Metocard Zk

Package Leaflet: Information for the Patient

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 package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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. Contents of the pack 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 heartbeat (arrhythmias)
• stable symptomatic heart failure (with symptoms such as shortness of breath or swelling of the ankles), in combination with other medicines used to treat heart failure
• palpitations (feeling of "beating" of the heart) caused by functional heart diseases.

It is used to prevent:

• recurrence of heart attack or heart damage after a heart attack
• migraine.

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

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)
• antiarrhythmic medicines, such as disopyramide.

Warnings and precautions

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

• have asthma
• have Prinzmetal's angina (severe chest pain at night)
• have diabetes(the medicine may mask low blood sugar levels)
• have pheochromocytoma(a rare tumor of the adrenal gland that causes high blood pressure)
• are taking allergy treatments- Metocard ZK may increase sensitivity to substances that cause allergies or worsen the severity of allergic reactions
• have hyperthyroidism(the medicine may mask symptoms such as rapid heartbeat, increased sweating, tremors, anxiety, increased appetite, or weight loss)
• have or have had psoriasis(severe skin rash)
• have circulatory disorders that may cause tingling, pallor, or cyanosis of 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
• kidney or liver dysfunction
• age below 40 or above 80 years
• valvular heart disease
• enlarged heart muscle
• 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 increased blood pressure-lowering effect)
• other blood pressure-lowering medicines, such as verapamil and diltiazem (may cause slowing of heart rate or excessive lowering of blood pressure)
• antiarrhythmic medicines, such as disopyramide (may increase the risk of irregular or slow heartbeat and decreased heart function).

Tell your doctor about all medicinesyou are taking, have recently taken, or 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(antihistamine)
• celecoxib(used to treat pain).
• The following medicines may weakenthe blood pressure-lowering effect:
• indomethacin(used to treat pain)
• rifampicin(antibiotic).
• Other medicines may interfere with the action of metoprolol or their action 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 using machines

Metocard ZK may cause fatigue or dizziness. Before driving a car or operating machinery, make sure these effects do not occur, especially when 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 not sure, ask 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:

• Hypertension:47.5 mg of metoprolol succinate once a day. If necessary, the dose may be increased to 95-190 mg once a day.
• Angina pectoris:95-190 mg of metoprolol succinate once a day.
• Arrhythmias:95-190 mg of metoprolol succinate once a day.
• Prevention of recurrence of 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.
• Prevention of migraine:95-190 mg of metoprolol succinate once a day.
• Patients with stable heart failure:Take as directed by your doctor.

Patient 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

Hypertension: in children over 6 years of age, the dose depends on the child's weight. Your doctor will prescribe the appropriate dose for your child.
Usual starting 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.
Your 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.
Metocard ZK tablets are not recommended for children under 6 years of age.

Taking a higher dose of Metocard ZK than recommended

If you have taken 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 heartbeat, 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 as before. Do not take a double dose to make up for a missed dose.

Stopping treatment with Metocard ZK

Do not stoptaking Metocard ZK suddenly, as this may worsen the symptoms of heart failure and increase the risk of heart attack. You can only change the dose or stop taking the medicine after consulting your doctor.
If you have any further questions about taking this medicine, ask 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, which may cause 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 serious but rare side effect.
Emergency medical treatment 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 package leaflet:

• Very common(occurring in more than 1 in 10 patients):
• markedly lowered 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 on 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
• decreased 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 heartbeat
• conduction disorders in the heart
• dryness of the mucous membranes of 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 those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
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 for storage are necessary.
Keep this medicine out of the 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. Contents of the pack and other information

What Metocard ZK contains

• The active substance 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, corn starch, 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 pack 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 on the medicine and its names in the Member States of the European Economic Area, please contact the local representative of the marketing authorization holder:

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