METOPROLOLO 100 mg Таблетки

Содержание инструкции

1. METOPROLOLO EG 100 mg tablets
   1. What is METOPROLOLO EG and what it is used for
   2. What you need to know before taking METOPROLOLO EG
   3. How to take METOPROLOLO EG
   4. Possible side effects
   5. How to store METOPROLOLO EG
   6. Contents of the pack and other information
2. METOPROLOLO EG 200 mg prolonged-release tablets
   1. What is METOPROLOLO EG and what is it used for
   2. What you need to know before taking METOPROLOLO EG
   3. How to take METOPROLOLO EG
   4. Possible side effects
   5. How to store METOPROLOLO EG
   6. Contents of the pack and other information

METOPROLOLO EG 100 mg tablets

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 METOPROLOLO EG is and what it is used for
• 2. What you need to know before you take METOPROLOLO EG
• 3. How to take METOPROLOLO EG
• 4. Possible side effects
• 5. How to store METOPROLOLO EG
• 6. Contents of the pack and other information

1. What is METOPROLOLO EG 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 that manifests with chest pain);
• treating a heart attack (acute myocardial infarction);
• treating irregular heartbeat (arrhythmias, with the exception of bradyarrhythmias);
• treating hyperkinetic cardiac syndromes (increased heart rate that can also be felt as palpitations or fluttering);
• preventing migraine (a type of headache).

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

2. What you need to know before taking METOPROLOLO EG

Do not take METOPROLOLO 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 defects in the conduction of the heart (atrioventricular block of II or III degree);
• if the function of your heart is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you are undergoing therapy with medicines belonging to the group of beta-receptor agonists;
• if you have a condition in which the heartbeats are slowed (clinically relevant sinus bradycardia);
• if you have severe circulatory disorders of the limbs;
• if you suffer from a heart disease called “sick sinus syndrome” which affects the area where the heartbeat originates (unless a permanent pacemaker has been implanted);
• in case of cardiogenic shock (a heart condition that occurs when blood is not adequately pumped by the heart throughout the body);
• if you suffer from severe kidney disorders (severe renal failure);
• if you have very low blood pressure (hypotension);
• if your doctor has diagnosed you with levels of acid in the blood higher than normal (metabolic acidosis);
• if you suffer from a tumor called “pheochromocytoma” not undergoing treatment (this tumor generally develops near a kidney and can 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;
• it is not recommended during pregnancy and breastfeeding (See section “Pregnancy and breastfeeding”).

If you are in any of the above situations, tell your doctor.
Metoprololo EG must notbe administered:

• in patients with suspected ongoing heart attack;
• to children and adolescents (see section “Children and adolescents”).

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

• if you suffer from asthma or have difficulty breathing (obstructive pulmonary conditions);
• if you have diabetes, a disease characterized by an excess of sugars in the blood;
• if the function of your heart is insufficient (heart failure);
• if you suffer from conduction disorders of the heart (moderate degree atrioventricular conduction disturbance) as METOPROLOLO EG may worsen the disease leading to atrioventricular block;
• if you have problems with blood circulation;
• if you suffer from a tumor called “pheochromocytoma” undergoing treatment. In this case, your doctor will prescribe you adequate therapy at the same time;
• if you have severe liver problems, as the amount of medicine in the blood may be higher;
• if you have undergone surgery for non-cardiac reasons;
• if you are taking a calcium channel blocker (particularly verapamil), another medicine for the treatment of 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 METOPROLOLO EG, a reduction in heart rate may occur,
i.e. a slowing of the heartbeat (see section “Possible side effects”). In this case,
consult your doctor, who will decide whether to reduce your dosage or gradually discontinue therapy.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
METOPROLOLO EG and, in particular, the anesthesiologist (the doctor responsible for the anesthesia) in case of
surgery. Do not discontinue therapy before surgery.

Diabetes or hypoglycemia (low blood sugar levels)
If you suffer from diabetes and are being treated with medicines to treat diabetes (see section “Other medicines and
METOPROLOLO EG”), this medicine may interfere with sugar metabolism or mask the
signs and symptoms of hypoglycemia.

Allergic reactions
In patients treated with beta-blockers, allergic reactions take a more severe and difficult-to-treat form.

Elderly
If you are elderly, take this medicine with great caution as an excessive reduction in blood
pressure or heartbeats may lead to serious circulatory problems (inadequate irrigation of the
vital organs).
For those who practice sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Children and adolescents
METOPROLOLO EG must notbe administered to children and adolescents under 18 years of age.

Other medicines and METOPROLOLO EG
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:

• medicines that block the activity of histamine (antihistamines);
• antipsychotics, medicines for the treatment of some psychiatric disorders;
• hydralazine (medicine for the treatment of high blood pressure);
• other medicines used to treat high blood pressure (antihypertensives);
• clonidine (medicine for the treatment of high blood pressure or for the prevention of migraine). If you are taking clonidine and METOPROLOLO EG together, do not interrupt treatment with clonidine or METOPROLOLO EG without first consulting your doctor;
• medicines that have an effect on the peripheral nervous system (drugs that block sympathetic ganglia);
• prazosin, a medicine used to facilitate the elimination of urine;
• antidepressants, drugs used to treat depression (such as, for example, monoamine oxidase inhibitors (MAOIs));
• digoxin (medicine used for heart disorders);
• nitroglycerin, a medicine used to treat some heart disorders, as it may cause an excessive reduction in blood pressure (hypotensive effect);
• medicines used when the number of heartbeats is irregular (antiarrhythmics such as quinidine and amiodarone);
• medicines for the treatment of high blood pressure or chest pain, called calcium channel blockers (particularly verapamil or diltiazem) (see section “Warnings and precautions”);
• adrenaline and other similar substances (sympathomimetic activity) that increase blood pressure and are contained in some medicines used to treat cough (antitussives), to reduce mucus build-up in the nose (nasal drops), for eye disorders (eye drops);
• medicines used to treat diabetes administered orally (oral antidiabetics);
• indometacin or ibuprofen or other medicines for pain and inflammation (NSAIDs);
• rifampicin (medicine for the treatment of infections);
• medicines that increase or decrease the metabolism of metoprolol (e.g. cimetidine, a medicine used to treat stomach lesions and heartburn (ulcers));
• lidocaine, a medicine used to treat alterations in the rhythm of the heartbeat, as metoprolol can influence its effects;
• anesthetic medicines administered by inhalation.

METOPROLOLO EG and alcohol
Tell your doctor if you drink alcohol, as this substance may increase the effect of
METOPROLOLO EG.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be administered during pregnancy and breastfeeding unless strictly
necessary. Beta-blockers, including metoprolol, can cause harm to the fetus and early miscarriage.
Children born to mothers who have taken METOPROLOLO EG before delivery or during breastfeeding
may be at risk of side effects including bradycardia (reduced heart rate).
If you are breastfeeding and are being treated with METOPROLOLO EG, your doctor must keep your baby under close
control.

Driving and using machines
Patients must be aware of their reaction to METOPROLOLO EG before driving or using machines, as dizziness and fatigue may occur. If you experience these symptoms, it is advisable
not to engage in these activities.

METOPROLOLO EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to some sugars, contact him 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 always exactly as your doctor or pharmacist has told you. If you have
doubts, ask 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. Take the tablets whole with a sufficient amount of liquid and
without chewing.
In the case of a single dose, unless otherwise prescribed, take the tablet in the morning, while if two
doses are planned, take one tablet in the morning and one in the evening.
Do not interrupt or change the dose and duration of treatment without consulting your doctor (see
paragraph “If you stop taking METOPROLOLO EG”).

Adults
High blood pressure (arterial hypertension)
The recommended dose is 1-2 tablets per day in a single dose in the morning or one
tablet in the morning and one in the evening.

Angina pectoris
The recommended dose is 1-3 tablets per day.

Heart rhythm disturbances (hyperkinetic cardiac syndrome)
The recommended dose is 1 tablet per day.

Acute myocardial infarction
The doctor will decide the dose based on the results of your blood tests (hemodynamic status).
The recommended dose is 2 tablets per day divided into 2 doses.

Cardiac arrhythmias (excluding bradyarrhythmias) and prevention of recurrent severe headaches
(migraine)
The recommended dose is 1-2 tablets per day divided into 1-2 doses.

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

Use in children and adolescents
METOPROLOLO EG must notbe given to children and adolescents under 18 years of age.

