Metoprolol EG

Package leaflet: Information for the patient

METOPROLOL EG 100 mg tablets

Equivalent medicine
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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METOPROLOLO EG is and what it is used for

METOPROLOLO EG contains the active substance metoprolol tartrate. Metoprolol tartrate belongs to a group of medicines called selective beta-blockers, which work by slowing down the heartbeat and making the heart beat with less force.
METOPROLOLO EG is indicated in adults for:

• treating high blood pressure (arterial hypertension);
• treating and preventing angina pectoris attacks (heart disease characterized by chest pain);
• treating a heart attack (acute myocardial infarction);
• treating irregular heartbeat (arrhythmias, except bradyarrhythmias);
• treating hyperkinetic cardiac syndromes (increased heart rate, which may also be perceived as palpitations or fluttering);
• preventing migraine (a type of headache).

If you do not feel better or feel worse, consult your doctor.

2. What you need to know before taking METOPROLOL EG

Do not take METOPROLOL EG

• if you are allergic to metoprolol tartrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same group (beta-blockers);
• if you have heart conduction disorders (second- or third-degree atrioventricular block);
• if your heart function is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you are being treated with medicines belonging to the group of beta-receptor agonists;
• if you have a condition in which your heart rate is slowed down (clinically significant sinus bradycardia);
• if you have severe circulatory disorders in the limbs;
• if you suffer from a heart disease called "sinoatrial node syndrome" affecting the area where the heartbeat originates (unless a permanent pacemaker has been implanted);
• in case of cardiogenic shock (a heart disorder occurring when blood is not adequately pumped by the heart throughout the body);
• if you have severe kidney problems (severe renal failure);
• if you have very low blood pressure (hypotension);
• if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis);
• if you have a tumour called "pheochromocytoma" not currently being treated (this tumour usually develops near a kidney and may cause high blood pressure);
• if you have breathing difficulties (bronchospasm);
• if you are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs), except for MAO-B inhibitors;
• it is not recommended during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding").

If you are in any of the above situations, inform your doctor.
Metoprolol EG must not be administered:

• in patients with suspected acute myocardial infarction;
• in children and adolescents (see section "Children and adolescents").

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

• if you suffer from asthma or have breathing difficulties (pulmonary obstructive disorders);
• if you have diabetes, a disease characterized by excess sugar in the blood;
• if your heart function is insufficient (heart failure);
• if you have heart conduction disorders (moderate atrioventricular conduction disorder), as METOPROLOL EG may worsen the condition leading to atrioventricular block;
• if you have blood circulation problems;
• if you suffer from a tumour called "pheochromocytoma" currently under treatment. In this case, your doctor will prescribe appropriate concomitant therapy;
• if you have severe liver problems, as the amount of medicine in the blood may be higher;
• if you have undergone surgery for non-cardiological reasons;
• if you are taking a calcium antagonist (particularly verapamil), another medicine for high blood pressure treatment, especially if administered intravenously;
• if you suffer from a skin disease called psoriasis.

Reduced heart rate (number of heartbeats per minute)
During treatment with METOPROLOL EG, your heart rate may decrease,
i.e. your heartbeat may slow down (see section "Possible side effects"). In such a case,
consult your doctor, who will decide whether to reduce your dose or gradually discontinue treatment.
Anaesthesia
If you are admitted to hospital, you must inform the medical staff about your ongoing treatment with
METOPROLOL EG, and particularly the anaesthetist (the doctor responsible for anaesthesia) if undergoing
surgery. Do not stop treatment before surgery.
Diabetes or hypoglycaemia (low blood sugar levels)
If you have diabetes and are being treated with medicines for diabetes (see section "Other medicines and
METOPROLOL EG"), this medicine may interfere with sugar metabolism or mask the signs and symptoms of hypoglycaemia.
Allergic reactions
In patients treated with beta-blockers, allergic reactions may take a more severe and difficult-to-treat form.
Elderly
If you are elderly, take this medicine with great caution, as excessive reduction in blood pressure or heart rate
may lead to serious circulatory problems (inadequate perfusion of vital organs).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
METOPROLOL EG must not be administered to children and adolescents under 18 years of age.
Other medicines and METOPROLOL EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking any of the following medicines:

• medicines that block histamine activity (antihistamines);
• antipsychotics, medicines used to treat certain psychiatric disorders;
• hydralazine (a medicine used to treat high blood pressure);
• other medicines used to treat high blood pressure (antihypertensives);
• clonidine (a medicine used to treat high blood pressure or prevent migraine). If you are taking clonidine and METOPROLOL EG together, do not stop treatment with clonidine or METOPROLOL EG without first consulting your doctor;
• medicines that act on the peripheral nervous system (ganglion-blocking drugs);
• prazosin, a medicine used to facilitate urine elimination;
• antidepressants, medicines used to treat depression (such as monoamine oxidase inhibitors (MAOIs));
• digoxin (a medicine used for heart disorders);
• nitroglycerin, a medicine used to treat certain heart disorders, as it may cause excessive reduction in blood pressure (hypotensive effect);
• medicines used when heart rate is irregular (antiarrhythmics such as quinidine and amiodarone);
• medicines used to treat high blood pressure or chest pain, called calcium antagonists (particularly verapamil or diltiazem) (see section "Warnings and precautions");
• adrenaline and similar substances (sympathomimetic activity) that increase blood pressure and are contained in some medicines used to treat cough (antitussives), reduce mucus buildup in the nose (nasal drops), or treat eye disorders (eye drops);
• oral medicines used to treat diabetes (oral antidiabetics); METOPROLOL EG may increase the risk of severe hypoglycaemia when used concomitantly with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
• indomethacin or ibuprofen or other medicines for pain and inflammation (NSAIDs);
• rifampicin (a medicine used to treat infections);
• medicines that increase or decrease metoprolol metabolism (e.g. cimetidine, a medicine used to treat stomach lesions and heartburn (ulcers));
• lidocaine, a medicine used to treat heart rhythm disturbances, as metoprolol may influence its effects;
• anaesthetic medicines administered by inhalation.

METOPROLOL EG and alcohol
Inform your doctor if you consume alcohol, as this substance may enhance the effect of METOPROLOL EG.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be administered during pregnancy or breastfeeding unless strictly necessary. Beta-blockers, including metoprolol, may cause harm to the foetus and early miscarriage.
Infants born to mothers who took METOPROLOL EG before delivery or during breastfeeding may be at risk of adverse effects, including bradycardia (reduced heart rate).
If you are breastfeeding while being treated with METOPROLOL EG, your doctor must closely monitor your baby.
Driving and using machines
Patients should be aware of their individual response to METOPROLOL EG before driving or operating machinery, as dizziness and fatigue may occur. If these symptoms occur, it is advisable not to perform such activities.
METOPROLOL EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take METOPROLOLO EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when, depending on your condition.
Take the medicine on an empty stomach. Swallow the tablets whole with a sufficient amount of liquid and
without chewing them.
If a single daily dose is prescribed, unless otherwise directed, take the tablet in the morning; if two doses are
prescribed, take one tablet in the morning and one in the evening.
Do not stop or change the dose or duration of treatment without first consulting your doctor (see section
"If you stop taking METOPROLOLO EG").

Adults
High blood pressure (arterial hypertension)
The recommended dose is 1–2 tablets daily, taken as a single morning dose or divided into one tablet in the
morning and one in the evening.

Angina pectoris
The recommended dose is 1–3 tablets daily.

Abnormal heart rhythm (hyperkinetic cardiac syndrome)
The recommended dose is 1 tablet daily.

Acute myocardial infarction
Your doctor will determine the dose based on the results of your blood tests (hemodynamic status).
The recommended dose is 2 tablets daily, divided into two doses.

Cardiac arrhythmias (excluding bradyarrhythmias) and prevention of recurrent attacks of severe headache
(migraine)
The recommended dose is 1–2 tablets daily, divided into 1–2 doses.

If you have severe liver problems
If you suffer from severe liver problems, your doctor may decide to prescribe a lower dose of
METOPROLOLO EG.

Use in children and adolescents
METOPROLOLO EG must not be given to children and adolescents under 18 years of age.

