MILLIBAR 2.5 mg Hard capsule

Зміст інструкції

1. MILLIBAR 2.5 mg hard capsules
   1. What is Millibar and what is it used for?
   2. What you need to know before taking Millibar
   3. How to take Millibar
   4. Possible side effects
   5. How to store Millibar
   6. Contents of the pack and other information

MILLIBAR 2.5 mg hard capsules

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

Contents of this leaflet:

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

1. What is Millibar and what is it used for?

Millibar is a medicine based on 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 hypertension).

2. What you need to 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
ingredients of this medicine (listed in section 6);
if you have a severe kidney disease (insufficient kidney function) or if you are unable to
urinate (a condition called anuria);
if you suffer from severe liver problems or a condition called hepatic encephalopathy
(brain alterations resulting from the circulation of "toxic" substances resulting from
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 a pheochromocytoma (a tumor of the adrenal glands that causes an increase in
blood pressure);
if you suffer from a disease called Conn's syndrome (a disease of the adrenal glands
which involves an excess production of the hormone aldosterone and which causes an increase
in blood pressure).

Warnings and precautions
Talk to your doctor or pharmacist before taking MILLIBAR
Your doctor may have you undergo blood diagnostic tests at the beginning of treatment and
subsequently to check if the levels of sodium or potassium have decreased or those of calcium
have increased.
Pay particular attention :
if you have suffered or are suffering from low levels of sodium in the blood (hyponatremia) especially
if you are elderly or suffer from liver cirrhosis;
if you have suffered or are suffering from low levels of potassium in the blood; a condition that may worsen
with the use of the drug and is particularly risky in patients:
or elderly,
or malnourished or in therapy with several drugs (polytherapy),
or with liver cirrhosis (with fluid accumulation in the abdominal cavity),
or with heart disease (coronary disease or heart failure, long QT syndrome);
or with heart rhythm disorders;
if you have been found to have increased levels of calcium in the blood (hypercalcemia): thiazide
diuretics can reduce the excretion of calcium with urine and cause an increase in
calcaemia, mild and transient. The increase in calcium may also be due to abnormal
functioning of the parathyroid glands.
If you have decreased vision or eye pain. These could be symptoms
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an
increase in eye pressure and can occur within a period ranging from a few hours
to weeks after taking MILLIBAR. This can lead to permanent
loss of vision if not treated. If you have previously experienced an allergy to penicillins or
sulfonamides, you may be at higher risk of developing it.
It is also advisable to pay attention:
if you suffer from gout (high levels of uric acid in the blood)
if you suffer from diabetes (high blood glucose levels) especially if potassium levels in the blood are low at the same time;
if your kidney function is decreased, as Millibar does not work properly
in patients with even minimally impaired kidney function;
if you suffer from liver problems as Millibar may cause the onset of
hepatic encephalopathy (See Do not take).

Photosensitivity
Cases of photosensitivity reactions have been reported with the use of indapamide and other similar drugs
(abnormal skin reaction to light that determines redness and burning of the skin; it is an abnormal and exaggerated reaction of the skin even after slight exposure to sunlight). If these reactions occur, stop treatment and consult your doctor.
If it is necessary to resume treatment with indapamide, it is recommended to protect
areas exposed to the sun or UVA artificial rays.

Children and adolescents
The safety and efficacy of the 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
There are medicines that can alter the effect of Millibar or whose effect can be altered
by the medicine, in particular:
lithium (used to treat depression). Millibar should not be taken with lithium due to
the risk of increased lithium levels in the blood;
drugs used in case of heart rhythm disorders such as quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, ibutilide, dofetilide;
bepridil (used to treat angina pectoris a disease that causes chest pain);
other diuretics (amiloride, spironolactone, triamterene);
drugs used to treat mental disorders such as depression, anxiety or schizophrenia for
example tricyclic antidepressants (e.g. imipramine), antipsychotics (e.g. chlorpromazine,
ciamenazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride,
sultopride, tiapride), butyrophenones (droperidol, haloperidol);
antibiotics such as moxifloxacin, sparfloxacin, erythromycin;
halofantrine (antiparasitic drug for the treatment of gastrointestinal disorders);
pentamidine (drug that acts against some protozoa);
mizolastine (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;
drugs against fungal infections (antimycotics) such as amphotericin B;
baclofen, a drug used to treat muscle stiffness in diseases such as multiple sclerosis;
metformin, an antidiabetic drug;
allopurinol, a drug used in gout;
cyclosporine and tacrolimus, therapies used in organ rejection prevention;
corticosteroids (glucocorticoids and mineralocorticoids), used to treat various conditions, including
severe asthma and rheumatoid arthritis;
tetracosactide (used as a diagnostic or employed in the treatment of Crohn's disease);
stimulant laxatives, which can determine potassium loss (hypokalemia);
digitalis, which are used in certain heart diseases;
cisapride, difemanil (used for the treatment of gastrointestinal disorders);
calcium tablets or other calcium supplements;
drugs containing iodine used in radiological investigations (iodinated contrast agents).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy.
This medicine should not be used during breastfeeding, as
a risk to newborns/infants cannot be ruled out.

