Igroseles

Patient Information Leaflet

IGROSELES 50 mg + 12.5 mg tablets

atenolol + chlorthalidone
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 questions, ask 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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Igroseles is and what it is used for

Igroseles contains two different active substances: atenolol and chlorthalidone. Atenolol belongs to a group of medicines called beta-blockers, which reduce heart rate and blood pressure. Chlorthalidone belongs to a group of medicines called diuretics, which work by increasing the amount of urine produced by the kidneys.
Igroseles is indicated for the treatment of mild to moderate high blood pressure (hypertension), particularly in cases that have not responded satisfactorily to treatment with atenolol (a beta-blocker) alone or with chlorthalidone (a diuretic) alone.

2. What you should know before taking Igroseles

Do not take Igroseles

• If you are allergic to atenolol or to chlorthalidone (or sulfonamide derivatives), or to any of the other ingredients of this medicine (listed in section 6).
• If you have a very slow heart rate (bradycardia).
  • If you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• If you have very low blood pressure (hypotension).
• If your doctor has diagnosed you with abnormally high levels of acid in your blood (metabolic acidosis).
• If you have severe peripheral arterial circulation disorders.
• If you have a heart rhythm disorder called "sinoatrial disease" or "second- or third-degree atrioventricular block".
• If you have an untreated tumour of the adrenal gland called "pheochromocytoma".
• If your heart function is inadequate and not controlled by appropriate therapy (uncontrolled heart failure).
• If you have severe liver and/or kidney problems.
• If you suffer from a condition called gout (high levels of uric acid in the blood causing severe pain and swelling in some joints).
• If you have abnormally low levels of potassium and/or sodium or abnormally high levels of calcium and/or uric acid in your blood.
• If you have Addison's disease (a disorder of the adrenal glands).
• If you are pregnant.
• If you are breastfeeding.

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

• If you suffer from heart failure.
• If you have a heart condition called Prinzmetal's angina, as Igroseles may increase the frequency and duration of angina attacks.
• If you have peripheral arterial circulation disorders, even if mild, as Igroseles may worsen these conditions.
• If you have a heart rhythm disorder called first-degree atrioventricular block, as Igroseles may worsen this condition.
• If you suffer from hypoglycaemia; this medicine may mask the symptoms indicating that your blood sugar levels (glycaemia) have dropped too low (hypoglycaemia), such as increased heart rate, palpitations, and excessive sweating. In addition, it may increase blood glucose levels, so regular monitoring during treatment is recommended.
• If you have a thyroid disorder (thyrotoxicosis). The medicine may mask symptoms of thyrotoxicosis such as rapid heartbeat, tremor, or excessive sweating.
• If you have an excessive reduction in heart rate. In such cases, your doctor may consider reducing the dosage.
• If you have a history of severe allergic reactions (e.g. anaphylaxis); this medicine may worsen such allergic reactions and reduce the response to adrenaline therapy. Igroseles may also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, your doctor may adjust the dosage.
• If you are being treated for a tumour called pheochromocytoma; in this case, your blood pressure must be closely monitored during treatment.
• If you have kidney problems (renal failure).
• If you are using ophthalmic beta-blockers, as the effects of Igroseles may be enhanced.
• If you have liver problems (impaired liver function or progressive hepatopathy).
• If you have altered blood levels of potassium, sodium, or uric acid, your doctor may prescribe periodic blood tests to monitor these parameters.
• If you develop symptoms suggestive of a lupus-like syndrome (a disease in which the immune system produces autoantibodies that primarily attack the skin and joints). Your doctor may decide to discontinue treatment.

If you are undergoing surgery, inform your doctor or healthcare staff that you are taking Igroseles.
It is important not to stop treatment with Igroseles abruptly, especially in patients with ischaemic heart disease.
Anti-doping tests
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Igroseles must not be administered to children and adolescents under 18 years of age.
Other medicines and Igroseles
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• Calcium antagonists (e.g. verapamil, diltiazem) or dihydropyridines (e.g. nifedipine), or clonidine, used to treat high blood pressure.
• Baclofen, used as a muscle relaxant acting on the central nervous system.
• Cardiac glycosides such as digitalis, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used to treat irregular heartbeats.
• Sympathomimetic medicines such as adrenaline, used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), used to control pain and inflammation.
• Oral antidiabetic medicines or insulin, used to treat diabetes.
• Medicines used to treat mental disorders (lithium). Concomitant use with Igroseles may require adjustment of the lithium medicine dosage.

If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking Igroseles. This is because low blood pressure (hypotension) may occur if certain types of anaesthetics are administered while you are taking this medicine.
Pregnancy and breastfeeding
Igroseles must not be taken during pregnancy.
Igroseles must not be taken during breastfeeding.
Driving and using machines
Igroseles may cause dizziness and fatigue. If these symptoms occur, do not drive and do not operate machinery.

3. How to take Igroseles

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one tablet daily.
Depending on your response to treatment, your doctor may prescribe a higher dose.
Use in children and adolescents
Igroseles must not be given to children and adolescents under 18 years of age.
Elderly patients
If you are elderly, your doctor may decide to prescribe Igroseles at lower doses.
Patients with reduced kidney function (renal impairment)
Igroseles must not be taken if you have severe kidney problems.
If you take more Igroseles than you should
If you take more Igroseles than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine package with you so that the doctor knows what you have taken.
The following symptoms may occur: slow heartbeat, low blood pressure, problems with the heart's pumping function (acute heart failure) and breathing difficulties, as well as narrowing of the lower airways (bronchi) causing breathing difficulty (bronchospasm).
If you forget to take Igroseles
If you forget to take a dose of Igroseles, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Igroseles
Do not stop taking Igroseles without talking to your doctor.
It is necessary to gradually discontinue treatment.
If you have any questions 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 gets them.

Common ( may affect up to 1 in 10 people)

• Cold hands and feet
• Slow heartbeat (bradycardia)
• Gastrointestinal disorders (including nausea)
• Feeling of tiredness
• Changes in some blood tests, such as increased levels of transaminases, increased levels of sugar (glucose), low sodium levels, low potassium levels, increased levels of uric acid.

Uncommon ( may affect up to 1 in 100 people)

• Sleep disorders

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

• Skin rashes (purpura)
• Reduction in the number of white blood cells (leucopenia) and platelets (thrombocytopenia) in the blood
• Mood changes
• Nightmares
• Changes in personality (psychosis) or hallucinations
• Psychiatric syndrome characterised by motor abnormalities including inability to move (catatonia)
• Worsening of nervous disorders with mental depression
• Feeling confused and memory disturbances
• Dizziness
• Headache
• Tingling or numbness in the hands or feet (paraesthesia)
• Dry eyes
• Visual disturbances
• Worsening of heart failure
• Disturbance of the electrical impulses that control the heartbeat (precipitation of heart block)
• Sudden drop in blood pressure upon sudden change in position (postural hypotension), which may be associated with loss of consciousness (syncope)
• Increased leg pain associated with physical exertion (worsening of intermittent claudication)
• Numbness and spasms in the fingers accompanied by heat and pain (Raynaud's disease)
• Sudden narrowing of the airways causing breathing difficulty (bronchospasm), if you suffer or have suffered from asthma
• Dry mouth
• Inflammation of the pancreas (pancreatitis)
• Liver damage (hepatic toxicity) and possible problems with bile retention in the liver (intrahepatic cholestasis)
• Hair loss
• Dry, scaly skin, as in psoriasis, or worsening of psoriasis
• Skin rash
• Worsening of colourless patches on the skin, if you suffer from vitiligo
• Inability to maintain an erection (impotence)

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

• Increase in antibodies that the body produces against itself, known as antinuclear antibodies (detected in blood tests). This has been observed, but its clinical significance is unknown.

Not known ( frequency cannot be estimated from the available data)

• Constipation
• Allergic reactions (hypersensitivity reactions) to the medicine
• Swelling of the face, hands, feet (angioedema)
• Hives (urticaria)
• Lupus-like syndrome (a disease in which the immune system produces autoantibodies that primarily attack the skin and joints)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Igroseles

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp."
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Igroseles contains

• The active substances are atenolol and chlorthalidone. Each tablet contains 50 mg of atenolol and 12.5 mg of chlorthalidone.
• The other components are magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate, and corn starch.

Description of the appearance of Igroseles and package contents
Igroseles 50 mg + 12.5 mg tablets are white, round and biconvex.
Igroseles 50 mg + 12.5 mg tablets are packaged in PVC/aluminum blisters and available in packs containing 28 tablets.
Marketing Authorization Holder
TEOFARMA S.R.L.
VIA FRATELLI CERVI, 8, 27010 - VALLE SALIMBENE - PAVIA (PV).
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
Quinto de’ Stampi
20089 Rozzano (MI)
Italy
Patient Information Leaflet

IGROSELES 100 mg + 25 mg tablets
atenolol + chlorthalidone

Please 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 for you only. Do not give it to others, even if their symptoms are the same as yours, as it may 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 Igroseles is and what it is used for
2. What you need to know before taking Igroseles
3. How to take Igroseles
4. Possible side effects
5. How to store Igroseles
6. Package contents and other information

1. What Igroseles is and what it is used for

Igroseles contains two different active substances: atenolol and chlorthalidone. Atenolol belongs to a group of medicines called beta-blockers, which reduce heart rate and blood pressure. Chlorthalidone belongs to a group of medicines called diuretics, which work by increasing the amount of urine produced by the kidneys.
Igroseles is indicated for the treatment of high arterial pressure (hypertension), particularly in cases that have not responded satisfactorily to treatment with atenolol (a beta-blocker) alone or with chlorthalidone (a diuretic) alone.

2. What you need to know before taking Igroseles

Do not take Igroseles

• If you are allergic to atenolol or chlorthalidone (or sulphonamide derivatives), or to any of the other ingredients of this medicine (listed in section 6).
• If you have a very slow heartbeat (bradycardia).
• If you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body.
• If you suffer from very low blood pressure (hypotension).
• If your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis).
• If you suffer from severe peripheral arterial circulatory disorders.
• If you have a heart rhythm disorder called "sinoatrial node disease" or "second- or third-degree atrioventricular block".
• If you have an untreated tumour of the adrenal gland called "pheochromocytoma".
• If your heart function is inadequate and not controlled by appropriate therapy (uncontrolled heart failure).
• If you have severe liver and/or kidney problems.
• If you suffer from gout (a condition characterized by high levels of uric acid in the blood causing severe pain and swelling in some joints).
• If you have abnormally low levels of potassium and/or sodium or abnormally high levels of calcium and/or uric acid in the blood.
• If you have Addison's disease (a disorder of the adrenal glands).
• If you are pregnant.
• If you are breastfeeding.

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

• If you suffer from heart failure.
• If you have a heart condition called Prinzmetal's angina, as Igroseles may increase the frequency and duration of angina attacks.
• If you suffer from peripheral arterial circulatory disorders, even if mild, as Igroseles may worsen these conditions.
• If you have a heart rhythm disorder called first-degree atrioventricular block, as Igroseles may worsen this condition.
• If you suffer from hypoglycaemia; this medicine may mask the symptoms indicating that blood sugar levels (glycaemia) have dropped too low (hypoglycaemia), such as increased heart rate, palpitations, and excessive sweating. Furthermore, it may increase blood glucose levels, so regular monitoring is recommended during treatment.
• If you have a thyroid disorder (thyrotoxicosis). This medicine may mask symptoms of thyrotoxicosis such as rapid heartbeat, tremor, or excessive sweating.
• If you experience excessive reduction in heart rate. In such cases, your doctor may consider reducing the dosage.
• If you have a history of severe allergic reactions (e.g. anaphylaxis); this medicine may worsen such allergic reactions and reduce the response to adrenaline therapy. Igroseles may also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, your doctor may adjust the dosage.
• If you are being treated for a tumour called pheochromocytoma; in this case, your blood pressure must be closely monitored during treatment.
• If you have kidney problems (renal failure).
• If you are using ophthalmic beta-blockers, as the effects of Igroseles may be enhanced.
• If you have liver problems (impaired liver function or progressive hepatopathy).
• If you have abnormal blood levels of potassium, sodium, or uric acid, your doctor may prescribe periodic blood tests to monitor these levels.
• If you develop symptoms suggestive of a lupus-like syndrome (a disease in which the immune system produces autoantibodies that primarily attack the skin and joints). Your doctor may decide to discontinue treatment.

If you are scheduled for surgery, inform your doctor or healthcare provider that you are taking Igroseles.
It is important not to stop treatment with Igroseles abruptly, especially in patients with ischaemic heart disease.

Anti-doping tests
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Children and adolescents
Igroseles must not be administered to children or adolescents under 18 years of age.

Other medicines and Igroseles
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• Calcium antagonists (e.g. verapamil, diltiazem) or dihydropyridines (e.g. nifedipine), or clonidine, used to treat high blood pressure.
• Baclofen, used as a muscle relaxant acting on the central nervous system.
• Cardiac glycosides such as digoxin, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used to treat irregular heartbeats.
• Sympathomimetic medicines such as adrenaline, used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), used to control pain and inflammation.
• Oral antidiabetic medicines or insulin, used to treat diabetes.
• Medicines used to treat mental disorders (lithium). Concomitant use with Igroseles may require adjustment of the lithium-based medicine dosage.

If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking Igroseles. This is because low blood pressure (hypotension) may occur if certain types of anaesthetics are administered while you are taking this medicine.

Pregnancy and breastfeeding
Igroseles must not be taken during pregnancy.
Igroseles must not be taken during breastfeeding.

Driving and using machines
Igroseles may cause dizziness and fatigue. If these symptoms occur, do not drive or operate machinery.

3. How to take Igroseles

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one tablet daily.
Depending on your response to treatment, your doctor may prescribe that you also take another antihypertensive medicine, for example a vasodilator, at the same time.
Use in children and adolescents
Igroseles must not be given to children and adolescents under 18 years of age.
Elderly patients
If you are elderly, your doctor may decide to prescribe lower doses of Igroseles.
Patients with reduced kidney function (renal impairment)
Igroseles must not be taken if you have severe kidney problems.
If you take more Igroseles than you should
If you take more Igroseles than prescribed by your doctor, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine’s packaging with you so that the doctor knows what you have taken.
The following symptoms may occur: slow heartbeat, low blood pressure, problems with the heart's pumping function (acute heart failure) and breathing difficulties, as well as narrowing of the lower airways (bronchi) causing breathing difficulties (bronchospasm).
If you forget to take Igroseles
If you forget to take a dose of Igroseles, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Igroseles
Do not stop taking Igroseles without talking to your doctor.
It is necessary to gradually discontinue treatment.
If you have any questions 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 everybody gets them.

Common ( may affect up to 1 in 10 people)

• Cold hands and feet
• Slowed heartbeat (bradycardia)
• Gastrointestinal disorders (including nausea)
• Feeling of tiredness
• Changes in certain blood tests, such as increased transaminase levels, increased blood sugar (glucose) levels, low sodium levels, low potassium levels, increased uric acid levels

Uncommon ( may affect up to 1 in 100 people)

• Sleep disorders

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

• Skin spots (purpura)
• Reduced number of white blood cells (leucopenia) and platelets (thrombocytopenia) in the blood
• Mood changes
• Nightmares
• Changes in personality (psychosis) or hallucinations
• Psychiatric syndrome characterized by motor abnormalities including inability to move (catatonia)
• Worsening of neurological disorders with mental depression
• Feeling confused and memory disorders
• Dizziness
• Headache
• Tingling or numbness in hands or feet (paraesthesia)
• Dry eyes
• Visual disturbances
• Worsening of heart failure
• Alteration of the impulses that regulate heartbeat (precipitation of heart block)
• Sudden drop in blood pressure upon changing position (postural hypotension), which may be associated with loss of consciousness (syncope)
• Increased leg pain associated with physical exertion (worsening of intermittent claudication)
• Numbness and spasm in fingers accompanied by heat and pain (Raynaud's disease)
• Sudden narrowing of the airways causing breathing difficulty (bronchospasm), if you have or have had asthma
• Dry mouth
• Inflammation of the pancreas (pancreatitis)
• Liver damage (hepatic toxicity) and possible impairment of bile flow within the liver (intrahepatic cholestasis)
• Hair loss
• Dry, scaly skin as in psoriasis, or worsening of psoriasis
• Skin rash
• Worsening of depigmented skin patches, if you suffer from vitiligo
• Inability to maintain an erection (impotence)

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

• Increase in antibodies produced by the body against itself, known as antinuclear antibodies (detected in blood tests). This has been observed, but its clinical significance is unknown

Not known ( frequency cannot be estimated from the available data)

• Constipation (stipsis)
• Allergic reactions (hypersensitivity reactions) to the medicine
• Swelling of the face, hands, feet (angioedema)
• Hives (urticaria)
• Lupus-like syndrome (a condition in which the immune system produces autoantibodies that primarily attack the skin and joints)

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: http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Igroseles

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 the word
Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Igroseles contains

• The active substances are atenolol and chlorthalidone. Each tablet contains 100 mg of atenolol and 25 mg of chlorthalidone.
• The other components are magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate, maize starch.

Description of the appearance of Igroseles and package contents
Igroseles 100 mg + 25 mg tablets are white, round, biconvex, with a break line on one side.
Igroseles tablets are packaged in PVC/aluminum blisters and are available in packs containing 28 tablets.
Marketing Authorization Holder
TEOFARMA S.R.L.
VIA FRATELLI CERVI, 8, 27010 - VALLE SALIMBENE - PAVIA (PV).
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
Quinto de’ Stampi
20089 Rozzano (MI)
Italy