Metocard

Patient Information Leaflet

Metocard 50 mg tablets
Metocard 100 mg tablets
Metoprololi tartras
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metocard is and what it is used for
2. Important information before taking Metocard
3. How to take Metocard
4. Possible side effects
5. How to store Metocard
6. Contents of the pack and other information

1. What Metocard is and what it is used for

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

• Hypertension
• Angina pectoris
• Cardiac arrhythmias
• As an adjunctive treatment in hyperthyroidism

Early initiation of metoprolol treatment following the acute phase of myocardial infarction reduces the area of necrosis and the risk of ventricular fibrillation, and also allows for the use of lower doses of analgesic drugs.

2. Important information before using Metocard

When not to use Metocard:

• if the patient is allergic to metoprolol, other beta-blocking agents, 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 poor circulation (manifested by pallor 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 (disturbance of acid-base balance in the body);
• if the patient has severe asthma or COPD (chronic obstructive pulmonary disease).

Warnings and precautions
Special caution is required when using Metocard:

• if the patient has asthma;
• if the patient has diabetes (metoprolol may mask symptoms of low blood sugar);
• if the patient has a pheochromocytoma (a benign tumor of the adrenal gland causing high blood pressure);
• if the patient has hyperthyroidism (metoprolol may mask symptoms such as rapid heartbeat, excessive sweating, tremor, 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take metoprolol together with the following medicines:

• MAO inhibitors (medicines used for depression);
• other blood pressure-lowering medicines such as diltiazem and verapamil;
• other medicines used for heart rhythm disorders, such as disopyramide. Medicines that may increase the effect of metoprolol:
• cimetidine (used for peptic ulcer disease);
• hydralazine (lowers blood pressure);
• terbinafine (used for fungal infections);
• paroxetine, fluoxetine, and sertraline (used for depression);
• hydroxychloroquine (used to treat malaria);
• chlorpromazine, triflupromazine, and cyproheptadine (antipsychotic medicines);
• amiodarone, quinidine, and propafenone (used for irregular heartbeat);
• diphenhydramine (antihistamine);
• celecoxib (used, for example, for pain). Medicines that may reduce the effect of metoprolol:
• indomethacin (used for pain);
• rifampicin (an antibiotic).

Other medicines may interfere with the action of metoprolol or their action may be affected by metoprolol:

• other beta-blocking agents, e.g. eye drops;
• anaesthetics (used during surgery);
• lidocaine;
• clonidine (used to treat migraine);
• reserpine, alpha-methyldopa, guanfacine, cardiac glycosides. Anaesthesia and surgery Inform the doctor or dentist about taking Metocard before anaesthesia or surgery due to the risk of excessive slowing of the heart. Metocard with food, drink, and alcohol Alcohol may enhance the effect of metoprolol.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is breastfeeding, or planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Due to the possibility of adverse effects on the fetus, the decision to use this medicine in pregnant women will be made by the doctor.
Breastfeeding
The medicine passes into breast milk. The decision to use this medicine in breastfeeding women will be made by the doctor.

Driving and operating machinery
Use of metoprolol may cause adverse effects such as dizziness or fatigue, which may impair the ability to drive or operate machinery.

Metocard contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Metocard

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The medicine is taken orally.
Hypertension
The daily dose of Metocard ranges from 100 to 400 mg, administered in one or two divided
doses.
Initially, 100 mg once daily is used. Depending on the patient's condition and treatment efficacy,
the doctor may recommend increasing the dose by 100 mg at weekly intervals, or prescribe
an additional diuretic or another antihypertensive agent.
Angina pectoris
50 to 100 mg of metoprolol 2 or 3 times daily.
Cardiac arrhythmias
50 to 100 mg of metoprolol 2 or 3 times daily.
If necessary, the doctor may recommend increasing the dose up to 300 mg, administered in
divided doses.
Hyperthyroidism
50 mg 4 times daily. The doctor may recommend reducing this dose.
After the acute phase of myocardial infarction
Oral therapy with Metocard should begin within 15 minutes after the last intravenous dose of
metoprolol. The medicine should be administered at a dose of 50 mg every 6 hours during the
first 48 hours.
Patients who did not tolerate the full intravenous dose should receive half the recommended
oral dose. The usual maintenance dose is 200 mg daily, given in divided doses.
Dosage in infants and children
Metocard is not indicated for use in children.
Dosage in elderly patients
Depending on renal function and clinical response to treatment in patients in this group, the
doctor may recommend reducing the metoprolol dose. It is recommended to use the lowest
possible initial dose.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Do not change the dosage of the medicine on your own.
Missed dose of Metocard
If you forget to take one dose, skip it and take the next dose at the scheduled 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 quickly as possible. Bring any remaining tablets or the packaging with you so the doctor can
identify the medicine taken.
Metoprolol overdose may cause:

• severe hypotension,
• marked sinus bradycardia,
• atrioventricular block,
• heart failure,
• cardiogenic shock,
• cardiac arrest,
• bronchospasm,
• loss of consciousness (even coma),
• nausea, vomiting, and cyanosis.
  Symptoms may be worsened by concomitant alcohol consumption or use of antihypertensive
  drugs, quinidine, or barbiturates. The first symptoms of overdose may appear from 20 minutes
  to 2 hours after taking the medicine.

Stopping Metocard treatment
Do not suddenly stop treatment or change the dosage without first consulting your doctor.
Sudden withdrawal of beta-adrenolytic agents may worsen heart failure and increase the risk of
myocardial infarction and sudden death.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine and contact your doctor immediately if you experience
an allergic reaction, which may be manifested by:

• skin itching, redness,
• swelling of the face, lips, tongue, and throat,
• difficulty breathing and swallowing. This is a very rare adverse reaction. Immediate treatment or hospitalization may be necessary.

You should inform your doctor if you experience any of the following or any other adverse reactions:
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):
• slowed heart rate,
• difficulty maintaining balance (very rarely with fainting),
• palpitations, dizziness, headache,
• nausea, diarrhoea, constipation, abdominal pain,
• shortness of breath associated with strenuous physical exertion.
  Uncommon (occurring in less than 1 in 100 patients, but more than 1 in 1,000 patients):
• temporary worsening of heart failure symptoms,
• disturbances in cardiac conduction,
• fluid retention in the body,
• chest pain,
• tingling and pricking sensations on the skin,
• cold hands and feet, muscle cramps, vomiting,
• weight gain,
• depression, reduced concentration, insomnia, nightmares,
• shortness of breath, skin rashes, increased sweating.
  Rare (occurring in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):
• worsening of diabetes,
• nervousness, tension,
• visual disturbances, dryness or irritation of the eyes, conjunctivitis,
• impotence, Peyronie's disease (plastic hardening of the penis),
• irregular heartbeat, disturbances in cardiac conduction,
• dry mouth, nasal congestion,
• hair loss,
• changes in liver function tests.
  Very rare (occurring in less than 1 in 10,000 patients, including single cases):
• decreased number of white blood cells or platelets,
• memory disturbances, disorientation, hallucinations, mood disturbances,
• tinnitus, hearing disturbances, taste disturbances,
• hepatitis, photosensitivity,
• worsening of psoriasis or development of psoriasis,
• muscle weakness, joint pain,
• tissue necrosis in patients with severe circulatory disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metocard

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

6. Contents of the package and other information

What Metocard contains

• The active substance in this medicinal product is metoprolol. Each tablet contains either 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 contents of the pack
Metocard 50 mg and 100 mg are white, round, biconvex tablets with a score line.
One pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01