicine used to treat gout);
corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
immunosuppressive medicines used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
anticancer medicines;
halofantrine (a medicine used to treat malaria);
pentamidine (a medicine used to treat pneumonia);
vinpocetine (a medicine used to treat cognitive disorders in elderly patients);
baclofen (a medicine used to treat muscle stiffness in conditions such as multiple sclerosis);
antidiabetic medicines, such as insulin, metformin, glimepiride, vildagliptin and other gliptins;
calcium, including calcium supplements;
stimulant laxatives (e.g. senna);
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid);
intravenous amphotericin B (a medicine used to treat severe fungal infections);
medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
tetracosactide (a medicine used to treat Crohn's disease);
gold preparations (sodium aurothiomalate) administered by injection (used to treat rheumatic diseases);
vasodilators, including nitrates;
medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline);
medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other mTOR kinase inhibitors). See section "Warnings and precautions".
If in doubt about what any of the listed medicines are, consult your doctor.

Panoprist with food and drink
Exercise particular caution if the patient is on a low-salt diet. Consult your doctor before taking the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
It is essential to inform the doctor if the patient is pregnant or may become pregnant.
Doctors usually recommend discontinuing Panoprist before pregnancy or as soon as pregnancy is confirmed, and prescribe an alternative medicine. Panoprist is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may be highly harmful to the unborn child.
Breastfeeding
Panoprist must not be used during breastfeeding.
If a woman is breastfeeding or plans to start breastfeeding, she should immediately inform her doctor.

Driving and operating machinery
The medicine does not affect concentration, but may cause dizziness or weakness due to lowered blood pressure, especially at the beginning of treatment or during dose escalation. In such cases, the ability to drive or operate machinery may be impaired.

Panoprist contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Panoprist

Panoprist should always be taken as directed by the physician. If in doubt, consult a 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 once daily.
Elderly patients
The appropriate dose will be determined by the doctor.
Patients with renal impairment
The doctor may decide to adjust the dosing regimen.
Use in children and adolescents
Panoprist must not be used in children and adolescents (see "Warnings and precautions").
Taking more Panoprist than recommended
If a patient takes too many tablets, they should go immediately to the nearest hospital or contact a doctor without delay. The most likely consequence of overdose is low blood pressure. If blood pressure drops significantly (symptoms include dizziness or fainting), lying down with legs elevated may be helpful.
Missed dose of Panoprist
It is important to take the medicine every day, as regular treatment is more effective. If a dose has been missed, the patient should take it as soon as they remember, then return to the normal dosing schedule. A double dose must not be taken to make up for a missed dose.
Stopping Panoprist
If a patient intends to stop taking the medicine, they should always consult their doctor. Continuing treatment may be necessary even if feeling well.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the adverse effects listed below, they should
STOP taking the tablets and contact a doctor immediately.
These are symptoms of a severe allergic reaction and must be treated immediately, usually
in a hospital setting.

swelling of the face, eyes, lips, mouth, tongue or throat, which may cause difficulty in
swallowing or breathing (angioedema); see "Warnings and precautions" in section 2;
(not common – may occur in less than 1 in 100 people taking the medicine);
chest tightness, wheezing and shortness of breath (bronchospasm) (not common – may
occur in less than 1 in 100 people taking the medicine);
severe dizziness or fainting due to low blood pressure (hypotension) (common – may occur
in less than 1 in 10 people taking the medicine);
severe skin reactions, including erythema multiforme (a skin rash often starting with red,
itchy spots on the face, arms or legs), severe skin rash, urticaria, redness of the entire skin,
intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions (very rare – may occur in less than 1 in 10,000 people taking the medicine).

Contact a doctor immediately if any of the following adverse effects occur:
(may occur in less than 1 in 1,000 people taking the medicine):

kidney function disorders with significantly reduced or no urine output, which may be accompanied by fever, nausea, fatigue, flank pain, swelling of legs, ankles, feet, face and hands, or blood in urine (acute kidney failure);
dark-coloured urine, nausea or vomiting, muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

Very rare (may occur in less than 1 in 10,000 people taking the medicine):

fast or irregular heartbeat
chest pain
heart attack
weakness of arms or legs, or difficulty speaking, which may be signs of stroke
pancreatitis, which may cause severe abdominal and back pain with very poor general condition
yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation

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

life-threatening irregular heartbeat
brain disease caused by liver disease (hepatic encephalopathy)
sudden onset of short-sightedness
visual impairment or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular membrane surrounding the eye — excessive fluid buildup between choroid and sclera — or acute angle-closure glaucoma)

Other adverse effects:

Common (may occur in less than 1 in 10 people taking the medicine)

constipation
nausea
vomiting
feeling of discomfort in the upper abdomen after meals (dyspepsia)
abdominal pain
diarrhoea
taste disturbances
dry cough
breathing difficulties
visual disturbances
ringing or buzzing in the ears
muscle cramps
feeling of weakness (asthenia)
headache
dizziness
sensation of tingling, itching or prickling without visible cause (paresthesia)
dizziness
skin reactions (rash, including nodular rash, itching)
changes in laboratory blood test parameters: low blood potassium concentration

Uncommon (may occur in less than 1 in 100 people taking the medicine)

purple spots on the skin (purpura)
clusters of blisters
itchy skin rash (urticaria)
mood disturbances and/or sleep disorders
depression
kidney function disorders
impotence (inability to achieve or maintain erection)
excessive sweating
increased number of eosinophils (a type of white blood cells)
changes in laboratory test parameters: high blood potassium concentration, which resolves after discontinuation of treatment, low blood sodium concentration, which may cause dehydration and low blood pressure
drowsiness
fainting
awareness of heartbeat (palpitations)
rapid heartbeat (tachycardia)
very low blood sugar (hypoglycaemia) in diabetic patients
inflammation of blood vessels
dry mouth
increased sensitivity of the skin to sunlight (photosensitivity reactions)
joint pain
muscle pain
chest pain
malaise
peripheral oedema
fever
increased blood urea concentration
increased blood creatinine concentration
falls

Rare (may occur in less than 1 in 1,000 people taking the medicine)

fatigue
worsening of psoriasis
changes in laboratory test parameters: increased liver enzyme activity, high serum bilirubin concentration, low blood chloride concentration, low blood magnesium concentration
reduced or absent urine output
sudden redness of the face and neck

Very rare (may occur in less than 1 in 10,000 people taking the medicine)

reduced platelet count
reduced white blood cell count, increasing the likelihood of infections
reduced red blood cell count, which may cause pale skin, weakness or shortness of breath (aplastic anaemia, haemolytic anaemia)
reduced haemoglobin concentration
eosinophilic pneumonia (a rare type of lung inflammation)
nasal congestion or watery nasal discharge
confusion
high blood calcium concentration
abnormal liver function

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

abnormal heart function detected on ECG
changes in blood laboratory test parameters: high blood uric acid concentration, high blood glucose concentration
blurred vision
bluish discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon)
if the patient has systemic lupus erythematosus (a type of collagenosis), symptoms of the disease may worsen

Blood, kidney, liver or pancreas disorders may occur, as well as changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Panoprist

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the stated month.
Blister packs made of Aluminium/Aluminium foil
Do not store above 30 °C.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 silicified, colloidal anhydrous silica, colloidal hydrated silica, and magnesium stearate.

What Panoprist looks like and contents of the pack
Panoprist tablets are white, oblong, biconvex, with an embossed "PI" symbol on one side.
The tablets are packed in aluminium/aluminium foil blisters and placed in a cardboard box.
Pack sizes contain 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
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, Poland
Lek Pharmaceuticals, d.d.
Trimlini 2D
9220 Lendava, Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Perindopril/Indapamide Sandoz 4 mg/1.25 mg tabletten
Finland: Perindopril/Indapamid Sandoz 4 mg / 1.25 mg tabletti
France: PERINDOPRIL/INDAPAMIDE SANDOZ 4 mg/1.25 mg, comprimé
Netherlands: Perindopril tert-butylamine/Indapamide Sandoz 4/1.25 mg, tabletten
Poland: PANOPRIST
Portugal: Perindopril + Indapamida Sandoz
Romania: PANINDORIL 4 mg/1.25 mg comprimate
Slovenia: Voxin Combo 4 mg/1.25 mg tablete
Slovakia: PERINDASAN 4 mg/1.25 mg tablety
Spain: Perindopril Indapamida Sandoz 4 mg/1.25 mg comprimidos EFG

(logo of the Marketing Authorisation Holder)