METOPROLOLO 100 mg Tablet

Зміст інструкції

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

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

1. What Metoprololo Hexal is and what it is used for

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

• the treatment of high blood pressure (hypertension), even in association with other medicines to treat high blood pressure (antihypertensives), such as diuretics, peripheral vasodilators and ACE inhibitors;
• the long-term prevention of chest pain caused by heart problems (angina pectoris);
• the treatment of certain or suspected heart attack and as secondary prevention, in people who have had a heart attack in the past;
• the treatment of heart rhythm disturbances (functional cardiac disturbances with palpitations);
• the prevention of recurrent attacks of severe headache (migraine).

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

2. What you need to know before taking Metoprololo Hexal

Do not take Metoprololo Hexal

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines similar to metoprolol (beta-blockers);
• if you have heart conduction defects (second or third degree atrioventricular block, sinoatrial node syndrome);
• if your heart function is insufficient to ensure adequate blood supply to the body, i.e. when the heart rate is less than 45-50 beats/minute (decompensated heart failure);
• if you have a very slow heart rate (clinically relevant sinus bradycardia);
• if you have severe circulatory disorders of the limbs (peripheral arterial circulatory disease);
• if you have a serious heart problem known as cardiogenic shock, which occurs when the heart does not pump enough blood throughout the body;
• if you have had a heart attack and have a slow heart rate (45 beats/minute), some problems with the heart rhythm (P-R interval greater than 0.24 seconds), very low blood pressure (systolic pressure less than 100 mmHg) and/or severe heart function problems (severe heart failure);
• if you suffer from low blood pressure (hypotension);
• if you suffer from asthma or have had breathing problems (bronchospasm);
• if you have a benign tumor of the adrenal gland (pheochromocytoma) and are not undergoing any therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metoprololo Hexal.
Pay particular attention and talk to your doctor before taking this medicine:

• if you have difficulty breathing (obstructive pulmonary conditions);
• if you have problems metabolizing sugars or have low blood sugar levels (hypoglycemia). Metoprolol can interfere with sugar metabolism or mask the signs and symptoms of hypoglycemia;
• if your heart function does not ensure adequate blood supply to the body (heart failure);
• if you suffer from conduction disorders of the heart (moderate degree atrioventricular conduction disorder), as metoprolol may worsen your condition (atrioventricular block);
• if you have a slow heart rate (progressive bradycardia);
• if you suffer from low blood pressure and have had a heart attack. Your doctor will monitor you closely during treatment.
• if you have circulatory problems in the limbs (peripheral arterial circulatory disorders);
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you are going to have surgery. In this case, inform the anesthesiologist that you are being treated with this medicine;
• if you are taking a calcium antagonist (particularly verapamil), another medicine for high blood pressure, especially if administered by intravenous injection;
• a type of angina (chest pain) called Prinzmetal's angina;
• an increase in the function of a gland called the thyroid (thyrotoxicosis);
• allergy. If you suffer from allergies and take beta-blockers, allergic reactions may be more severe than normal;
• liver problems (hepatic insufficiency) as your doctor may decide to change the dose.
• During treatment with Metoprololo Hexal you may experience the following conditions:
• the onset of particularly severe allergic reactions (anaphylactic reactions) that show an increased resistance to normal doses of adrenaline;
• an increase in the number and duration of episodes of chest pain (angina) in patients with Prinzmetal's angina;
• disappearance or attenuation of symptoms related to severe thyroid problems (thyrotoxicosis);
• an increased risk of developing eye and skin problems (oculo-muco-cutaneous syndrome).
• If such symptoms occur, it is advisable to stop therapy.

For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive anti-doping tests.

Children and adolescents
The efficacy and safety in children and adolescents under the age of 18 is limited, therefore Lopresor is not
recommended in this population (0-18 years).

Hepatic impairment
If you have liver problems (hepatic insufficiency) inform your doctor, as a
modulation of the dosage may be necessary.

Renal impairment
If your kidney function is impaired, no dosage adjustments are necessary.

Elderly
If you are elderly, take this medicine with great caution as excessive reduction of
blood pressure or heart rate may lead to serious circulatory problems (inadequate irrigation of vital organs).

Other medicines and Metoprololo Hexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Interactions with medicines whose concomitant use is not recommended.

• medicines for treating some heart disorders belonging to the class of Calcium Antagonists (administered intravenously) such as verapamil and diltiazem. This association can enhance the depressive effects of Metoprolol Hexal on the heart and blood pressure.

