Metoprolol Biofarm Zk

Leaflet attached to the packaging: patient information

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

1. What is Metoprolol Biofarm ZK and what is it used for

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

• high blood pressure
• severe chest pain caused by insufficient blood supply to the heart (angina pectoris)
• irregular heart rhythm (arrhythmia)
• stable heart failure with symptoms (such as shortness of breath or swollen ankles), when other heart failure medications are also used
• palpitations (feeling of heartbeat) caused by functional disorders of the heart.

It is used to prevent:

• another 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 Metoprolol Biofarm ZK

Do not takeMetoprolol Biofarm ZK and tell your doctorif you have:

• allergyto metoprolol, other beta-blockers, or any other ingredient of this medicine (listed in section 6)
• conduction disorders(second- or third-degree atrioventricular block) or heart rhythm disorders(sick sinus syndrome)
• untreated heart failure, you are receiving treatment to increase heart contractility, or you have shockdue to heart disorders
• severe circulatory disorders(severe peripheral circulatory disorders)
• slow heart rate(less than 50 beats per minute)
• low blood pressure
• increased blood acidity(metabolic acidosis)
• severe asthmaor COPD(chronic obstructive pulmonary disease)
• un-treated pheochromocytoma(a rare tumor in one of the adrenal glands causing high blood pressure)
• heart failure and systolic blood pressure below 100 mmHg.

The following medicines are used (see also "Metoprolol Biofarm 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. Particular caution should be exercisedwhen taking Metoprolol Biofarm ZK and tell your doctorif you have:
• asthma
• Prinzmetal's angina(severe chest pain occurring usually at night)
• diabetes(the medicine may mask low blood sugar symptoms)
• pheochromocytoma(a rare tumor in one of the adrenal glands causing high blood pressure)
• you are being treatedto reduce allergic reactions. Metoprolol Biofarm ZK may increase sensitivity to substances that cause allergies or worsen the severity of allergic reactions.
• hyperthyroidism(the medicine may mask symptoms such as rapid heart rate, increased sweating, tremors, anxiety, increased appetite, or weight loss)
• psoriasis(severe skin rash) has occurred or is occurring
• circulatory disorders that may cause tingling, pallor, or cyanosis of the fingers and toes
• conduction disorders in the heart (heart block)
• heart failure and one of the following:
• unstable heart failure (Class IV according to NYHA)
• heart attack or angina pectoris in the last 28 days
• impaired kidney or liver function
• age below 40 or above 80
• heart valve disease
• enlargement of the heart muscle
• heart surgery in the last 4 months.

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

Metoprolol Biofarm ZK and other medicines

Do not takeMetoprolol Biofarm ZK if you are also taking:

• monoamine oxidase inhibitors (MAOIs) used to treat depression (may increase blood pressure-lowering effect)
• other blood pressure-lowering medicines such as verapamilor diltiazem(may cause slowing of heart rate and excessive blood pressure reduction)
• anti-arrhythmic drugs such as disopyramide(may increase the risk of irregular or slow heartbeat and reduced heart efficiency).

Before takingMetoprolol Biofarm ZK, tell your doctor or pharmacistabout all medicines you are currently takingor have recently taken, as well as any medicines you plan to take. In particular, tell your doctor about the following medicines:

• The following medicines may increasethe blood pressure-lowering effect:
• cimetidine(used for stomach ulcers)
• hydralazineor clonidine(blood pressure-lowering medicines)
• terbinafine(used for fungal infections)
• paroxetine, fluoxetine, sertraline(used for depression)
• hydroxychloroquine(used for malaria treatment)
• chlorpromazine, triflupromazine, chlorprothixene(antipsychotic medicines)
• amiodarone, quinidine, propafenone(used for irregular heartbeat)
• diphenhydramine(antihistamine medicine)
• celecoxib(used for pain treatment).
• The following medicines may reducethe blood pressure-lowering effect:
• indomethacin(used for pain treatment)
• rifampicin(antibiotic).
• Other medicines may interfere with metoprolol or their effect may be altered 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 symptoms)
• lidocaine
• reserpine, alpha-methyldopa, guanfacine, digitalis glycosides.

Metoprolol Biofarm ZK with food and drink

Alcohol may increase the blood pressure-lowering effect of Metoprolol Biofarm 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.
It is not recommended to take Metoprolol Biofarm ZK during pregnancy and breastfeeding.

Driving and operating machinery

Metoprolol Biofarm 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 them with alcohol.

3. How to take Metoprolol Biofarm ZK

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 into two equal doses. Do not chew or crushbefore swallowing.

Usual doses are:

High blood pressure:

47.5 mg of metoprolol succinate once a day. If necessary, this 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.

Irrregular heart rhythm (arrhythmia):

95-190 mg of metoprolol succinate once a day.

