Patient Information Leaflet

PRESSURAL 2.5 mg coated tablets

Indapamide hemihydrate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pressural is and what it is used for
What you need to know before taking Pressural
How to take Pressural
Possible side effects
How to store Pressural
Contents of the pack and other information

1. What PRESSURAL is and what it is used for

Pressural contains the active substance indapamide (as indapamide hemihydrate), which belongs to a group of
medicines called diuretics. These work by increasing the amount of urine produced by the kidneys, thereby lowering
blood pressure.
Pressural is indicated for the treatment of high blood pressure (arterial hypertension).
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking PRESSURAL

Do not take PRESSURAL

if you are allergic to indapamide or to other similar medicines (sulfonamide-derived drugs) or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from severe liver disease (hepatic encephalopathy or severe impairment of liver function);
if you suffer from severe kidney problems (severe renal failure) or if you have significantly reduced urge to urinate (anuria);
if you have low levels of potassium in your blood (hypokalaemia);
if you have recently experienced a cerebrovascular event (stroke or similar);
if you have a tumour called "pheochromocytoma";
if you have Conn’s syndrome (a condition caused by excessive production of the hormone aldosterone by the adrenal gland).
If you are in any of the conditions listed above, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pressural.
If you suffer from liver problems (impaired liver function), you may develop a disorder called hepatic encephalopathy, characterized by mental confusion and drowsiness, especially if blood electrolyte levels (sodium, potassium) are imbalanced. Immediately stop treatment with this medicine if you experience these symptoms.
Stop taking this medicine if you develop skin irritation associated with itching in areas exposed to sunlight (photosensitivity reactions). If treatment must be resumed, protect the affected areas from light exposure.
If you experience visual disturbances or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure. These may occur from a few hours to several weeks after starting Pressural. If left untreated, this may lead to permanent vision loss. Your risk of this reaction is higher if you have previously had an allergy to penicillin or sulfonamides.

Be especially careful and inform your doctor:

if you have high levels of uric acid in your blood (hyperuricaemia) and are prone to joint inflammation (gout);
if you are elderly and have kidney problems (persistent renal impairment).

During treatment with this medicine, your doctor may periodically request blood tests to monitor levels of:

sodium, both before starting and during treatment. These checks should be even more frequent if you are elderly or suffer from liver problems (cirrhosis);
potassium, especially if you are elderly or malnourished, suffer from liver disease (cirrhosis with oedema and ascites), heart problems (heart failure, coronary artery disease, prolonged QT interval). The first check should be performed during the first week of treatment. If potassium levels drop (hypokalaemia), dose adjustment may be necessary;
glucose (blood sugar), particularly if you have diabetes or low potassium levels (hypokalaemia);
calcium, because increased calcium levels (hypercalcaemia) may indicate altered parathyroid gland function (hyperparathyroidism). Discontinue treatment before assessing parathyroid function;
uric acid, as gout attacks may increase.

The effect of Pressural may be enhanced if you have undergone surgery (sympathectomy).
For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Pressural must not be given to children and adolescents under 18 years of age, as safety and efficacy have not been established in this patient group.
Other medicines and PRESSURAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be particularly careful and inform your doctor if you are taking:

lithium-containing medicines, used to treat depression. Concomitant use, if necessary, requires monitoring of lithium blood levels and dose adjustment;
non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain, especially if you are dehydrated;
other medicines used to treat high blood pressure, such as ACE inhibitors, particularly if you have low sodium levels;
baclofen, used to treat muscle disorders. Increase fluid intake and monitor kidney function before starting treatment;
digitalis medicines, used to treat heart rhythm disorders;
amphotericin B (if administered intravenously), used to treat fungal infections;
systemic glucocorticoids and mineralocorticoids, used for various conditions such as asthma and rheumatoid arthritis;
tetracosactide, used to treat various conditions (rheumatoid arthritis, terminal stages of certain cancers, Crohn’s disease and other autoimmune disorders);
stimulant laxatives, used to promote intestinal motility;
potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
metformin, used to treat diabetes;
iodinated contrast media;
calcium salts;
cyclosporine and tacrolimus, used in transplant patients;
imipramine-like antidepressants, used to treat depression;
neuroleptics, used to treat mental disorders (psychosis).

Inform your doctor and avoid taking Pressural if you have low potassium levels (hypokalaemia) and are taking any of the following medicines:

medicines used to treat heart rhythm disorders, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide;
medicines used to treat mental disorders (antipsychotics) such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol;
bepridil, used to treat heart problems;
cisapride and difemanil, used for stomach and intestinal problems;
intravenous erythromycin;
halofantrine, used to treat a type of malaria;
mizolastine, used to treat allergies;
pentamidine, used to treat certain types of pneumonia;
sparfloxacin, moxifloxacin and intravenous erythromycin, antibiotics used to treat bacterial infections;
intravenous vincamine, used to treat certain nervous system disorders;
allopurinol, used to treat hyperuricaemia (high levels of uric acid in the blood).

Combining this medicine with any of the above may increase the risk of heart problems (torsade de pointes), especially if you have low potassium levels. Before starting treatment with this medicine, blood electrolyte levels and heart activity (electrocardiogram) should be checked.
If you have low potassium levels, they must be corrected to normal levels before taking Pressural.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid using this medicine during pregnancy and breastfeeding. Diuretic medicines can cause serious harm to fetal development.
In men, no effects on fertility are expected.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery. However, individual reactions due to blood pressure reduction may occur, especially at the beginning of treatment or when this medicine is combined with another antihypertensive agent. In such cases, your ability to drive or use machinery may be impaired.
Pressural contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PRESSURAL

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet daily, taken in the morning, whole, with water and without chewing.

Use in patients with kidney problems (renal impairment)
Your doctor will adjust the dose according to kidney function.
This medicine is effective only if the kidneys are functioning normally or are only slightly impaired (See section 2).
Do not use this medicine if you have severe renal impairment (See section 2).

Use in patients with liver problems (hepatic impairment)
If you have hepatic impairment, a dose reduction is required.
Do not use this medicine if you have severe hepatic impairment (See section 2).

Use in elderly patients
Your doctor will adjust the dosage based on age, weight, and sex.
Take this medicine only if you have normal kidney function or only slightly impaired kidney function (See section 2, Warnings and precautions).

If you take more PRESSURAL than you should
This medicine has not shown toxicity even at doses much higher than the therapeutic dose. Signs of overdose mainly involve changes in blood sodium and potassium levels:
Symptoms include:

nausea and vomiting;
low blood pressure (hypotension);
involuntary muscle contractions associated with pain (cramps);
dizziness;
drowsiness, confusion;
increased or decreased urine production (polyuria and oliguria), up to possible absence of urine production (anuria).

In case of accidental ingestion or overdose of Pressural, contact your doctor immediately or go to the nearest hospital. The doctor will determine the most appropriate treatment based on your symptoms.

If you forget to take PRESSURAL
Do not take a double dose to make up for the missed tablet.

If you stop taking PRESSURAL
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

maculopapular rash (skin eruptions).

Uncommon (may affect up to 1 in 100 people)

vomiting;
skin disorder associated with bleeding (purpura). Rare (may affect up to 1 in 1,000 people)
dizziness;
feeling of fatigue and drowsiness;
headache;
tingling in hands and feet (paraesthesiae);
nausea and constipation;
dry mouth;
muscle pain (cramps).

Very rare (may affect up to 1 in 10,000 people)

decrease in platelet levels (thrombocytopenia), decrease in white blood cell levels (leucopenia, agranulocytosis), decrease in all blood components (aplastic anaemia), and decrease in red blood cells (haemolytic anaemia);
changes in heart rhythm (arrhythmias);
drop in blood pressure (hypotension);
inflammation of the pancreas (pancreatitis);
liver disorders;
swelling around eyes and mouth (angioneurotic oedema);
skin irritation (urticaria), severe skin disease (toxic epidermal necrolysis), and allergic-type reactions (Stevens-Johnson syndrome);
kidney problems (renal failure);
increased calcium levels in the blood. Not known (frequency cannot be estimated from available data)
loss of consciousness (syncope);
confusion;
heart problems such as torsade de pointes (see section 2);
feeling of dizziness upon standing due to a rapid drop in blood pressure (orthostatic hypotension);
hepatic encephalopathy, characterized by mental confusion and drowsiness, if you have liver problems (hepatic insufficiency);
hepatitis;
skin disorders such as itching, irritation (erythema, rash, photosensitivity);
worsening of a skin disease called lupus erythematosus;
kidney problems (acute renal failure);
falls;
changes in heart rhythm (prolongation of the QT interval);
decrease in potassium and sodium levels in the blood (see section 2). If chloride ion levels also decrease simultaneously, a condition called metabolic alkalosis may occur;
increased uric acid levels and increased blood sugar levels (glycaemia); pay particular attention if you have diabetes or gout;
increased liver enzyme levels;
slight increase in blood urea nitrogen;
decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), blurred vision, myopia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRESSURAL

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the
last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PRESSURAL contains

the active substance is: indapamide 2.5 mg (as indapamide hemihydrate);
the other components are: lactose (see section 2 "Pressural contains lactose and sucrose"), maize starch, gum arabic, talc, magnesium stearate, acrylic resin, gelatin, sucrose (see section 2 "Pressural contains lactose and sucrose"), magnesium carbonate, titanium dioxide (E171), kaolin, white wax, spermaceti.

Description of the appearance of PRESSURAL and package contents
Carton pack containing 50 film-coated tablets of 2.5 mg, white in colour, packed in two blisters of 25 tablets each.
Marketing Authorization Holder
POLIFARMA S.p.A. Viale dell’Arte 69 - 00144 Roma
Manufacturer
ISTITUTO DE ANGELI S.r.l. Località Prulli n. 103/C - 50066 Reggello (FI)