Patient Information Leaflet

Metoprolol VP, 50 mg, tablets
Metoprolol tartrate
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Metoprolol VP is and what it is used for
Important information before taking Metoprolol VP
How to take Metoprolol VP
Possible side effects
How to store Metoprolol VP
Contents of the pack and other information

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

Metoprolol VP is a selective blocker of one group of receptors located in the heart muscle (beta-adrenergic receptors). Blocking these receptors slows down an accelerated heart rate, reduces elevated blood pressure, rarely causing orthostatic hypotension (i.e. a sudden drop in blood pressure when changing position from lying down to sitting or standing, or from sitting to standing), prevents cardiac arrhythmias, and exerts cardioprotective effects (i.e. protects the heart) by reducing the frequency of angina attacks (angina pectoris). It is used in the treatment of angina pectoris (chest pain due to coronary artery disease), hypertension, functional circulatory disorders of the hyperkinetic circulation type (a condition in which the heart beats faster or contracts more strongly than normal), and tachyarrhythmia (a cardiac rhythm disorder characterized by an increased heart rate).

2. Important information before taking Metoprolol VP

When not to take Metoprolol VP

if the patient is allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6) or other beta-blocking drugs with similar structure;
if the patient has:
- second- or third-degree atrioventricular block (a condition which may be treated by implanting a cardiac pacemaker);
- cardiogenic shock (heart-originating shock);
- clinically significant sinus bradycardia (slowed heart rate);
- uncontrolled heart failure (causes shortness of breath and swelling of limbs);
- severe peripheral arterial disease;
- hypotension;
- metabolic acidosis (increased acid concentration in serum);
- untreated phaeochromocytoma (a type of tumour);
- sick sinus syndrome (a condition which may be treated by implanting a cardiac pacemaker);
- myocardial infarction associated with marked bradycardia, first-degree atrioventricular block, systolic hypotension (<100 mmHg), and/or severe heart failure.
if the patient has ever had severe asthma or severe bronchospastic conditions.

Warnings and precautions
Before starting treatment with Metoprolol VP, discuss it with your doctor or pharmacist.
Exercise particular caution:

if the patient has obstructive lung disease (dose adjustments of medications used for this condition or additional treatment may be required);
when the patient is at increased risk of anaphylactic reaction (a type of immediate allergic reaction following contact with an allergen), e.g. if such a reaction occurred previously after taking a medicine (during treatment with Metoprolol VP, such reactions may be particularly severe and resistant to adrenaline treatment);
if the patient develops significant bradycardia (heart rate less than 55 beats per minute), as this may require reducing the dose of Metoprolol VP or gradually discontinuing the medicine;
when the patient has heart failure or limited cardiac reserve (appropriate treatment of these conditions may be necessary before initiating Metoprolol VP);
if the patient has first-degree atrioventricular block (metoprolol may worsen this condition);
when the patient has diabetes (the medicine may mask some symptoms of hypoglycaemia, e.g. tachycardia, and may necessitate adjustment of antidiabetic drug doses);
if the patient has hyperthyroidism or a suspected hyperthyroid state (metoprolol may mask symptoms of excessive thyroid hormone levels in blood);
when the patient is being treated for phaeochromocytoma (in such cases, an alpha-adrenergic blocking agent, e.g. doxazosin, should be administered concomitantly with metoprolol);
if the patient is to receive adrenaline (its use in a person taking metoprolol may lead to increased blood pressure and bradycardia);
if the patient is undergoing surgery (inform the anaesthesiologist about taking Metoprolol VP, as it may cause low blood pressure);
if the patient has Prinzmetal’s angina (metoprolol may increase the number and duration of anginal episodes);
when the patient develops dry eyes, especially with accompanying skin rash (these symptoms may indicate Stevens-Johnson syndrome, requiring discontinuation of the medicine);
if the patient has impaired liver function (lower doses of Metoprolol VP may be required);
when the patient has psoriasis (treatment may exacerbate it).

Metoprolol VP and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Metoprolol VP may increase the risk of severe hypoglycaemia when used concomitantly with certain antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glyburide, glimepiride, tolbutamide, or repaglinide).
It is especially important to inform your doctor about taking:

other antihypertensive medicines, especially other beta-blockers (e.g. propranolol, bisoprolol), clonidine, prazosin, and calcium channel blockers (e.g. nifedipine, diltiazem);
eye drops containing beta-blocking agents (e.g. timolol);
ganglion-blocking agents such as trimethaphan (a medicine used to lower blood pressure);
MAO inhibitors such as selegiline or moclobemide (medicines mainly used in depression treatment);
antidepressants such as fluoxetine, paroxetine, or bupropion;
medicines used in psychiatric disorders, such as thioridazine;
antiarrhythmics such as propafenone and amiodarone;
antiviral medicines such as ritonavir;
antihistamines such as diphenhydramine (medicines used, among others, in allergy treatment);
antimalarial medicines such as hydroxychloroquine or quinidine;
antifungal medicines such as terbinafine;
antiulcer medicines such as cimetidine;
nitroglycerin (a medicine used in angina pectoris);
cardiac glycosides (medicines used in heart diseases);
sympathomimetic agents (medicines used, among others, to dilate bronchi);
antidiabetic medicines, including insulin;
non-steroidal anti-inflammatory drugs (medicines mainly used to relieve pain and inflammation);
lidocaine (a medicine used for local anaesthesia);
medicines used for general anaesthesia;
rifampicin (an antibiotic used, among others, in tuberculosis) and other medicines affecting liver enzyme activity.