Prevention of another heart attack or heart damage after a heart attack:

190 mg of metoprolol succinate once a day.

Palpitations related to heart disease:

95 mg of metoprolol succinate once a day. This dose may be increased if necessary to 190 mg once a day.

Migraine prevention:

95-190 mg of metoprolol succinate once a day.

Patient with stable heart failure:

Take as directed by your doctor.

Patient with liver function disorders:

In patients with severeliver function disorders, your doctor will adjust the dose. Always take as directed by your doctor.

Children and adolescents:

High blood pressure: in children over 6 years of age, the dose depends on the child's weight.
Your doctor will determine the appropriate dose for your child.
Usually, the initial dose is 0.5 mg/kg body weight, not more than 50 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 2 mg/kg body weight, depending on the patient's response to treatment.
No studies have been conducted on the use of doses above 200 mg once a day in children and adolescents.
It is not recommended to use Metoprolol Biofarm ZK tablets in children under 6 years of age.

Taking a higher dose of Metoprolol Biofarm ZK than recommended

If you have taken a higher dose than recommended by your doctor, go to the nearest hospital or contact your doctor or pharmacist immediately. Symptoms of overdose are: excessively low blood pressure (fatigue and dizziness), slow heart rate, irregular heartbeat, cardiac arrest, shortness of breath, deep unconsciousness, nausea, vomiting, and cyanosis of the skin.

Missing a dose of Metoprolol Biofarm ZK

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

Stopping treatment with Metoprolol Biofarm ZK

Do not stop takingMetoprolol Biofarm ZK suddenly, as this may worsen heart failure symptoms and increase the risk of heart attack. The dose can only be changed or treatment 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, this medicine 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, facial flushing, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. This is a very rare side effect. Immediate treatment or hospitalization may be necessary.
Tell your doctor if you experienceany of the following or any other side effects:

• Very common(occurring in more than 1 in 10 patients):
• orthostatic hypotension when standing up due to excessive blood pressure reduction,
• fatigue.

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

• slow heart rate,
• difficulty maintaining balance (rarely with fainting),
• cold hands and feet,
• palpitations,
• dizziness, headaches,
• nausea, diarrhea, constipation, abdominal pain,
• shortness of breath associated with intense physical exertion.

Uncommon(occurring in less than 1 in 100 but more than 1 in 1000 patients):

• periodic worsening of heart failure symptoms,
• fluid retention in the body (edema),
• chest pain,
• tingling and numbness sensation,
• muscle cramps,
• vomiting,
• weight gain,
• depression,
• reduced concentration,
• difficulty falling asleep (insomnia),
• drowsiness,
• nightmares,
• shortness of breath,
• rash,
• increased sweating.

Rare(occurring in less than 1 in 1000 but more than 1 in 10,000 patients):

• worsening of diabetes symptoms,
• nervousness, anxiety,
• vision disorders,
• dryness or irritation of the eyes,
• conjunctivitis (eye disease),
• impotence (erectile dysfunction),
• Peyronie's disease (penile fibrosis),
• irregular heartbeat,
• conduction disorders in the heart,
• dry mouth,
• runny nose,
• hair loss,
• liver function test changes.

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

• blood cell count changes (thrombocytopenia, leukopenia),
• memory disorders,
• disorientation,
• hallucinations,
• mood disorders,
• ringing in the ears,
• hearing disorders,
• taste disorders,
• hepatitis,
• photosensitivity,
• worsening of psoriasis or occurrence of psoriasis (skin disease),
• muscle weakness,
• joint pain,
• tissue death 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoprolol Biofarm ZK

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP):". The expiry date is also stated on the blister after "EXP:". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Metoprolol Biofarm ZK contains

• The active substance of the medicine (the substance that makes the tablet work) is metoprolol succinate. Each tablet contains:
• 95 mg of metoprolol succinate, equivalent to 100 mg of metoprolol tartrate.
• The other ingredients of the medicine are:
• tablet core:microcrystalline cellulose, methylcellulose, cornstarch, glycerol, ethylcellulose, and magnesium stearate;
• tablet coating:microcrystalline cellulose, hypromellose, stearic acid, and titanium dioxide (E171).

What Metoprolol Biofarm ZK looks like and package contents

Metoprolol Biofarm ZK 95 mg are white, oval, biconvex, film-coated tablets with a dividing line on both sides.
The package contains:
10, 14, or 28 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Manufacturer
Zakłady Farmaceutyczne Polpharma S.A:
Production Department in Nowa Dęba
ul. Szypowskiego 1,
39-460 Nowa Dęba,
Poland
To obtain more detailed information, contact the local representative of the marketing authorization holder:

Poland

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
biofarm@biofarm.pl
Date of last revision of the leaflet:05.04.2016