IGROTON 25 mg Tablet

Зміст інструкції

1. Igroton 25 mg tablets
   1. What is Igroton and what is it used for
   2. What you need to know before taking IGROTON
   3. How to take Igroton
   4. Possible side effects
   5. How to store Igroton
   6. Contents of the pack and other information

Igroton 25 mg tablets

Clortalidone

Read this leaflet carefully before you start using 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.

Consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Igroton and what is it used for

Igroton contains the active ingredient clortalidone which is a diuretic that reduces the amount of salt and water in the
body, increasing the elimination of urine.
Igroton is used for:

• reducing high blood pressure;
• reducing fluid retention that occurs with some diseases affecting the heart, kidneys or liver and in other clinical conditions (premenstrual bloating and swelling of undefined nature).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking IGROTON

Do not take Igroton

• If you are allergic to chlortalidone or other similar medicines or to any of the other components of this medicine (listed in section 6)
• if you suffer from a severe liver or kidney disease;
• if you suffer from urinary retention (difficulty passing urine);
• if your potassium or sodium levels in the blood are very low or if the calcium level in the blood is very high;
• if you suffer (or have suffered) from gout or kidney stones from uric acid;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Igroton:

• if you suffer from a kidney or liver disorder
• if you suffer from blood circulation problems or heart disease - if you are affected by diabetes
• if the level of potassium, sodium or magnesium in the blood is too low or the level of calcium in the blood is too high because:
• low blood levels of potassium can cause muscle weakness, muscle cramps or abnormal heartbeat.
• low blood levels of sodium can cause fatigue, confusion, muscle spasms, convulsions or coma.
• high blood levels of calcium can cause loss of appetite, fatigue or muscle weakness
• if the level of cholesterol in the blood is too high
• if you have high blood levels of uric acid
• if you are taking other medicines (see section "Other medicines and Igroton)")
• if you have myopia or closed-angle glaucoma (increased eye pressure). Untreated closed-angle glaucoma can lead to permanent vision loss.
• if you suffer from systemic lupus erythematosus

It is important that the doctor regularly checks your condition to verify that the medicine is working correctly.
It may be necessary to take blood samples at regular intervals, especially if you are over 65 years of age, if you suffer from a heart, liver or kidney disorder or if you are taking potassium. You should undergo periodic monitoring of electrolytes because hyponatremia, hypokalemia, hypomagnesemia or hypercalcemia may occur.
Caution for those who practice sports: the active ingredient contained in this preparation is
included in the list of prohibited substances for doping

Other medicines and Igroton
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
It may be necessary to adjust the dose or, in some cases, stop taking a medicine. This applies in particular to the following medicines:

• medicines that lower blood pressure or used in the treatment of heart problems such as ACE inhibitors (for example, lisinopril) or angiotensin II receptor antagonists (for example candesartan, losartan) or beta blockers (for example, propranolol hydrochloride) or methyldopa, guanethidine or vasodilators (for example bosentan) or diazoxide or calcium antagonists (for example amlodipine)
• adrenocorticotropic hormone (ACTH) - used to treat various conditions, such as some autoimmune diseases
• corticosteroids such as prednisolone or betamethasone - used for the treatment of allergic and inflammatory diseases and immune reactions
• cytotoxic agents such as cyclophosphamide or methotrexate - used to cure cancer
• beta agonists (medicines for the treatment of asthma, such as salbutamol or formoterol)
• medicines used to treat infections (amphotericin)
• medicines used to treat ulcers (carbenoxolone)
• medicines used to treat some mental disorders (lithium, barbiturates, narcotics, antidepressants)
• anticholinergics such as atropine sulfate or scopolamine butylbromide - for abdominal or stomach spasms or cramps
• medicines used to reduce cholesterol levels and prevent heart disease (cholestyramine)
• medicines used for the treatment of Parkinson's disease or viral infections (amantadine)
• medicines used to treat gout (allopurinol)
• pain relievers or anti-inflammatory drugs such as aspirin or indometacin
• medicines used for the treatment of irregular heartbeat (digoxin)
• medicines used for diabetes (insulin and other treatments for diabetes, such as chlorpropamide or glibenclamide. It may be necessary to adjust the dose)
• medicines used for the treatment of skin diseases or rheumatic disorders or after a transplant (cyclosporine)
• vitamin D and calcium salts used for replacement therapy
• curare derivatives (used in anesthesia)
• drugs used in the treatment of some cancers (such as cyclophosphamide and methotrexate)

Igroton with alcohol
Avoid consuming alcohol before discussing it with your doctor. Alcohol can further lower blood pressure and/or increase the possibility of dizziness or fainting.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Igroton if you are pregnant or planning a pregnancy (See section “Do not take Igroton”).
Tell your doctor immediately if you notice that you are pregnant while being treated with Igroton .
Breastfeeding
Do not use Igroton if you are breastfeeding because chlortalidone passes into breast milk and could harm your baby.

Driving and using machines
As with many other medicines used to treat high blood pressure, Igroton can cause dizziness and affect concentration. Therefore, before driving a vehicle or using machinery or performing other activities that require quick reactions, you need to make sure you know how Igroton affects you.

3. How to take Igroton

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

Recommended dose

Blood pressure
The doctor will prescribe the lowest possible dose that meets your needs. Follow your doctor's instructions.
Treatment starts with the lowest dose (half a tablet) and then the dosage is gradually increased
gradually.
Generally, the recommended initial dose is 12.5 mg/day or 25 mg/day.
Normally, the tablets should be taken with liquid during meals, preferably in the morning.
If this dose does not yet produce satisfactory results, the doctor may add another medicine for the
treatment.
The doctor will prescribe the lowest possible dose that meets your needs. It is recommended not to exceed
the dose of 50 mg/day.

Use in the elderly
The recommended dose is the standard effective lowest dose of Igroton. In elderly patients, the elimination of
chlortalidone occurs more slowly than in young healthy adults. Therefore, if you are an elderly patient and are being treated with chlortalidone, you must be closely monitored and a
dose reduction may be necessary.
Elderly patients are more sensitive to electrolyte imbalances.

In case of altered kidney function
The standard effective lowest dose of Igroton is recommended if you are a patient with mild renal
insufficiency.
Igroton and thiazide diuretics reduce their diuretic effect if creatinine clearance is <30 ml/min.

If you take more Igroton than you should
If you use more Igroton than you should, contact your doctor, pharmacist or poison control center immediately.
In case of overdose, the following symptoms may occur:

• dizziness
• drowsiness
• lowering of blood pressure
• nausea
• irregular heartbeat
• unusual fatigue, weakness or muscle cramps.

If you forget to take Igroton
If you forget to take a dose, take it as soon as possible, unless it is almost time to take the
next dose. Do not take a double dose.

If you stop taking Igroton
There are no predictable symptoms when treatment with Igroton is stopped.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using Igroton. Inform your doctor immediately, or go to the nearest hospital emergency room:
Allergic reactions: skin rash, swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing.

Tell your doctor as soon as possible if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)

• low blood levels of potassium which can cause muscle weakness, muscle cramps or abnormal heartbeat;
• increased levels of uric acid;
• increased levels of fats in the blood.

Common (may affect up to 1 in 10 people)

• skin rash or itching;
• low levels of sodium, which can cause fatigue, confusion, muscle spasms, convulsions or coma;
• low levels of magnesium;
• high levels of sugar in the blood which can cause fatigue, weakness or feeling thirsty;
• dizziness;
• lowering of blood pressure;
• abdominal discomfort;
• loss of appetite;
• hives and skin rashes;
• impotence.

Rare (may affect up to 1 in 1,000 people)

• changes in blood cells (reduction of platelets, increase or reduction of white blood cells);
• liver disorders and; yellowish discoloration of the eyes and skin (jaundice);
• numbness or tingling in the hands, feet or lips;
• blurred vision;
• irregular heartbeat;
• sugar in the urine (which is detected when your doctor or nurse performs a urine test);
• worsening of diabetes;
• increased calcium in the blood which can cause agitation, sore eyes, abdominal pain;
• gout;
• headache;
• nausea, vomiting, abdominal pain, diarrhea or constipation;
• skin reaction following exposure to sunlight.

Very rare (may affect up to 1 in 10,000 people)

• low levels of chloride in the blood
• inflammation of the pancreas (pancreatitis);
• breathing problems (signs of pneumonia and pulmonary edema);
• inflammation of the kidneys;
• inflammation of blood vessels, often with skin rash.

Not known (frequency cannot be estimated from available data)

• acute myopia and closed-angle glaucoma. Symptoms include eye pain and blurred vision.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Igroton

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 Igroton contains

• The active ingredient is chlortalidone. Each tablet contains 25 mg of chlortalidone.
• The other ingredients are: microcrystalline cellulose; magnesium stearate; anhydrous colloidal silica; sodium carboxymethylcellulose; red iron oxide; yellow iron oxide (E 172)

Description of the appearance of Igroton and contents of the pack
Igroton tablets have a dividing line on one side. Igroton is available in packs of 30
tablets containing 25 mg.

Marketing Authorisation Holder
Amdipharm Ltd
3 Burlington Road, Dublin 4 Temple Chambers - Ireland

Manufacturer
NOVARTIS FARMA S.p.A., Via Provinciale Schito, 131, 80058 - Torre Annunziata (NA)
AMDIPHARM UK Limited, Capital House, 85 King William Street, London - EC4N 7BL (UK)
Cenexi SAS 52 Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois, France