PRESSURAL 2.5 mg Coated tablet

Зміст інструкції

1. PRESSURAL 2.5 mg coated tablets
   1. What is PRESSURAL and what is it used for
   2. What you need to know before you take PRESSURAL
   3. How to take PRESSURAL
   4. Possible side effects
   5. How to store PRESSURAL
   6. Contents of the pack and other information

PRESSURAL 2.5 mg coated tablets

Indapamide hemihydrate
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pressural is and what it is used for
• 2. What you need to know before you take Pressural
• 3. How to take Pressural
• 4. Possible side effects
• 5. How to store Pressural
• 6. Contents of the pack and other information

1. What is PRESSURAL and what is it used for

Pressural contains the active ingredient indapamide (as indapamide hemihydrate); belonging to the group of
medicines called diuretics, which work by increasing the amount of urine produced by the kidneys and therefore 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 need to know before you take PRESSURAL

Do not take PRESSURAL

• if you are allergic to indapamide or other similar medicines (sulphonamide derivatives) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe liver disorder (hepatic encephalopathy or severe impairment of liver function);
• if you suffer from a severe kidney disorder (severe renal failure) and if you have a reduced urge to urinate (anuria);
• if you have low levels of potassium in your blood (hypokalaemia)
• if you have recently had problems with the circulation of the brain (cerebrovascular accidents);
• if you suffer from a tumor called “pheochromocytoma”
• if you suffer from Conn's syndrome (a disease due to an excess production of a hormone, aldosterone, by the adrenal gland) If you are in any of the conditions described above, inform your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking Pressural.
If you suffer from liver problems (impaired liver function), you may experience a disorder called
hepatic encephalopathy, characterized by mental confusion and drowsiness, especially if there is an alteration
of the levels of salts in the blood (sodium, potassium). Immediately discontinue treatment with this
medicine if you experience these symptoms.
Discontinue treatment with this medicine if you experience skin irritation accompanied by itching in areas
that have been exposed to the sun (photosensitivity reactions). If it is necessary to resume treatment, protect
the irritated areas from the light.
If you have a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the
vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and
can occur within a period ranging from a few hours to a few weeks after taking Pressural.
If left untreated, this can lead to permanent vision loss. If you have previously had a history of
allergy to penicillin or sulfonamides, you will be at greater risk of developing this event.
Pay particular attention to the use of the medicine and inform your doctor:

• if you have high levels of uric acid in your blood (hyperuricemia) and are predisposed to joint inflammation (gout);
• if you are elderly and have kidney problems (persistent renal insufficiency)

During the use of this medicine, your doctor may prescribe you periodic blood tests to
check the levels of:

• sodium, both before starting and during treatment. If you are elderly or if you suffer from liver problems (cirrhosis), these checks should be even more frequent;
• potassium, especially if you are elderly or malnourished, if you suffer from liver problems (cirrhosis with edema and ascites), if you suffer from heart problems (heart failure and coronary heart disease, prolonged QT interval). The first check should be carried out during the first week after starting treatment. If the levels of potassium in the blood decrease (hypokalaemia), an adjustment of the dosage is necessary;
• sugar (glycaemia), especially if you have diabetes and if your potassium levels in the blood are low (hypokalaemia);
• calcium, because an increase in calcium levels (hypercalcemia) may indicate an altered activity of the parathyroid gland (hyperparathyroidism). Stop treatment before checking the functioning of the parathyroid gland;
• uric acid, because gout attacks may increase.

The effect of Pressural may be increased if you have undergone surgery (sympathectomy).

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in positive anti-doping tests.

Children and adolescents
Pressural must notbe administered to children and adolescents under the age of 18 years, 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.
Pay particular attention and inform your doctor if you are taking:

• medicines containing lithium, used for the treatment of depression. The association with this medicine, if necessary, requires monitoring of lithium levels in the blood and dose adjustment;
• non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of pain, especially if you are dehydrated;
• other medicines used to treat high blood pressure, such as ACE inhibitors, if you have low sodium levels in your blood;
• baclofen, used for the treatment of muscle disorders. Increase your fluid intake and check kidney function before starting treatment;
• digitalis medicines, used for the treatment of heart rhythm disorders;
• amphotericin B (when administered intravenously), a medicine used for fungal infections;
• glucocorticoids and mineralocorticoids (systemic), used for various disorders such as asthma and rheumatoid arthritis;
• tetracosactide, a medicine used for the treatment of various diseases (rheumatoid arthritis, terminal stages of some cancers, Crohn's disease and other autoimmune diseases);
• stimulant laxatives, used to promote intestinal motility;
• potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
• metformin, a medicine used for the treatment of diabetes;
• iodinated contrast agents;
• calcium salts;
• cyclosporine and tacrolimus, medicines used in case of transplants;
• imipramine-like antidepressants, used for the treatment of depression;
• neuroleptics, used for the treatment of mental disorders (psychoses).