Interactions to be considered
Pay particular attention and talk to your doctor if you are taking:

• other medicines used for the treatment of high blood pressure (antihypertensives), especially if you are following a therapy with clonidine. If the two medicines are administered simultaneously, treatment with Metoprololo Hexal must be stopped several days before discontinuing therapy with clonidine;
• prazosin, a medicine used to facilitate urine elimination;
• medicines that lower blood pressure (alpha-adrenergic blockers: guanethidine, betanidine, reserpine, alpha-methyldopa);
• other medicines similar to metoprolol (beta-blockers), even in the form of eye drops (ophthalmic drops);
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs) even within 14 days of stopping treatment;
• nitroglycerin, a medicine used to treat some heart disorders, as it can cause an excessive reduction in blood pressure (hypotensive effect);
• medicines used to treat some heart rhythm disorders (antiarrhythmics such as quinidine or propafenone, tocainide, procainamide, ajmaline, amiodarone, flecainide and disopyramide);
• medicines for treating some heart and high blood pressure disorders belonging to the class of Calcium Antagonists, (such as verapamil and diltiazem), administered orally;
• medicines used to treat some respiratory problems (such as asthma and cough) or to clear the nose (nasal drops) or to treat some eye disorders (ophthalmic drops) for example: adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, xanthine derivatives;
• medicines used to treat diabetes such as insulin and oral hypoglycemic agents;
• rifampicin, a medicine used to treat tuberculosis;
• lidocaine, a medicine used to reduce pain during operations, as metoprolol can affect its effects;
• medicines used to induce anesthesia (see section “Warnings and precautions”);
• medicines used for the treatment of inflammation and pain (NSAIDs and COX-2 inhibitors), as they can decrease the effects of metoprolol;
• hydralazine and prazosin, medicines used to treat high blood pressure (anti-hypertensives);
• digitalis glycosides, used to treat serious heart problems (heart failure);
• medicines that can affect the metabolism of metoprolol such as those used for the treatment of depression (fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine, desipramine), for the treatment of psychiatric disorders (chlorpromazine, fluphenazine haloperidol and thioridazine), for the treatment of HIV (ritonavir), for the treatment of allergies (diphenhydramine), for the treatment of malaria (hydroxychloroquine or quinine) and for the treatment of fungal infections (terbinafine);
• medicines used to treat migraine: ergot alkaloids. Stop treatment with this medicine before undergoing an exercise test in which you are injected with dipyridamole; in this case the doctor will check your heart rate after the injection.

Metoprololo Hexal and alcohol
Avoid consuming alcoholic beverages during treatment with this medicine.

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.
Do not take this medicine during pregnancy unless absolutely necessary and always under strict
medical supervision.
Metoprololo Hexal passes into breast milk, therefore this medicine is not recommended during breastfeeding.
However, if you are breastfeeding and are being treated with Metoprololo Hexal, your doctor must monitor
your baby closely.

Driving and using machines
This medicine can impair your ability to drive vehicles and operate machinery.

This medicine contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take Metoprololo Hexal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Take the tablets whole with a sufficient amount of liquid and without chewing them.
Take the tablets every day, at the same time.
Metoprololo Hexal 100 mg tablets should be taken on an empty stomach.
Metoprololo Hexal 200 mg prolonged-release tablets can be taken with or without food,
preferably in the morning.

Treatment of high blood pressure (hypertension)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 or 2 tablets (100 - 200 mg) per day.
This dose can be taken in a single dose (in the morning) or in 2 separate doses
(morning and evening).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning
to be taken in a single dose.

Prevention of chest pain (angina pectoris)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 or 2 tablets (100 - 200 mg) per day,
to be taken in 2 doses.
If necessary, your doctor may increase the dose to 4 tablets (400 mg).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning
to be taken in a single dose.

Treatment of heart attack (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 2 tablets (200 mg) per day, to be taken in 2
doses. The duration of treatment is at least 3 months.

Treatment of heart rhythm disturbances (functional cardiac disorders) with palpitations
and prevention of recurrent severe headaches (migraine)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 tablet (100 mg) per day to
be taken in the morning in a single dose. If necessary, your doctor may increase the dose to 2
tablets (200 mg), to be taken in 2 doses per day (morning and evening).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning
to be taken in a single dose.

