METOPROLOL 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Metoprolol VP, 50 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Metoprolol VP and what is it used for
4. Important information before taking Metoprolol VP
   1. When not to take Metoprolol VP
   2. Warnings and precautions
   3. Metoprolol VP and other medicines
   4. Metoprolol VP with food, drink, and alcohol
   5. Metoprolol may enhance and prolong the effects of alcohol.
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Metoprolol VP contains sodium
5. How to take Metoprolol VP
   1. Taking a higher dose of Metoprolol VP than recommended
   2. Missing a dose of Metoprolol VP
   3. Stopping Metoprolol VP treatment
6. Possible side effects
   1. Side effects are enhanced by alcohol.
   2. Reporting side effects
7. How to store Metoprolol VP
8. Contents of the pack and other information
   1. What Metoprolol VP contains
   2. What Metoprolol VP looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Metoprolol VP, 50 mg, Tablets

Metoprolol Tartrate

Read the package 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 as yours.
• 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 Metoprolol VP and what is it used for
• 2. Important information before taking Metoprolol VP
• 3. How to take Metoprolol VP
• 4. Possible side effects
• 5. How to store Metoprolol VP
• 6. Contents of the pack and other information

1. What is Metoprolol VP and what is it used for

Metoprolol VP is a medicine that selectively blocks one group of receptors found in the heart muscle (beta-adrenergic receptors). Blocking these receptors slows down the accelerated heart activity, reduces increased blood pressure, rarely causing orthostatic hypotension (i.e., a sudden drop in blood pressure when changing body position from lying down to sitting or standing, or from sitting to standing), counteracts heart arrhythmias, and has a cardioprotective effect (i.e., protective effect on the heart) by reducing the frequency of angina pectoris (chest pain). It is used to treat angina pectoris (chest pain in coronary artery disease), high blood pressure, functional circulatory disorders of the hyperkinetic type (a condition in which the heart works faster or contracts more strongly than normal), and tachyarrhythmia (heart rhythm disorders with accelerated heart activity).

2. Important information before taking Metoprolol VP

When not to take Metoprolol VP

• if you are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6) or other beta-adrenergic blockers with a similar structure.
• if you have:
• second- or third-degree atrioventricular block (a disorder that can be treated with a pacemaker);
• cardiogenic shock (shock caused by heart problems);
• clinically significant sinus bradycardia (slow heart rate);
• uncontrolled heart failure (causes shortness of breath and swelling of the limbs);
• severe peripheral arterial occlusive disease;
• hypotension;
• metabolic acidosis (increased acid levels in the blood);
• untreated pheochromocytoma (a type of tumor);
• sick sinus syndrome (a disorder that can be treated with a pacemaker);
• myocardial infarction with significant bradycardia, first-degree atrioventricular block, hypotension, or severe heart failure.
• if you have ever had severe asthma or severe bronchospastic conditions.

Warnings and precautions

Before starting to take Metoprolol VP, discuss it with your doctor or pharmacist. Be particularly cautious:

• if you have obstructive pulmonary disease (you may need to adjust the doses of medicines used for this disease or take additional medication);
• if you are at increased risk of anaphylactic reactions (a type of allergic reaction that occurs immediately after contact with the allergen), e.g., if you have had such a reaction after taking any medicine (during Metoprolol VP treatment, such reactions may be particularly severe and resistant to adrenaline treatment);
• if you have significant bradycardia (heart rate less than 55 beats per minute), as you may need to reduce the dose of Metoprolol VP or gradually discontinue it;
• if you have heart failure or limited cardiac reserve (you may need to receive appropriate treatment for these conditions before taking Metoprolol VP);
• if you have first-degree atrioventricular block (metoprolol may worsen it);
• if you have diabetes (the medicine may mask some symptoms of low blood sugar, e.g., tachycardia, and may require adjusting the doses of antidiabetic medicines);
• if you have hyperthyroidism or suspect you have it (metoprolol may mask symptoms of excessive thyroid hormone levels in the blood);
• if you are being treated for pheochromocytoma (you should also take a medicine that blocks alpha-adrenergic receptors, e.g., doxazosin);
• if you are to be given adrenaline (its use in a person taking metoprolol may cause increased blood pressure and bradycardia);
• if you are to undergo surgery (you should inform the anesthesiologist about taking Metoprolol VP, as it may cause low blood pressure);
• if you have Prinzmetal's angina (metoprolol may increase the number and duration of angina attacks in such patients);
• if you have dry eyes, especially with accompanying skin rash (these symptoms may indicate the occurrence of oculo-mucocutaneous syndrome, which may require discontinuing the medicine);
• if you have liver function disorders (you may need to take lower doses of Metoprolol VP);
• if you have psoriasis (taking the medicine may worsen it).

Metoprolol VP and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as those you plan to take. It is especially important to inform your doctor about taking:

• other antihypertensive medicines, especially other beta-adrenergic blockers (e.g., propranolol, bisoprolol), clonidine, prazosin, and calcium channel blockers (e.g., nifedipine, diltiazem);
• eye drops containing beta-adrenergic blockers (e.g., timolol);
• medicines that block sympathetic nerve endings, such as trimethaphan (a medicine used to lower blood pressure);
• monoamine oxidase inhibitors (MAOIs), such as selegiline or moclobemide (medicines used mainly to treat depression);
• antidepressants, such as fluoxetine, paroxetine, or bupropion;
• medicines used to treat mental disorders, such as thioridazine;
• antiarrhythmic medicines, such as propafenone and amiodarone;
• antiviral medicines, such as ritonavir;
• antihistamines, such as diphenhydramine (medicines used, among other things, to treat allergies);
• antimalarial medicines, such as hydroxychloroquine or quinidine;
• antifungal medicines, such as terbinafine;
• anti-ulcer medicines, such as cimetidine;
• nitroglycerin (a medicine used to treat angina pectoris);
• digitalis glycosides (medicines used to treat heart conditions);
• sympathomimetic medicines (medicines used, among other things, to dilate airways);
• antidiabetic medicines, including insulin;
• nonsteroidal anti-inflammatory medicines (medicines used mainly to combat pain and inflammation);
• lidocaine (a medicine used for local anesthesia);
• medicines used for general anesthesia;
• rifampicin (an antibiotic used, among other things, to treat tuberculosis) and other medicines that affect liver enzyme activity.

Metoprolol VP with food, drink, and alcohol

Take Metoprolol VP during or immediately after a meal.

Metoprolol may enhance and prolong the effects of alcohol.

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. Do not take Metoprolol VP during pregnancy or breastfeeding unless it is absolutely necessary. Taking the medicine during pregnancy or breastfeeding may cause the fetus, newborn, or breastfed child to experience, among other things, slow heart rate, low blood pressure, and low blood sugar levels. If your doctor considers it necessary to take Metoprolol VP during pregnancy, they will use the smallest possible doses and discontinue the medicine at least 2 to 3 days before delivery to avoid excessive uterine contractions and side effects in the newborn.

Driving and using machines

The medicine may cause dizziness, drowsiness, vision disturbances, dryness, and irritation of the eyes – if these occur, do not drive or operate machines.

Metoprolol VP contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Metoprolol VP

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. The recommended dose is as follows: Angina pectoris: on average 50 mg 2 or 3 times a day. If necessary, your doctor may increase the dose. High blood pressure: usually 100 to 150 mg per day. The daily dose can be taken once (in the morning). Sometimes a dose of 50 to 100 mg per day is sufficient. Hyperkinetic circulation symptoms: usually 50 mg 1 or 2 times a day. Tachyarrhythmia: 50 mg 2 or 3 times a day. If necessary, the dose can be increased to 200-300 mg per day. Your doctor will determine the dose individually for you. Take the medicine regularly.

Taking a higher dose of Metoprolol VP than recommended

If you take more Metoprolol VP than you should, you may experience severe low blood pressure, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, respiratory disorders, bronchospasm, impaired consciousness, coma, confusion, seizures, nausea, vomiting, cyanosis, low blood sugar levels, and sometimes high potassium levels in the blood. The first symptoms of overdose appear 20 minutes to 2 hours after taking too much of the medicine and, in the case of significant overdose, may persist for several days, despite decreasing metoprolol levels in the blood. If you have taken too much of the medicine, seek medical attention immediately. Treatment of overdose should be carried out in a hospital setting (usually requiring intensive care with continuous monitoring of vital functions). In the case of oral ingestion of a potentially life-threatening dose, the procedure includes inducing vomiting, gastric lavage (if the overdose occurred no more than 4 hours earlier), and (or) administering activated charcoal to remove metoprolol from the gastrointestinal tract. Additionally, symptomatic treatment is used. Metoprolol cannot be removed from the body by hemodialysis.

Missing a dose of Metoprolol VP

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Metoprolol VP treatment

Do not stop taking Metoprolol VP on your own or abruptly (especially if you have coronary artery disease). If possible, discontinuation should be gradual and last about 10 days. During the last 6 days, your doctor will recommend taking a dose of 25 mg. While discontinuing metoprolol, your doctor will closely monitor you to start taking another medicine to replace metoprolol if necessary. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metoprolol VP can cause side effects, although not everybody gets them. Common (less than 1 in 10, but more than 1 in 100 patients) side effects include:

• dizziness or headaches
• bradycardia (slow heart rate)
• fatigue
• orthostatic hypotension (related to changing body position from lying down to standing), sometimes with fainting
• exertional dyspnea
• nausea and vomiting
• abdominal pain
• Rare (less than 1 in 1000, but more than 1 in 10,000 patients) side effects include: depression, decreased mental alertness, drowsiness or insomnia, nightmares, paresthesia (tingling and burning sensation), muscle cramps, heart failure, arrhythmias, palpitations, edema, Raynaud's phenomenon (intermittent constriction of blood vessels in the hands, less often in the feet), bronchospasm (may occur in patients who have never had obstructive pulmonary disease), diarrhea or constipation, skin rash (in the form of urticaria, psoriasis-like, and degenerative skin changes). Very rare (less than 1 in 10,000 patients) side effects include: thrombocytopenia (reduced platelet count), weight gain, personality disorders, hallucinations, vision disturbances, dryness, and (or) irritation of the eyes, tinnitus, hearing loss (after taking doses higher than recommended), conduction disorders in the heart, chest pain, excessive sweating, gangrene (in patients who already have severe circulatory disorders), rhinitis, dry mouth, abnormal liver function tests, hypersensitivity to light, hair loss, exacerbation of psoriasis, arthritis, libido and potency disorders. The frequency is unknown (cannot be estimated from available data): hepatitis, retroperitoneal fibrosis, Peyronie's disease (a condition affecting the penis).

Side effects are enhanced by alcohol.

If any side effect worsens or you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Monitoring, 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. You can also report side effects 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 Metoprolol VP

Store in a temperature below 25°C. Store in the original package. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Metoprolol VP contains

• The active substance is metoprolol tartrate (50 mg per tablet).
• The other ingredients (excipients) are: microcrystalline cellulose, potato starch, povidone, sodium carboxymethylcellulose (type A), talc, magnesium stearate.

What Metoprolol VP looks like and contents of the pack

The tablets are white, round, flat, with beveled edges and a score line on one side, and the marking "M" above the line and "50" below the line. The tablets are packaged in blisters and cardboard boxes. The pack size is 30 or 40 tablets.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer

ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów

Date of last revision of the leaflet: