Ipamix

Patient Information Leaflet

IPAMIX

2.5 mg 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 doubts, consult 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, because 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:
1. What IPAMIX is and what it is used for
2. What you need to know before taking IPAMIX
3. How to take IPAMIX
4. Possible side effects
5. How to store IPAMIX
6. Contents of the pack and other information
1. What IPAMIX is and what it is used for
IPAMIX is a diuretic containing indapamide as the active substance.
It is used to reduce high blood pressure (hypertension).
Contact your doctor if you do not notice any improvement or if your symptoms worsen after the prescribed duration of treatment.

2. What you need to know before taking IPAMIX

Do not take IPAMIX

• if you are allergic to indapamide, to other similar medicinal products (sulfonamide-derived drugs) or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal failure);
• if you suffer from a condition causing failure to pass urine (anuria);
• if you have altered brain function due to impaired liver function (hepatic encephalopathy), or
• if you have severe impairment of liver function;
• if you have a tumour of the adrenal gland (pheochromocytoma);
• if you have Conn's syndrome: high blood pressure due to altered adrenal gland activity;
• if you have recently had a stroke (cerebrovascular accident);
• if you have low levels of potassium in the blood (hypokalaemia).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking IPAMIX.

Before starting and during treatment with indapamide, your doctor will perform periodic checks of electrolyte levels in your blood (sodium, potassium and calcium). This is particularly important if:

• you are elderly;
• you are undernourished and/or taking other medicines;
• you suffer from liver problems (hepatic cirrhosis, with or without oedema or ascites);
• you suffer from coronary heart disease or heart problems (heart failure, QT interval prolongation);
• you suffer from kidney problems (renal failure);
• you have a slow heart rate (bradycardia).

If your liver function is impaired, consult your doctor before taking IPAMIX, as your condition may worsen.

Be cautious and protect exposed areas from exposure to sunlight or artificial UVA rays, as this medicine may cause skin reactions (photosensitivity).

During treatment with indapamide, your doctor will regularly monitor your blood glucose (blood sugar concentration), especially if you have diabetes, your creatinine levels (especially if you are elderly), and your uric acid levels (uricemia), particularly if your blood uric acid levels are normally high, as gout attacks may become more frequent.

Since blood calcium levels may increase during treatment with indapamide, your doctor will advise you to stop treatment if you need to undergo tests assessing the function of certain glands called parathyroid glands.

If you experience a decrease in vision or eye pain, seek medical attention immediately. 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 IPAMIX. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition.

For athletes

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

Children and adolescents

IPAMIX is not recommended for use in children and adolescents, as there is no data available on its safety and efficacy.

Other medicines and IPAMIX

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Combinations not recommended

Do not take indapamide together with lithium, as lithium concentrations in your blood may increase, potentially causing lithium overdose.

Combinations requiring precautions

Medicines that cause a heart problem known as torsade de pointes:

• Antiarrhythmic medicines such as (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide);
• Antipsychotic medicines such as chlorpromazine, carbamazepine, levopromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol;
• other medicines: bepridil, cisapride, difemanyl, erythromycin i.v., halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine i.v.;
• Non-steroidal anti-inflammatory drugs (NSAIDs) and high doses of salicylic acid;
• Medicines used to treat hypertension known as ACE inhibitors;
• Medicines that may cause a marked reduction in potassium levels in the blood (hypokalaemia), such as amphotericin B (i.v.), glucocorticoids and mineralocorticoids (systemic), tetracosactide, stimulant laxatives;
• Other medicines such as: baclofen, digitalis-based medicines (digitalis glycosides), allopurinol.

Other combinations requiring attention

• Potassium-sparing diuretics such as amiloride, spironolactone, triamterene, because their combination with indapamide may cause imbalances in blood potassium levels (hypokalaemia and hyperkalaemia);
• Metformin;
• Substances used in certain diagnostic tests (iodinated contrast media);
• Imipramine-like antidepressants and neuroleptics, as they may enhance the antihypertensive effect, leading to excessive lowering of blood pressure;
• Calcium salts, due to the risk of increased calcium levels in the blood;
• Immunosuppressive medicines such as cyclosporine and tacrolimus;
• Systemically administered corticosteroids and tetracosactide.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, consult your doctor or pharmacist before taking this medicine.

The use of IPAMIX is not recommended during pregnancy.

Breast-feeding

The use of IPAMIX is not recommended during breast-feeding.

Driving and using machines

IPAMIX does not interfere with the ability to drive or use potentially dangerous machinery. However, you may experience effects due to reduced blood pressure, especially at the beginning of treatment. In such cases, exercise caution before driving or operating machinery.

IPAMIX contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use IPAMIX

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
1 tablet (2.5 mg) in the morning with a glass of water.

Renal impairment
If you have renal impairment, your doctor will adjust the dosage according to the severity of your
condition.

Hepatic impairment
If you have hepatic impairment, your doctor will adjust the dosage according to the severity of your
condition.

Elderly
If you are elderly but have normal kidney function, you may take Ipamix.

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

If you take more IPAMIX than you should
In case of accidental ingestion or overdose of IPAMIX, inform your doctor immediately or go to the nearest hospital.
At doses higher than recommended, indapamide exerts a significant diuretic effect, leading to reduced blood volume (hypovolemia) and disturbances in blood concentration (electrolyte and acid-base balance), which may result in nausea, vomiting, low blood pressure (hypotension), muscle cramps, dizziness, drowsiness, confusion, urinary problems (polyuria or oliguria), and even inability to urinate (anuria). If you take an excessive dose of Ipamix, contact your doctor who will initiate appropriate supportive measures for respiratory and cardiovascular function.

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

If you have any doubts 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.
Most of the side effects affecting clinical or laboratory parameters are dose-dependent.

Common (may affect up to 1 in 10 people):
maculopapular rash.

Uncommon (may affect up to 1 in 100 people):
vomiting,
bleeding into tissues causing skin spots (purpura).

Rare (may affect up to 1 in 1,000 people):
dizziness,
fatigue,
headache,
altered sensation in arms and legs (paraesthesia),
drowsiness,
nausea,
constipation,
dry mouth,
muscle cramps.

Very rare (may affect up to 1 in 10,000 people):
decrease in platelets in the blood (thrombocytopenia),
decrease in white blood cells (leucopenia),
decrease in white blood cells known as granulocytes (agranulocytosis),
reduced production of blood cells (aplastic anaemia),
reduced concentration of haemoglobin in the blood (haemolytic anaemia),
changes in heart rhythm (arrhythmia),
reduction in blood pressure (hypotension),
inflammation of the pancreas (pancreatitis),
liver function abnormalities,
swelling of the face, tongue and larynx (angioneurotic oedema) and/or urticaria,
painful localized erythema, with desquamation accompanied by chills, pain and fever (toxic epidermal necrolysis),
skin lesions accompanied by desquamation, high fever, vomiting and diarrhoea (Stevens-Johnson syndrome),
renal failure,
increased levels of calcium in the blood (hypercalcaemia).

Not known (frequency cannot be estimated from the available data):
loss of consciousness (syncope),
myopia,
blurred vision,
visual impairment,
decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)),
mental confusion,
disturbance in heart rhythm known as torsade de pointes (potentially fatal) (see "Precautions for use" and "Interactions"),
excessive drop in blood pressure when standing up (orthostatic hypotension),
impairment of brain function due to inadequate liver function (hepatic encephalopathy),
inflammation of the liver (hepatitis),
possible worsening of a pre-existing skin condition known as systemic lupus erythematosus,
skin rash,
photosensitivity (see "Warnings and precautions"),
falls,
acute renal failure,
change in heart rhythm known as QT interval prolongation,
increased levels of glucose and uric acid in the blood,
slight increase in blood urea nitrogen,
elevated levels of liver enzymes,
reduction in potassium levels (hypokalaemia),
reduction in sodium levels (hyponatraemia) and blood volume (hypovolaemia).

The concomitant loss of chloride ions may lead to a compensatory secondary metabolic alkalosis: the incidence and extent of this effect are mild.

Reporting of side effects
If you experience any side effects, 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 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 IPAMIX

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 IPAMIX 2.5 mg, 50 coated tablets contains
The active substance is: indapamide
One coated tablet contains: indapamide 2.5 mg
The other components are: maize starch, glycerol 85%, monohydrate lactose, magnesium stearate, hypromellose, macrogol 6000, povidone, sodium lauryl sulfate, talc, titanium dioxide.
Description of the appearance of IPAMIX and the contents of the pack
IPAMIX is available as 2.5 mg coated tablets, in packs of 50 tablets.
Marketing Authorization Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Italy
Responsible manufacturer for batch release
IPAMIX 2.5 mg coated tablets, 50 tablets
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo 103012 Anagni (FR)