If you take more Metoprololo Hexal than you should
In case of ingestion/taking of an excessive amount of this medicine, immediately contact your
doctor or the nearest hospital.
If you take an excessive dose of this medicine, you may experience the following symptoms:

• severe decrease in blood pressure (hypotension);
• slowing of the heartbeat (sinus bradycardia);
• serious heart problems (atrioventricular block, heart failure, cardiogenic shock and cardiac arrest, myocardial infarction);
• difficulty breathing (bronchospasm);
• alteration of consciousness, up to coma;
• nausea, vomiting;
• convulsions;
• severe disturbance of blood circulation characterized by bluish discoloration of the skin (cyanosis);
• death.

Generally, these symptoms appear 20 minutes-2 hours after taking an excessive dose of this
medicine and are more severe if you take alcohol, other medicines for the treatment of
high blood pressure (antihypertensives), quinidine (a medicine used for heart rhythm disturbances) or
barbiturates (medicines used for the treatment of seizures and anxiety) at the same time.

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

If you stop taking Metoprololo Hexal
Do not suddenly stop treatment with this medicine without consulting your doctor. It is necessary
that the interruption of treatment with Metoprololo Hexal occurs gradually, and under the close supervision
of your doctor.
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 following side effects may also occur:

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

• dizziness and headache;
• slowed heartbeat (bradycardia);
• significant reduction in blood pressure when standing up (orthostatic hypotension), occasionally with transient loss of consciousness (syncope);
• severe difficulty breathing (dyspnea on exertion);
• nausea, vomiting, abdominal pain;
• fatigue.

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

• depression
• drowsiness or insomnia;
• reduced level of consciousness;
• tingling in the extremities (paresthesia);
• muscle cramps;
• sleep disturbances (nightmares);
• heart failure;
• irregular heartbeat (arrhythmias);
• swelling due to fluid retention (edema);
• increased awareness of heartbeats (palpitations);
• tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• skin irritation (rash, in the form of hives, psoriatic and dystrophic skin lesions);
• diarrhea and constipation;
• difficulty breathing (bronchospasm).

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

• reduced number of platelets in the blood (thrombocytopenia);
• personality disorders, hallucinations;
• irritation and/or dryness of the eyes;
• reduced vision (e.g. blurred vision);
• ringing in the ears (tinnitus) and hearing disturbances, especially if taking doses higher than those prescribed by the doctor;
• heart problems and pain (cardiac conduction disturbances, chest pain);
• tissue damage and death (gangrene), in patients with peripheral circulatory problems;
• irritation and inflammation of the nose (rhinitis);
• dry mouth (dryness of the oral mucosa);
• formation of a mass in the back of the abdomen (retroperitoneal fibrosis);
• abnormal results of tests performed to assess liver function;
• liver inflammation (hepatitis);
• skin sensitivity to light (photosensitivity);
• increased sweating (hyperhidrosis);
• hair loss (alopecia);
• worsening of a skin condition (psoriasis exacerbation);
• inflammation of the joints (arthritis);
• sexual problems (decreased libido, erectile dysfunction and Peyronie's disease);
• weight gain.

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

• confusional state;
• changes in certain diagnostic tests such as increased triglycerides in the blood (hypertriglyceridemia) and reduced HDL.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 Hexal

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 “Expiry”. The
expiry date refers to the last day of that month.

Metoprololo Hexal 100 mg tablets:
This medicine does not require any special storage conditions.

Metoprololo Hexal 200 mg prolonged-release tablets:
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 Metoprololo Hexal contains
Metoprololo Hexal 100 mg tablets

• The active ingredient is: metoprolol (as metoprolol tartrate). Each tablet contains 100 mg of metoprolol tartrate.
• The other ingredients are: lactose, corn starch, magnesium stearate, colloidal silica, hydroxypropylcellulose, calcium monophosphate, crospovidone, microcrystalline cellulose.

Metoprololo Hexal 200 mg prolonged-release tablets

• The active ingredient is: metoprolol (as metoprolol tartrate). Each tablet contains 200 mg of metoprolol tartrate.
• The other ingredients are:
• Tablet core: Eudragit RS PO, lactose monohydrate, magnesium stearate, corn starch, anhydrous colloidal silica.
• Tablet coating: hypromellose, macrogol 4000, talc, titanium dioxide (E171).

Description of the appearance of Metoprololo Hexal and contents of the pack
Metoprololo Hexal 100 mg tablets
PP/Alu blisters of 30 tablets.
Metoprololo Hexal 200 mg prolonged-release tablets
PP/Alu blisters of 28 tablets.

Marketing Authorisation Holder
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA) Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee, 1 - D-39179 Barleben (Germany)
LEK S.A., ul. Podlipie 16, 95-010 Strykow (Poland) (only for Metoprololo Hexal 200 mg prolonged-release tablets

)