Metoprolol VP with food, drink and alcohol
Metoprolol VP should be taken during or immediately after a meal.
Metoprolol may enhance and prolong the effects of alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Metoprolol VP must not be used during pregnancy and breastfeeding unless absolutely necessary.
Use of the medicine in pregnant women or women who are breastfeeding may cause, among others, bradycardia, hypotension, and decreased blood glucose levels in the foetus, newborn, or breastfed infant.
If the doctor considers the use of Metoprolol VP during pregnancy absolutely necessary, the lowest possible dose should be used, and the medicine should be discontinued at least 2 to 3 days before delivery to avoid excessive uterine contractions and adverse effects in the newborn.

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

Metoprolol VP contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Metoprolol VP

This medicine should always be taken as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Recommended dose
Angina pectoris: average dose is 50 mg twice or three times daily. The doctor may increase the dose if necessary.
Hypertension: usually 100 to 150 mg once daily. The daily dose may be taken as a single dose (in the morning). Sometimes a dose of 50 to 100 mg daily is sufficient.
Hyperkinetic circulatory symptoms: usually 50 mg once or twice daily.
Tachyarrhythmia: 50 mg two or three times daily. If necessary, the dose may be increased to 200–300 mg daily.
The doctor will determine the dosage individually for each patient.
The medicine should be taken regularly.

Taking more Metoprolol VP than recommended
In case of overdose of Metoprolol VP, severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, respiratory disorders, bronchospasm, disturbances of consciousness, coma, confusion, seizures, nausea, vomiting, cyanosis, decreased serum glucose concentration, and sometimes increased serum potassium concentration may occur.
The first symptoms of overdose appear from 20 minutes to 2 hours after taking an excessive dose and, in cases of significant overdose, may persist for several days despite decreasing blood concentrations of metoprolol.
If an excessive dose has been taken, seek immediate medical attention.
Treatment of overdose should be carried out in a hospital setting (most often requiring treatment in an intensive care unit with continuous monitoring of vital functions). In cases of potentially life-threatening oral ingestion, management includes inducing vomiting, gastric lavage (if no more than 4 hours have passed since the overdose), and (or) administration of activated charcoal to remove metoprolol from the gastrointestinal tract. Additionally, symptomatic treatment is applied.
Metoprolol cannot be removed from the body by hemodialysis.

Missing a dose of Metoprolol VP
If a dose is missed at the scheduled time, 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 a missed dose.

Stopping treatment with Metoprolol VP
Metoprolol VP should not be discontinued abruptly or without medical supervision (especially in patients with ischemic heart disease). Whenever possible, discontinuation should be gradual and take approximately 10 days. During the last 6 days, the doctor will recommend a dose of 25 mg daily.
During discontinuation of metoprolol, the doctor will monitor the patient closely and, if necessary, initiate treatment with another medicine to replace metoprolol.

If you have any further doubts regarding 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 everybody will experience them.

Common (less than 1 in 10 but more than 1 in 100 patients):

dizziness or headache
bradycardia (slowing of the heart rate)
fatigue
orthostatic hypotension (related to changing from lying to standing position), sometimes with fainting
exertional dyspnea (shortness of breath on exertion)
nausea and vomiting
abdominal pain

Uncommon (less than 1 in 1,000 but more than 1 in 10,000 patients):

depression, reduced mental alertness, drowsiness or insomnia, nightmares
paresthesia (tingling and burning sensations)
muscle cramps
heart failure
cardiac arrhythmias
palpitations
edema (swelling)
Raynaud's phenomenon (episodic arterial spasm affecting the hands, less commonly the feet)
bronchospasm (may occur in patients who have never had obstructive lung disease)
diarrhea or constipation
skin rash (urticaria, psoriasiform or dystrophic skin changes)

Rare (less than 1 in 10,000 patients):

thrombocytopenia (reduced platelet count)
weight gain
personality disorders
hallucinations
visual disturbances
dryness and/or eye irritation
tinnitus (ringing in the ears)
hearing loss (after doses higher than recommended)
cardiac conduction disorders
precordial pain (chest pain)
excessive sweating
gangrene (in patients who previously had severe peripheral circulatory disorders)
rhinitis (nasal inflammation)
dry mouth sensation
abnormal liver function tests
photosensitivity
hair loss
worsening of psoriasis
arthritis
libido and potency disorders

Frequency not known (cannot be estimated from the available data):

hepatitis (liver inflammation)
retroperitoneal fibrosis
Peyronie's disease (penile disorder)

Adverse reactions may be intensified by alcohol.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

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 Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +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 authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Metoprolol VP

Store below 25°C.
Keep in the original packaging.
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 stated month.

6. Contents of the pack and other information

What Metoprolol VP contains

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

What Metoprolol VP looks like and contents of the pack
The tablets are white, round, biconvex with bevelled edges and a break line imprinted on one side, with the mark "M" above the line and "50" below the line.
The tablets are packed in blister packs and cardboard boxes.
Pack sizes: 30 or 40 tablets.

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

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-105 Rzeszów
Poland

Metoprolol vp