Metocard

Leaflet attached to the packaging: patient information

Metocard 50 mg tablets

Metocard 100 mg tablets

Metoprolol tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Metocard and what is it used for
• 2. Important information before taking Metocard
• 3. How to take Metocard
• 4. Possible side effects
• 5. How to store Metocard
• 6. Package contents and other information

1. What is Metocard and what is it used for

Metocard belongs to a group of medicines called beta-blockers.
Metocard is used to treat:

• Hypertension
• Angina pectoris
• Heart rhythm disorders (arrhythmias)
• Assisted - hyperthyroidism Early initiation of metoprolol treatment after acute myocardial infarction reduces the area of necrosis and the risk of ventricular fibrillation, and also allows the use of smaller doses of painkillers.

2. Important information before taking Metocard

When not to take Metocard:

Warnings and precautions

Be particularly careful when taking Metocard:

Children

Metocard is not indicated for use in children.

Metocard and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take metoprolol at the same time as the following medicines:

• MAO inhibitors (medicines used in depression);
• other blood pressure-lowering medicines such as diltiazem and verapamil;
• other medicines used in heart rhythm disorders, such as disopyramide. Medicines that may increasethe effect of metoprolol:
• cimetidine (used in stomach ulcers);
• hydralazine (blood pressure-lowering);
• terbinafine (used in fungal infections);
• paroxetine, fluoxetine, and sertraline (used in depression);
• hydroxychloroquine (used in malaria treatment);
• chlorpromazine, triflupromazine, chlorprothixene (antipsychotic medicines);
• amiodarone, quinidine, and propafenone (used in irregular heartbeat);
• diphenhydramine (antihistamine);
• celecoxib (used e.g. in pain). Medicines that may decreasethe effect of metoprolol:
• indomethacin (used in pain);
• rifampicin (antibiotic).

Other medicines may interfere with the effect of metoprolol or their effect may be interfered with by metoprolol:

• other beta-blockers, e.g. eye drops;
• anesthetics (used during surgery);
• lidocaine;
• clonidine (used in migraine treatment);
• reserpine, alpha-methyldopa, guanfacine, digitalis glycosides.

Anesthesia and surgery

Inform your doctor or dentist about taking Metocard before anesthesia or surgery, due to the possibility of excessive slowing of heart activity.

Metocard with food, drink, and alcohol

Alcohol may enhance the effect of metoprolol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Due to the possibility of side effects in the fetus, the decision to use the medicine in pregnant women will be made by the doctor.
Breastfeeding
The medicine passes into breast milk. The decision to use the medicine in breastfeeding women will be made by the doctor.

Driving and using machines

Taking metoprolol may cause side effects such as dizziness or fatigue, which may impair your ability to drive or operate machinery.

Metocard contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Metocard

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Take the medicine orally.

Hypertension

The daily dose of Metocard is 100 to 400 mg, given in one or two divided doses.
Initially, 100 mg is given per day. Depending on the patient's condition and the effectiveness of the treatment, the doctor may recommend increasing the dose at weekly intervals by 100 mg or prescribe an additional diuretic or other antihypertensive medicine.

Angina pectoris

50 to 100 mg of metoprolol 2 or 3 times a day.

Heart rhythm disorders

50 to 100 mg of metoprolol 2 or 3 times a day.
If necessary, the doctor may recommend increasing the dose to 300 mg, which is given in divided doses.

Hyperthyroidism

50 mg 4 times a day. The doctor may recommend reducing this dose.

After acute myocardial infarction

Oral therapy with Metocard should be started within 15 minutes after the last intravenous administration of metoprolol. The medicine should be given in a dose of 50 mg every 6 hours for the first 48 hours.
A patient who did not tolerate the full intravenous dose should receive half of the recommended oral dose. The maintenance dose is usually 200 mg per day, given in divided doses.

Dosing in infants and children

Metocard is not indicated for use in children.

Dosing in the elderly

Depending on the patient's renal function and clinical response to treatment, the doctor may recommend reducing the dose of metoprolol in this group of patients. It is recommended to use the lowest possible initial dose.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor. Do not change the dose of the medicine yourself.

Missing a dose of Metocard

If you forget to take a dose, skip it and take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Taking more than the recommended dose of Metocard

If you take more than the recommended dose, inform your doctor or go to the nearest hospital as soon as possible. Take the remaining tablets or packaging with you to identify the medicine taken by the doctor.
Overdose of metoprolol may cause:

• severe hypotension,
• significant slowing of the heart rate,
• atrioventricular block,
• heart failure,
• cardiogenic shock,
• cardiac arrest,
• bronchospasm,
• loss of consciousness (even coma),
• nausea, vomiting, and cyanosis. Symptoms may worsen if you also consume alcohol, take blood pressure-lowering medicines, quinidine, or barbiturates. The first symptoms of overdose appear 20 minutes to 2 hours after taking the medicine.

Stopping Metocard treatment

Do not suddenly stop treatment or change the dose yourself without consulting your doctor first.
Sudden withdrawal of beta-blockers may worsen heart failure and increase the risk of myocardial infarction and sudden death.
If you have any further doubts about taking 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.
Stop taking the medicine and contact your doctor immediatelyif you experience an allergic reaction, which may manifest as:

• skin itching, redness,
• swelling of the face, lips, tongue, and throat,
• difficulty breathing and swallowing. This is a very rare side effect. You may need immediate treatment or hospitalization.

Tell your doctor if you experience any of the following or any other side effects:

Very common(occurring in more than 1 in 10 patients):

• fatigue. Common(occurring in less than 1 in 10 patients, but more than 1 in 100 patients):
• slow heart rate,
• balance disorders (very rarely with fainting),
• palpitations, dizziness, headaches,
• nausea, diarrhea, constipation, abdominal pain,
• shortness of breath related to strenuous physical exertion. Uncommon(occurring in less than 1 in 100 patients, but more than 1 in 1000 patients):
• temporary worsening of heart failure symptoms,
• conduction disorders in the heart,
• fluid retention in the body,
• chest pain,
• tingling and numbness on the skin,
• cold hands and feet, muscle cramps, vomiting,
• weight gain,
• depression, decreased concentration, insomnia, nightmares,
• shortness of breath, rash, increased sweating. Rare(occurring in less than 1 in 1000 patients, but more than 1 in 10,000 patients):
• worsening of diabetes,
• nervousness, tension,
• vision disorders, dryness or irritation of the eyes, conjunctivitis,
• impotence, Peyronie's disease (plastic induration of the penis),
• irregular heartbeat, conduction disorders in the heart,
• dry mouth, runny nose,
• hair loss,
• changes in liver function tests. Very rare(occurring in less than 1 in 10,000 patients, including single cases):
• decreased white blood cell or platelet count,
• memory disorders, disorientation, hallucinations, mood disorders,
• tinnitus, hearing disorders, taste disorders,
• hepatitis, hypersensitivity to light,
• worsening of psoriasis or occurrence of psoriasis,
• muscle weakness, joint pain,
• necrosis of tissues in patients with severe circulatory disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metocard

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Metocard contains

• The active substance of the medicine is metoprolol. Each tablet contains 50 mg or 100 mg of metoprolol tartrate.
• The other ingredients are: rice starch, microcrystalline cellulose, lactose monohydrate, povidone, talc, magnesium stearate.

What Metocard looks like and what the package contains

Metocard 50 mg and 100 mg are white, round, biconvex tablets with a dividing line.
One package of the medicine contains 30 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: