Metoprolol Medreg

Leaflet attached to the packaging: information for the user

Metoprolol Medreg, 50 mg, coated tablets

Metoprolol Medreg, 100 mg, coated tablets

Metoprolol tartrate

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 Medreg and what is it used for
• 2. Important information before taking Metoprolol Medreg
• 3. How to take Metoprolol Medreg
• 4. Possible side effects
• 5. How to store Metoprolol Medreg
• 6. Contents of the packaging and other information

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

Metoprolol Medreg contains the active substance metoprolol tartrate, which belongs to a group of medicines called beta-blockers. Metoprolol tartrate acts mainly by blocking certain heart receptors (cardioselective beta-blockers). This lowers blood pressure and improves heart function.
Metoprolol Medreg is used:

• for high blood pressure (hypertension)
• for chest pain caused by blocked coronary arteries in the heart (stable angina pectoris)
• in patients who have had a heart attack and to prevent further heart attacks
• for rapid heart rate (tachyarrhythmia)
• to prevent migraine attacks.

Metoprolol Medreg is intended for adults.

2. Important information before taking Metoprolol Medreg

When not to take Metoprolol Medreg:

• if the patient is allergic to metoprolol tartrate, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has conduction disorders in the heart (second or third degree atrioventricular block, sick sinus syndrome with the exception of patients with a permanent pacemaker)
• if the patient has unstable heart failure and is being treated with medicines that increase the contraction of the heart muscle
• if the patient's heart beats very slowly (less than 50 beats per minute)
• if the patient has very poor blood circulation in the limbs
• if the patient has had a shock caused by poor heart function
• if the patient has an untreated tumor of the adrenal gland (pheochromocytoma)
• if the patient has very low blood pressure (systolic blood pressure below 90 mmHg)
• if the patient has severe lung disease with narrowing of the airways (asthma or chronic obstructive pulmonary disease)
• if the patient has metabolic acidosis of the blood
• if the patient is taking certain antidepressants (MAOIs, with the exception of certain MAO-B inhibitors)
• if the patient is being treated with certain intravenously administered medicines that lower blood pressure or certain medicines used to treat irregular heartbeat (e.g., calcium channel blockers of the verapamil or diltiazem type, disopyramide), with the exception of medicines used in intensive care
• if the patient suspects that they are having an acute heart attack, and their heart rate is slower than 45 beats per minute, systolic blood pressure is less than 100 mmHg, and they have certain irregular heartbeats (PQ interval longer than 0.24 seconds).

Warnings and precautions

Before taking Metoprolol Medreg, consult a doctor or pharmacist:

• if the patient has asthma. Metoprolol Medreg may affect the action of certain asthma medicines, and their dosage may need to be adjusted. Do not take Metoprolol Medreg if you have severe asthma or severe chronic obstructive pulmonary disease.
• if the patient has diabetes. Symptoms of low blood sugar (e.g., rapid heartbeat, tremors) may be reduced by Metoprolol Medreg. The doctor will monitor blood sugar levels at short intervals.
• if the patient has an overactive thyroid gland. Metoprolol Medreg may mask the symptoms of this condition, and they may worsen after stopping Metoprolol Medreg.
• if the patient has conduction disorders in the heart (first-degree atrioventricular block).
• if the patient has circulation disorders in the limbs (Raynaud's syndrome, intermittent claudication), as they may worsen. Do not take Metoprolol Medreg if you have severe circulation disorders.
• if the patient has a tumor of the adrenal gland (pheochromocytoma). The tumor should be treated (with alpha blockers) before and during treatment with Metoprolol Medreg.
• if the patient is going to have surgery and will be under anesthesia. Inform the doctor or dentist that you are taking Metoprolol Medreg.
• if the patient is taking clonidine, a medicine for high blood pressure. At the end of treatment, Metoprolol Medreg should be gradually discontinued, and then clonidine.
• if the patient has ever had a severe allergic reaction or is being treated for an existing allergy (desensitization therapy). Metoprolol Medreg may increase both the sensitivity to allergens and the severity of allergic reactions.
• if the patient has certain circulation disorders in the coronary arteries (Prinzmetal's angina). The number and duration of angina attacks may increase or prolong.
• if the patient or a family member has had psoriasis.
• if the patient wears contact lenses. Metoprolol Medreg may reduce tear flow.

Taking Metoprolol Medreg may result in positive doping test results.

Children and adolescents

Metoprolol Medreg is not recommended for children and adolescents.

Metoprolol Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Metoprolol Medreg at the same time as:

• certain antidepressants (MAOIs, with the exception of certain MAO-B inhibitors)
• certain intravenously administered medicines that lower blood pressure or certain medicines used to treat irregular heartbeat (e.g., calcium channel blockers of the verapamil or diltiazem type, disopyramide), with the exception of medicines used in intensive care.

