Package leaflet: Information for the patient

METOPROLOL DOC Generics 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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What METOPROLOL DOC Generics is and what it is used for
What you need to know before taking METOPROLOL DOC Generics
How to take METOPROLOL DOC Generics
Possible side effects
How to store METOPROLOL DOC Generics
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 substance metoprolol, which belongs to a group of medicines called beta-blockers, which slow down the heart rate and the force of contraction of the heart.

METOPROLOLO DOC Generici is indicated for:

treating arterial hypertension (high blood pressure);
treating and preventing angina pectoris (heart disease causing chest pain);
treating acute myocardial infarction (heart attack caused by death of heart cells due to prolonged lack of oxygen supply);
treating cardiac arrhythmias (heart rhythm disorders), except bradyarrhythmias (arrhythmias characterized by slowing of the heartbeat or absence of heartbeat);
treating hyperkinetic cardiac syndromes (increased heart rate which may also be perceived as palpitations or fluttering);
prevention of migraine (a type of headache).

2. What you should 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 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 (clinically significant sinus bradycardia);
if you have severe circulatory disorders in the limbs and suffer from severe forms of Raynaud's phenomenon (circulatory disturbances affecting symmetrically the fingers, often triggered by cold, with numbness, bluish skin, and pain);
if you suffer from a heart condition 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 not adequately pumped by the heart throughout the body);
if you have severe kidney problems (severe renal failure);
if you suffer from severe asthma or chronic conditions affecting the bronchi and lungs with congestion;
if you have low blood pressure (hypotension);
if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis);
if you have a tumor called "pheochromocytoma" that is not currently being treated (this tumor usually develops near a kidney and may cause high blood pressure).
If you are in any of the above situations, inform your doctor. METOPROLOLO DOC Generici must not be administered:
in patients with suspected ongoing heart attack;
in children and adolescents (see section “Children and adolescents”);
in combination with intravenous verapamil or diltiazem therapy.

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

if you have difficulty breathing (obstructive lung diseases);
if you have problems metabolizing sugars or suffer from low blood sugar levels (hypoglycemia). Metoprolol may interfere with sugar metabolism or mask the signs and symptoms of hypoglycemia;
if your heart function is insufficient (heart failure);
if you suffer from heart conduction disorders (moderate atrioventricular conduction disorder), as metoprolol may worsen your condition (atrioventricular block);
if you have circulation problems 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 blood levels of the medicine may be higher;
if you are scheduled for surgery. In this case, inform the anesthetist that you are being treated with this medicine.

For athletes:
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

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).

Other medicines and METOPROLOLO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and consult your doctor if you are taking:

other medicines used to treat high blood pressure (antihypertensives), especially if you are being treated with clonidine. If both medicines are administered together, treatment with METOPROLOLO DOC Generici must be discontinued several days before stopping clonidine;
prazosin, a medicine used to facilitate urine elimination;
medicines that reduce certain body functions controlled by the brain (sympathetic nervous system inhibitors);
other medicines similar to metoprolol (beta-blockers), including eye drops (ophthalmic solutions);
antidepressant medicines called monoamine oxidase inhibitors (MAOIs);
nitroglycerin, a medicine used to treat certain heart conditions, as it may cause excessive lowering of blood pressure (hypotensive effect);
medicines used to treat irregular heart rhythms (antiarrhythmics such as quinidine and amiodarone) and/or a specific type of medicine for high blood pressure called calcium antagonists (such as verapamil), especially if administered intravenously;
adrenaline and similar substances (sympathomimetic activity) that increase blood pressure and are contained in some medicines used to treat cough (antitussives), to reduce mucus buildup in the nose (nasal drops), or for eye disorders (ophthalmic drops);
medicines used to treat diabetes such as insulin and oral hypoglycemics. METOPROLOLO DOC Generici may increase the risk of severe hypoglycemia when used concomitantly with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide);
indomethacin, 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 heartburn (ulcers));
lidocaine, a medicine used to treat irregular heart rhythms, as metoprolol may affect 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 may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.
If you are breastfeeding while being treated with METOPROLOLO DOC Generici, your doctor must closely monitor your baby.

Driving and using machines
This medicine may impair your ability to drive or operate machinery.

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

3. How to take METOPROLOLO DOC Generici

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Arterial hypertension
The recommended dose is 1-2 tablets daily, taken as a single morning dose or
one tablet in the morning and one in the evening.
Angina pectoris
The recommended dose is 1-3 tablets daily.
Acute myocardial infarction
The recommended dose is 2 tablets daily, divided into two doses.
Cardiac arrhythmias (excluding bradyarrhythmias) and migraine prevention
The recommended dose is 1-2 tablets daily.
Hyperkinetic cardiac syndromes
The recommended dose is 1 tablet daily, taken as a single daily dose.
Administration instructions
The tablet cannot be divided into equal doses.
The score line is not intended for breaking the tablet. Tablets must be taken
on an empty stomach and must not be chewed.
If you take more METOPROLOLO DOC Generici than you should
In case of accidental ingestion/overdose of METOPROLOLO DOC Generici,
contact your doctor immediately or go to the nearest hospital.
In hospital, appropriate intervention protocols will be followed (e.g. gastric lavage,
administration of activated charcoal).
Symptoms of overdose with METOPROLOLO DOC Generici 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 in which the heart is unable to adequately pump blood throughout the body), cardiac arrest, altered consciousness/coma, nausea, vomiting, severe circulatory disturbance characterized by bluish discoloration of the skin (cyanosis), and airway obstruction due to contraction of the muscles surrounding the respiratory tract (bronchospasm).
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 stop treatment abruptly without consulting your doctor.
Discontinuation of METOPROLOLO DOC Generici must be gradual, over a period of 10 days, and under close medical supervision.
If you have any doubts about how to use 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 any of the following symptoms during treatment with this medicine, stop taking it immediately and contact your doctor:

slowing of the heartbeat (bradycardia);
severe drop in 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).

Additionally, the following side effects may occur:

Rare (may affect up to 1 in 1,000 patients)

depression, severe mental disorder (catatonia), confusion, memory problems (memory disturbances);
tingling in the extremities (paresthesia);
muscle cramps;
loss of mental abilities (decreased mental alertness);
sleep disorders (sleep disturbances, nightmares);
inadequate heart function (heart failure);
swelling due to fluid accumulation (edema);
increased awareness of heartbeats (palpitations);
tingling and pain in the fingers, followed by a sensation of heat and pain (Raynaud's phenomenon).

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

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

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 METOPROLOLO DOC Generici

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 "Expiry". 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 no longer in 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 substance is metoprolol tartrate. Each tablet contains 100 mg of metoprolol tartrate.
The other components are: monohydrate lactose, povidone, sodium croscarmellose, magnesium stearate, talc, anhydrous colloidal silica.

Description of the appearance of METOPROLOLO DOC Generici and the contents of the pack
White, round, flat tablet with a score line on one side.
Pack sizes of 30, 50 and 100 tablets in PVC/Al blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy.
Manufacturer
LACHIFARMA S.r.l. - Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale -
73010 Zollino (LE), Italy.