IPAMIX 50 mg Dragee

Зміст інструкції

1. IPAMIX
   1. What you need to know before using IPAMIX
   2. How to use IPAMIX
   3. Possible side effects
   4. How to store IPAMIX
   5. Contents of the pack and other information

IPAMIX

2.5 mg coated tablets
Indapamide
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 only for you. Do not give it to other people even if they have the same
symptoms as you, as it could be dangerous.
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 IPAMIX is and what it is used for

2. What you need to know before you use IPAMIX

3. How to use 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 whose active ingredient is indapamide.
It is used to reduce high blood pressure (hypertension).
Consult your doctor if you do not notice any improvement or if your symptoms worsen after the
days of prescribed therapy.

2. What you need to know before using IPAMIX

Do not take IPAMIX

• if you are allergic to indapamide, to other similar medicinal products (sulphonamide derivatives) or to any of the other components of this medicine (listed in section 6).
• if you have severe kidney problems (severe renal insufficiency)
• if you suffer from a condition that causes the failure to pass urine (anuria)
• if you have a brain dysfunction due to insufficient 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 activity
• if you have recently had a stroke (cerebrovascular accident)
• if you have reduced levels of potassium in the blood (hypokalaemia) Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking IPAMIX.

Before starting and during therapy with indapamide, your doctor will subject you to periodic checks of blood electrolytes (sodium, potassium and calcium). This is particularly important if:

• you are an elderly patient,
• you are malnourished and/or being treated with other medicines,
• you suffer from liver problems (liver cirrhosis, with or without edema or ascites)
• you suffer from coronary heart disease or heart problems (heart failure, prolongation of the QT interval)
• if you suffer from kidney problems (renal insufficiency)
• you have a slowed heartbeat (bradycardia)

If your liver function is impaired, consult your doctor before taking Ipamix, as your condition may worsen. Be careful and protect exposed areas in case of exposure to the sun or artificial UVA rays, as this medicine can cause skin reactions (photosensitivity). During therapy with indapamide, your doctor will subject you to regular checks of blood glucose (blood sugar concentration), especially if you suffer from diabetes, of blood creatinine especially if you are elderly, and of uric acid concentration, especially if your blood uric acid levels are normally high because gout attacks could be more frequent. Since calcium levels in the blood may increase during therapy with indapamide, your doctor will tell you to stop treatment if you have to undergo tests that evaluate the function of certain glands called parathyroid glands. 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 weeks after taking IPAMIX. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this disorder.

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

Children and adolescents
Ipamix is not recommended for use in children and adolescents as there is no data on its safety and efficacy.

Other medicines and IPAMIX
Tell your doctor or pharmacist if you are takingor have recently taken or might take any other medicines.

Associations not recommended
Do not take indapamide together with lithium, as lithium concentrations in your blood may increase with possible overdose effects.

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

• Antiarrhythmic drugs such as (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide)
• Antipsychotic drugs such as chlorpromazine, ciamemazine, levopromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol;
• other drugs: bepridil, cisapride, difemanil, 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 can cause a severe reduction in potassium in the blood (hypokalaemia), such as amphotericin B (i.v.), gluco- and mineralocorticoids (systemic), tetracosactide, stimulant laxatives
• Other medicines such as: baclofen, drugs based on digitalis (digitalics), allopurinol

Other associations to be careful with

• Potassium-sparing diuretics such as amiloride, spironolactone, triamterene, because the association with indapamide could cause imbalances in potassium levels in the blood (hypokalaemia and hyperkalaemia).
• Metformin
• Substances used in some diagnostic tests (iodinated contrast media)
• Imipramine-like antidepressants and neuroleptics, as they may increase the antihypertensive effect by lowering blood pressure too much
• Calcium salts, due to the risk of increased calcium levels in the blood
• Immunosuppressive drugs such as cyclosporine and tacrolimus
• Corticosteroids and tetracosactide administered systemically.

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.

The use of Ipamix is not recommended during pregnancy.
Breastfeeding
The use of Ipamix is not recommended during breastfeeding.

Driving and using machines
IPAMIX does not interfere with the ability to drive and use potentially dangerous machinery, however you may experience effects due to the reduction in pressure, especially at the beginning of treatment. In these cases, be careful before driving vehicles or using machinery.

Ipamix contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to use IPAMIX

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

The recommended dose is:
1 tablet (2.5 mg) in the morning with a little water.
Renal insufficiency
If you suffer from renal insufficiency, your doctor will modify the dosage based on the severity of your
condition.
Hepatic insufficiency
If you suffer from hepatic insufficiency, your doctor will modify the dosage based on the severity of your
condition.
Elderly
If you are elderly but your kidney function is normal, you can take Ipamix.
Children and adolescents
Ipamix is not recommended in children and adolescents due to the lack of data on
safety and efficacy.

If you use more IPAMIX than you should
In case of ingestion/accidental intake of an excessive dose of IPAMIX, immediately
inform your doctor or go to the nearest hospital.
At doses higher than those recommended, indapamide exerts a significant diuretic action with
reduction of blood volume (volemia) and alterations in blood concentration (electrolyte and acid-base
balance), which may lead to nausea, vomiting, low blood pressure
(hypotension), cramps, dizziness, drowsiness, confusion, and problems with urination (polyuria or
oliguria) up to the inability to urinate (anuria). If you take an excessive dose of Ipamix
consult your doctor who will adopt adequate measures to support respiratory and
cardiovascular function.

If you forget to take IPAMIX
Do not take a double dose to make up for a missed dose.
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 everyone will experience them.
Most of the side effects on clinical or laboratory parameters are dose
dependent.

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

Uncommon (may affect up to 1 in 100 people):
vomiting,
bleeding at the level of the tissues with the appearance of spots (purpura).

Rare (may affect up to 1 in 1000 people):
dizziness,
fatigue,
headache,
altered sensitivity of arms and legs (paresthesia),
drowsiness,
nausea,
constipation,
dry mouth,
muscle cramps.

Very Rare (may affect up to 1 in 10,000 people):
decreased platelets in the blood (thrombocytopenia),
decreased white blood cells (leukopenia),
decreased white blood cells known as granulocytes (agranulocytosis),
reduced production of blood cells (aplastic anemia),
reduced concentration of hemoglobin in the blood (hemolytic anemia),
irregular heartbeat (arrhythmia),
decreased blood pressure (hypotension),
inflammation of the pancreas (pancreatitis),
liver function abnormalities,
swelling of the face, tongue and larynx (angioedema) and/or hives,
painful localized erythema, with desquamation accompanied by chills, pain and fever
(toxic epidermal necrolysis),
skin lesions accompanied by desquamation, high fever, vomiting and diarrhea (Stevens-Johnson
syndrome),
kidney failure,
increased calcium levels in the blood (hypercalcemia).

Not Known (frequency cannot be estimated from available data):
loss of consciousness (syncope),
myopia,
blurred vision,
visual impairment,
Decreased vision or eye pain due to high pressure (possible signs of
fluid accumulation in the vascular layer of the eye (choroidal effusion))
mental confusion,
heart rhythm disorder known as torsades de pointes (potentially fatal) (see
“Precautions for use” and “Interactions”),
excessive decrease in blood pressure when standing up (orthostatic hypotension),
alteration of brain function due to insufficient liver function
(hepatic encephalopathy),
liver inflammation (hepatitis),
possible worsening of a pre-existing skin condition known as acute disseminated lupus
erythematosus,
skin rash,
photosensitivity (see “Warnings and precautions”),
falls,
acute kidney failure,
heart rhythm disorder known as QT interval prolongation,
increased glucose and uric acid levels in the blood,
mild increase in blood urea nitrogen,
elevated liver enzyme levels,
decreased potassium levels (hypokalemia),
decreased sodium levels (hyponatremia) and blood volume (hypovolemia),
Concomitant loss of chloride ions can lead to a secondary compensatory metabolic alkalosis:
the incidence and severity of this effect are mild.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult 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 IPAMIX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 IPAMIX 2.5 mg, 50 coated tablets contains
The active ingredient is:indapamide

1 coated tablet contains:indapamide 2.5 mg

The other ingredients are: Corn starch, glycerol 85%, lactose monohydrate, magnesium stearate,
hypromellose, macrogol 6000, povidone, sodium lauryl sulfate, talc, titanium dioxide.

Description of IPAMIX and contents of the pack
IPAMIX is presented in 2.5 mg coated tablets, in packs of 50 tablets.

Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Italy

Manufacturer responsible for batch release
IPAMIX 2.5mg coated tablets 50 tablets
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo 103012 Anagni (FR)