Package leaflet: Information for the patient

MILLIBAR 2.5 mg hard capsules

Indapamide hemihydrate
Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Millibar is and what it is used for

Millibar is a medicine containing indapamide, a substance that belongs 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.
Millibar is used to reduce high blood pressure (essential arterial hypertension).

2. What you should know before taking Millibar

Do not take Millibar:
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 (inadequate kidney function) or if you are unable to
urinate (a condition called anuria);
if you suffer from severe liver problems or from a condition called hepatic encephalopathy
(brain disturbances caused by the entry into circulation of "toxic" substances due 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
Talk to your doctor or pharmacist before taking MILLIBAR.
Your doctor may carry out blood tests at the beginning of treatment and periodically thereafter to check whether your levels of sodium or potassium have decreased or your calcium levels have increased.

Take particular care:
if you have suffered or are suffering from low levels of sodium in the blood (hyponatraemia), especially
if you are elderly or have liver cirrhosis;
if you have suffered or are suffering from low levels of potassium in the blood; this condition may worsen
with the use of the medicine and is particularly risky in patients who are:
o elderly,
o malnourished or receiving treatment with multiple medicines (polypharmacy),
o with liver cirrhosis (with fluid accumulation in the abdominal cavity),
o with heart diseases (coronary heart disease or heart failure, long QT syndrome);
o with cardiac arrhythmias;
if you have been diagnosed with increased levels of calcium in the blood (hypercalcaemia): thiazide diuretics can reduce the excretion of calcium in the urine and cause a mild and transient increase in blood calcium levels. Increased calcium levels may also result from abnormal functioning of the parathyroid glands.
If you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking MILLIBAR. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillins or sulfonamides, you may be at higher risk of developing such reactions.

In addition, you should be cautious:
if you suffer from gout (high levels of uric acid in the blood);
if you suffer from diabetes (high blood glucose levels), especially if your blood potassium levels are also low;
if your kidney function is reduced, as Millibar does not work properly in patients with even mildly impaired renal function;
if you suffer from liver problems, as Millibar could trigger the onset of hepatic encephalopathy (see Do not take).

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

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

Other medicines and Millibar
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 Millibar or their effects may be altered by Millibar, particularly:
lithium (used to treat depression). Millibar 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, for example 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 acting 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 in the treatment of high blood pressure;
antifungal medicines (antimycotics) such as amphotericin B;
baclofen, a medicine used to treat muscle stiffness in conditions such as multiple sclerosis;
metformin, an antidiabetic medicine;
allopurinol, a medicine used in gout;
cyclosporine 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, suspect you may 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.
This medicine must not be used during breastfeeding, as a risk to newborns/infants cannot be excluded.

Driving and using machines
Millibar does not affect alertness, but in individual cases different reactions related to blood pressure reduction may occur, especially at the beginning of treatment or when combined with another antihypertensive medicine.

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

Millibar contains:

Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Millibar

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule per day (in the morning), regardless of the severity of the disease.
It is not necessary to follow a sodium-free diet.

Elderly patients:
Elderly patients may be treated with Millibar only if renal function is normal or only slightly impaired (see Warnings and precautions). Therefore, before starting treatment with Millibar, renal function parameters (serum creatinine) must be adjusted according to age, 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. The dose should be reduced according to the degree of renal impairment.
Millibar is contraindicated in cases of severe renal failure (see 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 (see Warnings and precautions).

Children and adolescents:
Millibar is not recommended in children and adolescents due to lack of data on safety and efficacy.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

If you take more Millibar than you should:
In case of accidental ingestion or overdose of Millibar, contact your doctor immediately or go to the nearest hospital.
Signs and symptoms of accidental overdose may 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 Millibar:
Do not take a double dose to make up for the missed 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 (paraesthesiae)
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);
blood pressure too low (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);
kidney failure;
increased levels of calcium in the blood (hypercalcaemia).
Frequency not known (frequency cannot be estimated from the available data):
low levels of potassium in the blood (hypokalaemia)
transient loss of consciousness (syncope)
mental confusion
vision disorders (myopia, blurred vision, visual impairment)
reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion))
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 alterations resulting from the entry into circulation of "toxic" substances due to liver failure (see Do not take Millibar ))
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 Warnings and Precautions )
sudden falls
acute kidney failure
long QT syndrome (a potentially life-threatening heart rhythm disorder) (see Warnings and Precautions )
increased levels of sugar (glucose) and uric acid in the blood, and slight increase in nitrogen in urine
elevated liver enzymes
excessive loss of potassium (hypokalaemia), particularly serious in certain patients (see Warnings and Precautions )
low levels of sodium 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 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 Millibar

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
The expiry date refers to the product in its original, unopened packaging, properly stored.
Do not use this medicine after the expiry date shown on the carton and blister pack. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Millibar contains
The active substance is indapamide. Each capsule contains 2.5 mg of indapamide hemihydrate (equivalent to 2.44 mg of anhydrous indapamide).
The other components are:
Lactose, starch, magnesium stearate, titanium dioxide (E171), quinoline yellow (E104), erythrosine (E127), gelatin.

Description of the appearance of Millibar and contents of the pack
Millibar is supplied in a box containing 50 capsules in blisters.

Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro, 212 – 00141 Rome, Italy

Manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licino, 11 – 22036 ERBA (CO)