Medicines that may enhance the action of Metoprolol Medreg include:

• certain antidepressants (selective serotonin reuptake inhibitors, e.g., paroxetine, fluoxetine, and sertraline)
• diphenhydramine (a medicine used to treat insomnia and allergies)
• hydroxychloroquine (used to prevent and treat malaria)
• celecoxib (used to treat joint diseases)
• terbinafine (used to treat fungal infections)
• medicines used to treat mental disorders (neuroleptics, e.g., chlorpromazine, trifluoperazine, chlorprothixene)
• cimetidine (used to treat heartburn and stomach upset)
• hydralazine (used to treat high blood pressure)
• amiodarone, quinidine, and possibly propafenone (medicines used to treat irregular heartbeat)
• certain anesthetics (inhalation anesthetics). Inform your doctor or dentist that you are taking Metoprolol Medreg.

Medicines that may reduce the action of Metoprolol Medreg include:

• rifampicin (an antibiotic)
• certain anti-inflammatory and pain-relieving medicines (e.g., indomethacin).

Medicines that may affect the action of Metoprolol Medreg or whose action may be affected by Metoprolol Medreg include:

• other medicines used to treat high blood pressure, irregular heartbeat, or heart failure (e.g., reserpine, alpha-methyldopa, clonidine, guanfacine, antiarrhythmic medicines of class I, e.g., disopyramide, cardiac glycosides)
• other beta-blockers, e.g., eye drops for glaucoma
• medicines used to treat diabetes (insulin and oral hypoglycemic medicines). Metoprolol Medreg may reduce the symptoms of hypoglycemia (especially rapid heartbeat). Blood sugar levels should be monitored regularly. The doctor may adjust the dosage of medicines that lower blood sugar.
• medicines that increase blood pressure (e.g., adrenaline, noradrenaline). Blood pressure may rise significantly. The action of adrenaline in treating allergic reactions may be reduced.
• medicines containing xanthines (e.g., aminophylline, theophylline for asthma)
• lidocaine (a local anesthetic)
• certain antidepressants (MAO-B inhibitors).

If the patient wants to stop taking clonidine (a medicine for high blood pressure) at the same time, Metoprolol Medreg should be stopped a few days earlier.

Metoprolol Medreg with food, drink, and alcohol

Alcohol may enhance the blood pressure-lowering effect of Metoprolol Medreg.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Metoprolol Medreg should not be taken during pregnancy, unless it is absolutely necessary.
Metoprolol Medreg may harm the unborn child and lead to premature birth. Metoprolol Medreg may cause side effects such as slow heart rate in the unborn child and newborn.
The active substance of the medicine passes into human milk. The child should be closely monitored during treatment with Metoprolol Medreg while breastfeeding.

Driving and using machines

This medicine may affect the ability to react and drive vehicles.
Dizziness or fatigue may occur, especially at the beginning of treatment, when increasing the dose, changing the preparation, or drinking alcohol. If any of these side effects occur, do not drive vehicles or operate machines.

Metoprolol Medreg contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Metoprolol Medreg

Take this medicine always as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
The recommended dose is:

High blood pressure (hypertension)

The recommended dose is 50 mg to 100 mg of metoprolol tartrate twice daily or 100 mg to 200 mg of metoprolol tartrate once daily.

Chest pain caused by blocked coronary arteries in the heart (stable angina pectoris)

The recommended dose is 50 mg to 100 mg of metoprolol tartrate twice daily.

Acute treatment of heart attack and prevention of further heart attacks

Acute treatment:
After initial intravenous administration of metoprolol tartrate, 50 mg of metoprolol tartrate is taken four times daily for the next 48 hours, starting 15 minutes after the last intravenous injection.
In patients who received less than 15 mg of metoprolol tartrate intravenously, treatment with tablets should be started cautiously with a dose of 25 mg of metoprolol tartrate.
Prevention:
The recommended dose is 100 mg of metoprolol tartrate twice daily.

Rapid heart rate (tachyarrhythmia)

The recommended dose is 50 mg to 100 mg of metoprolol tartrate twice daily.

Prevention of migraine attacks

The recommended dose is 50 mg to 100 mg of metoprolol tartrate twice daily.
Special populations
Patient with liver function disorders
In patients with severe liver function disorders, the dose may need to be adjusted.
Method of administration
Tablets should be swallowed without chewing, with a glass of water. Metoprolol Medreg should be taken in the morning in a single dose or in the morning and evening in two doses.
The tablet can be divided into equal doses.

Taking a higher dose of Metoprolol Medreg than recommended

If the patient has accidentally taken too many tablets, they should contact their doctor immediately.
The most common symptoms, depending on the degree of overdose, are a sudden drop in blood pressure, slow heart rate, irregular heartbeat, decreased cardiac output, cardiogenic shock, and cardiac arrest, as well as breathing difficulties with narrowing/constriction of the airways, disturbances of consciousness, coma, nausea, vomiting, blue discoloration of the skin and mucous membranes (cyanosis), low blood sugar, and seizures.
Symptoms may worsen if alcohol, other blood pressure-lowering medicines, quinidine (used to treat irregular heartbeat), or barbiturates (sedatives) are taken at the same time.
The first signs of overdose usually appear within 20 minutes to 2 hours after taking the medicine.
The doctor may decide on the necessary measures depending on the severity of the overdose or the type of symptoms.

Missing a dose of Metoprolol Medreg

If a dose of Metoprolol Medreg is missed, take the missed dose as soon as possible, and then continue treatment as usual. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Metoprolol Medreg

Treatment with Metoprolol Medreg should only be changed or stopped after consulting a doctor. The treatment must be slowly and gradually discontinued by the doctor. Abrupt discontinuation may worsen heart disease and increase the risk of heart attack and sudden cardiac death.
Discontinuation or cessation of this medicine should only be done after consulting a doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metoprolol Medreg can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):

• fatigue.

Common(may affect up to 1 in 10 people):

• dizziness, headaches
• slow heart rate, low blood pressure, drop in blood pressure when standing up (sometimes with fainting), palpitations
• feeling of cold in the limbs, poor circulation in the fingers (Raynaud's syndrome)
• breathing difficulties after physical exertion
• nausea, abdominal pain, diarrhea, constipation.

Uncommon(may affect up to 1 in 100 people):

• weight gain
• depression, difficulty concentrating, decreased awareness, drowsiness or sleep disorders, nightmares
• abnormal sensations, such as tingling or numbness in the limbs (paresthesia)
• temporary worsening of heart failure, cardiogenic shock in patients with acute heart attack, abnormal heart conduction (first-degree atrioventricular block), fluid retention in the tissues, chest pain
• breathing difficulties due to narrowing/constriction of the airways (bronchospasm)
• vomiting
• rash, increased sweating
• muscle weakness, muscle cramps.

Rare(may affect up to 1 in 1,000 people):

• onset or worsening of existing diabetes, increased hypoglycemia associated with insulin
• disorders of fat metabolism (decreased HDL cholesterol, increased triglycerides)
• nervousness, anxiety
• vision disorders, dry eye syndrome, eye irritation, conjunctivitis
• irregular heartbeat (conduction disorders, arrhythmias)
• rhinitis (runny nose)
• dry mouth
• liver function test abnormalities
• hair loss
• impotence, sexual disorders.

Very rare(may affect up to 1 in 10,000 people):

• spontaneous bleeding or bruising, possible signs of low platelet count (thrombocytopenia), significant decrease in the number of certain white blood cells (agranulocytosis)
• disorders of fat metabolism (increased VLDL cholesterol)
• amnesia, memory loss, confusion, hallucinations
• hearing disorders, ringing or buzzing in the ears (tinnitus), transient hearing loss
• worsening of existing circulation disorders in the limbs to tissue death (gangrene)
• taste disorders
• hepatitis
• increased sensitivity of the skin to sunlight, worsening or onset of psoriasis (red/silver skin plaques), skin rash similar to psoriasis
• joint pain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can also 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Metoprolol Medreg

Store the medicine out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the blister and outer packaging after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metoprolol Medreg contains

• The active substance of the medicine is metoprolol tartrate. Metoprolol Medreg, 50 mg, coated tablets: Each coated tablet contains 50 mg of metoprolol tartrate. Metoprolol Medreg, 100 mg, coated tablets: Each coated tablet contains 100 mg of metoprolol tartrate.
• Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal silica, anhydrous, sodium croscarmellose, maize starch paste, magnesium stearate. Tablet coating: hypromellose, titanium dioxide, talc, macrogol, iron oxide red (E172) (only in Metoprolol Medreg, 50 mg, coated tablets).

What Metoprolol Medreg looks like and contents of the pack

Metoprolol Medreg, 50 mg, coated tablets
Pink, round (diameter 7.8 mm - 8.2 mm), biconvex coated tablets with a score line on one side and engraved with "50" on the other side.
The tablet can be divided into equal doses.
Metoprolol Medreg, 100 mg, coated tablets
White or almost white, round (diameter 9.8 mm - 10.2 mm) biconvex coated tablets with a score line on one side and engraved with "100" on the other side.
The tablet can be divided into equal doses.
Transparent, colorless blister pack with PVC/Aluminum foil containing 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Metoprolol Medreg
Poland:
Metoprolol Medreg
Romania:
Metoprolol Gemax Pharma 50 mg film-coated tablets
Metoprolol Gemax Pharma 100 mg film-coated tablets
Slovakia:
Metoprolol Medreg 50 mg
Metoprolol Medreg 100 mg

Date of last revision of the leaflet: