Metoprolol

Patient Information Leaflet: Instructions for Use

Metocard, 1 mg/ml, solution for injection
Metoprolol tartrate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What Metocard is and what it is used for

Metoprolol, the active substance in Metocard, belongs to a group of medicines known as β-adrenergic receptor blockers (β-blockers). The drug works by blocking β-receptors located in the heart, resulting in reduced heart rate and myocardial contractility, which in turn leads to a reduction in blood pressure.
Metocard is used:

• in the treatment of tachyarrhythmias, particularly supraventricular ones,
• in patients with acute myocardial infarction.

2. Important information before using Metocard

When not to use Metocard:

• if the patient is allergic to metoprolol tartrate, another beta-blocker, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other beta-adrenergic blocking agents, e.g. atenolol, propranolol,
• if the patient has:
• cardiogenic shock, characterised by: cold, clammy, pale skin, low blood pressure, rapid and weak pulse, fast shallow breathing, reduced urine output,
• sick sinus syndrome (unless a pacemaker has been implanted),
• second- or third-degree atrioventricular block (a condition which may be treated by pacemaker implantation),
• uncontrolled heart failure (shortness of breath, ankle swelling),
• bradycardia (slowed heart rate below 45 beats per minute),
• very low blood pressure which may cause fainting,
• severe peripheral arterial circulatory disorders,
• metabolic acidosis (disturbance of acid-base balance in the body),
• untreated phaeochromocytoma (a benign adrenal gland tumour causing high blood pressure),
• suspected recent myocardial infarction if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 s, or systolic blood pressure is less than 100 mmHg.
• if the patient is receiving (short- or long-term) drugs with inotropic action stimulating beta-adrenergic receptors.

Warnings and precautions
Before starting treatment with Metocard, discuss this with your doctor or nurse.
Exercise particular caution when using Metocard:

• if the patient has bronchial asthma, wheezing or other similar breathing disorders, or allergic reactions, e.g. to insect venom, food or other substances. If the patient has ever experienced an asthma attack or wheezing, do not use this medicine without consulting a doctor,
• if the patient has chest pain caused by Prinzmetal's angina,
• if the patient has circulatory disorders or heart failure,
• if the patient has liver disease,
• if the patient has first-degree heart block (conduction disturbances in the heart),
• if the patient has intermittent claudication (tiring and weakening of one or both legs during walking),
• if the patient has diabetes (the doctor may recommend adjusting doses of antidiabetic medicines),
• if the patient has hyperthyroidism – Metocard may mask symptoms of hyperthyroidism such as rapid heartbeat, excessive sweating, tremor, increased appetite and weight loss,
• if the patient has phaeochromocytoma,
• if the patient has psoriasis.

Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
Children
Metocard must not be used in children.
Metocard and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
In particular, inform your doctor or nurse if the patient is taking any of the following medicines:

• clonidine (used to treat high blood pressure or migraine). When treating with both clonidine and Metocard, do not discontinue clonidine without consulting your doctor. If discontinuation of clonidine or Metocard becomes necessary, your doctor will advise how to do so.
• terbinafine (used to treat fungal infections),
• diphenhydramine (used for allergies),
• antihypertensive medicines (dihydropyridine derivatives, e.g. amlodipine, tricyclic antidepressants),
• ganglion-blocking agents, sympathomimetics (may be present in some cold remedies),
• beta-blockers (e.g. eye drops used in glaucoma treatment, such as timolol),
• monoamine oxidase inhibitors (used for depression),
• verapamil, diltiazem, nifedipine (used to treat high blood pressure and chest pain),
• quinidine, amiodarone, propafenone or digitalis glycosides (used in heart disease treatment),
• hydralazine (used to treat high blood pressure),
• cimetidine (used in peptic ulcer disease),
• rifampicin (used in bacterial infections),
• adrenaline (a medicine stimulating heart function),
• indomethacin, celecoxib (analgesic and anti-inflammatory medicines, used e.g. in joint inflammation),
• selective serotonin reuptake inhibitors (e.g. paroxetine, fluoxetine and sertraline, used in depression treatment),
• phenothiazines (used to treat psychiatric disorders),
• barbiturates (sedative and anticonvulsant medicines),
• insulin or other antidiabetic medicines (dose adjustment may be necessary),
• lidocaine (a local anaesthetic),
• ergotamine derivatives (medicines used in migraine treatment).

Also inform your doctor about any disturbing reactions that occurred after taking other medicines.
Anaesthesia and surgery
Inform your doctor or dentist about taking Metocard before anaesthesia or surgery, due to the risk of excessive slowing of heart function.
Metocard with food, drink or alcohol
Inform your doctor or nurse about alcohol consumption before taking Metocard. Alcohol may affect the action of Metocard.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Metocard must not be used in pregnant women unless the benefits of treatment outweigh the risks to the foetus.
If a woman treated with Metocard becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Metocard must not be used during breastfeeding unless the benefits of treatment outweigh the risks to the breastfed infant.
Driving and operating machinery
Treatment with Metocard may cause adverse effects such as dizziness or fatigue, which may impair the ability to drive or operate machinery.
Metocard contains sodium
The medicine contains 3.6 mg of sodium per 1 ml of solution. 5 ml of solution (one ampoule) contains 18 mg of sodium.
This corresponds to 0.9% of the maximum recommended daily dietary sodium intake for adults.
The medicine may be diluted – see section "Information intended exclusively for healthcare professionals". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution. For accurate information on sodium content in the diluent solution used, refer to the patient leaflet of the diluent used. This should be considered in patients with impaired renal function and in patients controlling sodium intake in their diet.

3. How to use Metocard

This medicine should always be used according to the instructions given by the doctor or nurse. If in doubt,
consult the doctor or pharmacist.
Adults

• Metocard is administered by a doctor or nurse.
• The medicine is given as an injection into a vein (intravenous administration).
• The dose is determined by the doctor. The amount of medicine given depends on the type of disease.

Children
Metocard must not be used in children.
Detailed dosage information is provided in the section "Information intended exclusively for healthcare professionals".
Use of a larger or smaller than recommended dose of Metocard
If the patient suspects that an overdose has been administered, inform the doctor or nurse immediately.
Discontinuation of Metocard
The decision to stop using the medicine is made by the doctor or nurse.
If there are any further doubts regarding the use of this medicine, consult the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should tell your doctor if any of the side effects listed below occur, or any other
adverse reactions:

Very common (occur in more than 1 in 10 patients)

• fatigue

Common (occur in less than 1 in 10 patients)

• dizziness
• headache
• slowing of heart function; inform your doctor immediately, as the doctor may reduce the dose or gradually discontinue the medicine
• palpitations
• changes in blood pressure related to change in body position (very rarely with fainting)
• shortness of breath during exertion
• nausea
• abdominal pain
• diarrhoea
• constipation
• coldness in hands and feet

Uncommon (occur in less than 1 in 100 patients)

• depression
• insomnia
• nightmares
• difficulty concentrating
• drowsiness
• burning, tingling or numbness sensation (paraesthesia)
• worsening of existing heart failure
• conduction disorders in the heart, detected during ECG examination (first-degree heart block)
• sudden drop in blood pressure during heart attack (cardiogenic shock)
• bronchospasm
• vomiting
• skin rash
• excessive sweating
• muscle cramps
• chest pain
• oedema
• weight gain

Rare (occur in less than 1 in 1,000 patients)

• nervousness
• anxiety states
• visual disturbances
• dryness and (or) irritation of the eyes
• conjunctivitis
• conduction disorders in the heart, cardiac arrhythmias, worsening of existing atrioventricular block
• pallor, cyanosis, followed by redness of fingers with associated numbness and pain (Raynaud's phenomenon)
• nasal mucosal inflammation
• dryness of the oral mucosa
• hair loss
• erectile dysfunction (impotence)
• liver function disorders (detected in blood tests)
• positive antinuclear antibody titer (antibodies used in diagnosing connective tissue diseases)

Very rare (occur in less than 1 in 10,000 patients)

• tissue necrosis (gangrene) in patients with severe peripheral circulatory disorders
• reduced platelet count, which may lead to easy bruising
• confusion
• hallucinations
• loss or disturbances of memory
• taste disturbances
• tinnitus
• worsening of intermittent claudication (leg pain during walking)
• hepatitis
• photosensitivity
• exacerbation of psoriasis
• joint pain

Conditions that may worsen
The following conditions may be aggravated during treatment with this medicine:

• shortness of breath, feeling of fatigue or swelling around the ankles (in case of heart attack). These are uncommon adverse reactions, occurring in less than 1 in 100 patients.
• psoriasis (skin disease), circulatory disorders. These are very rare adverse reactions, occurring in less than 1 in 10,000 patients.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Metocard

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
The diluted solution can be stored for up to 2 hours at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the month indicated.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Medicines must not be disposed of via the sewage system 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 is metoprolol tartrate. Each ml of solution contains 1 mg of metoprolol tartrate. Each ampoule contains 5 mg of metoprolol tartrate.
• The other components are: sodium chloride, water for injections.

What Metocard looks like and contents of the pack
Metocard is a colourless, clear solution.
The pack contains 5 ampoules of 5 ml each made of colourless glass, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01

Information intended solely for healthcare professionals

• Metocard is intended for hospital use and should be administered by personnel experienced in treatment with this medicine.
• The medicine is administered intravenously.
• The dose to be administered is determined by the physician. The required dose depends on the type of condition being treated.
• Metocard is a ready-to-use solution that may also be mixed with the following diluents: 0.9% sodium chloride solution (9 mg/ml), 15% mannitol solution (150 mg/ml), 10% glucose solution (100 mg/ml), 5% glucose solution (50 mg/ml), Ringer's solution. Up to 40 mg of metoprolol can be diluted in 1000 ml of solution.

Dosage
Dosage in tachyarrhythmias
Initially, 5 mg of metoprolol is administered intravenously at a rate of 1 mg to 2 mg per minute. This dose may be repeated at 5-minute intervals until the desired clinical effect is achieved. A total dose of 10 mg to 15 mg is usually sufficient.

Dosage in myocardial infarction
Metocard for intravenous injection should be administered as soon as possible after the onset of symptoms of myocardial infarction.
Treatment should be initiated on a cardiology ward or similar setting, immediately after hemodynamic stabilization of the patient, with an intravenous dose of 5 mg. Subsequently, 5 mg bolus injections should be given every 2 minutes, up to a maximum total dose of 15 mg, depending on the patient's hemodynamic status.
In patients who tolerate the total intravenous dose (15 mg), 50 mg of metoprolol tartrate should be administered orally 15 minutes after the last intravenous dose, followed by continued oral administration of 50 mg of metoprolol tartrate every 6 hours for 48 hours.
In patients who do not tolerate the full intravenous dose (15 mg) of Metocard, oral treatment should be initiated cautiously at half the recommended oral dose.
The recommended maintenance dose is 100 mg of metoprolol tartrate twice daily (morning and evening) or 200 mg of metoprolol succinate once daily.

After each intravenous dose (5 mg) of Metocard, blood pressure and heart rate should be monitored. The next dose should not be administered if the heart rate is slower than 40 beats per minute, systolic blood pressure is below 90 mmHg, or the PQ interval is longer than 0.26 s. The next dose should also not be administered if there is worsening dyspnea or if the patient's skin becomes cold and clammy.