If you take more METOPROLOLO EG than you should
In case of accidental ingestion or overdose of METOPROLOLO EG, contact your doctor immediately or go to
the nearest hospital.
In hospital, you will be treated according to appropriate intervention protocols (e.g. gastric lavage,
administration of activated charcoal).
Symptoms of overdose with METOPROLOLO EG may include:

• slowing of the heartbeat (bradycardia and bradyarrhythmia);
• low blood pressure (hypotension);
• heart failure, disturbances in the heart's electrical conduction, atrioventricular block;
• cardiogenic shock (a condition occurring when blood is inadequately pumped by the heart throughout the body);
• cardiac arrest;
• seizures;
• airway obstruction due to contraction of muscles around the airways (bronchospasm);
• altered level of consciousness/coma;
• nausea;
• vomiting;
• severe circulatory disorder characterized by bluish discoloration of the skin (cyanosis);
• severe reduction in muscle tone (hypotonia).

If you forget to take METOPROLOLO EG
Do not take a double dose to make up for the missed tablet.

If you stop taking METOPROLOLO EG
An improvement in your health condition should not lead you to discontinue treatment unless instructed by your
doctor.
Discontinuation of treatment must occur gradually and under close medical supervision.
In most patients, treatment can be stopped over 14 days by gradually reducing the daily dose.

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 experiences them.
The side effects that may occur with METOPROLOL EG are:
Very common (may affect more than 1 in 10 people):

• fatigue

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

• slow heartbeat
• drop in blood pressure upon sudden change from sitting or lying down to standing (orthostatic hypotension), possibly leading to loss of consciousness
• cold hands and feet
• heightened awareness of heartbeat (palpitations)
• dizziness, headache
• nausea, abdominal pain, diarrhoea, constipation
• shortness of breath during exertion

Uncommon (may affect up to 1 in 100 people):

• depression, difficulty concentrating, drowsiness or insomnia, nightmares;
• tingling in hands or feet;
• muscle cramps;
• vertigo;
• worsening of heart failure symptoms (a condition in which the heart is unable to pump adequate blood to meet the body's needs), cardiogenic shock (a condition occurring when blood is not adequately pumped by the heart throughout the body) in patients with heart attack, first-degree atrioventricular block, chest pain;
• chest pain;
• tingling and pain in fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
• difficulty breathing;
• vomiting;
• weight gain;
• increased sweating;
• skin rash (such as urticaria and skin lesions);
• swelling due to fluid accumulation and pain (oedema).

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

• irregular heartbeat;
• emotional instability;
• nervousness, anxiety;
• increased blood glucose concentration (diabetes) or worsening of existing diabetes;
• worsening of tingling and pain in fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
• reduction in white blood cells (leucopenia) in the blood;
• severe, potentially fatal allergic reaction (anaphylactic shock);
• dry eyes, visual disturbances, eye inflammation (conjunctivitis), especially in contact lens wearers;
• hearing disturbances;
• reduction in blood pressure (hypotension);
• worsening of symptoms in patients suffering from intermittent claudication due to circulatory problems;
• inflammation of the nasal mucosa (rhinitis);
• dry mouth;
• hair loss;
• skin irritation (psoriasis);
• abnormal liver function blood tests (transaminases);
• joint inflammation (arthritis);
• impotence (inability to achieve erection), sexual dysfunction, Peyronie's disease;
• increased blood glucose levels (glycaemia).

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

• tissue or organ death (gangrene) in patients with pre-existing severe peripheral circulatory disorders
• taste disturbances
• reduction in the number of platelets in the blood (thrombocytopenia)
• liver disease (hepatitis)
• joint pain (arthralgia)
• memory disorders (including amnesia), confusion, hallucinations
• ringing in the ears (tinnitus)
• allergic reactions to sunlight
• worsening of a skin condition called "psoriasis".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 METOPROLOL EG

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What METOPROLOLO EG 100 mg tablets contain

• The active substance is metoprolol tartrate. Each tablet contains 100 mg of metoprolol tartrate.
• The other components are: monohydrate lactose, polyvinylpyrrolidone, sodium croscarmellose, magnesium stearate, talc, anhydrous colloidal silica.

