Package leaflet: Information for the patient

INDAPAMIDE PENSA 2.5 mg film-coated tablets

Indapamide
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Indapamide Pensa is and what it is used for

This medicine contains the active substance indapamide, a substance belonging to a group of
medicines called "thiazide diuretics", which increase the amount of urine produced by the kidneys. However,
indapamide is different from other diuretics because it causes only a slight increase in the amount of
urine produced.
Indapamide Pensa is used to reduce high blood pressure (essential arterial hypertension).

2. What you need to know before taking Indapamide Pensa

Do not take Indapamide Pensa:
if you are allergic to indapamide or to any other sulfonamide, or to any of the other
components of this medicine (listed in section 6);
if you have severe kidney disease (insufficient kidney function or absence of urine (anuria));
if you suffer from severe liver problems or a condition called hepatic encephalopathy (brain disturbances caused by the circulation of "toxic" substances related to liver failure);
if you have low levels of potassium in your blood (hypokalaemia);
if you have recently had a stroke (cerebral vascular infarction);
if you have phaeochromocytoma (a tumour of the adrenal glands causing high blood pressure);
if you suffer from a disease called Conn's syndrome (a disorder of the adrenal glands causing excessive production of the hormone aldosterone, leading to high blood pressure).

Warnings and precautions
Exercise particular caution:
if you have suffered or are suffering from low levels of sodium in your blood (hyponatraemia);
if you have suffered or are suffering from low levels of potassium in your blood; low potassium levels may occur in elderly or debilitated patients, in patients taking multiple medications (polypharmacy), in patients with liver cirrhosis (a liver disease causing fluid accumulation in the abdominal cavity), in patients with heart disease (coronary artery disease or heart failure, long QT syndrome), or in patients with cardiac arrhythmias (particularly torsades de pointes).
if you have been found to have increased levels of calcium in your blood (hypercalcaemia): thiazide diuretics can reduce the excretion of calcium in the urine and may cause a mild and transient increase in blood calcium levels.
Your doctor may perform blood tests to check whether you have low levels of sodium or potassium, or high levels of calcium in your blood.

In addition, you should be cautious:
if you suffer from gout or diabetes;
if your kidney function is reduced, as Indapamide Pensa may not work properly in patients even with slightly impaired kidney function;
if you have liver problems, as Indapamide Pensa could trigger hepatic encephalopathy (see section Do not take Indapamide Pensa);
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 pressure inside the eye, which may occur from a few hours to several weeks after taking INDAPAMIDE PENSA. If untreated, this may lead to permanent vision impairment. The risk may be higher if you have previously had an allergic reaction to penicillins or sulfonamides.

Photosensitivity
Cases of photosensitivity reactions (skin reactions to light causing redness and burning sensations) have been reported with the use of indapamide. This is an abnormal and exaggerated reaction, even after brief exposure to sunlight. If such reactions occur, stop treatment immediately and consult your doctor.
If treatment with indapamide needs to be resumed, it is recommended to protect skin areas exposed to sunlight or artificial UVA rays.

Children and adolescents
The safety and efficacy of this medicine in children and adolescents under 18 years of age have not been established, and its use is therefore not recommended.

Other medicines and Indapamide Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Indapamide Pensa, or their effects may be altered by this medicine, particularly:

lithium (used to treat depression). Indapamide Pensa must not be taken with lithium due to the risk of increased lithium levels in the blood;
medicines used for cardiac arrhythmias such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide;
bepridil (used to treat angina pectoris, a condition causing chest pain);
other diuretics (amiloride, spironolactone, triamterene);
medicines used to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants (e.g. imipramine), antipsychotics (e.g. chlorpromazine, carbamazepine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol);
antibiotics such as moxifloxacin, sparfloxacin, erythromycin;
halofantrine (an antiparasitic drug used to treat gastrointestinal disorders);
pentamidine (a drug active against certain protozoa);
mizolastine (a drug used to treat allergic reactions such as hay fever);
non-steroidal anti-inflammatory drugs (e.g. ibuprofen), including selective COX-2 inhibitors or high doses of salicylic acid;
angiotensin-converting enzyme (ACE) inhibitors, used to treat high blood pressure;
antifungal medicines (antimycotics) such as amphotericin B;
baclofen, a medicine used to treat muscle stiffness in diseases such as multiple sclerosis;
metformin, an antidiabetic drug;
allopurinol, a drug used in the treatment of gout;
ciclosporin and tacrolimus, therapies used to prevent organ rejection;
corticosteroids (gluco- and mineralocorticoids), used to treat various conditions including severe asthma and rheumatoid arthritis;
tetracosactide (used as a diagnostic agent or in the treatment of Crohn's disease);
stimulant laxatives, which may cause potassium loss (hypokalaemia);
digitalis glycosides, used in certain heart conditions;
cisapride, difemanil (used to treat gastrointestinal disorders);
calcium tablets or other calcium supplements;
iodine-containing medicines used in radiological investigations (iodinated contrast media).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine must not be used during pregnancy.
The use of this medicine during breastfeeding is not recommended, as a risk to newborns/infants cannot be excluded.

Driving and using machines
Indapamide Pensa does not usually affect alertness. However, in individual cases, different reactions related to blood pressure reduction may occur, especially at the beginning of treatment or when combined with other antihypertensive medicines.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

INDAPAMIDE PENSA 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 Indapamide Pensa

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet daily, taken in the morning.

Elderly patients
Elderly patients may be treated with Indapamide Pensa only if renal function is normal or only slightly impaired (see section Warnings and precautions). Therefore, before starting treatment with Indapamide Pensa, values of renal function parameters (serum creatinine) must be adjusted according to age, body weight, and sex.

Patients with impaired renal function
If you have kidney problems, consult your doctor, as the usual dose may need to be adjusted. Dose reduction should be based on the degree of renal impairment.
Treatment is contraindicated in case of severe renal impairment (see section Warnings and precautions).

Patients with impaired hepatic function
If you have liver problems, consult your doctor, as the usual dose may need to be adjusted.
Treatment is contraindicated in case of severe renal impairment (see section Warnings and precautions).

Children and adolescents
Indapamide Pensa is not recommended for children and adolescents due to lack of data on safety and efficacy.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you take more Indapamide Pensa than you should
If you accidentally take too much Indapamide Pensa, contact your doctor immediately or go to the nearest hospital.
Signs and symptoms of accidental overdose include: nausea, vomiting, excessive drop in blood pressure (hypotension), cramps, dizziness, drowsiness, confusion, frequent need to urinate, followed by reduced urine output or complete absence of urine (oliguria and anuria).

If you forget to take Indapamide Pensa
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common (may affect up to 1 in 10 people):
skin rashes.
Uncommon (may affect up to 1 in 100 people):
vomiting, purpura (small red spots on the skin) in subjects predisposed to allergic reactions.
Rare (may affect up to 1 in 1,000 people):
dizziness, fatigue, headache, drowsiness, tingling sensations (paraesthesia), nausea, constipation, dry mouth, muscle cramps.
Very rare (may affect up to 1 in 10,000 people):
blood cell disorders (thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia);
heart rhythm disorders (arrhythmias);
low blood pressure (hypotension);
inflammation of the pancreas (pancreatitis);
liver function abnormalities;
angioedema and/or urticaria, severe skin reactions;
severe skin allergic reactions (toxic epidermal necrolysis);
severe allergic reactions (Stevens-Johnson syndrome);
renal failure;
increased calcium levels in the blood (hypercalcaemia).
Frequency not known (frequency cannot be estimated from the available data):
transient loss of consciousness (syncope);
mental confusion;
vision disorders (myopia, blurred vision, visual impairment); decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
severe heart arrhythmia (torsades de pointes, potentially fatal);
low blood pressure when standing (orthostatic hypotension);
onset of a serious liver disease called hepatic encephalopathy (brain disturbances due to circulation of "toxic" substances related to liver failure (see section Do not take Indapamide Pensa));
inflammatory liver disease (hepatitis);
possible worsening of pre-existing systemic lupus erythematosus (an autoimmune disease causing inflammation and damage to joints, tendons and organs, skin rash, fatigue, loss of appetite, weight gain and joint pain);
rash (transient skin redness);
cases of photosensitivity reactions (see section Warnings and Precautions);
sudden falls;
acute renal failure;
long QT syndrome (a potentially fatal heart rhythm disorder) (see section Warnings and Precautions);
increased blood sugar (glucose) and uric acid levels, and slight increase in nitrogen in urine;
excessive loss of potassium (hypokalaemia), particularly severe in certain patients (see section Warnings and Precautions);
low sodium levels in the blood and excessive reduction in circulating fluid volume (hypovolaemia) leading to dehydration and low blood pressure;
excessive loss of chlorides in the urine (which may lead to mild metabolic alkalosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 Indapamide Pensa

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.
The stated expiry date applies to the product stored correctly in its original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What INDAPAMIDE PENSA contains

The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.
The other components are lactose, corn starch, sucrose, talc, acacia gum, magnesium carbonate, magnesium stearate, titanium dioxide, erythrosine red (E 127).

Description of the appearance of INDAPAMIDE PENSA and contents of the pack
Pack of 20 coated tablets.
Pack of 30 coated tablets.
Pack of 50 coated tablets.
Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan
Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.r.l.
Via Campobello, 15
00040 Pomezia (Rome)
Italy