If you take more METOPROLOLO EG than you should
In case of accidental ingestion/intake of an excessive dose of METOPROLOLO EG, immediately warn
your doctor or go to the nearest hospital.
In hospital you will be subjected to appropriate intervention protocols (e.g. gastric lavage, administration of
activated charcoal).
Symptoms of METOPROLOLO EG overdose may include:

• slowing of the heartbeat (bradycardia and bradyarrhythmia);
• lowering of blood pressure (hypotension);
• heart failure, disturbances of the electrical conduction of the heart, atrioventricular block;
• cardiogenic shock (a condition that occurs when blood is not adequately pumped by the heart throughout the body)
• cardiac arrest;
• convulsions;
• obstruction of the bronchi due to a contraction of the muscles around the airways (bronchospasm);
• altered state of consciousness/coma;
• nausea;
• vomiting;
• severe disturbance of blood circulation characterized by bluish discoloration of the skin (cyanosis);
• severe decrease 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
Improvement of your health status should not lead to interruption of treatment unless
requested by your doctor.
Interruption of treatment must occur gradually, and under strict medical control.
In most patients, treatment can be discontinued within 14 days, gradually decreasing the dose
daily.
If you have any questions 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.
The side effects that may occur with METOPROLOLO EG are:

Very common(may affect more than 1 in 10 people):

• fatigue

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

• slowed heartbeat
• low blood pressure when suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension) with the possibility of loss of consciousness
• cold hands and feet
• increased awareness of heartbeat (palpitations)
• dizziness, headache
• nausea, stomach pain, diarrhea, 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 is unable to pump enough blood to meet the body's needs), cardiogenic shock (a condition that occurs when blood is not adequately pumped by the heart throughout the body) in patients with a heart attack, first-degree atrioventricular block, chest pain;
• chest pain;
• tingling and pain in the fingers, followed by a sensation of warmth 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 retention and pain (edema). Rare(may affect up to 1 in 1,000 people):
• irregular heartbeat;
• emotional instability;
• nervousness, anxiety;
• increased blood glucose levels (diabetes) or worsening of existing diabetes;
• worsening of tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• decreased white blood cells (leukopenia) in the blood;
• severe allergic reaction, potentially fatal (anaphylactic shock);
• dry eyes, visual disturbances, eye inflammation (conjunctivitis), especially if wearing contact lenses;
• hearing disorders;
• low 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);
• alteration of blood tests related to liver function (transaminases);
• joint inflammation (arthritis);
• impotence (inability to achieve an erection), sexual dysfunction, Peyronie's disease;
• increased blood glucose levels (glycemia).

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

• death of body tissues or organs (gangrene) in patients with pre-existing severe peripheral blood circulation disorders
• taste disorders
• decreased 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store METOPROLOLO EG

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the packaging after “Scad”. 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 wastewater 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 METOPROLOLO EG 100 mg tablets contain

• The active ingredient is metoprolol tartrate. Each tablet contains 100 mg of metoprolol tartrate.
• The other ingredients are: lactose monohydrate, polyvinylpyrrolidone, sodium croscarmellose, magnesium stearate, talc, anhydrous colloidal silicon dioxide.

Description of the appearance of METOPROLOLO EG and contents of the pack
Packs of 30, 50 and 100 tablets.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano

Manufacturers
COSMO S.p.A. - Via C. Colombo, 1 - 20045 Lainate (MI).

METOPROLOLO EG 200 mg prolonged-release tablets

Generic medicine

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 they have the same symptoms as you, as it may 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 METOPROLOLO EG is and what it is used for
• 2. What you need to know before you take METOPROLOLO EG
• 3. How to take METOPROLOLO EG
• 4. Possible side effects
• 5. How to store METOPROLOLO EG
• 6. Contents of the pack and other information

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

METOPROLOLO EG contains the active ingredient metoprolol tartrate. Metoprolol tartrate belongs to a
group of medicines called selective beta-blockers, which work by slowing 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 attacks of angina pectoris (heart disease that manifests with chest pain);
• the treatment during a certain heart attack and following it;
• treating accelerated heart rhythms (tachycardic arrhythmias);
• treating hyperkinetic cardiac syndromes (increased heart rate that can also be felt with palpitations or fluttering);
• preventing migraine (a type of headache).

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

2. What you need to know before taking METOPROLOLO EG

Do not take METOPROLOLO 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 defects in the heart’s conduction system (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 the heartbeat is slowed (clinically relevant sinus bradycardia);
• if you have severe circulatory disorders in the limbs;
• if you suffer from a heart condition called “sick sinus syndrome” which affects the area where the heartbeat originates (unless you have had a permanent pacemaker implanted);
• in case of cardiogenic shock (a heart condition that occurs when blood is not adequately pumped throughout the body);
• if you suffer from severe kidney disorders (severe renal insufficiency);
• if you have 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 a tumor called “pheochromocytoma” that is not being treated (this tumor usually develops near a kidney and can 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. Not recommended during pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

If you are in any of the above situations, tell your doctor.
METOPROLOLO EG must notbe administered:

• to patients with suspected ongoing heart attack;
• to children and adolescents (see section “Children and adolescents”).

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

• if you suffer from asthma or have difficulty breathing (obstructive pulmonary conditions);
• if you have diabetes, a condition characterized by an excess of sugars in the blood;
• if your heart function is insufficient (heart failure);
• if you suffer from conduction disorders of the heart (moderate degree of atrioventricular conduction) as METOPROLOLO EG may worsen the condition leading to atrioventricular block;
• if you have problems with blood circulation;
• if you suffer from a tumor called “pheochromocytoma” that is being treated. In this case, your doctor will prescribe appropriate therapy at the same time;
• if you have severe liver problems, as the amount of medicine in the blood may be higher;
• if you have undergone surgery for non-cardiac reasons;
• if you are taking a calcium channel blocker (particularly verapamil), another medicine for treating high blood pressure, especially if administered by intravenous injection;
• if you suffer from a skin condition called psoriasis.

Reduced heart rate (number of heartbeats per minute)
During treatment with METOPROLOLO EG, a reduction in heart rate may occur,
that is, a slowing of the heartbeat (see section “Possible side effects”). If this happens,
consult your doctor, who will decide whether to reduce the dosage or gradually discontinue therapy.

Anesthesia
If you are to be hospitalized, you must inform the medical staff about the ongoing treatment with
METOPROLOLO EG and, in particular, the anesthesiologist (the doctor responsible for anesthesia) in case of
surgery. Do not stop therapy before surgery.

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are being treated with medicines to treat diabetes (see section “Other medicines and
METOPROLOLO EG”), this medicine may interfere with sugar metabolism or mask the
signs and symptoms of hypoglycemia.

Allergic reactions
In patients treated with beta-blockers, allergic reactions take a more severe and difficult-to-treat form.

Elderly
If you are elderly, take this medicine with great caution as excessive reduction of blood
pressure or heartbeats can lead to serious circulation problems (inadequate irrigation of the
vital organs).
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Children and adolescents
METOPROLOLO EG must notbe administered to children and adolescents under the age of 18 years.

Other medicines and METOPROLOLO EG
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:

• medicines that block the activity of histamine (antihistamines);
• antipsychotics, medicines for the treatment of some psychiatric disorders;
• hydralazine (medicine for the treatment of high blood pressure);
• other medicines used to treat high blood pressure (antihypertensives);
• clonidine (medicine for the treatment of high blood pressure or for preventing migraine). If you are taking clonidine and METOPROLOLO EG together, do not stop treatment with clonidine or METOPROLOLO EG without first consulting your doctor;
• medicines that have an effect on the peripheral nervous system (drugs that block sympathetic ganglia);
• prazosin, a medicine used to facilitate the elimination of urine;
• antidepressants, drugs used to treat depression (such as, for example, monoamine oxidase inhibitors (MAOIs));
• digoxin (medicine used for heart disorders);
• nitroglycerin, a medicine used to treat some heart disorders, as it may cause an excessive reduction in blood pressure (hypotensive effect);
• medicines used when the heartbeat is irregular (antiarrhythmics such as quinidine and amiodarone);
• medicines for the treatment of high blood pressure or chest pain, called calcium channel blockers (particularly verapamil or diltiazem) (see section “Warnings and precautions”);
• adrenaline and other similar substances (sympathomimetic activity) that increase blood pressure and are contained in some medicines used to treat cough (antitussives), to reduce mucus build-up in the nose (nasal drops), for eye disorders (eye drops);
• medicines used to treat diabetes administered orally (oral antidiabetics);
• indometacin and ibuprofen or other medicines for pain and inflammation;
• rifampicin (medicine for treating infections);
• medicines that increase or decrease the metabolism of metoprolol (e.g. cimetidine, a medicine used to treat stomach lesions and heartburn (ulcers));
• lidocaine, a medicine used to treat alterations in the rhythm of the heartbeat, as metoprolol can affect its effects;
• anesthetic medicines administered through inhalation.

METOPROLOLO EG and alcohol
Tell your doctor if you drink alcohol, as this substance may increase the effect of
METOPROLOLO EG.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
This medicine should not be administered during pregnancy and breastfeeding unless strictly
necessary. Beta-blockers, including metoprolol, can cause harm to the fetus and early miscarriage.
Children born to mothers who have taken METOPROLOLO EG before delivery or during breastfeeding
may be at risk of side effects including bradycardia (slowing of the heartbeat).
If you are breastfeeding and are being treated with METOPROLOLO EG, your doctor must closely
monitor your baby.

Driving and operating machinery
Patients must be aware of their reaction to METOPROLOLO EG before driving or operating machinery, as
dizziness and fatigue may occur. If you experience these symptoms, it is advisable
not to engage in these activities.

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

3. How to take METOPROLOLO EG

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
doubts, ask 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. Take the tablets whole with a sufficient amount of liquid and
without chewing.
In the case of a single dose, unless otherwise prescribed, take the tablet in the morning, while if two
doses are planned, take one tablet in the morning and one in the evening.
Do not stop or change the dose and duration of treatment without consulting your doctor (see
paragraph “If you stop taking METOPROLOLO EG”).

Adults
High blood pressure (arterial hypertension)
The recommended dose is 100-200 mg per day in a single dose.

Angina pectoris
The recommended dose is 100-200 mg per day in a single dose. In the case of nocturnal angina pectoris
you can take the recommended dose in the evening.

Heart rhythm disturbances (hyperkinetic cardiac syndrome)
The recommended dose is 100-200 mg per day in a single dose.

Myocardial infarction
The doctor will decide the dose based on the results of your blood tests (hemodynamic status).
The recommended dose for maintenance therapy is 100-200 mg per day to be taken in a single
dose.

Heart rhythm disturbances (arrhythmias) and prevention of recurrent severe headaches (migraine)
The recommended dose is 200 mg per day to be taken in 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 should not be given to children and adolescents under the age of 18 years.

If you take more METOPROLOLO EG than you should
In case of accidental ingestion/taking of an excessive amount of METOPROLOLO EG, immediately inform
your doctor or go to the nearest hospital. In hospital you will be subjected to appropriate intervention
protocols (e.g. gastric lavage, administration of activated charcoal).
Symptoms of METOPROLOLO EG overdose may include:

• slowing of the heartbeat (bradycardia and bradiarrhythmia);
• lowering of blood pressure (hypotension);
• heart failure, disturbances of the electrical conduction of the heart, atrioventricular block;
• cardiogenic shock (a condition that occurs when blood is not adequately pumped by the heart throughout the body);
• cardiac arrest;
• convulsions;
• obstruction of the bronchi due to a contraction of the muscles around the airways (bronchospasm);
• altered state of consciousness/coma;
• nausea;
• vomiting;
• severe disturbance of blood circulation characterized by bluish discoloration of the skin (cyanosis);
• severe decrease in muscle tone (hypotonia).

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

If you stop taking METOPROLOLO EG
Improvement of your health condition should not lead to interruption of treatment unless
requested by your doctor.
Interruption of treatment must occur gradually, and under strict medical supervision.
In most patients, treatment can be discontinued within 14 days, gradually decreasing the dose
daily.
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 gets them.
The side effects that may occur with METOPROLOLO EG are:

Very common(may affect more than 1 in 10 people):

• fatigue.

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

• slowed heartbeat;
• low blood pressure when suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension) with possible loss of consciousness;
• cold hands and feet;
• increased awareness of heartbeat (palpitations);
• dizziness, headache;
• nausea, abdominal pain, diarrhea, 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 is unable to pump enough blood to meet the body's needs), cardiogenic shock (a condition that occurs when the heart does not pump enough blood throughout the body) in patients with heart attack, first-degree atrioventricular block, chest pain;
• chest pain;
• tingling and pain in the fingers, followed by a sensation of warmth 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 retention and pain (edema). Rare(may affect up to 1 in 1,000 people):
• irregular heartbeat;
• emotional instability;
• nervousness, anxiety;
• increased blood glucose levels (diabetes) or worsening of existing diabetes;
• worsening of tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• decreased white blood cells (leukopenia) in the blood;
• severe allergic reaction, including life-threatening (anaphylactic shock);
• dry eyes, visual disturbances, eye inflammation (conjunctivitis) especially in contact lens wearers;
• hearing disorders;
• low 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);
• alteration of blood tests related to liver function (transaminases);
• joint inflammation (arthritis);
• impotence (inability to get an erection), sexual dysfunction, Peyronie's disease;
• increased blood glucose levels (glycemia).

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

• death of body tissues or organs (gangrene) in patients with pre-existing severe peripheral blood circulation disorders;
• taste disturbances;
• decreased 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 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
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 METOPROLOLO EG

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the packaging after “Scad.”. 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 wastewater 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 METOPROLOLO EG 200 mg prolonged-release tablets contain

• The active ingredient is metoprolol tartrate. Each tablet contains 200 mg of metoprolol tartrate.
• The other ingredients are: lactose monohydrate, corn 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 of 50 and 100 prolonged-release tablets.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia 6 - 20136 Milan

Manufacturers
COSMO S.p.A. - Via C. Colombo, 1 - 20045 Lainate (MI).
Stada Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel – Germany (only for the pack of 100 tablets)