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

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

The association of this medicine with those listed above may increase the risk of heart problems
(torsades de pointes), especially if you have low levels of potassium in your blood. Before starting treatment with
this medicine, it is necessary to check the levels of salts in the blood and heart activity
(electrocardiogram).
If you have low levels of potassium in your blood, they must be brought back to normal levels before taking Pressural

Pregnancy, breastfeeding and Fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Avoid using the medicine during pregnancy and breastfeeding. Diuretic
medicines can cause serious harm to fetal growth.
No effects on fertility are expected in men.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery, but different reactions may occur due to the reduction of pressure, especially at the beginning of treatment or when
this medicine is combined with another antihypertensive agent. In this case, the ability to drive motor vehicles 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 him before taking this medicine.

3. How to take PRESSURAL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended doseis 1 tablet a day, to be taken in the morning, whole, with water and without chewing.

Use in patients with kidney problems (renal insufficiency)
The doctor will adjust the dose based on kidney function.
This medicine is effective only if you have a correct kidney function or if this is minimally reduced
(See section 2).
Do not use this medicine if you suffer from severe renal insufficiency (See section 2).

Use in patients with liver problems (hepatic insufficiency)
If you suffer from hepatic insufficiency, a dose reduction is necessary.
Do not use this medicine in case of severe hepatic insufficiency (See section 2).

Use in elderly people
The doctor will adjust the dosage based on age, weight and sex.
Take this medicine only if you have normal kidney function or if this is minimally
compromised (See section 2 Warnings and precautions).

If you use more PRESSURAL than you should
This medicine has not shown toxicity for doses much higher than the therapeutic dose. Signs
of intoxication manifest mainly with alterations in sodium and potassium levels in the blood:
Symptoms include:

• nausea and vomiting;
• decreased blood pressure (hypotension);
• involuntary muscle contractions associated with pain (cramps);
• dizziness;
• drowsiness, confusion;
• increased or decreased urine production (polyuria and oliguria) up to a possible absent urine production (anuria). In case of accidental ingestion/administration of an excessive dose of Pressural, immediately inform your doctor or go to the nearest hospital. The doctor will establish the most appropriate therapy based on your symptoms.

If you forget to use PRESSURAL
Donot take a double dose to compensate for the forgotten tablet.

If you stop taking PRESSURAL
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• maculopapular rashes (skin rashes).

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• skin disease associated with bleeding (purpura). Rare(may affect up to 1 in 1000 people)
• dizziness;
• feeling tired and sleepy;
• headache;
• tingling in the hands and feet (paresthesia);
• nausea and constipation;
• dry mouth;
• muscle pain (cramps).

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

• decreased levels of platelets (thrombocytopenia), decreased levels of white blood cells (leukopenia, agranulocytosis), decreased levels of all blood components (aplastic anemia) and decreased red blood cells (hemolytic anemia);
• irregular heartbeats (arrhythmias);
• low blood pressure (hypotension);
• inflammation of the pancreas (pancreatitis);
• liver disorders;
• swelling around the eyes and mouth (angioedema);
• 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);
• confusional state;
• heart disorders such as Torsades de Pointes (See section 2);
• feeling dizzy when standing up due to a rapid drop in blood pressure (orthostatic hypotension);
• hepatic encephalopathy, characterized by mental confusion and drowsiness, if you have liver problems (liver failure);
• hepatitis;
• skin disorders such as itching, irritation (erythema, rash, photosensitivity);
• worsening of a skin disease called lupus erythematosus;
• kidney problems (acute renal failure);
• falls;
• altered heartbeat (prolongation of the QT interval);
• lowering of potassium and sodium levels in the blood (See section 2). If chloride ion levels are lowered simultaneously, a condition called metabolic alkalosis may occur;
• increased levels of uric acid and blood sugar (glycemia), pay particular attention if you suffer from diabetes or gout;
• increased levels of liver enzymes;
• slight increase in blood urea nitrogen;
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), blurred vision, myopia.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PRESSURAL contains

• the active ingredient is: indapamide 2.5 mg (as indapamide hemihydrate);
• the other ingredients are :lactose(see section 2 “PRESSURAL contains lactose and sucrose”), corn 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 contents of the pack
Pack containing 50 coated tablets of 2.5 mg, white in colour, packaged in two blisters of 25
tablets.

Marketing Authorisation Holder
POLIFARMA S.p.A. Viale dell’Arte 69 - 00144 Rome

Manufacturer
ISTITUTO DE ANGELI S.r.l. Località Prulli n. 103/C - 50066 Reggello (FI)