METOPROLOLO 100 mg Tablet

Зміст інструкції

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

METOPROLOLO DOC Generici 100 mg tablets

Metoprolol tartrate

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

1. What METOPROLOLO DOC Generici is and what it is used for

METOPROLOLO DOC Generici contains the active ingredient metoprolol, which belongs to a
group of medicines called beta-blockers, which work by slowing down the heartbeat and making the
heart beat with less force.
METOPROLOLO DOC Generici is indicated for:

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

2. What you need to know before taking METOPROLOLO DOC Generici

Do not take METOPROLOLO DOC Generici

• if you are allergic to metoprolol or to any of the other ingredients of this medicine (listed in section 6);
• if you have defects of the heart’s conduction system (second or third degree atrioventricular block, sino-atrial node syndrome);
• if your heart function is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you have a very slow heartbeat (clinically relevant sinus bradycardia);
• if you have severe disturbances of blood circulation in the limbs (peripheral arterial circulatory disease);
• if you have a severe heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have had a heart attack and have a slow heartbeat (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 problems with heart function (severe heart failure).

Warnings and precautions
Talk to your doctor or pharmacist before taking METOPROLOLO DOC Generici.
Pay particular attention and talk to your doctor before taking this medicine:

• if you have difficulty breathing (obstructive pulmonary diseases);
• 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 is insufficient (heart failure);
• if you suffer from disturbances of the conduction of the heart (moderate degree atrio-ventricular conduction disorder), as metoprolol may worsen your condition (atrio-ventricular block);
• if you have problems with blood circulation in the limbs (peripheral arterial circulatory disorders);
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you have severe liver problems (hepatic cirrhosis), as the amount of medicine in the blood may be higher;
• if you are going to have surgery. In this case, inform the anesthesiologist that you are being treated with this medicine.

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

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 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and talk to your doctor if you are taking:

• other medicines used to treat high blood pressure (antihypertensives), especially if you are undergoing therapy with clonidine. If the two medicines are administered simultaneously, treatment with METOPROLOLO DOC Generici must be stopped several days before discontinuing therapy with clonidine;
• prazosin, a medicine used to facilitate urine elimination;
• medicines that reduce some functions of your body controlled by the brain (inhibitors of the sympathetic nervous system);
• other medicines similar to metoprolol (beta-blockers), even in the form of eye drops (ophthalmic drops);
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs);
• nitroglycerin, a medicine used to treat certain heart disorders, as it may cause an excessive reduction in blood pressure (hypotensive effect);
• medicines used to treat heart rhythm disturbances (antiarrhythmics such as quinidine and amiodarone) and/or a particular type of medicine for treating high blood pressure, called calcium antagonists (such as verapamil), especially if administered by intravenous injection;
• 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 (ophthalmic drops);
• medicines used to treat diabetes such as insulin and oral hypoglycemic agents;
• indometacin, a medicine used to relieve pain and treat inflammation, as it may reduce the effect of metoprolol;
• rifampicin, a medicine used to treat tuberculosis;
• medicines that increase or decrease the metabolism of metoprolol (e.g. cimetidine, a medicine used to treat stomach lesions and burns (ulcers));
• lidocaine, a medicine used to treat heart rhythm disturbances, as metoprolol may influence its effects;
• medicines used to induce anesthesia (see section “Warnings and precautions”).

METOPROLOLO DOC Generici 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, or if you are breastfeeding, 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.
If you are breastfeeding and are being treated with METOPROLOLO DOC Generici, your doctor must closely monitor your baby.

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

METOPROLOLO DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take METOPROLOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take the medicine on an empty stomach. Take the tablets whole with a sufficient amount of
liquid and without chewing.

Treatment of high blood pressure (hypertension)
The recommended dose is 1 or 2 tablets (100 - 200 mg) per day. This dose can be taken
in a single administration or in 2 separate administrations (morning and afternoon), especially
when the dose is high. If necessary, your doctor may prescribe you another medicine
used to lower high blood pressure (antihypertensive).

Prevention of chest pain (angina pectoris)
The recommended dose is 1 or 2 tablets (100 - 200 mg) per day, to be taken in 2 administrations.
If necessary, your doctor may increase the dose to 4 tablets (400 mg).

Treatment of heart rhythm disturbances (cardiac arrhythmias)
The recommended dose is 1 tablet or 1 and a half tablets (100 - 150 mg) per day, to be taken in
2-3 administrations.
If necessary, your doctor may increase the dose to 3 tablets (300 mg) per day.

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 administrations. The duration of treatment is at least 3 months.

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

If you take more METOPROLOLO DOC Generici than you should
In case of ingestion/taking of an excessive amount of this medicine, contact
immediately your doctor or the nearest hospital.
In case of taking 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);
• difficulty breathing (bronchospasm);
• alteration of the state of consciousness, up to coma;
• nausea, vomiting;
• severe disturbance of blood circulation characterized by bluish discoloration of the skin (cyanosis).

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 DOC Generici
Do not take a double dose to make up for the missed tablet.

If you stop taking METOPROLOLO DOC Generici
Do not abruptly stop treatment with this medicine without consulting your doctor. It
is necessary that the interruption of treatment with METOPROLOLO DOC Generici takes place in
a gradual manner, over a period of 10 days, and under the close supervision of your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following symptoms during treatment with this medicine, stop taking it immediately
and inform your doctor:

• slowing of the heartbeat (bradycardia);
• severe lowering of blood pressure (hypotension);
• appearance of red spots on the skin and bleeding (thrombocytopenic purpura);
• reduction in the number of a particular type of white blood cells (granulocytopenia);
• skin irritations (urticaria, psoriasiform and dystrophic skin lesions);
• difficulty breathing (bronchospasm). The following side effects may also occur: Rare(may affect up to 1 in 1,000 patients)
• depression, severe mental disorder (catatonia), confusion, memory disorders (memory impairment);
• tingling in the extremities (paresthesia);
• muscle cramps;
• loss of mental abilities (decreased mental vivacity);
• sleep disorders (sleep disturbances, nightmares);
• heart failure (congestive heart failure);
• 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).

Frequency not known(the frequency of which cannot be estimated from available data)

• fatigue;
• dizziness and headache (cephalalgia);
• slowing of the heartbeat (bradycardia);
• postural disorders, sometimes accompanied by fainting with loss of consciousness (syncope);
• nausea, vomiting, abdominal pain, diarrhea, constipation;
• severe difficulty breathing (dyspnea on exertion);
• heart problems and pain (cardiac conduction disorders, precordial pain);
• tissue damage and death (gangrene), in patients with severe blood circulation problems in the limbs;
• personality disorders, hallucinations;
• dry mouth (oral mucosa);
• abnormal results of tests performed to assess liver function and liver inflammation (hepatitis);
• skin sensitivity to light (photosensitivity);
• increased sweating;
• hair loss (alopecia);
• irritation and inflammation of the nose (rhinitis);
• sexual problems (decreased libido, sexual dysfunction);
• irritation and/or dryness of the eyes;
• vision problems (visual disturbances);
• ringing in the ears (tinnitus) and hearing disorders, especially if you take higher doses than prescribed by your doctor;
• weight gain;
• reduction in the number of platelets in the blood (thrombocytopenia);
• inflammation of the joints (arthritis).

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 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 METOPROLOLO DOC Generici

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 “Expiry”.
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 DOC Generici 100 mg tablets contain

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milano.

Manufacturer
COSMO S.p.A. - Via C. Colombo, 1 - 20020 Lainate (MI).
LACHIFARMA S.r.l. - Laboratorio Chimico Salentino - S.S. 16 Zona Industriale - 73010 Zollino
(LE).