Driving and using machines
Millibar does not affect the degree of alertness but in individual cases different reactions related to the reduction of blood pressure may occur, especially at the beginning of treatment or if
another drug for high blood pressure is associated.

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still determine
positive doping tests.

Millibar contains:

• lactose: if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Millibar

Take this medicine following exactly the instructions of 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 adopt a low-sodium diet.

Elderly:
Elderly patients may be treated with Millibar only when renal function is normal or
slightly impaired (see Warnings and precautions). Therefore, before treatment with Millibar, the values
of kidney function indices (creatinine levels) must be adjusted in relation to age,
weight and sex.

Patients with impaired renal function
If you have kidney problems, consult your doctor, as the normal dose may need to be modified. A
dose reduction must be made according to the degree of renal insufficiency.
In case of severe renal insufficiency, treatment is contraindicated (see Warnings and
precautions).

Patients with impaired hepatic function
If you have liver problems, consult your doctor, as the normal dose may need to be modified
(see Warnings and precautions).

Children and adolescents
Millibar is not recommended in children and adolescents due to the lack of data on
safety and efficacy.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you take more Millibar than you should
In case of accidental ingestion/intake of an excessive dose of Millibar, immediately
notify your doctor or go to the nearest hospital.
The signs and symptoms in case of accidental ingestion of an excessive dose are: nausea, vomiting, excessive drop in pressure (hypotension), cramps, dizziness, drowsiness, confusion, need to
urinate frequently and subsequently reduction of urine until disappearance (oliguria and anuria).

If you forget to take Millibar
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 individuals predisposed to allergic reactions.

Rare (may affect up to 1 in 1,000):
dizziness
fatigue
headache
drowsiness
tingling (paresthesia)
nausea
constipation
dry mouth
muscle cramps

Very rare (may affect up to 1 in 10,000):
blood cell disorders (thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia,
hemolytic anemia);
heart rhythm disorders (arrhythmias);
blood pressure too low (hypotension);
inflammation of the pancreas (pancreatitis);
liver function abnormalities;
angioedema and/or urticaria, severe skin manifestations;
severe allergic skin reactions (toxic epidermal necrolysis);
severe allergic reactions (Stevens-Johnson syndrome);
kidney failure;
increased calcium levels in the blood (hypercalcemia).

Frequency not known (frequency cannot be estimated from available data):
low potassium levels in the blood (hypokalaemia)
transient loss of consciousness (syncope)
mental confusion
vision disorders (myopia, blurred vision, impaired vision)
decreased vision or eye pain due to high 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 up (orthostatic hypotension)
onset of a serious liver disease called hepatic encephalopathy(brain alterations resulting from the circulation of "toxic" substances due to
liver failure (see Do not take Millibar))
inflammatory liver disease (hepatitis)
possible worsening of pre-existing acute disseminated lupus erythematosus(an autoimmune disease
that causes inflammation and damage to joints, tendons and organs,
skin redness, fatigue, loss of appetite, weight gain and joint pain)
rash (transient skin redness)
cases of sensitivity to light reactions (see Warnings and Precautions)
sudden falls
acute kidney failure
QT prolongation syndrome (a potentially fatal heart rhythm disease) (see

Warnings and Precautions)
increased levels of sugar (glucose) and uric acid in the blood and slight increase
of nitrogen in the urine
high levels of liver enzymes
excessive loss of potassium (hypokalaemia), particularly severe in certain patients (see

Warnings and Precautions)
low sodium levels in the blood and excessive decrease in the volume of circulating fluids in the
body (hypovolemia) causing dehydration and low blood pressure
excessive loss of chlorides with urine (which can cause mild metabolic alkalosis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. 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 Millibar

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Do not use this medicine after the expiry date that is reported on the box and on the blister. 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 that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Millibar contains
The active ingredient is indapamide. Each capsule contains 2.5 mg of indapamide hemihydrate (equivalent to 2.44
mg of anhydrous indapamide).
The other ingredients are:
Lactose, starch, magnesium stearate, titanium dioxide (E171), quinoline yellow (E 104), erythrosine (E
127), gelatin.

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

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

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