Metocard Zk

Leaflet attached to the packaging: patient information

Metocard ZK, 23.75 mg, prolonged-release tablets

Metocard ZK, 47.5 mg, prolonged-release tablets

Metocard ZK, 95 mg, prolonged-release tablets

Metoprolol succinate

Read the 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 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 ZK and what is it used for
• 2. Important information before taking Metocard ZK
• 3. How to take Metocard ZK
• 4. Possible side effects
• 5. How to store Metocard ZK
• 6. Package contents and other information

1. What is Metocard ZK and what is it used for

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

• high blood pressure (hypertension)
• severe chest pain caused by insufficient oxygen supply to the heart (angina pectoris)
• irregular heart rhythm (arrhythmias)
• stable symptomatic heart failure (with symptoms such as shortness of breath or swelling of the ankles), in combination with other heart failure medications
• palpitations (feeling of "heart pounding") caused by functional heart diseases.

It is used to prevent:

• recurrent heart attack or heart damage after a heart attack
• migraines.

Children and adolescents aged 6 to 18 years
Treatment of high blood pressure (hypertension).

2. Important information before taking Metocard ZK

When not to take Metocard ZK

• if the patient is allergic to metoprolol, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if there are conduction disorders (second- or third-degree atrioventricular block) or arrhythmias (sick sinus syndrome)
• if the patient has untreated heart failure, is taking medications that increase heart contractility, or has cardiogenic shock
• if there are severe circulatory disorders (severe peripheral arterial diseases)
• if there is slow heart rate (below 50 beats per minute)
• if there is low blood pressure
• if there is increased blood acidity (metabolic acidosis)
• if there is severe asthma or chronic obstructive pulmonary disease (COPD)
• if there is an untreated pheochromocytoma (a rare tumor of the adrenal gland that causes high blood pressure)
• if there is heart failure and systolic blood pressure is below 100 mmHg.

Do not take Metocard ZK if you are taking any of the following medicines (see also "Metocard ZK and other medicines"):

• monoamine oxidase inhibitors (MAOIs) used to treat depression
• verapamil and diltiazem (used to lower blood pressure)
• anti-arrhythmic drugs, such as disopyramide.

Warnings and precautions

Before starting Metocard ZK, discuss with your doctor if you:

• have asthma
• have Prinzmetal's angina (severe chest pain that usually occurs at night)
• have diabetes(the medicine may mask low blood sugar levels)
• have a pheochromocytoma(a rare tumor of the adrenal gland that causes high blood pressure)
• are taking allergy treatments- Metocard ZK may increase sensitivity to allergens or worsen allergic reactions
• have hyperthyroidism(the medicine may mask symptoms such as rapid heart rate, increased sweating, tremors, anxiety, increased appetite, or weight loss)
• have or have had psoriasis(a severe skin rash)
• have circulatory disorders that may cause tingling, pallor, or cyanosis of the fingers and toes
• have conduction disorders (heart block)
• have heart failure and any of the following conditions:
• unstable heart failure (NYHA class IV)
• heart attack or angina pectoris within the last 28 days
• renal or hepatic impairment
• age below 40 or above 80
• valvular heart disease
• hypertrophic cardiomyopathy
• heart surgery within the last 4 months.

If you are scheduled for surgery or a procedure with anesthesia, inform your doctor or dentist that you are taking metoprolol tablets.

Metocard ZK and other medicines

Do not takeMetocard ZK if you are taking:

• monoamine oxidase inhibitors (MAOIs) used to treat depression (may cause enhanced blood pressure-lowering effect)
• other blood pressure-lowering medicines, such as verapamil and diltiazem (may cause slowed heart rate or excessive blood pressure lowering)
• anti-arrhythmic drugs, such as disopyramide (may increase the risk of irregular or slow heart rate and weakened heart function).

Tell your doctor about all medicinesyou are currently taking or have recently taken, as well as any medicines you plan to take.

• The following medicines may enhancethe blood pressure-lowering effect:
• cimetidine(used to treat stomach ulcers)
• hydralazineor clonidine(blood pressure-lowering medicines)
• terbinafine(used to treat fungal infections)
• paroxetine, fluoxetine, sertraline(used to treat depression)
• hydroxychloroquine(used to treat malaria)
• chlorpromazine, triflupromazine, chlorprothixene(antipsychotic medicines)
• amiodarone, quinidine, propafenone(used to treat arrhythmias)
• diphenhydramine(an antihistamine)
• celecoxib(used to treat pain).
• The following medicines may weakenthe blood pressure-lowering effect:
• indomethacin(used to treat pain)
• rifampicin(an antibiotic).
• Other medicines may interfere with metoprolol or their effect may be interfered with by metoprolol:
• other beta-blockers, e.g., eye drops
• adrenaline(epinephrine), noradrenaline(norepinephrine), or other sympathomimetics
• medicines used to treat diabetes(may mask low blood sugar levels)
• lidocaine
• reserpine, alpha-methyldopa, guanfacine,digitalis glycosides.

Metocard ZK with alcohol

Alcohol may enhance the blood pressure-lowering effect of Metocard ZK tablets.

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.
Metocard ZK is not recommended during pregnancy and breastfeeding. Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery

Metocard ZK may cause fatigue or dizziness. Before driving a car or operating machinery, make sure these effects do not occur, especially after changing medicines or taking with alcohol.

3. How to take Metocard ZK

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Take the tablets in the morning, once a day, with a glass of water. Swallow the tablets whole or divided. Do notchew or crush them before swallowing.

Usual doses are:

• High blood pressure:47.5 mg of metoprolol succinate once a day. If necessary, the dose may be increased to 95-190 mg once a day.
• Severe chest pain (angina pectoris):95-190 mg of metoprolol succinate once a day.
• Irregular heart rhythm (arrhythmias):95-190 mg of metoprolol succinate once a day.
• Prevention of recurrent heart attack or heart damage after a heart attack:190 mg of metoprolol succinate once a day.
• Palpitations caused by heart diseases:95 mg of metoprolol succinate once a day. If necessary, the dose may be increased to 190 mg once a day.
• Migraine prevention:95-190 mg of metoprolol succinate once a day.
• Patients with stable heart failure:Take as directed by your doctor.

Patients with liver function disorders

In patients with severeliver failure, the doctor will adjust the dose of the medicine. Take as directed by your doctor.

Children and adolescents

High blood pressure: in children aged 6 and older, the dose depends on the child's weight. The doctor will prescribe the appropriate dose for your child.
Usual initial dose is 0.48 mg/kg body weight, not more than 47.5 mg, given once a day in the form of a tablet with a strength close to the estimated dose.
The doctor may increase the dose to 1.90 mg/kg body weight, depending on the patient's response to treatment.
No studies have been conducted on the use of doses above 190 mg once a day in children and adolescents.
It is not recommended to use Metocard ZK tablets in children under 6 years of age.

Taking a higher dose of Metocard ZK than recommended

In case of taking more tablets than recommended, go to the nearest hospital or contact your doctor or pharmacist immediately. Symptoms of overdose include: low blood pressure (fatigue and dizziness), slow heart rate, irregular heart rhythm, cardiac arrest, shortness of breath, deep unconsciousness, nausea, vomiting, and blue discoloration of the skin.

Missing a dose of Metocard ZK

If you miss a dose, take it as soon as possible, and then continue with the previously established administration schedule. Do not take a double dose to make up for the missed dose.

Stopping Metocard ZK treatment

Do not stopMetocard ZK treatment abruptly, as this may worsen heart failure symptoms and increase the risk of heart attack. The dose can only be changed or the medicine stopped after consulting your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metocard ZK can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediatelyif you experience an allergic reaction, characterized by itching skin rash, sudden redness (especially of the face), swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. This is a very severe but rare side effect.
Emergency medical attention or hospitalization may be necessary.

Tell your doctor if you experience any of the following side effects

or any other side effects not listed in this leaflet:

• Very common(occurring in more than 1 in 10 patients):
• markedly low blood pressure (also when standing up from a lying position), very rarely with fainting
• fatigue.

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

• slow heart rate
• balance disorders (very rarely with fainting)
• cold hands and feet
• palpitations
• dizziness, headache
• nausea, diarrhea, constipation, abdominal pain
• shortness of breath associated with strenuous physical exertion.

Uncommon(occurring in less than 1 in 100 but more than 1 in 1,000 patients):

• transient worsening of heart failure symptoms
• fluid retention (edema)
• chest pain
• tingling sensation
• muscle cramps
• vomiting
• weight gain
• depression
• reduced concentration
• insomnia
• drowsiness
• nightmares
• shortness of breath
• skin rash
• increased sweating.

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

• worsening of diabetes
• nervousness, anxiety
• vision disorders
• dryness or irritation of the eyes
• conjunctivitis
• impotence (erectile dysfunction)
• Peyronie's disease (plastic induration of the penis)
• irregular heart rhythm
• conduction disorders in the heart
• dryness of the mucous membranes in the mouth
• rhinitis
• hair loss
• changes in liver function test results.

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

• changes in blood cell count (thrombocytopenia, leukopenia)
• memory disorders
• disorientation
• hallucinations
• mood disorders
• tinnitus
• hearing disorders
• taste disorders
• hepatitis
• photosensitivity
• exacerbation or occurrence of psoriasis (skin disease)
• muscle weakness
• joint pain
• gangrene in patients with severe circulatory disorders.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: ndl@urpl.gov.pl. Side effects can also be reported 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 Metocard ZK

No special precautions are required for storing the medicine.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date is also stated on the blister pack after: EXP. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines should 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. Package contents and other information

What Metocard ZK contains

• The active substance of the medicine is metoprolol succinate. Each tablet contains:
• 23.75 mg of metoprolol succinate, equivalent to 25 mg of metoprolol tartrate
• 47.5 mg of metoprolol succinate, equivalent to 50 mg of metoprolol tartrate
• 95 mg of metoprolol succinate, equivalent to 100 mg of metoprolol tartrate
• Other ingredients are:
• microcrystalline cellulose, methylcellulose, cornstarch, glycerol, ethylcellulose, magnesium stearate;
• tablet coating: microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E171).

What Metocard ZK looks like and contents of the pack

Metocard ZK 23.75 mg, 47.5 mg, and 95 mg:
White, oval, biconvex, film-coated tablets with a score line on both sides.
The package contains 28 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Farmaprojects, S.A.
Santa Eulalia 240-242, 08902 L’Hospitalet de Llobregat- Barcelona
Spain
Polpharma S.A.
Production Plant in Nowa Dęba
Szypowskiego 1, 39-460 Nowa Dęba, Poland
Sofarimex Industria Química e Farmacêutica, SA.
Av. Das Indústrias- Alto de Colaride
2735-213 - Cácem, Portugal
Metocard ZK, 47.5 mg, 95 mg:
Rontis Hellas S.A., Medical and Pharmaceutical Products
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004
Greece

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:

POLPHARMA Trade Office Ltd.
Bobrowiecka 6
00-728 Warsaw
tel. 22 364 61 01
Date of last revision of the leaflet:March 2020