Description of the appearance of METOPROLOLO EG and package contents
Pack sizes of 30, 50 and 100 tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturers
COSMO S.p.A. - Via C. Colombo, 1 - 20045 Lainate (MI)
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale, 73010 Zollino (LE)

Patient Information Leaflet

METOPROLOL EG 200 mg prolonged-release tablets

Generic medicine
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 reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METOPROLOLO EG is and what it is used for

METOPROLOLO EG contains the active substance metoprolol tartrate. Metoprolol tartrate belongs to a group of medicines called selective beta-blockers, which work by slowing down the heartbeat and making the heart beat with less force.
METOPROLOLO EG is indicated in adults for:

• treating high blood pressure (arterial hypertension);
• treating and preventing angina pectoris attacks (heart disease characterized by chest pain);
• treatment during and after a heart attack;
• treating increased heart rate (tachyarrhythmias);
• treating hyperkinetic cardiac syndromes (increased heart rate which may also be perceived as palpitations or fluttering);
• preventing migraine (a type of headache).

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

2. What you should know before taking METOPROLOL EG

Do not take METOPROLOL EG

• if you are allergic to metoprolol tartrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same group (beta-blockers);
• if you have heart conduction disorders (second- or third-degree atrioventricular block);
• if your heart function is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you are being treated with medicines belonging to the group of beta-receptor agonists;
• if you have a condition in which your heartbeat is slowed (clinically significant sinus bradycardia);
• if you have severe circulatory disorders in the limbs;
• if you suffer from a heart disease called "sick sinus syndrome" affecting the area where the heartbeat originates (unless a permanent pacemaker has been implanted);
• in case of cardiogenic shock (a heart disorder occurring when blood is inadequately pumped throughout the body);
• if you have severe kidney problems (severe renal failure);
• if your blood pressure is very low (hypotension);
• if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis);
• if you have a tumour called "pheochromocytoma" that is not being treated (this tumour usually develops near a kidney and may cause high blood pressure);
• if you have difficulty breathing (bronchospasm);
• if you are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs), except for MAO-B inhibitors.
  METOPROLOL EG is not recommended during pregnancy and while breastfeeding (see section "Pregnancy and breastfeeding").

If you are in any of the above situations, inform your doctor.
METOPROLOL EG must not be administered:

• in patients with suspected acute myocardial infarction;
• in children and adolescents (see section "Children and adolescents").

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

• if you have asthma or breathing difficulties (obstructive lung diseases);
• if you have diabetes, a disease characterized by excess sugar in the blood;
• if your heart function is insufficient (heart failure);
• if you have moderate heart conduction disorders (moderate atrioventricular conduction disturbances), as METOPROLOL EG may worsen the condition leading to atrioventricular block;
• if you have blood circulation problems;
• if you have a tumour called "pheochromocytoma" under treatment. In this case, your doctor will prescribe appropriate concomitant therapy;
• if you have severe liver problems, as the amount of medicine in your blood may be higher;
• if you are undergoing non-cardiological surgery;
• if you are taking a calcium antagonist (particularly verapamil), another medicine for high blood pressure, especially if administered by intravenous injection;
• if you suffer from a skin disease called psoriasis.

Reduced heart rate (number of heartbeats per minute)
During treatment with METOPROLOL EG, your heart rate may decrease,
i.e. your heartbeat may slow down (see section "Possible side effects"). In this case,
consult your doctor, who will decide whether to reduce your dose or gradually discontinue treatment.
Anaesthesia
If you are admitted to hospital, you must inform medical staff that you are currently being treated with
METOPROLOL EG, and particularly the anaesthetist (the doctor responsible for anaesthesia) if undergoing
surgery. Do not stop treatment before surgery.
Diabetes or hypoglycaemia (low blood sugar levels)
If you have diabetes and are being treated with medicines for diabetes (see section "Other medicines and
METOPROLOL EG"), this medicine may interfere with sugar metabolism or mask the signs and symptoms of hypoglycaemia.
Allergic reactions
In patients treated with beta-blockers, allergic reactions may be more severe and difficult to treat.
Elderly patients
If you are elderly, take this medicine with great caution, as excessive reduction in blood pressure or heart rate may lead to serious circulatory problems (inadequate perfusion of vital organs).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
METOPROLOL EG must not be administered to children and adolescents under 18 years of age.
Other medicines and METOPROLOL EG
Tell 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:

• medicines that block histamine activity (antihistamines);
• antipsychotics, medicines used to treat certain psychiatric disorders;
• hydralazine (a medicine used to treat high blood pressure);
• other medicines used to treat high blood pressure (antihypertensives);
• clonidine (a medicine used to treat high blood pressure or prevent migraine). If you are taking clonidine and METOPROLOL EG together, do not stop treatment with clonidine or METOPROLOL EG without first consulting your doctor;
• medicines that affect the peripheral nervous system (ganglion-blocking agents);
• prazosin, a medicine used to facilitate urine elimination;
• antidepressants, medicines used to treat depression (such as monoamine oxidase inhibitors (MAOIs));
• digoxin (a medicine used for heart disorders);
• nitroglycerin, a medicine used to treat certain heart disorders, as it may cause excessive reduction in blood pressure (hypotensive effect);
• medicines used when heart rate is irregular (antiarrhythmics such as quinidine and amiodarone);
• medicines used to treat high blood pressure or chest pain, called calcium antagonists (particularly verapamil or diltiazem) (see section "Warnings and precautions");
• adrenaline and similar substances (sympathomimetic activity) that increase blood pressure and are contained in certain medicines used to treat cough (antitussives), reduce mucus buildup in the nose (nasal drops), or treat eye disorders (eye drops);
• oral medicines used to treat diabetes (oral antidiabetics); METOPROLOL EG may increase the risk of severe hypoglycaemia when used concomitantly with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
• indometacin and ibuprofen or other medicines for pain and inflammation;
• rifampicin (a medicine used to treat infections);
• medicines that increase or decrease metoprolol metabolism (e.g. cimetidine, a medicine used to treat stomach ulcers and heartburn);
• lidocaine, a medicine used to treat heart rhythm disorders, as metoprolol may affect its effects;
• anaesthetic medicines administered by inhalation.

METOPROLOL EG and alcohol
Inform your doctor if you consume alcohol, as this substance may enhance the effect of METOPROLOL EG.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be given during pregnancy and while breastfeeding unless strictly necessary. Beta-blockers, including metoprolol, may cause harm to the foetus and early miscarriage.
Babies born to mothers who took METOPROLOL EG before delivery or during breastfeeding may be at risk of adverse effects, including bradycardia (reduced heart rate).
If you are breastfeeding while being treated with METOPROLOL EG, your doctor must closely monitor your baby.
Driving and using machines
Patients should be aware of their individual response to METOPROLOL EG before driving or operating machinery, as dizziness and fatigue may occur. If these symptoms occur, such activities should be avoided.
METOPROLOL EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take METOPROLOLO EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when, depending on your condition.
Take the medicine after a meal. Swallow the tablets whole with a sufficient amount of liquid and
without chewing them.
If you are taking a single daily dose, unless otherwise prescribed, take the tablet in the morning; if two doses are prescribed, take one tablet in the morning and one in the evening.
Do not stop or change the dose or duration of treatment without first consulting your doctor (see section “If you stop treatment with METOPROLOLO EG”).

Adults
High blood pressure (arterial hypertension)
The recommended dose is 100–200 mg daily as a single dose.

Angina pectoris
The recommended dose is 100–200 mg daily as a single dose. In cases of nocturnal angina pectoris, the recommended dose may be taken in the evening.

Heart rhythm disorders (hyperkinetic cardiac syndrome)
The recommended dose is 100–200 mg daily as a single dose.

Myocardial infarction
Your doctor will determine the dose based on the results of your blood tests (hemodynamic status).
The recommended dose for maintenance therapy is 100–200 mg daily as a single dose.

Heart rhythm disorders (arrhythmias) and prevention of recurrent severe headaches (migraine)
The recommended dose is 200 mg daily as a single dose.

If you have severe liver problems
If you suffer from severe liver problems, your doctor may decide to prescribe a lower dose of
METOPROLOLO EG.

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

If you take more METOPROLOLO EG than you should
In case of accidental ingestion or overdose of METOPROLOLO EG, contact your doctor immediately or go to the nearest hospital. In hospital, you will receive appropriate treatment protocols (e.g. gastric lavage, administration of activated charcoal).
Symptoms of overdose with METOPROLOLO EG may include:

• slowing of the heartbeat (bradycardia and bradyarrhythmia);
• low blood pressure (hypotension);
• heart failure, disturbances in the heart's electrical conduction, atrioventricular block;
• cardiogenic shock (a condition occurring when the heart fails to pump blood adequately throughout the body);
• cardiac arrest;
• seizures;
• airway obstruction due to contraction of muscles around the airways (bronchospasm);
• altered level of consciousness/coma;
• nausea;
• vomiting;
• severe circulatory disorder characterized by bluish discoloration of the skin (cyanosis);
• severe reduction in muscle tone (hypotonia).

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

If you stop treatment with METOPROLOLO EG
An improvement in your health condition should not lead you to discontinue treatment unless instructed by your doctor.
Treatment should be stopped gradually and under close medical supervision.
In most patients, treatment can be discontinued over 14 days by gradually reducing the daily dose.

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 will experience them.
The side effects that may occur with METOPROLOL EG are:
Very common (may affect more than 1 in 10 people):

• fatigue.

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

• slowed heartbeat;
• drop in blood pressure upon sudden change from sitting or lying down to standing (orthostatic hypotension), possibly leading to loss of consciousness;
• cold hands and feet;
• increased awareness of heartbeat (palpitations);
• dizziness, headache;
• nausea, abdominal pain, diarrhoea, constipation;
• shortness of breath during exertion.

Uncommon (may affect up to 1 in 100 people):

• depression, difficulty concentrating, drowsiness or insomnia, nightmares;
• tingling in the hands or feet;
• muscle cramps;
• vertigo;
• worsening of heart failure symptoms (a condition in which the heart cannot pump enough blood to meet the body's needs), cardiogenic shock (a condition occurring when blood is inadequately pumped by the heart throughout the body) in patients with heart attack, first-degree atrioventricular block, chest pain;
• chest pain;
• tingling and pain in the fingers, followed by sensation of heat and pain (Raynaud's phenomenon);
• difficulty breathing;
• vomiting;
• weight gain;
• increased sweating;
• skin rash (in the form of urticaria and lesions);
• swelling due to fluid accumulation and pain (edema).

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

• irregular heartbeat;
• emotional instability;
• nervousness, anxiety;
• increased blood glucose concentration (diabetes) or worsening of pre-existing diabetes;
• worsening of tingling and pain in the fingers, followed by sensation of heat and pain (Raynaud's phenomenon);
• reduction in white blood cells (leucopenia) in the blood;
• severe, potentially fatal allergic reaction (anaphylactic shock);
• dry eyes, visual disturbances, eye inflammation (conjunctivitis), especially in contact lens wearers;
• hearing disturbances;
• reduction in blood pressure (hypotension);
• worsening of symptoms in patients with intermittent claudication due to circulatory problems;
• inflammation of the nasal mucosa (rhinitis);
• dry mouth;
• hair loss;
• skin irritation (psoriasis);
• changes in liver function blood tests (transaminases);
• joint inflammation (arthritis);
• impotence (inability to achieve erection), sexual dysfunction, Peyronie's disease;
• increased blood glucose levels (glycaemia).

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

• death of tissue or organ parts (gangrene) in patients with pre-existing severe peripheral circulatory disorders;
• taste disturbances;
• reduction in the number of platelets in the blood (thrombocytopenia);
• liver disease (hepatitis);
• joint pain (arthralgia);
• memory disorders (including amnesia), confusion, hallucinations;
• ringing in the ears (tinnitus);
• allergic reactions to sunlight;
• worsening of a skin condition called "psoriasis".

Reporting of side effects
If you experience any side effect, 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 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 METOPROLOL EG

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 packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 METOPROLOLO EG 200 mg prolonged-release tablets contain

• The active substance is metoprolol tartrate. Each tablet contains 200 mg of metoprolol tartrate.
• Other components: monohydrate lactose, maize starch, ammonium methacrylate copolymer (type B), magnesium stearate, talc, anhydrous colloidal silica, hypromellose, polyethylene glycol 4000, titanium dioxide (E 171).

Description of the appearance of METOPROLOLO EG and contents of the pack
Packs containing 50 and 100 prolonged-release tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia 6 - 20136 Milan, Italy
Manufacturers
COSMO S.p.A. - Via C. Colombo, 1 - 20045 Lainate (MI), Italy.
STADA Arzneimittel AG, Stadastrasse 2-18, 60488 Bad Vilbel – Germany (only for the pack of 100 tablets)