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, you may need to read it again.
• In case of any doubts, consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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)
• As an adjunct - 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:

• if the patient is allergic to metoprolol, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has conduction disorders or heart block;
• if the patient has untreated heart failure;
• if the patient has very poor circulation (manifested by paleness and cyanosis of the fingers or toes);
• if the patient has a slow heart rate (below 50 beats per minute);
• if the patient has very low blood pressure;
• if the patient has metabolic acidosis (imbalance of acid-base balance in the body);
• if the patient has severe asthma or COPD (chronic obstructive pulmonary disease).

Warnings and precautions

Particular caution should be exercised when taking Metocard:

• if the patient has asthma;
• if the patient has diabetes (metoprolol may mask low blood sugar levels);
• if the patient has a pheochromocytoma (a benign tumor of the adrenal gland that causes high blood pressure);
• if the patient has hyperthyroidism (metoprolol may mask symptoms of hyperthyroidism, such as rapid heart rate, excessive sweating, tremors, increased appetite, and weight loss);
• if the patient is undergoing surgery;
• if the patient has psoriasis.

Children

Metocard is not indicated for use in children.

Metocard and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Metoprolol should not be taken with 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 peptic ulcer disease);
• 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

The patient should inform their doctor or dentist about taking Metocard before anesthesia or surgery, due to the possibility of excessive slowing of heart rate.

Metocard with food, drink, and alcohol

Alcohol may enhance the effect of metoprolol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The decision to use the medicine in pregnant women will be made by the doctor, due to the possibility of side effects in the fetus.
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 the ability to drive vehicles and operate machinery.

Metocard contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Metocard

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is taken 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 blood pressure-lowering 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.
The patient who did not tolerate the full intravenous dose should receive half of the recommended oral dose. Usually, the maintenance dose is 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 the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
The patient should not change the dosage of the medicine on their own.

Missing a dose of Metocard

In case of forgetting to take a dose of the medicine, it should be skipped, and the next dose should be taken at the right time. A double dose should not be taken to make up for the missed dose of the medicine.

Taking a higher dose of Metocard than recommended

In case of taking a higher dose of the medicine than recommended, the patient should inform their doctor or go to the nearest hospital as soon as possible. The patient should take the remaining tablets or packaging with them to identify the taken medicine to 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 alcohol, hypotensive medicines, quinidine, or barbiturates are taken at the same time. The first symptoms of overdose appear within 20 minutes to 2 hours after taking the medicine.

Stopping Metocard treatment

The patient should not suddenly stop treatment or change the dosage on their own without consulting their doctor first.
Sudden withdrawal of beta-blockers may worsen heart failure and increase the risk of myocardial infarction and sudden death.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metocard can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and contact their doctor immediatelyif they 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. Immediate treatment or hospitalization may be necessary.

The patient should tell their doctor if they 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):
• decrease in white blood cell or platelet count,
• memory disorders, disorientation, hallucinations, mood disorders,
• ringing in the ears, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Metocard

The medicine should be stored 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 stated on the packaging is the last day of the given 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. The patient should ask their 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: