IGROSELES 100 mg/25 mg Coated Tablet

Зміст інструкції

1. IGROSELES 50 mg + 12,5 mg tablets
   1. What is Igroseles and what is it 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
2. IGROSELES 100 mg + 25 mg tablets
   1. What is Igroseles and what is it 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

IGROSELES 50 mg + 12,5 mg tablets

atenolol + clortalidone

Read this leaflet carefully before you start to take 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.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Igroseles and what is it used for

Igroseles contains two different active ingredients: atenolol and clortalidone. Atenolol belongs to a
group of medicines called beta-blockers which reduce the heart rate and blood
pressure. Clortalidone 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 or
moderate high blood pressure (hypertension) particularly in those forms that have not responded satisfactorily to
treatment with atenolol (beta-blocker) alone or with clortalidone (diuretic) alone.

2. What you need to know before taking Igroseles

Do not take Igroseles

• If you are allergic to atenolol or chlortalidone (or to sulfonamide 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 serious heart problem, known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout your body;
• If you suffer from very low blood pressure (hypotension).
• If your doctor has diagnosed you with higher than normal acid levels in your blood (metabolic acidosis).
• If you suffer from severe peripheral arterial circulation disorders.
• If you have a heart rhythm disorder called “sick sinus syndrome” or “second or third degree atrioventricular block”.
• If you have a tumor of the adrenal gland, called “pheochromocytoma” that has not been treated.
• If your heart function is insufficient and is not controlled by adequate therapy (uncontrolled heart failure).
• If you have serious problems with your liver and/or kidneys.
• If you suffer from a condition called gout (high concentration of uric acid in the blood that causes intense pain and swelling in some joints).
• If you have very low levels of potassium and/or sodium or very high levels of calcium and/or uric acid in your blood.
• If you suffer from Addison's disease (a disease 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 because Igroseles can increase the number and duration of angina attacks.
• If you suffer from peripheral arterial circulation disorders, even if mild, because Igroseles can worsen these disorders.
• If you have a heart rhythm disorder called first-degree atrioventricular block because Igroseles can worsen this condition.
• If you suffer from hypoglycemia; this medicine can mask the symptoms that signal that blood sugar (glycemia) levels have dropped too low (hypoglycemia) such as increased heart rate, palpitations and excessive sweating. In addition, it can increase blood sugar, so it is good to measure it repeatedly during treatment.
• If you have thyroid problems (thyrotoxicosis). The medicine can hide the symptoms of thyrotoxicosis such as a fast heartbeat, tremors or excessive sweating.
• If you have an excessive reduction in heart rate. In such cases, your doctor may consider reducing the dosage of the medicine.
• If you have a history of severe allergic reactions (e.g., anaphylaxis); this medicine can worsen such allergic reactions and reduce the response to epinephrine therapy. Igroseles can also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, your doctor may consider adjusting the dosage of the medicine.
• If you are being treated for a type of tumor called pheochromocytoma; in this case, blood pressure will need to be closely monitored during treatment;
• If you have kidney problems (renal insufficiency).
• If you are in therapy with ophthalmic beta-blockers as the effects of Igroseles may be potentiated.
• If you have liver problems (impaired liver function or progressive liver disease).
• If you have altered blood concentrations of potassium, sodium and uric acid, your doctor may prescribe you to have blood tests for a periodic check of these elements in the blood.
• If you develop symptoms indicative of a lupus-like syndrome (a disease in which the immune system produces autoantibodies that attack mainly the skin and joints). Your doctor may decide to stop treatment.

If you are going to undergo surgery, inform your doctor or healthcare personnel that you are
taking Igroseles.
It is important not to abruptly stop treatment with Igroseles, especially in
patients with ischemic heart disease.

Anti-doping tests
For those who engage in sports: the use of this medicine without therapeutic need constitutes
doping and may still result in a positive doping test.

Children and adolescents
Igroseles should not be given to children and adolescents under the age of 18 years.

Other medicines and Igroseles
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 with action on the nervous system.
• Cardiac glycosides such as digitalis, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used for the treatment of irregular heartbeats.
• Sympathomimetic medicines such as epinephrine used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indometacin) used for pain and inflammation control.
• Oral antidiabetic medicines or insulin administered for the treatment of diabetes.
• Medicines used to treat mental illnesses (lithium). Concomitant use with Igroseles may require an adjustment of the dosage of the lithium-based medicine.

If you have to go to hospital for surgery, inform the anesthesiologist or medical
personnel that you are taking Igroseles. This is because a drop in
blood pressure (hypotension) may occur if you are given certain types of anesthetics while
taking this medicine.

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

Driving and using machines
Igroseles can cause dizziness and fatigue. If you experience these symptoms, do not drive and
do not use machines.

3. How to take Igroseles

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

Adults
The recommended dose is one tablet a day.
Based on your response to treatment, your doctor may prescribe a higher dose.

Use in children and adolescents
Igroseles should not be administered to children and adolescents under the age of 18 years.

Elderly patients
If you are elderly, your doctor may decide to prescribe Igroseles at lower doses.

Patients with reduced kidney function (renal insufficiency)
Igroseles should not be taken if you suffer from 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 emergency room of the nearest hospital.
Bring the package of the medicine 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 difficulty breathing, as well as
narrowing of the lower airways (bronchi) with difficulty breathing (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 to take the next dose, skip the forgotten dose. Do not take a double
dose to make up for the missed dose.

If you stop taking Igroseles
Do not stop taking Igroseles without talking to your doctor.
It is necessary to stop taking it gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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)

• Cold hands and feet
• Slowed heartbeat (bradycardia)
• Gastrointestinal disorders (including nausea)
• Feeling tired
• Changes in some blood tests, such as an increase in the levels of transaminases,

of 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)
• Reduction in the number of white blood cells (leukopenia) and platelets (thrombocytopenia) in the blood
• Changes in mood
• Nightmares
• Changes in personality (psychosis) or hallucinations
• Psychiatric syndrome characterized by motor anomalies including inability to move (catatonia)
• Worsening of nervous disorders with mental depression
• Feeling of confusion and memory disorders
• Dizziness
• Headache
• Sensations of tingling or numbness in the hands or feet (paresthesia)
• Dry eyes
• Visual disturbances
• Worsening of heart failure
• Alteration of the impulses that determine the heartbeat (precipitation of cardiac block)
• Sudden drop in blood pressure following a sudden change in position (postural hypotension) which may be associated with loss of consciousness (syncope)
• Increased leg pain in association with physical exertion (worsening of intermittent claudication)
• Numbness and spasm in the fingers accompanied by warmth and pain (Raynaud's disease)
• Sudden narrowing of the airways causing difficulty breathing (bronchospasm) if you suffer from or have suffered from asthma
• Dry mouth
• Inflammation of the pancreas (pancreatitis)
• Liver damage (hepatic toxicity) and possible problems with bile stagnation in the liver (intrahepatic cholestasis)
• Hair loss
• Dry and scaly skin, such as in psoriasis, or worsening of psoriasis
• Skin rash
• Worsening of colorless 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, called antinuclear antibodies (highlighted by blood tests). This has been observed, but its clinical significance is unknown

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist.
You can also report side effects directly through the national 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 which is stated on the pack after the designation
Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Igroseles contains

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

Description of the appearance of Igroseles and contents of the pack
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 are
available in packs containing 28 tablets.

Marketing Authorisation 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

IGROSELES 100 mg + 25 mg tablets

atenolol + clortalidone

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Igroseles and what is it used for

Igroseles contains two different active ingredients: atenolol and clortalidone. Atenolol belongs to a
group of medicines called beta-blockers which reduce the heart rate and blood
pressure. Clortalidone 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 blood pressure (hypertension) in
particular in those forms that have not responded satisfactorily to treatment with
atenolol (beta-blocker) alone or with clortalidone (diuretic) alone.

2. What you need to know before taking Igroseles

Do not take Igroseles

• If you are allergic to atenolol or chlortalidone (or to sulfonamide 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 serious heart problem, 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 higher than normal levels of acid in the blood (metabolic acidosis).
• If you suffer from severe disorders of peripheral arterial circulation.
• If you have a heart rhythm disorder called “sick sinus syndrome” or “second or third degree atrioventricular block”.
• If you have an untreated tumor of the adrenal gland, called “pheochromocytoma”;
• If your heart function is insufficient and is not controlled by adequate therapy (uncontrolled heart failure);
• If you have serious problems with your liver and/or kidneys.
• If you suffer from a condition called gout (high concentration of uric acid in the blood that causes intense pain and swelling in some joints).
• If you have very low levels of potassium and/or sodium or very high levels of calcium and/or uric acid in the blood.
• If you suffer from Addison's disease (a disease 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 because Igroseles can increase the number and duration of angina attacks.
• If you suffer from disorders of peripheral arterial circulation even if mild, because Igroseles can worsen these disorders.
• If you have a heart rhythm disorder called first-degree atrioventricular block because Igroseles can worsen this condition.
• If you suffer from hypoglycemia; this medicine can mask the symptoms that signal that blood sugar (glycemia) levels have dropped too low (hypoglycemia) such as, for example, increased heart rate, palpitations and excessive sweating. Furthermore, it can increase blood sugar, so it is good to measure it repeatedly during treatment.
• If you have problems with your thyroid (thyrotoxicosis). The medicine can hide the symptoms of thyrotoxicosis such as a 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 of the medicine.
• If you have a history of severe allergic reactions (e.g., anaphylaxis); this medicine can worsen such allergic reactions and reduce the response to adrenaline therapy. Igroseles can also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, your doctor may consider adjusting the dosage of the medicine
• If you are being treated for a type of tumor called pheochromocytoma; in this case, blood pressure will need to be closely monitored during treatment;
• If you have kidney problems (renal insufficiency).
• If you are in therapy with ophthalmic beta-blockers as the effects of Igroseles may be potentiated.
• If you have liver problems (impaired liver function or progressive liver disease).
• If you have altered blood concentrations of potassium, sodium and uric acid, your doctor may prescribe you to undergo blood tests for periodic monitoring of these elements in the blood.
• If you develop symptoms indicative of a lupus-like syndrome (a disease in which the immune system produces autoantibodies that primarily attack the skin and joints). The doctor may decide to stop the treatment.

If you are going to have surgery, tell your doctor or healthcare professionals that you are
taking Igroseles.
It is important not to stop treatment with Igroseles abruptly, especially in
patients with ischemic heart disease.

Doping control
For those who engage in sports: the use of this medicine without therapeutic need constitutes
doping and may still result in a positive doping test.

Children and adolescents
Igroseles should not be given to children or adolescents under the age of 18 years.

Other medicines and Igroseles
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 with action on the nervous system.
• Cardiac glycosides such as digitalis, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used for the treatment of irregular heartbeats.
• Sympathomimetic medicines such as adrenaline used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indometacin) used for pain and inflammation control.
• Oral antidiabetic medicines or insulin administered for the treatment of diabetes.
• Medicines used to treat mental illnesses (lithium). Concomitant use with Igroseles may require an adjustment of the dosage of the lithium-based medicine.

If you have to go to hospital for surgery, tell the anesthesiologist or medical
staff that you are taking Igroseles. This is because a drop in
blood pressure (hypotension) may occur if you are given certain types of anesthetics while
taking this medicine.

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

Driving and using machines
Igroseles can cause dizziness and fatigue. If you experience these symptoms, do not drive and
do not use machines.

3. How to take Igroseles

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

Adults
The recommended dose is one tablet a day.
Based on your response to treatment, your doctor may prescribe you to take
simultaneously another antihypertensive medicine, for example a vasodilator.

Use in children and adolescents
Igroseles must not be administered to children and adolescents under 18 years of age.

Elderly patients
If you are elderly, your doctor may decide to prescribe you Igroseles at lower doses.

Patients with reduced kidney function (renal insufficiency)
Igroseles must not be taken if you suffer from 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 room.
Bring the package of the medicine 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 difficulty breathing, as well as
narrowing of the lower airways (bronchi) with difficulty breathing (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 to take the next dose, skip the forgotten 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 stop taking it gradually.
If you have any doubts about the use of this medicine, ask 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 tired
• Changes to some blood tests such as for example increased levels of transaminases, increased levels of sugar (glucose), low levels of sodium, low levels of potassium, 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 spots (purpura)
• Reduction in the number of white blood cells (leukopenia) and platelets (thrombocytopenia) in the blood
• Changes in mood
• Nightmares
• Changes in personality (psychosis) or hallucinations
• Psychiatric syndrome characterized by motor anomalies including inability to move (catatonia)
• Worsening of nervous disorders with mental depression
• Feeling of confusion and memory disorders
• Dizziness
• Headache
• Sensations of tingling or numbness in the hands or feet (paresthesia)
• Dry eyes
• Visual disturbances
• Worsening of heart failure
• Alteration of the impulses that determine the heartbeat (precipitation of heart block)
• Sudden drop in blood pressure following a sudden change in position (postural hypotension) which may be associated with loss of consciousness (syncope)
• Increased leg pain during physical exertion (worsening of intermittent claudication)
• Numbness and spasm of the fingers which is accompanied by heat and pain (Raynaud's disease)
• Sudden narrowing of the airways causing difficulty breathing (bronchospasm) if you suffer from or have suffered from asthma
• Dry mouth
• Inflammation of the pancreas (pancreatitis)
• Liver damage (hepatic toxicity) and possible problems with bile stagnation in the liver (intrahepatic cholestasis)
• Hair loss
• Dry and scaly skin like 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, called antinuclear antibodies (detected by blood tests). This has been observed, but its clinical importance is not known

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national system of
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 which is stated on the pack after the designation
Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Igroseles contains

• The active ingredients are atenolol and chlortalidone. Each tablet contains 100 mg of atenolol + 25 mg of chlortalidone.
• The other ingredients are magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate, corn starch.

Description of the appearance of Igroseles and contents of the pack
Igroseles 100 mg + 25 mg tablets are white, round, biconvex with a fracture line
on one side.
Igroseles tablets are packaged in PVC/aluminum blisters and are available in
packs containing 28 tablets.

Marketing Authorisation 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